A / Caird Response to the FDA ANS 510K
Software Specification / 06/12/2010 / JHB
A. Initial Release
A- Initial release / [x]
[x]
[x]
[x] / Caird Technology, Inc.
205 Camden Chase
Columbia, South Carolina 9223
(803) 736-1289
Sales / [x] / Drawing
Title / Caird Response to the FDA ANS 510K
Software Specification / Date: 6/12/2010
Drawing
Number / ANS-001-001-00100-A / Approval: JHB
TYPE / II / Drawing is the property of Caird Technology, Inc. / Confidential [x] / Page 1 of 3
1. Introduction
The FDA sent a request for additional information. Because of the length of this request this document was created and added tpo the documentation file.
A copy of the request follows:
EMAIL REQUEST FOR ADDITIONAL INFORMATION
FROM:
James Cheng
Senior Regulatory Reviewer
Office of Device Evaluation
Center for Devices and Radiological Health
FDA
10903 New Hampshire Avenue
WO66-1326
Silver Spring, MD 20993-0002
Tel: 301-796-6306
Fax: 301-847-8116
Email:
TO:
Mr. James H. Brown
President
Caird Technology Inc.
205 Camden Chase
Columbia, South Carolina 29223
Tel: +803-237-8175
Fax: N/A
E-mail:
RE:
K101016 Caird Technology ANS System
June 9, 2010
Dear Mr. Brown,
We have reviewed your 510(k) application for the Caird Technology Inc., ANS System. To complete the review of your submission, we require you to submit responses to the following deficiencies.
- Throughout your labeling, you make claims that your device can diagnose autonomic dysfunction and you appear to imply that the device contributes to the diagnosis of various underlying diseases responsible for the autonomic dysfunction (such as diabetes, myocardial infarction, and Parkinson’s disease). As the device can only provide data on one component of the autonomic nervous system (i.e. heart rate variability) these claims are not appropriate. Therefore, please remove all such claims from your labeling and limit your claims to the measurement of heart rate variability.
Response: The device has been relabeled to be named “Heart Rate Variability Test”. All references to Autonomic Nervius system Test have been removed and replaced with Heart Rate Variability Test. All references to ANS Testhave been removed and replaced with HRV Test. Internally all documentation will still retain the title ANS. This documentation is not available to the public and is used for Caird Specification and Documentation.
2.Your proposed device name, “ANS System,” implies that your device is intended to diagnose or assess the autonomic nervous system (ANS). Please modify or change the device name to address this deficiency.
Response: The device has been relabeled to be named “Heart Rate Variability Test”. All references to Autonomic Nervius system Test have been removed and replaced with Heart Rate Variability Test. All references to ANS Testhave been removed and replaced with HRV Test. Internally all documentation will still retain the title ANS. This documentation is not available to the public and is used for Caird Specification and Documentation.
3.Please modify your proposed indications for use as follows: “The Caird Technology (NAME) system is intended to measure time domain heart rate variability (HRV) in response to a series of uniform and controlled exercises performed by the patient under the supervision of the physician or technician. The Caird Technology (NAME) system is not intended to be used as the basis of a specific clinical diagnosis. The clinical significance of the test should be determined by the physician.” Please resubmit the indications for use using the attached ODE revised Indications for Use form (attached) and indicate the prescription status of the proposed device.
Response: This was done. See the updated Indications for Use.
4.Please provide a statement on the traceability of the device software. You will need to describe the traceability among requirements, specifications, identified hazards and mitigations, and verification and validation testing of the software.
Response: The traceability for the software lies in the Caird development procedures. From these procedures the software documentation is developed, the software revisions are tracked and the software can be traced. The Documentation system calls for an Engineering Change Notice (ECN) to be issued for any changes. Because of the requested changes a new ECN was issued. A copy of the initial Release ECN and the second ECN are being supplied.
5.Please revise your 510(k) Summary according to the requirements of 21 CFR 807.92. Please see the attached form on 510(k) summary requirements.
Response: The 510K summary has been expanded to include all the items in the attacvhed document.
6. Please re-submit all documentation and labeling modified in response to the above deficiencies (instructions for use, promotional material, intended use, indications for use, 510(k) summary, etc.) and highlight the changes.
Response:
a. All changes are being submitted an email to .
b. The updated hard copy documents with pdf files will be submitted on Monday June 15, 2010 via UPS to the FDA.
Your file will be placed on administrative hold until we receive the requested information. Please respond by email (), followed by a hardcopy to the Document Mail Center (WO66-0609). Please reference the 510(k) number on the cover letter to any correspondence submitted to the Agency. Please contact me if you have any questions.
Sincerely yours,
James Cheng
Senior Regulatory Reviewer
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health
<INDICATIONS FOR USE FORM ODE REVISED.DOC> <510(k) summary requirements.doc>
Item 1: Remove Autonomic Nervious System or ANS and replace with Heart Rate Variability or HRV
Section 00 - Table of Contents / None
Section 01 - Cover Letter / Trade or Proprietary Name
Common or Usual Name
Section 02 - Indications for Use Statement / Device Name
Indications for use changed per FDA Comment.
Section 03 - Summary / Trade Name
Common Name
Classification Name
Device Description
Overview
Intended Use / Several other references to ANS and
Autonomic Nervious System changed.
The intended use was changed per FDA
recommendation.
The document was expanded per the attached document.
Section 04 - Truth and Accuracy Statement / No Change
Section 05 - Declarations of Conformity / No Change
Section 06 - Executive Summary / Reference Changes / Several other references to ANS and
Autonomic Nervious System changed.
Section 07 - Description of the Device / Caird HRV Operators Manual / Several other references to ANS and
Autonomic Nervious System changed.
Section 08 - Substantial Equivalence Discussion / Reference Changes / Several other references to ANS and
Autonomic Nervious System changed.
Section 09 - Device labeling / Device labeling
Software License Agreement
Read Me
HRV CD Cover
HRV Recorder Label / No change to the prefix ANS for the Caird Documention System.
Several other references to ANS and
Autonomic Nervious System changed.
Section 10 - Intended Use Statement / Reference Changes / Several other references to ANS and
Autonomic Nervious System changed.
Section 11 - Advertisements and Promotional Materials / ANS Software Brochure
Conditions of the autonomic nervous system Brochure
VX3+ New Recorder Brochure
Autonomic Neuropathy: Diagnosis and Treatment / Changed to HRV Software Brochure
No changes this describes How HRV is related to the Autonomic Nervious system.
No changes
No changes this describes the Autonomic Nervious System diseases with footnotes.
Section 12 - Biocompatibility / Reference Changes / References to Autonomic Nervious System changed.
Section 13 - Software Verification and Validation / No Changes / These documents are all internal to Caird. They will be updated as new releases are made
Section 14 - EMC and Electrical Safety / No Changes
Section 15 - Intended Use Statement / Reference Changes / Several other references to ANS and
Autonomic Nervious System changed.
Document Number: ANS-001-001-00100-A Caird Response to the ANS 510K FDA Page 3 of 6
Caird Technology Inc. Confidential
205 Camden Chase
Columbia, S.C.
29223