VENDYS, MODEL 6000 B B/C

K072919 · Endothelix, Inc. · DQK · Nov 2, 2007 · Cardiovascular

Device Facts

• Record ID: K072919
• Device Name: VENDYS, MODEL 6000 B B/C
• Applicant: Endothelix, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands). It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during, and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

Device Story

VENDYS Model 6000 B/BC is a non-invasive digital temperature monitoring system. Inputs: continuous body surface temperature data from multiple sites (e.g., fingertips). Operation: device monitors temperature fluctuations before, during, and after a 2-5 minute cuff occlusion (reactive hyperemia test). Output: temperature data used to assess vascular reactivity. Used in clinical settings by healthcare professionals. Output assists clinicians in evaluating vascular function; provides objective data for vascular reactivity assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Non-invasive digital temperature monitoring system. Features multi-site temperature sensors and cuff occlusion capability for reactive hyperemia testing. Programmable diagnostic computer architecture. Class II device.

Indications for Use

Indicated for non-invasive, continuous monitoring of body surface temperature at multiple sites to measure vascular reactivity via reactive hyperemia testing using a 2-5 minute cuff occlusion procedure.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized emblem. The emblem consists of four curved lines that resemble a stylized human figure, with the lines representing different aspects of health and human services. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

Mr. Douglas W. Blakely Vice President-Regulatory Affairs Endothelix, Incorporated 8275 El Rio, Suite 100 Houston, Texas 77054

Re: K072919

Trade/Device Name: VENDYS Model 6000 B B/C Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II Product Code: DQK Dated: October 8, 2007 Received: October 15, 2007

Dear Mr. Blakely:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Mr. Blakely

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chien-Liang, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K072919
1 of 1

## Indications for Use Statement 5

510(k) Number:

Device Name: VENDYS Model 6000 B B/C

The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands).

It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during, and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chm

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ 人 472 9/4

Image /page/2/Picture/14 description: The image shows the text "Page S.2". The word "Page" is written in a serif font, while "S.2" is handwritten and underlined. The text likely refers to a page number within a document.