VENDYS MODEL 5000 B/BC

K060980 · Endothelix, Inc. · DQK · Aug 16, 2007 · Cardiovascular

Device Facts

• Record ID: K060980
• Device Name: VENDYS MODEL 5000 B/BC
• Applicant: Endothelix, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The VENDYS Model 5000 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 5000 B/BC is a non-invasive digital thermal monitor for vascular function assessment. Device inputs: skin surface temperature signals from multiple digits (1-2 channels) via sensors. Electronics module (Model 5000 B) connects to a PC via USB. Software records signals, plots temperature response before/during/after reactive hyperemia (2-5 minute cuff occlusion), and calculates vascular reactivity indices. Used in clinical settings by healthcare providers to evaluate cardiovascular risk. Output: temperature plots and calculated indices displayed on PC. Benefits: provides objective data on vascular reactivity to aid clinical decision-making regarding cardiovascular health.

Clinical Evidence

Bench testing only. Device performance validated against recognized consensus standards including ASTM E112-00 for electronic thermometers, IEC 60601-1, IEC 60601-1-2, and ISO 10993 for biocompatibility.

Technological Characteristics

Programmable diagnostic computer; non-invasive digital thermal monitor. Connectivity: USB interface to PC. Standards: ASTM E112-00 (electronic thermometer), IEC 60601-1, IEC 60601-1-2, ISO 10993. Multi-channel temperature sensing. Software-based analysis of thermal signals.

Indications for Use

Indicated for patients requiring non-invasive measurement of vascular reactivity via continuous monitoring of body surface temperature at multiple sites (e.g., fingertips) before, during, and after a 2-5 minute reactive hyperemia 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.

Predicate Devices

• VivaTherm Temp Monitor Sys (K031556)
• Endocare Electronic Therm Sys (K961365)
• URI TX-100 Multi Chan Thermo (K843381)
• Endo PAT 2000 (K032519)

Submission Summary (Full Text)

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| of 3 June 28, 2007

KO60980

### 510(k) Summary for Vendys Model 5000 B/BC 6

### Sponsor

Endothelix, Inc. 2472 Bolsover, Suite 439C Houston, Texas 77005

AUG 16 2007

Tel [phone] Fax [phone] Email [e-mail]

Date Prepared: June 28th, 2007

### Contact Person:

Douglas W. Blakely VP-Director Clinical & Regulatory Affairs Endothelix, Inc. 2472 Bolsover, Suite 439C Houston, Texas 77005

Tel [phone] Fax [phone] Email [e-mail]

### Device Classification:

| Proprietary name: | Vendys Model 5000 B/BC |
|----------------------|----------------------------------|
| Common/Usual name: | Digital Thermal Monitor |
| Classification Name: | Programmable Diagnostic Computer |
| Product Code: | DQK |
| Regulation Number: | CFR 870.1425 |
| Class: | II |
| Panel: | Cardiovascular |

### Predicate Devices

| Manufacturer | Device | Approval No. |
|------------------|-------------------------------|--------------|
| Vivant Medical | VivaTherm Temp Monitor Sys | K031556 |
| Endocare, Inc. | Endocare Electronic Therm Sys | K961365 |
| URI Therm-X, Inc | URI TX-100 Multi Chan Thermo | K843381 |
| Itamar Medical | Endo PAT 2000 | K032519 |

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K060780

June 28, 2007

### 510(k) Summary for Vendys Model 5000 B/BC (cont'd) 6

# Device Description

The VENDYS Model 5000 B/BC is a non-invasive, Programmable Diagnostic Computer device capable of providing digital thermal monitoring of multiple digits that can aid in studies of vascular function and evaluation of future cardiovascular risk.

The device provides continuous and simultaneous monitoring of skin surface temperature at multiple digits (e.g. fingertips on the study and control hands). It displays temperature changes before, during and after a reactive hyperemia procedure, and calculates multiple indices based on temperature changes.

The surface temperature signal (1 or 2 channels) is recorded at the digit (e.g. fingertip) and processed in the Vendys Model 5000 B electronics module. The signal processing electronics module (Vendys Model 5000 B) is attached to a PC computer via a standard USB cable through a USB port. The Vendys Data Acquisition and Analysis software is necessary to calculate, display, and archive the test data and is intended to be loaded on an IBM-compatible computer (notebook or desktop). The Vendys software records the signals from the Vendys Model 5000 B electronics module, displays a plot of the temperature response before, during and after a reactive hyperemia procedure, and calculates multiple indices based on temperature changes. These temperature indices and the temperature plot are further explained in Section 12 of the submission. The Vendys software program also allows user input of other pertinent patient information and provides the operator with instructions for use.

## Intended Use

The VENDYS Model 5000 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.

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Koco980
3+f3
June 28, 2007

### 510(k) Summary for Vendys Model 5000 B/BC (cont'd) 6

## Performance Standards

The following FDA Recognized Consensus Standards have been adopted in the course of development.

Item 80: ASTM E112-00, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. (General Plastic/General Hospital)

Date of Standard: 2000

Recognition List Number: 007 Effective Date: 05/31/2002 Part B: Supplementary Information

CDRH Office and Division Associated with Recognized Standards: Office of Device Evaluation (ODE) Div of Anesthesiology, Gen. Hospital, Infection Control & Dental Device

In addition the Vendys Model 5000 B/C has adopted the following voluntary standards in the course of development

-IEC 60601-1:1998+A1:1991+:1995 -IEC 60601-1-2:1993 -ISO10993

## Technological Characteristics and Substantial Equivalence

Endothelix, Inc. believes that, based on verification, validations, and safety and performance testing results, the Vendys Model 5000 B/BC is substantially equivalent to other legally marketed devices and to the standard procedures cited above without raising new safety and/or effectiveness issues. Moreover, any differences in their technological characteristics that do exist would not have a significant effect on the safety or effectiveness of the device.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a symbol of medicine and health.

AUG 16 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060980

Trade/Device Name: Vendys Model 5000 B/BC Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II Product Code: DQK Dated: June 4, 2007 Received: July 2, 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.

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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 vours,

Clues

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

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APPENDIX 5

June 28, 2007 DOFFS C

#### Indications For Use Statement 5

510(k) Number: K060980

Vendys Model 5000 B/BC Device Name:

The VENDYS Model 5000 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
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

~~~~

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

310(k) Number:

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