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 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.

AI/ML Overview

The provided text describes the Vendys Model 5000 B/BC, a digital thermal monitor, and its 510(k) summary. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format typically requested for medical device performance.

Instead, the document focuses on:

Device Description and Intended Use: Explaining what the device does and why it's used.
Predicate Devices: Listing similar devices that were already approved.
Compliance with Standards: Stating that the device adopted certain FDA Recognized Consensus Standards and voluntary standards (ASTM E112-00, IEC 60601-1, IEC 60601-1-2, ISO10993). This implies that meeting these standards served as a form of "acceptance criteria" for regulatory submission regarding safety and basic performance characteristics like accuracy and EMC.
Substantial Equivalence Claim: The core of a 510(k) submission, asserting that the new device is as safe and effective as predicate devices.

Given the information, I cannot provide a table with "reported device performance" against explicit "acceptance criteria" where those criteria are detailed numerical targets (e.g., accuracy +/- X degrees, sensitivity Y%, specificity Z%). The document implies that meeting the standards for electronic thermometers (like ASTM E112-00) and substantial equivalence to predicate devices constituted the acceptance criteria for this regulatory submission.

Therefore, the requested information elements related to specific performance studies, sample sizes, ground truth, expert adjudication, or MRMC studies are not present.

Here's a breakdown of what can be extracted or inferred, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from standards and claims)	Reported Device Performance (Inferred from compliance statements)
Safety & Effectiveness equivalent to predicates	"Based on verification, validations, and safety and performance testing results, the Vendys Model 5000 B/BC is substantially equivalent to other legally marketed devices..."
Electronic Thermometer Standards (e.g., ASTM E112-00)	"The following FDA Recognized Consensus Standards have been adopted... Item 80: ASTM E112-00, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature." (Implies compliance, but no specific performance data listed).
Electrical Safety Standards (IEC 60601-1)	"The Vendys Model 5000 B/C has adopted the following voluntary standards in the course of development: -IEC 60601-1:1998+A1:1991+:1995" (Implies compliance).
Electromagnetic Compatibility (IEC 60601-1-2)	"-IEC 60601-1-2:1993" (Implies compliance).
Biocompatibility (ISO10993)	"-ISO10993" (Implies compliance).

2. Sample size used for the test set and the data provenance:

Not specified. The document mentions "verification, validations, and safety and performance testing results" but does not detail the size or nature of any specific test sets, nor their provenance (country of origin, retrospective/prospective).
For a 510(k) of this type (Programmable Diagnostic Computer / Digital Thermal Monitor), the "test set" demonstrating performance would likely involve calibration and accuracy tests against a known standard, as implied by the ASTM standard. However, specifics are missing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not specified. This device is a measurement tool (digital thermometer) rather than an AI diagnostic device where expert ground truth for interpretation is typically required. Its "ground truth" would be highly accurate reference thermometers or devices, and expert interpretation of results is not described as part of its internal performance validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable / Not specified. No adjudication method is described, as the device's function is automated temperature measurement, not interpretive diagnostic output requiring human consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted diagnostic device in the modern sense. It's a digital thermal monitor. It processes signals and calculates indices, but it's not described as having an AI component that would assist human readers in interpretation or diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in essence, the device operates standalone for temperature measurement and index calculation. The device "provides continuous and simultaneous monitoring of skin surface temperature... and calculates multiple indices based on temperature changes." The performance would be assessed purely on its accuracy and precision as a measurement device, without a human-in-the-loop component for its primary function. However, the details of such a standalone study (e.g., accuracy against a gold standard) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Implied to be instrument-based reference standards. For a digital thermometer, the ground truth for accuracy and precision would be established using validated reference temperature sources or highly accurate primary standards. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable / Not specified. The document does not describe a machine learning model that would require a "training set." The device performs calculations based on established physiological principles and algorithms for signal processing, not learned patterns from data.

9. How the ground truth for the training set was established:

Not applicable. As no training set for a machine learning model is described, this question is not applicable.

Summary

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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 713-529-2599 Fax 832-201-9192 Email info@endothelix.com

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 713-529-2599 Fax 832-201-9192 Email dougwb@attg.net

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

Intended Use

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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:

PAGE 5.1

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).