The Venometer Strain Gauge Plethysmograph is a hydraulic plethysmograph used to estimate the blood flow in thighs and calves of the body. Its primary purpose is as a screening device for deep vein thrombosis.

Device Description

The Venometer is a portable instrument with which nurses can test patients at their bedside for potentially fatal blood clots in their legs. It first inflates a pressure cuff around the thigh to allow veins to fill with blood, and then releases this pressure and measures this pressure and measures the rate at which the veins subsequently empty. It automatically calculates the likelihood of a DVT based on these measurements. The Advanced Medical Technology Venometer is a noninvasive measurement system in which a silicon rubber tube filled with an electrically conductive liquid metal is wrapped around a patient's leg. Any change in girth will stretch the tubing, thus changing the resistance of the material in the tubing in proportion to the change in girth. This resistance change is converted by an electronic circuit to a voltage that can be easily measured and recorded. The electrically conductive liquid metal is an alloy of gallium and indium. A computer has been incorporated into the Venometer to provide step-by-step guidance for the operator throughout the test as a way of minimizing operator error; and to eliminate the need for an operator to consult a chart to make a diagnosis.

AI/ML Overview

Here's an analysis of the provided text regarding the Advanced Medical Technology Limited Venometer, structured to address your request:

Based on the provided text, the submission focuses on asserting substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance criteria. The document highlights safety and efficacy through compliance with European standards for risk analysis, electromagnetic compatibility, and general medical electrical equipment standards. There is no mention of a clinical performance study with specific acceptance criteria or device performance data as one would typically find in a modern 510(k) submission for a diagnostic device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be fully answered from this regulatory document.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for DVT detection) nor does it provide a table of reported device performance metrics against such criteria. The focus is on demonstrating safety and general efficacy through compliance with manufacturing and design standards, and substantial equivalence to a predicate device.

Table 1: Acceptance Criteria and Reported Device Performance (Information Not Provided in Text)

Performance Metric	Acceptance Criteria	Reported Device Performance
No specific clinical performance criteria or results are provided in the document.
The document focuses on regulatory compliance and substantial equivalence to a predicate device for safety and general efficacy.
Safety (e.g., electrical safety, EMC)	Compliance with European Standards (prEN1441:1994, EN55011, EN60601-1)	Certified as in compliance.

Detailed Study Information (Based on Available Text)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not describe a clinical performance study with a test set of patient data. It focuses on engineering and regulatory compliance. The "test" mentioned refers to compliance with European standards for safety (prEN1441:1994, EN55011, EN60601-1) rather than a clinical performance evaluation.

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

This information is not applicable as no clinical performance study with a test set and ground truth establishment is described.

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

This information is not applicable as no clinical performance study with a test set requiring adjudication is described.

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 MRMC study or AI assistance is mentioned. The device is described as a standalone diagnostic tool, not one designed to augment human reading or incorporate AI.

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

The document describes the Venometer as a standalone instrument that provides "step-by-step guidance for the operator throughout the test" and "automatically calculates the likelihood of a DVT." This suggests a standalone performance, although no specific performance data is provided in this document. The device's primary purpose is described as a "screening device," and the text notes that "a Nurse can rule out DVT with ten minutes at the bedside." While this implies standalone use, there's no formal "standalone performance study" report here with metrics like sensitivity or specificity.

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

This information is not applicable as no clinical performance study with a ground truth reference is described. The device's mechanism suggests its output (likelihood of DVT based on blood flow measurements) would ideally be compared to a definitive diagnostic method for DVT (e.g., venography, ultrasound), but no such comparison is reported.

8. The sample size for the training set

The document does not mention a training set. This device, based on strain gauge plethysmography, is likely based on established physiological principles and signal processing rather than machine learning requiring a training set.

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

This information is not applicable as no training set is mentioned.

Summary of what is present:

The 510(k) notification for the Advanced Medical Technology Limited Venometer focuses on demonstrating substantial equivalence to an existing legally marketed device (Medasonics Incorporated Model SPG16 Strain Gauge Plethysmograph, K782132). The safety and efficacy claims are primarily backed by:

Compliance with European Standards:
- prEN1441:1994 for Risk Analysis.
- EN55011 for Electromagnetic Compatibility (meeting Class A limits).
- EN60601-1 for design and manufacture of medical electrical equipment.
Technological Equivalence: The device uses a similar "electrically conductive liquid metal" strain gauge technology licensed from the manufacturer of the predicate device.
Operational Guidance: A computer provides step-by-step guidance and automatically calculates DVT likelihood to minimize operator error and obviate chart consultation.

The document does not include a detailed clinical performance study with quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or corresponding results for detecting DVT in a patient cohort. This type of submission relies heavily on the established safety and efficacy of the predicate device and the similarity of the new device's technology and intended use.

Summary

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K983900

SAFETY AND EFFECTIVENESS SUMMARY Advanced Medical Technology Limited Venometer

Name and address of Device Manufacturer submitting 510(k) Notification:

Advanced Medical Technology Limited 15 Trench Road, Mallusk, Co Antrim Northern Ireland, BT36 4TY United Kingdom

Regulatory Correspondent of Device Manufacturer:

Dr. Andrew Barr Advanced Medical Technology Limited 15 Trench Road, Mallusk, Co Antrim Northern Ireland, BT36 4TY United Kingdom Phone: +44-1232-341422 FAX: +44-1232-341420

Date Summary was prepared:

October 29, 1998

21CFR 870.2780

Name of the device:

Venometer Strain Gauge Plethysmograph

Classification:

Indications for Use:

Plethysmograph, Hydraulic, (Strain Gauge). Class II per

Description of the device:

The Venometer is a portable instrument with which nurses can test patients at their bedside for potentially fatal blood clots in their legs.

It was developed to tackle the growing problem of hospital bed shortages and waiting lists where these are caused by disease of blood clotting in leg veins (DVT).

The definitive description of a DVT is that it blocks normal blood flow. This feature is exploited innovatively by the Venometer. It first inflates a pressure cuff around the thigh to allow veins to fill with blood, and then releases this pressure and measures this pressure and measures the rate at which the veins subsequently empty.

It automatically calculates the likelihood of a DVT based on these measurements.

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Typically 8 out of ten patients with symptoms of DVT do not have the disease, but they only learn this after waiting 2 days in the hospital for an expensive specialist investigation. Using a Venometer, a Nurse can rule out DVT with ten minutes at the bedside, to the benefit of both the patient and hospital.

The Advanced Medical Technology Venometer is a noninvasive measurement system in which a silicon rubber tube filled with an electrically conductive liquid metal is wrapped around a patient's leg. Any change in girth will stretch the tubing, thus changing the resistance of the material in the tubing in proportion to the change in girth. This resistance change is converted by an electronic circuit to a voltage that can be easily measured and recorded.

The electrically conductive liquid metal is an alloy of gallium and indium. This technology is licensed from Medasonics Incorporated, the manufacturer of the predicate device.

A computer has been incorporated into the Venometer to provide step-by-step guidance for the operator throughout the test as a way of minimizing operator error; and to eliminate the need for an operator to consult a chart to make a diagnosis.

Substantial Equivalence:

The Advanced Medical Technology Limited Venometer is substantially equivalent to the following legally marketed device:

Medasonics Incorporated Fremont, California Model SPG16 Strain Gauge Plethysmograph 510(k) K782132, cleared 2/26/79

Safety and Efficacy:

In part fulfillment of the essential requirements of European Directive 93/42/EEC and certified by SGS Yarsley ICS, the Risk Analysis of the Venometer which was performed prior to commencement of manufacturer was in accordance with the requirements of European Standard prEN1441:1994.

In part fulfillment of the essential requirements of European Directive 93/42/EEC and certified by SGS Yarsley ICS, the Northern Ireland Technology Centre has tested the Venometer for Electromagnetic Compatibility and has certified the product as in compliance with European Standard EN55011 and in particular meeting the limits specified by Class A as defined in the standard.

In part fulfillment of the essential requirements of European Directive 93/42/EEC and certified by SGS Yarsley ICS, the Venometer is designed and manufactured in compliance with European Standard EN60601-1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human figures facing to the right, which is a common symbol associated with the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1999

Mr. William E. McKay Advanced Medical Technology Limited c/o Romdi 9712 S. Altamont Drive Sandy, UT 84092

K983900 Re: Venometer Regulatory Class: II (two) Product Code: 74 JOM Dated: October 31, 1998 Received: November 3, 1998

Dear Mr. McKay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to The general controls the general controls provisions of the Act. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. William E. McKay

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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k 983900 510(k) Number (if known): Not yet assigned

Device Name: _Venometer Strain Gauge Plethysmograph

Indications For Use:

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

Concurrence of CDRH, Office if Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR
Over-The-Counter Use
Division Sign-Off (Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number .

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Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).