The Vasocor PVR-100 (Pulse Volume Recorder) is a non-invasive medical device used in conjunction with other devices such as; continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of limbs and digits. Use of the PVR in this manner allows the physician to non-invasively diagnosis extremity arterial and venous disorders.

Device Description

The Vasocor PVR-100 provides Pulse Volume Recording (PVR) made possible through air plethysmography. The PVR-100 device, which is based on a PC platform, includes various standard blood pressure cuff sizes that allow use of the PVR measurement on various limb and digit extremities, a pneumatic circuit that allows for internal calibration as well as inflation cuff pressure, and a user interface that includes various menus and screens for inputting patient demographic data, performing tests, displaying and entering results, and printing reports. The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. Once atmospheric air is injected into the cuff to provide skin contact, a pressure transducer records the pressure change in the PVR cuff secondary to change in volume of the extremity segment under the cuff during repeated cardiac cycles. PVR measurement is accomplished by calculating the volume change in the extremity segment under evaluation, where the PVR tracing shows the change in pressure of the same segment during the cardiac cycle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasocor PVR-100 device:

Vasocor PVR-100: Acceptance Criteria and Study Details

The provided document describes the Vasocor PVR-100, a Pulse Volume Recorder (PVR) that utilizes air plethysmography for non-invasive vascular studies. The submission aims to establish substantial equivalence to a predicate device, the Life Sciences Pulse Volume Recorder.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., target specificity, sensitivity, or amplitude correlation coefficient). Instead, the non-clinical and clinical testing sections describe a comparison methodology to demonstrate equivalence to the predicate device. The primary "acceptance criteria" can be inferred as: producing PVR amplitude measurements and contours that are comparable to those produced by the predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance (Vasocor PVR-100)
PVR amplitude measurements are comparable to the predicate device.	Amplitudes were measured in millimeters to the nearest 0.5mm. (Comparison to predicate was made, implying similar performance and measurement precision).
PVR contour analysis is comparable to the predicate device.	Contour analysis was made by visual analysis (method used clinically). (Comparison to predicate was made, implying similar visual characteristics).
Ability to mimic human circulation in lower extremities under varying hemodynamic conditions (non-clinical).	Hemodynamic model produced Pressure and Volume contours mimicking normal human circulation and was responsive to changes in flowrate, system compliance, and resistance.
Functions equivalently for both normal subjects and subjects with known peripheral vascular disease (clinical).	Successfully tested on 3 normal subjects and 3 subjects with known peripheral vascular disease on various limb and digit extremities.
Overall, device is "substantially equivalent" to predicate within the stated intended use.	Conclusion: The Vasocor PVR is substantially equivalent to the Life Sciences Pulse Volume Recorder.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Non-clinical (In-vitro): Not explicitly stated how many distinct "tests" or parameter variations were run on the hemodynamic model, but the model itself served as the synthetic "test set."
- Clinical: Six subjects (3 normal, 3 with known peripheral vascular disease).
Data Provenance: The document does not specify the country of origin for the clinical subjects. Given the submitter's address (Miami, Florida), it's highly probable the clinical data was collected in the USA.
Retrospective or Prospective:
- Non-clinical: The hemodynamic model was "developed specifically for the Vasocor PVR," suggesting a controlled, prospective experimental setup.
- Clinical: The six subjects were "evaluated using the new Vasocor PVR-100 subject to this 510(k) and the predicate device," indicating a prospective comparative study.

3. Number of Experts and Qualifications for Ground Truth

Non-clinical: The ground truth for the in-vitro model was based on its design to "produce Pressure and Volume contours that mimic the normal human circulation in lower extremities." This effectively means the model itself is the ground truth based on established hemodynamic principles. No external experts are mentioned for this part.
Clinical: The document mentions "known peripheral vascular disease" for three subjects, implying a pre-existing clinical diagnosis by qualified medical professionals (e.g., vascular specialists, radiologists). The "visual analysis" of PVR contours is stated as a "method used clinically," implying interpretation by clinical experts. However, the exact number and qualifications of experts involved in establishing the ground truth for the study itself (e.g., confirming the disease status of the patients, or interpreting the PVR tracings for comparison) are not explicitly stated.

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The comparison of PVR amplitude and contour was made between the Vasocor PVR-100 and the predicate device. "Amplitudes were measured in millimeters to the nearest 0.5mm." "Contour analysis were made by visual analysis (method used clinically)." This suggests a direct comparison, likely by the study investigators or a designated clinical expert, rather than a multi-reviewer adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. The study's focus was on the substantial equivalence of the device's output (PVR tracings) compared to a predicate device, not on how human readers' diagnostic performance might improve with or without AI assistance. This device is an output-generating tool, not an AI-assisted diagnostic aid for human interpretation.

6. Standalone Performance Study

Yes, a standalone performance essentially was done for the device itself. The PVR-100's ability to generate PVR tracings and measurements was evaluated directly, both in a hemodynamic model and on human subjects, in comparison to the predicate device. The performance being measured is the device's output, independent of human interpretation for diagnostic purposes, though the output is intended for human interpretation.

7. Type of Ground Truth Used

Non-clinical: Hemodynamic model (designed to mimic normal human circulation) and its controlled variations.
Clinical:
- For subject selection: Pre-existing clinical diagnosis (e.g., "known peripheral vascular disease").
- For performance comparison: The output of the predicate device (Life Sciences Pulse Volume Recorder) was used as the reference against which the Vasocor PVR-100's output was compared. This implies the predicate device's output is considered the "ground truth" for what a functional PVR tracing should look like.

8. Sample Size for the Training Set

Not applicable. The document describes a 510(k) submission for a medical device that produces physiological measurements (PVR tracings), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI model development. The device's operation is based on pneumatic and pressure transducer technology, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used/described.

Summary

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DFC 17 1997

APPENDIX E

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VASOCOR PVR

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K973659

Submitter Vasocor 4001 N.W. 97th Avenue, Suite 101 Miami. Florida 33178 Ph (305) 592-7260 Fax (305)-592-7937

Date summary was prepared: September 20, 1995

Name(s) of the device Vasocor PVR100

Identification of predicate device(s) Life Sciences Pulse Volume Recorder (preamendment and K832679)

Description of the device

Intended Use

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Table of Technological Characteristics
Device Name	Vasocor PVR	Life Science PVR IV	Parks MedicalMini Lab VI
510(k) numbers	new submission	K832679	unknown
Indications for use	venous and arterialstudies of limbs	same	same
Contraindications	none	same	same
Warnings / Precautions	prescription device	same	same
General Design	computer based,provides PVRtracings, includespnematic circuit,standard bloodpressure cuffs andtubing	mechanical design, manualcalibration	same as Life SciencesPVR IV
Features	Internal calibration,computer controlled ,external printer, savepatient data, printpatient reports	built in strip chart printer,cannot print reports or savepatient data	comes with either abuilt in strip chartrecorder or a PCcomputer for recordmanagement andprinting, or both
Gauges & Sensors	pressure transducer	pressure transducer	pressure transducer
Software	software control ofpatient records,tracings, andpneumatics	none	software control ofpatient records andtracings
Anatomical Site(s)	extremities and digits	same	same
Biocompatibility	blood pressure cuffsare standard marketedproducts are the sameones used by the LifeSciences PVR IV	same	similar

)

E-2

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Non clinical testing:

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A hemodynamic model of the arterial circulation in the lower extremity was developed specifically for the Vasocor PVR. The major feature of this model is that it produces Pressure and Volume contours that mimic the normal human circulation in lower extremities. By changing various parameters the operator can control hemodynamic variables. Flowrate, system compliance, and resistance to control pule pressure and heart rate were varied in the in-vitro comparison testing. The major comparative parameter is the PVR amplitude and contour. Amplitudes were measured in millimeters to the nearest 0.5mm. Contour analysis were made by visual analysis (method used clinically).

Clinical testing:

Six subjects were evaluated using the new Vasocor PVR-100 subject to this 510(k) and the predicate device, the Life Sciences Pulse Volume Recorder. Three(3) normal subjects with no evidence of peripheral vascular disease and three(3) subjects with known peripheral vascular disease were selected for this comparison. Standard blood pressure cuffs were connected to the subjects. The cuffs were placed on upper arm, thumb, calf, and ankle for comparisons in both the normal subjects and subjects with known peripheral vascular disease.

Conclusion:

The Vasocor PVR is substatntially equivalent to the Life Sciences Pulse Volume Recorder

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

DEC 17 1997

Jeff Raines, M.D., Ph.D. Vasocor, Inc. 4001 NW 97th Avenue, Suite 101 Miami, FL 33178

Re : K973659 Vasocor PVR 100 Trade Name: Regulatory Class: II Product Code: 74 JOM Dated: September 5, 1997 Received: September 25, 1997

Dear Dr. Raines:

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 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 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 (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 A substantially equivalent determination assumes compliance to 895. 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 regulatory 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 requlations.

Image /page/4/Picture/9 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread.

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Page 2 - Jeff Raines, M.D., Ph.D.

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 requlation 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callanan, 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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510(k) Number None assigned as of this time

Device Name Vasocor PVR-100

Indications for Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) ロ Over-the Counter Use

(Division Sign-09 12/6/97
Division of Cardiova
and Neurological Devices
510(k) Number K973659

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).