VASOCOR PVR 100

K973659 · Vasocor, Inc. · JOM · Dec 17, 1997 · Cardiovascular

Device Facts

• Record ID: K973659
• Device Name: VASOCOR PVR 100
• Applicant: Vasocor, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended Use

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 Story

Vasocor PVR-100 is a PC-based air plethysmography system for pulse volume recording (PVR). It uses standard blood pressure cuffs applied to limbs or digits; a pneumatic circuit injects air to ensure skin contact. A pressure transducer records pressure changes within the cuff caused by volume changes in the underlying extremity segment during cardiac cycles. The device performs internal calibration and manages patient data, test performance, and report printing. Used in clinical settings by physicians, it complements other vascular diagnostic tools like Doppler ultrasound or treadmill testing. The output consists of PVR tracings and reports, which assist clinicians in diagnosing arterial and venous disorders. The system benefits patients by providing a non-invasive method for vascular assessment.

Clinical Evidence

Clinical evaluation compared the Vasocor PVR-100 to the Life Sciences Pulse Volume Recorder in 6 subjects (3 normal, 3 with peripheral vascular disease). Cuffs were placed on the upper arm, thumb, calf, and ankle. Results demonstrated substantial equivalence in PVR tracing and contour analysis. Bench testing included a hemodynamic model of lower extremity arterial circulation, varying flowrate, compliance, and resistance to validate PVR amplitude and contour accuracy.

Technological Characteristics

PC-based system; pneumatic circuit for cuff inflation and internal calibration; pressure transducer for sensing volume-related pressure changes. Uses standard blood pressure cuffs. Software controls patient records, tracings, and pneumatic functions. Connectivity includes external printer. No specific material standards or software architecture class provided.

Indications for Use

Indicated for non-invasive diagnosis of extremity arterial and venous disorders in patients requiring vascular studies of limbs and digits. No specific contraindications noted.

Regulatory Classification

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.

Predicate Devices

• Life Sciences Pulse Volume Recorder (K832679)

Reference Devices

• Parks Medical Mini Lab VI

Submission Summary (Full Text)

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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 [phone] Fax [phone]

## 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

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.

#### Intended Use

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.

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| Table of Technological Characteristics | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Vasocor PVR | Life Science PVR IV | Parks Medical<br>Mini Lab VI |
| 510(k) numbers | new submission | K832679 | unknown |
| Indications for use | venous and arterial<br>studies of limbs | same | same |
| Contraindications | none | same | same |
| Warnings / Precautions | prescription device | same | same |
| General Design | computer based,<br>provides PVR<br>tracings, includes<br>pnematic circuit,<br>standard blood<br>pressure cuffs and<br>tubing | mechanical design, manual<br>calibration | same as Life Sciences<br>PVR IV |
| Features | Internal calibration,<br>computer controlled ,<br>external printer, save<br>patient data, print<br>patient reports | built in strip chart printer,<br>cannot print reports or save<br>patient data | comes with either a<br>built in strip chart<br>recorder or a PC<br>computer for record<br>management and<br>printing, or both |
| Gauges & Sensors | pressure transducer | pressure transducer | pressure transducer |
| Software | software control of<br>patient records,<br>tracings, and<br>pneumatics | none | software control of<br>patient records and<br>tracings |
| Anatomical Site(s) | extremities and digits | same | same |
| Biocompatibility | blood pressure cuffs<br>are standard marketed<br>products are the same<br>ones used by the Life<br>Sciences PVR IV | same | similar |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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.

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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