VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)

K011625 · Vasocor, Inc. · DXN · Jan 23, 2002 · Cardiovascular

Device Facts

• Record ID: K011625
• Device Name: VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
• Applicant: Vasocor, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), ankle/brachial index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.

Device Story

Vasocor Model 300 is a cart-based vascular laboratory for clinical use by physicians/healthcare professionals. It integrates an oscillometric NIBP module (Colin M1050) to measure blood pressure and pulse rates via segmental cuffs. The device processes these inputs to calculate clinical indices: ABI, segmental pressure differentials, BMI, Framingham risk scores (CHD, stroke, peripheral disease), and arterial compliance (elasticity). Output is displayed on a monitor and printed for clinician review. These outputs assist clinicians in assessing patients for underlying cardiovascular or peripheral vascular disease, potentially identifying those requiring further diagnostic evaluation. Administrative features include system usage reporting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and the use of a cleared, off-the-shelf oscillometric blood pressure module (Colin M1050) which has passed UL and SP-10 testing.

Technological Characteristics

Cart-based system including motherboard, pneumatic circuit, monitor, keyboard, joystick, printer, and blood pressure cuffs. Incorporates Colin Medical Instruments M1050 oscillometric NIBP module. Complies with UL and SP-10 standards for NIBP systems.

Indications for Use

Indicated for use by physicians and healthcare professionals to measure blood pressure (systolic, diastolic, pulse pressure), heart pulse rates, and calculate risk scores (Framingham CHD, stroke, peripheral disease), BMI, ABI, segmental pressure differentials, and arterial compliance indices in patients potentially requiring cardiovascular disease assessment.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Touritu Engineering MS-2000 (K961144)
• Hypertension Diagnostics, Inc. CVProfilor DO-2020 CardioVascular Profiling System (K001948)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 2 3 2002

# 510(k) Summary

### Premarket Notification {510(k)}:

### Vasocor™ Vascular Diagnostic Center (Model 300)

- Submitter: Vasocor, Inc. 1. 499-A Jessen Lane Charleston, SC 29492 843-284-4000 Fax: [phone] Walter M. Rosebrough, President and Chief Executive Officer Contact:
This summary was prepared on April 25, 2001 and revised October, 29, 2001.

### Vasocor™ Vascular Diagnostic Center (Model 300) 2. Proprietary Name: Vascular Laboratory Common Name: Classification Name: Non-invasive Blood Pressure Measurement System

#### Statement of Equivalence 3.

The Vasocor™ Vascular Diagnostic Center (Model 300) is substantially equivalent to two cleared devices: (1) Touritu Engineering's MS-2000, K961144; and (2) Hypertension Diagnostics, Inc.'s CVProfilor DO-2020 CardioVascular Profiling System, K001948. All three products are non-invasive electronic devices that use the oscillometric method of blood pressure measurement to take various measurements; all three perform various calculations on the data collected, which are used to assess potential underlying vascular disease.

#### Device Description 4.

The Vasocor Vascular Diagnostic Center (Model 300) is a vascular laboratory that integrates, into one device, various modules that provide indices of significance to peripheral vascular and cardiovascular function. These modules include Patient Data, Framingham and BMI, ABIgram™ Ankle/Brachial Index, PADogram™ Segmental Pressure Analysis, and Vasogram™ Arterial Compliance Procedure. The Vascular Diagnostic Center (Model 300) also offers administrative capabilities such as creating periodic system usage reports which show test dates, procedures performed, patient names, and physician names.

#### ഗ് Intended Use

The Vasocor Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental

{1}------------------------------------------------

measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), oolonary Livel index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have (alarti, crasherly including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.

#### Technological Characteristics 6.

Physically, the system consists of hardware and electronics housed in a cart with four wheels. I Hystoury, the byother board, pneumatic circuit, monitor, keyboard, joystick, printer, tubing, blood pressure cuffs, and power cord. It also incorporates Colin Medical Instruments' oscillometric blood pressure module M1050, a standard high-end, off-the-shelf NIBP system which has passed UL and SP-10 testing.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used to represent the Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2002

Mr. Walter M. Rosenbrough President and Chief Executive Officer Vasocor, Inc. 499 A Jessen Lane Charleston, SC 29492

Re: K011625

Trade Name: Vascular Diagnostic Center Model 300 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 29, 2001 Received: October 31, 2001

Dear Mr. Rosebrough:

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.

{3}------------------------------------------------

Page 2 - Mr. Walter M. Rosenbrough

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 and additionally 21 CFR Part 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Kala Tiller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Indications for Use Statement

## Premarket Notification [510(k)]:

## Vasocor™ Vascular Diagnostic Center (Model 300)

Indications for Use:

The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that The Vasocol by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental (Systement. The Vascular Diagnostic Center (Model 300) also calculates Framingham moasurement. The Tusers, stroke, and peripheral disease risk scores, body mass index (BMI), coronaly index (AB), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance segments, and provides indications of arrastis in assessing and managing patients that may have (that ts, clusticle) including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.

Concurrence of CDRH, Office of Device Evaluation (ODE)

- Prescription Use
(Per 21 C.F.R. § 801.109)

OR

Over-The-Counter Use*_*

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number