CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

K023427 · Cardiomedics, Inc. · DRN · Jan 7, 2003 · Cardiovascular

Device Facts

• Record ID: K023427
• Device Name: CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
• Applicant: Cardiomedics, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Jan 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

Device Story

Non-invasive circulatory assist device; provides external counterpulsation (ECP). Inputs: ECG signals via 3-lead cable; pulse data via finger plethysmograph. Operation: Portable console with computer/pumps inflates three sets of flexible fabric leg/buttock cuffs sequentially (40ms apart) during diastole; pressure up to 310 mmHg. Synchronized with patient ECG; retrograde pressure increases diastolic perfusion in coronary vasculature. Output: Enhanced blood flow to heart/upper body. Used in clinical settings; operated by healthcare professionals. Benefits: Reduced angina pain/impairment; improved coronary function; reduced cardiac workload.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological and functional characteristics to legally marketed predicate devices.

Technological Characteristics

Portable console containing computer, pumps, touch screen interface, and strip chart recorder. Includes finger plethysmograph and 3-lead ECG cable. Uses flexible fabric cuffs for pneumatic compression. Synchronized with ECG. No specific material standards or software architecture details provided.

Indications for Use

Indicated for patients with angina pectoris, congestive heart failure, myocardial infarction, and cardiogenic shock requiring external counterpulsation therapy to increase diastolic perfusion and reduce cardiac workload.

Regulatory Classification

Identification

An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.

Special Controls

*Classification.* (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition; (ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules; (iii) Software design and verification and validation must be appropriately documented; (iv) The skin-contacting components of the device must be demonstrated to be biocompatible; (v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and (vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis. (c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• CardiAssist™ ECP System (K022107)
• Vasomedical EECP Therapy System Model TS3 (K020857)

Submission Summary (Full Text)

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JAN 0 7 2003

K023427

# Attachment 7

## 510(k) Summary

#### CardioMedics, Inc. CardiAssist Counterpulsation System Mark 3000

- 1. Date Prepared: October 9, 2002 CardioMedics, Inc. Submitter's Name: 2. 18872 Bardeen Avenue and Address Irvine, CA 92612 Gary Clark, 3. Contact Person: Director Quality Assurance/Regulatory Affairs CardioMedics, Inc. Ph: [phone] x106 Fax: [phone] Email: [e-mail] 4. Device Name: CardiAssist™ Counterpulsation System, Mark 3000 CardiAssist™ Counterpulsation System, Mark 3000 Proprietary Name: Classification Name: Device, Counter-pulsating, External ડ. Predicate Device: The CardiAssist™ Counterpulsation System, Mark 3000, for treatment of CHF patients is substantially equivalent in function and intended use to the currently marketed CardiAssist™ ECP System cleared for market entry under 510(k) #K022107 (predicate device) as well as the Vasomedical EECP Therapy System Model TS3, cleared for market entry under 510(k) #K020857 on June 14, 2002. The CardioMedics CardiAssist™ ECP System is a non-Device Description: 6. invasive circulatory assist device which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, angina pectoris, myocardial infarction and cardiogenic shock. External counterpulsation therapy improves cardiac function by enhancing the perfusion of the coronary vasculature, the development of coronary collateral circulation, and by reducing the workload of the heart. The CardiAssist ECP System consists of the portable console
containing the computer and pumps with a touch screen for

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510(k) Notification CardioMedics CardiAssist CounterPulsation System October 9, 2002

> user interface, an integral strip chart recorder, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 3-lead ECG cable and leads.

This CardiAssist™ ECP System sequentially compresses the legs from the calves, thighs and buttocks, 40 milliseconds apart, by inflating three sets of flexible fabric cuffs during diastole. This results in movement of blood from the legs to the heart and entire upper body. Pressure, up to 310 mmHg, is applied with the timing and duration of each pulse, synchronized with the patient's ECG. When properly triggered, the pressure pulses applied to the vascular bed of the legs and buttocks transmit retrograde pressure through the entire vascular system. At the aorta, the aortic valve prevents retrograde flow into the left ventricle. Thus, a peak pulse of diastolic pressure occurs at or above systolic levels which increases the driving pressure in the coronary vasculature.

The difference between the new device and the predicate device is the indication. The indication is being expanded to include the treatment of non-chronic angina pectoris patients. The treatment of all angina pectoris patients with the CardiAssist™ ECP System does not require any changes in software, device design, or treatment regimen. The treatment of this patient population does not significantly change the safety or effectiveness of the device.

- The CardioMedics, Inc., CardiAssist™ CounterPulsation Intended Use: 7. System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.
- Technological and functional characteristics of the modified 8. Comparison of Technological Differences: device are identical to those of the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, composed of three overlapping silhouettes. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

JAN 0 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CardioMedics, Inc. c/o Mr. Gary Clark Director Quality Assurance/Regulatory Affairs 18872 Bardeen Avenue Irvine, CA 92612

Re: K023427 Trade Name: CardiAssist CounterPulsation System Regulation Number: 21 CFR 870.5225 Regulation Name: External Counterpulsation Device Regulatory Class: Class III (three) Product Code: DRN Dated: October 9, 2002 Received: October 11, 2002

Dear Mr. Clark:

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. Iisting 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. Gary Clark

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 (OS) 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 [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) you may obtain. 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.

K. Don Tellh
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Notification CardioMedics CardiAssist CounterPulsation System October 9, 2002

#### Attachment 8 - Statement of Intended Use

510(k) Number: K023427

Device Name: CardiAssist CounterPulsation System

Indications for Use:

The CardioMedics, Inc., CardiAssist™ CounterPulsation System is intended to provide external counterpulsation (ECP) by increasing perfusion during diastole for the treatment of angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock and may enhance coronary function.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Deaton Teda

vascular Devices

**510(k) Number** K023427

PRESCRIPTION USE

OR OVER-THE COUNTER USE (Per 21 CFR 801.109)

(Optional Format 1-2-96)