CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000

K050172 · Cardiomedics, Inc. · DRN · Mar 31, 2005 · Cardiovascular

Device Facts

• Record ID: K050172
• Device Name: CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
• Applicant: Cardiomedics, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic 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 or myocardial infarction and may enhance coronary function.

Device Story

Non-invasive circulatory assist device; provides external counterpulsation (ECP). Inputs: patient ECG (5-lead or 12-lead), finger plethysmograph, blood pressure. Operation: microprocessor-controlled system triggers inflation of three sets of leg cuffs (calves, thighs, buttocks) during diastole; sequential compression 40ms apart; pressures up to 310 mmHg. Output: retrograde pressure transmitted through vascular system to increase diastolic aortic pressure; displayed on console touch screen. Used in clinical settings; operated by trained personnel. Benefits: enhanced coronary perfusion, reduced cardiac workload, improved collateral circulation. System includes portable console, computer, pumps, printer, cuffs, and hoses.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Microprocessor-based control system; ECG R-wave triggering; pneumatic cuff system (no vacuum required); touch screen interface; through-hole circuit board; safety interlock requiring ECG signal; max pressure 310 mmHg.

Indications for Use

Indicated for patients with ischemic heart disease, including chronic angina pectoris, congestive heart failure, myocardial infarction, and cardiogenic shock, to increase diastolic perfusion and enhance coronary function.

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, Mark 3000 (K023427)
• Nicore NCP-1 Device (K023016)

Submission Summary (Full Text)

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MAR 3 1 2005

510(k) Notification for New Device Cardiomedics CardiAssist Counter Pulsation System – 4000 Series December 2004

## Attachment 7

## 510(k) Summary

## Cardiomedics, Inc. CardiAssist Counter Pulsation System - Series 4000

- Date Prepared: 1.
January 20, 2005

- Cardiomedics, Inc. 2. Submitter's Name: 18872 Bardeen Avenue and Address Irvine, CA 92612
- John Hutchins, Contact Person: 3. Vice President, Marketing and Clinical Affairs Cardiomedics, Inc. Ph: [phone] x104 Fax: [phone] Email: [e-mail]
- CardiAssist Counter Pulsation System 4. Device Name:
- CardiAssist Counter Pulsation System Series 4000 Proprietary Name:

Device, Counter-pulsating, External Classification Name:

- The CardiAssist Series 4000 Counter Pulsation System is equivalent 5. Predicate Device: in function and intended use to the currently marketed CardiAssist ECP System, Mark 3000 cleared for market entry under 510(k) K023427 on January 7, 2003 as well as technologically and functionally equivalent to the Nicore NCP-1 Device, cleared for market entry under 510(k) K023016 on December 4, 2002.

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510(k) Notification for New Device Cardiomedics Series 4000 - CardiAssist Counter Pulsation System December 2004

- The Cardiomedics CardiAssist External Counter Pulsation System -6. Device Description: Series 4000 is a non-invasive circulatory assist device, which provides increased circulation via external counterpulsation (ECP) for the treatment of ischemic heart disease including congestive heart failure, chronic angina pectoris, acute 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 External Counter Pulsation System - Series 4000 consists of the portable console containing the computer and pumps with a touch screen for user interface, an integral patient chart printer, and leg cuffs and hoses. Additional components provided with the System include a finger plethysmograph and 5-lead ECG cable and leads (12 lead optional) and blood pressure cuff. 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 Cardiomedics, Inc., CardiAssist External Counter Pulsation 7. Intended Use: System - Series 4000, is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic 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 or myocardial infarction and may enhance coronary function. Technological characteristics of this device which are similar to those 8. Comparison of of the Cardiomedics 3000 Series predicate system include: the Technological triggering mechanism (patient's ECG R-wave); microprocessor based Characteristics control system; emergency system power down; limited maximum
pressure used for treatment; through-hole circuit board; safety interlock requiring external ECG signal before treatment can start; and the Cardiomedics cuff system which eliminates the need for vacuum cuff deflation.

Technological characteristics of this device which are similar to those

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510(k) Notification for New Device Cardiomedics Scries 4000 - CardiAssist Counter Pulsation System December 2004

> of the Nicore predicate device include: the triggering mechanism (patient's ECG R-wave), microprocessor based control system, limited maximum pressure used for treatment, operator's console and data display with mouse based interface.

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MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiomedics, Inc.. c/o Mr. John Hutchins 18872 Bardeen Avenue Irvine, CA 92612

Re: K050172

Cardiomedics CardiAssist Counter Pulsation System – Series 4000 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter Pulsation Device Regulatory Class: Class III (three) Product Code: DRN Dated: January 20, 2005 Received: February 1, 2005

Dear Mr. Hutchins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. 310(t) pe device is substantially equivalent (for the indications ferenced above and nave acterings ally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary and eath of the Medical Device Amendments, or to connineree prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassined in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requently of the general controls provisions of the Act. The You may, merenne, market the dorres, basjoct on the morements for annual registration, listing of general controls provisions of the rice 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 If your device is classified (see above) into existing major regulations affecting your device can Illay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be Numd in the Oode of I ourself in the Federal Register.

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Page 2- Mr. John Hutchins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase to advisou that I Dr usean that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I edetails 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. product in the low you to begin marketing your device as described in your Section 510(k) I mis lotter with and in Joint FDA finding of substantial equivalence of your device to a legally promaticated predicated. " Thesults 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 If you desire 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 from the Division of Small other golleral micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(2017) 115 097 fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mocel Mayr

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 for New Device 910(k) Notycation Jor 1000 - CardiAssist Counter Pulsation System December 2004

## Attachment 8 - Statement of Intended Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CardiAssist Counter Pulsation System - Series 4000

Indications for Use:

The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to The Cardiomedics, Inc., CalulAssist Counter Fuloaten of isschemic heat disease by provide external Counterpulsation CEOT / Tell the chronic angina perforis, congestive heat.
Increasing perfusion during diastole in people with chrise may reduce pain and increasing perfusion during diastole in poople with of lease this device may request and fallure, myocardial infarction and cardiogenie oneon. "So on the libre or myocardial infarction and may enhance coronary function.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The Counter Use_

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mokey Moyer

scular Devices Oit L 510(k) Number