The CPCA2000™ Counterpulsation System is a non-invasive external counterpulsation device intended for use in the treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute 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 Description

The CPCA2000 Counter Pulsation System consists of a portable console containing computer, electrocardiogram. plethysmogram, pump and reservoir, integral strip chart recorder, and leg cuffs and hoses. The microprocessor is used to operate and monitor the system via proprietary software, with the operator using touch screen interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. An external floppy disk drive is used to record data onto transferable media, and a printer is used to produce a hard copy of site, patient and physiologic data. The system accommodates the use of any bed or treatment table.

AI/ML Overview

The provided document is a 510(k) summary for the CPCA2000 Counterpulsation System. It focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical tests conducted.

It does not contain the kind of information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them with specific performance metrics. This type of information is usually found in clinical trial results, which are not detailed in this regulatory submission.

Therefore, I cannot provide the requested information from the given document. The document primarily describes:

Device Name: CPCA2000™ Counterpulsation System
Intended Use: Treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute myocardial infarction, and cardiogenic shock.
Predicate Device: Enhanced External Counterpulsation Device - Model EECP-MC2 (K940264).
Non-Clinical Tests:
- IEC60601-1-2; 2001 Medical Electrical Equipment Safety (Electromagnetic Compatibility)
- UL 2601-1 Medical Electrical Equipment Safety
- Software Verification & Validation (per CDRH guidance)
- Device Risk & Hazard Analysis (per 21CFR820.30(g), Design Validation)

The document asserts that the "principle technological and functional characteristics of the current device are same as the predicate devices" and that treating congestive heart failure patients "does not significantly change the safety and effectiveness of the device" or "require any changes in software, device design or treatment regimen." This suggests that the substantial equivalence argument relies heavily on the predicate device's established safety and effectiveness.

To answer your specific questions, a clinical study report would be required, which is not available in these provided materials.

Summary

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1030532

(510k) Summary

CPCA2000, Inc. CPCA2000 Counterpulsation System

MAR 1 4 2003

1. Date Prepared:

2. Submitter's Nameand Address:	CPCA2000, Inc.6336 17Th Street Circle EastSarasota, FL 34243
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Rod Shipman, President 3. Contact Person: CPCA2000, Inc. Telephone (941) 727-4370 Facsimile: (941) 727-4371
CPCA2000TM Counterpulsation System 4. Device Name:

CPCA2000TM Counterpulsation System Proprietary Name:

Classification Name: Device, Counter-pulsating, External

The CPCA2000TM Counterpulsation System is substantially 5. Predicate Device: equivalent to the Enhanced External Counterpulsation Device -Model EECP-MC2. FDA granted 510(k) clearance for the predicate device on February 23, 1995 (K940264).

Device Description: The CPCA2000 Counter Pulsation System consists of a portable console containing computer, electrocardiogram. plethysmogram, pump and reservoir, integral strip chart recorder, and leg cuffs and hoses. The microprocessor is used to operate and monitor the system via proprietary software, with the operator using touch screen interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. An external floppy disk drive is used to record data onto transferable media, and a printer is used to produce a hard copy of site, patient and physiologic data. The system accommodates the use of any bed or treatment table.

External pressure is applied via the patient cuff set to the lower extremities of the patient in synchronization with the heart, i.e., the cuffs compress vascular beds in the calves, lower thighs and upper though/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing

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coronary perfusion pressure and coronary flow (diastolic augmentation), as well as venous return. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload). The CPCA2000™ Counterpulsation System is a non-invasive 7. Intended Use: external counterpulsation device intended for use in the treatment of patients with stable or unstable angina pectoris, congestive heart failure, acute 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. The principle technological and functional characteristics of the 8. Comparison of current device are same as the predicate devices. The treatment of Technological congestive heart failure patients with the CPCA2000 ECP system

9. Non-Clinical Tests:

Characteristics:

not significantly change the safety and effectiveness of the device. Key non-clinical testing conducted on the CPCA2000™ Counterpulsation System includes the following:

treatment regimen. The treatment of this patient population does

does not require any changes in software, device design or

IEC60601-1-2; 2001 Medical Electrical Equip., Part 1-. 2. General Requirements for Safety; Collateral Standard, Electromagnetic Compatibility
. UL 2601-1 Medical Electrical Equipment, Part1: General Requirements for Safety
Software Verification & Validation, per Guidance for . the Content of Premarket Submission for Medical Devices Containing Software, CDRH, ODE, FDA, May, 1998.
Device Risk & Hazard Analysis per 21CFR820.30(g), . Design Validation

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle's head or a stylized representation of human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2003

CPCA2000, Inc. c/o Mr. Michael P. Dayton BioMed Research, Inc. 4608 Rue Bordeaux Lutz. FL 33558

Re: K030532

Trade Name: CPCA2000™ Counterpulsation System Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class III (three) Product Code: DRN Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Dayton:

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.

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Page 2 – Mr. Michael P. Dayton

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), please contact the Office of Compliance at (301) 594-4646. 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510k Number (if known):

Device Name: CPCA2000™ Counterpulsation System

Indications For Use:

The CPCA2000™ Counterpulsation System is a non-invasive external counterpulsation device intended for use in the treatment of patients with stable angina pectoris, congestive heart failure, acute 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.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off
	Division of Cardiovascular
510(k) Number	K030537
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
	(Optional Format 1-2-

Regulation Number and Section

§ 870.5225 External counter-pulsating device.

(a)
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.(b)
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.