The CardioMedics, Inc., CardiAssist CounterPulsation System 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 Description

The CardioMedics CardiAssist ECP System 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 ECP System consists of the portable console containing the computer and pumps with a touch screen for 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 congestive heart failure patients. The treatment of congestive heart failure 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.

AI/ML Overview

The provided text is a 510(k) summary for the CardioMedics CardiAssist Counterpulsation System Mark 3000. It focuses on demonstrating substantial equivalence to a predicate device and expanding the indication for use to include congestive heart failure.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing or clinical trials. The 510(k) process for this device relies on demonstrating substantial equivalence to a previously cleared device, not on new performance studies with acceptance criteria in the way you've described.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here's what I can extract regarding some of your questions, based on the nature of a 510(k) submission for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not provide specific acceptance criteria or performance data for the device. The 510(k) summary focuses on demonstrating that the technological and functional characteristics of the new device are "identical" to a predicate device (K010261) and that the expanded indication for congestive heart failure "does not require any changes in software, device design, or treatment regimen" and "does not significantly change the safety or effectiveness of the device."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. No new test set data is provided or discussed for the CardiAssist Counterpulsation System Mark 3000 in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a medical device (a counterpulsation system), not an AI/imaging diagnostic device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. As above, this is not an AI/algorithm-based diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new ground truth data is presented. The existing predicate device's safety and effectiveness (implicitly based on clinical understanding and possibly prior clinical data from its own clearance) serve as the foundation for equivalence.

8. The sample size for the training set

Not Applicable. This document does not describe a training set as it's not a machine learning or AI device requiring such data.

9. How the ground truth for the training set was established

Not Applicable. As above.

Summary

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AUG 0 8 2002

K022107

Attachment 7

510(k) Summary

CardioMedics, Inc. CardiAssist Counterpulsation System Mark 3000

l. Date Prepared: June 27, 2002 2. Submitter's Name: CardioMedics, Inc. 18872 Bardeen Avenue and Address Irvine, CA 92612 3. Gary Clark, Contact Person: Director Quality and Regulatory Affairs CardioMedics, Inc. Ph: (949) 863-2500 x106 Fax: (949) 474-2446 Email: gclark@cardiomedics.com 4. Device Name: CardiAssist Counterpulsation System, Mark 3000 Proprietary Name: CardiAssist Counterpulsation System, Mark 3000 Classification Name: Device, Counter-pulsating, External న. 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) #K010261 (predicate device) as well as the Vasomedical EECP Therapy System Model TS3, cleared for market entry under 510(k) #K020857 on June 14, 2002.

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510(k) Notification CardioMedics CardiAssist CounterPulsation System June 27, 2002

Device Description: 6.
The CardioMedics CardiAssist ECP System 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.

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510(k) Notification CardioMedics CardiAssist CounterPulsation System June 27, 2002

The CardioMedics, Inc., CardiAssist CounterPulsation System, 7. Intended Use: Mark 3000, 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 and functional characteristics of the modified 8. Comparison of Technological device are identical to those of the predicate device. Differences:

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2002

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

Re: K022107

Trade Name: CardiAssist CounterPulsation System Mark 3000 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counterpulsation Device Regulatory Class: Class III (three) Product Code: DRN Dated: June 27, 2002 Received: June 28, 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, 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. 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 (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 (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). 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,

K. D. Tel

Donna-Bea Tillman, Ph.D. Acting 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 June 27, 2002

Attachment 8 - Statement of Intended Use

510(k) Number:	K0222107
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Device Name: CardiAssist CounterPulsation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE
OR
OVER-THE COUNTER USE __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices

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.