Current indications for use of the ACS™ Model NCP-2 are:
. Stable Angina Pectoris
. Unstable Angina Pectoris
Acute Myocardial Infarction .
Cardiogenic Shock .
Congestive Heart Failure

Device Description

The ACS Model NCP-2 External Counterpulsation Device (ECP) is comprised of three major components, a Control Console, a Treatment Bed, and a set of patient Cuffs. The device is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therary.

The Control Console is comprised of a signal amplifier module, a power module, a microprocessor control module, a keyboard control panel with trackball, a Liquid Crystal Display (LCD) panel, and a Personal Computer (PC) with storage drives, data entry QERTY keyboard, network card, and printer. Control console input and data from the ECG, finger plethysmograph, and the pressure/vacuum transducers are processed by the microprocessor to control the valve timing and pressure delivered to the cuffs. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set point maintained by a closed-loop control system. Valve inflation and deflation timing is also set by the operator based on the relative position of the R-wave of the patients ECG.

The PC is used to enter patient demographics, record pre and post-treatment data, and process data acquired by the microprocessor module to display user feedback for the ECP treatment on the LCD showing treatment parameters and patient waveforms during use.

An internal hard disk drive is used to store data on the system, a CD/DVD drive is used to record data onto removable media, and a printer is used to produce hard copy of a report that includes all of the pertinent treatment data for individual treatments and a session summary of all treatment data collected for 35 or more days.

The Treatment Bed accommodates the air compressor, a pressure and vacuum reservoir, inflation and deflation valves and a motorized lifting mechanism for the mattress assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation and deflation valves that open and close on command to inflate or deflate the patient Cuffs with air. The valve manifold assembly is connected to the air compressor and pressure/vacuum reservoir components via connecting air hoses. External pressure is delivered 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 thighs/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 coronary perfusion pressure and coronary blood 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 re-conforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased after-load).

Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and performance data in a quantifiable manner that would typically be found in a study demonstrating device efficacy to meet specific thresholds. Instead, it focuses on regulatory submission aspects, including comparison to a predicate device and non-clinical/clinical testing for substantial equivalence.

However, based on the information provided, here's an attempt to structure the answer according to your request, acknowledging the limitations of the input text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the ACS Model NCP-2 External Counterpulsation Device primarily focuses on demonstrating substantial equivalence to a predicate device (Nicore NCP (ESP) External Counterpulsation Device). Therefore, the "acceptance criteria" are implied by meeting the established safety and performance characteristics of the predicate. The "reported device performance" is essentially that it operates identically and safely.

Acceptance Criteria Category	Specific Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Functional Equivalence	Identical principles of operation and functionality to the predicate device.	"Principles of operation are identical."
Safety	Meet safety requirements as identified in safety risk analysis (EN 1497-1-1, IEC 601-1-4).	Non-clinical testing included safety risk analysis and verification of system operation to these standards.
Software Validation	Software functions as defined in requirements specifications, undergoes boundary/stress testing, and validated according to FDA guidance (May 1998, January 2002) and IEC 601-1-4.	Software verification and validation performed, addressing functional, boundary, stress, and safety requirements.
Biocompatibility	Meet recognized standards for biocompatibility (ISO 10993-1, -5, -10, -12).	Additional verification tests performed at the component level to recognized ISO standards for biocompatibility.
Intended Use	Device is safe and effective for the same indications for use as the predicate device.	"ACS Model NCP-2 ... is a non-invasive external Counterpulsation device intended for the use in the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock or congestive heart failure."
Clinical Equivalence	Clinical results demonstrate substantial equivalence to the predicate device.	"An Independent Review Board has overseen the clinical investigation... Results have demonstrated substantial equivalence to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "An Independent Review Board has overseen the clinical investigation of the External Counterpulsation Device. Results have demonstrated substantial equivalence to the predicate device."

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of Experts and their Qualifications for Ground Truth

The document mentions an "Independent Review Board" overseeing the clinical investigation.

Number of Experts: Not specified.
Qualifications of Experts: The specific qualifications (e.g., medical specialty, years of experience) of the members of the Independent Review Board are not specified.

4. Adjudication Method for the Test Set

The document does not provide details on the adjudication method used for the clinical investigation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The submission focuses on demonstrating substantial equivalence of the device itself rather than its effectiveness in aiding human readers in interpretation or diagnosis.

6. Standalone (Algorithm Only) Performance

The device described is a physical medical device (External Counterpulsation Device) that provides therapy, not an algorithm for diagnosis or interpretation. Therefore, the concept of "standalone (i.e. algorithm only without human-in-the loop performance)" does not apply in this context.

7. Type of Ground Truth Used

The "clinical investigation" demonstrating substantial equivalence suggests that patient outcomes, clinical parameters, and potentially comparisons to the efficacy of the predicate device would form the basis of the "ground truth." However, the specific type of ground truth data (e.g., detailed clinical endpoints, symptom resolution, physiological measurements) is not specified.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/ML algorithm. The device is a hardware and software system for therapy. The software validation involved functional testing and stress testing, but this is distinct from data-driven training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's functionality and safety was established through adherence to engineering specifications, recognized safety and biocompatibility standards, and clinical investigation demonstrating equivalence to the predicate device.

Summary

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K042413

DEC - 9 2004

000758

APPLIED CARDIAC SYSTEMS INC. NCP-2 510 (k) Summary

1. Date Prepared:	24 August 2004
2. Submitter's Name:and Address	Applied Cardiac Systems, Inc.22912 El Pacifico DriveLaguna Hills, CA 92653
3. Contact Person:	R. Ben GhadimiSenior Vice President of Regulatory AffairsApplied Cardiac Systems, Inc.Telephone: (949) 855-9366Facsimile: (949) 581-1009E-mail: bghadimi@acs.occoxmail.com
4. Device Name:	ACS Model NCP-2 External Counterpulsation Device
Proprietary Name:	ACS Model NCP-2 External Counterpulsation Device
Common Name:	External Counterpulsation Device (ECP)
Classification Name:	Device, Counter-pulsating, External
5. Predicate Device:	Nicore NCP (ESP) External Counterpulsation DeviceK980937 and by reference K023016 (adding Congestiveheart failure to the indications for use of the device)

6. Device Description:

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000759

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.

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ACS Model NCP-2 External Counterpulsation Device is a non-7. Intended Use: invasive external Counterpulsation device intended for the use in the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock or congestive heart failure.

8. Comparison of Technological and functional characteristics :

Characteristics of the ACS Model NCP-2 External Counterpulsation Device are identical to the predicate device; Nicore Model NCP (ESP) (K9809770 and (K023016). Principles of operation are identical.

1. Non-clinical Tests: Non-clinical testing on the ACS Model NCP-2 External Counterpulsation Device included the following:

> Software verification and validation, as follows:

Functional requirements as defined in the NCP (ESP) System 트 Requirements Specification.
Boundary values and stress testing as defined by FDA's Guidance 트 for the Content of Premarket Submission for Medical Devices Containing Software, CDRH, ODE, FDA, May, 1998.
Safety requirements as identified safety risk analysis performed in I accordance with EN 1497 1 - 1 Medical Device Risk Analysis, October, 1994, the "Essential Requirements of the Medical Devices Directives", 14 June, 1993, and IEC 601-1-4, Medical Electrical Equipment Part 1 : General requirements for safety. 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
Testing in support of validation in accordance with the FDA's 롤 General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11,2002, and IEC 601-1-4, Medical Electrical Equipment Part 1: General requirements for safety, 4 Collateral Standard: Programmable electrical medical systems, 1996-05.

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000761

> Verification of System operation, as follows:

Functional requirements as defined in the NCP (ESP) System Requirements Specification to verify the performance of the device at the system level.
트 Safety requirements as identified in the safety risk analysis performed in accordance with EN 1497 1 - 1, Medical Device Risk Analysis
. Additional verification tests, as indicated, to verify performance at the component level recognized standards ISO 10993-1, ISO 10993-5, IS010993-10 and IS0 10993-12.

10. Clinical Evaluation:

An Independent Review Board has overseen the clinical investigation of the External Counterpulsation Device. Results have demonstrated substantial equivalence to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2004

Applied Cardiac Systems, Inc. c/o Mr. R. Ben Ghadimi Senior Vice President of Regulatory Affairs 22912 El Pacifico Drive Laguna Hills, CA 92653

Re: K042413

ACSTM Model NCP-2 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class III (three) Product Code: DRN Dated: November 22, 2004 Received: November 26, 2004

Dear Mr. Ghadimi:

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. R. Ben Ghadimi

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,

Duwa R. lacluner

(1 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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Indications for Use

510(k) Number (if known): K042413

Device Name: Device, Counterpulsating, External

Indications For Use:

Current indications for use of the ACS™ Model NCP-2 are:

. Stable Angina Pectoris
. Unstable Angina Pectoris
Acute Myocardial Infarction .
Cardiogenic Shock .
Congestive Heart Failure

Predicate Indication for Use

Taken from Predicate literature (See also, Predicate Labeling, Section C)

"The Nicore™ Model NCP (ESP) External Counterpulsation System is a non-invasive external counter pulsation device for the treatment of patients suffering from stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock, and congestive heart failure."

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma P. Voelker

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non of Cardiovascular Devices

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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.