NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE

K023016 · Nicore Equipment & Leasing, Inc. · DRN · Dec 4, 2002 · Cardiovascular

Device Facts

• Record ID: K023016
• Device Name: NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
• Applicant: Nicore Equipment & Leasing, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Dec 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NICORE Model NCP-1 is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.

Device Story

NICORE Model NCP-1 is a non-invasive, microprocessor-controlled external counterpulsation (ECP) device. It utilizes three pairs of air cuffs applied to calves, thighs, and buttocks. The system triggers inflation/deflation cycles based on the patient's ECG R-wave to compress vascular beds, enhancing diastolic augmentation. The device features a contoured treatment surface, vacuum-assisted cuff deflation, and a safety interlock requiring an external ECG signal for operation. It is intended for clinical use to treat cardiac conditions by improving blood flow. Healthcare providers monitor therapy via an external strip chart recorder and console displays. The device aims to improve patient outcomes by increasing diastolic pressure relative to systolic pressure, thereby supporting cardiac function.

Clinical Evidence

Clinical study conducted with nine healthy volunteers (mean age 44). Subjects were treated with both the NCP-1 and the predicate device at pressures ranging from 0.15 to 0.40 KPa. Primary endpoints were diastolic augmentation measured by peak diastolic to peak systolic pressure amplitude ratio and area ratio. Results showed mean amplitude ratios of 1.50 (NCP-1) vs 1.51 (predicate) and mean area ratios of 1.84 (NCP-1) vs 1.82 (predicate). Data analysis confirmed the devices are substantially equivalent.

Technological Characteristics

Microprocessor-controlled external counterpulsation system. Components include three pairs of air cuffs, air pump, air supply hoses, and circuit boards (through-hole). Triggering mechanism: patient ECG R-wave. Features: vacuum-assisted cuff deflation, contoured treatment surface, patient call button, and safety interlock. Non-PC based architecture. Connectivity: external strip chart recorder.

Indications for Use

Indicated for patients with stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

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

• Vasomedical Model EECP-MC2

Submission Summary (Full Text)

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K023016

4897 W. Waters Avenue, Suite J Tampa, Florida 33634 Tel: [phone] Fax: [phone]

DEC (1 4 2002

# Premarket Notification [510(k)] Summary

1. Submitted by: NICORE, Inc. 4897 W. Waters Ave., Suite J Tampa, FL 33634 Telephone: [phone] Fax: [phone]

- 2. Contact person: Jeff Mogilewicz Quality Assurance Manager
#### 3. Name of the Device

- NICORE Model NCP-1 External Counterpulsation Device a. Trade Name:
- External Counterpulsation Device (ECP) b. Common Name:
- c. Classification Name: Counter-pulsating device, external

### 4. Legally Marketed Device for Which We are Claiming Substantial Equivalence:

Vasomedical Model EECP-MC2

### 5. Description of the Device:

The NICORE Model NCP-1 is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It 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 therapy.

### 6. Intended use of the Device:

Current Indications for use includes treatment of patients with:

- Stable and unstable angina pectoris .
- Acute myocardial infarction .
- Cardiogenic shock ●
- . Congestive Heart Failure

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#### 7. Summary Comparison of Technological Characteristics to Predicate Device

Technological characteristics of this device which are similar to those of the predicate include: The number of major components (four); the triggering mechanism (patient's ECG R-wave); manual controls; non-PC based; emergency system power down; external strip chart recorder; circuit boards; maximum pressure used for treatment.

Technological characteristics of this device which are different than the predicate include: Through-hole circuit board versus a handwired/soldered board; patient's call button; operator's console displays more data simultaneously; pressure cuffs are vacuum deflated; treatment surface is contoured for safety and comfort; safety interlock requiring external ECG signal before treatment can start; air pump and air supply hoses are housed within the treatment table.

#### 8. Discussion of Clinical Tests

Prior to marketing approval of the NCP-1 a clinical study was completed to compare the NCP-1 device with the predicate. The study used nine healthy volunteers, average age 44 (range 29-59). Following screening, the subjects were randomly assigned to each device in an alternating manner and the sequential readings were taken at treatment pressures of 0.15 KPa, 0.20, 0.25, 0.30, 0.35, and 0.40 KPa. After a 90-minute rest, the subjects underwent final treatment on the other brand of the device.

Data collected included the degree of diastolic augmentation. This was measured as a ratio of peak diastolic to peak systolic pressure, as determined by measurement and calculation of the amplitude and area of the representation of the patient's pulse pressure wave. The mean for the amplitude ratio on the NICORE device was 1.50, as compared to the Vasomedical device of 1.51. The mean for the area ratio on the NICORE device was 1.84 and on the Vasomedical device was 1.82. The means for the two ratios are within one standard deviation of the overall mean of the combined data. The combined amplitude ratio overall mean for both devices was 1.50 at one standard deviation of 0.62; for the area relation for both devices, the combined overall mean was 1.83, at one standard deviation of 0.82

#### 9. Summary of Conclusions Drawn from Clinical Tests

Based on the testing performed on the test subjects, data analysis of the results indicates that the two sets of data obtained from the NICORE and Vasomedical devices belong to the same population and are therefore substantially equivalent,

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

C 04 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NICORE, Inc. c/o Mr. Jeff Mogilewicz Quality Assurance Manager 4897 W. Waters Avenue, Suite J Tampa, FL 33634

#### Rc: K023016

Trade Name: NICORE Model NCP-1 External Counterpulsation Device Regulation Number: 21 CFR 870.5225 Regulation Name: External Counterpulsation Device Regulatory Class: Class III (three) Product Code: DRN Dated: September 6, 2002 Received: September 10, 2002

#### Dear Mr. Mogilewicz:

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jeff Mogilewicz

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 [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). 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,

Qutur

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) Number (if known): K023016

Device Name: NICORE Model NCP-1 External Counterpulsation Device

Indications For Use: The NICORE Model NCP-1 is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Oatter

510(k) Number K023016

(Optional Format 3-10-98)

X Prescription Use