NICORE MODEL ESP -1

K980937 · Nicore Equipment & Leasing, Inc. · DRN · Sep 15, 2000 · Cardiovascular

Device Facts

• Record ID: K980937
• Device Name: NICORE MODEL ESP -1
• Applicant: Nicore Equipment & Leasing, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Sep 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Stable Angina Pectoris

Device Story

NICORE ESP-1 is a non-invasive external counterpulsation device. System uses microprocessor-controlled air inflation/deflation of three cuff pairs applied to calves, lower thighs, and upper thighs/buttocks. Device compresses vascular beds to perform sequential counterpulsation therapy. Operated by clinical staff to treat patients with stable angina pectoris. Output consists of automated pneumatic compression cycles synchronized with patient vascular activity to improve blood flow.

Technological Characteristics

Microprocessor-controlled pneumatic system; three pairs of air cuffs for sequential compression of lower extremities; non-invasive; external counterpulsation principle.

Indications for Use

Indicated for patients with stable angina pectoris.

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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SEP 1 5 2000

K980937

# NICORE, Inc. Manufacturing Division

5415 NW 24" Sc. . Suite 102 . Margate, FL 33063 . 954-977-8420

## PREMARKET NOTIFICATION [510(k)] SUMMARY

1. Submitted by:

SRS International® Corporation Suite 1000, 1625 K St., NW Washington, DC 20006 202-223-0157 Telephone: [phone] Fax:

2. Contact Person: Michael G. Farrow, Ph.D.

3. Name of the Device:

| a. Trade Name: | NICORETM ESP-1TM |
|-------------------------|-----------------------------------|
| b. Common Name: | External Couterpulsation Device |
| c. Classification Name: | Counterpulsation 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 ESP-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 calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.

6. Intended Use of the Device: Currem Indication for use includes patients with:

Stable Angina Pectoris

** This is a modified version of page 251 of the original 510(k) submission (K98-0937).

Modified by: Garrett Bates Vice President of Research & Development NICORE, Inc.

Signature:

Date: 3 - 2 - 9 9

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2000

Michael G. Farrow, Ph.D. Official Correspondent J-Mar Leasing, Inc. SRS International Corporation C/O 1625 K Street, N.W. Suite 1000 Washington, DC 20006

K980937 Re : Nicore™ Model ESP™-1 External Counterpulsation Device Regulatory Class: III (three) Product Code: DRN Dated: December 1, 1998 Received: December 2, 1998

Dear Dr. Farrow:

We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encebure, or any 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 In accordinos with one may, therefore, market the device, subject to the general controls provisions of the Act. The general controls ene golloral 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 (Premarket Approval), it may be subject to such echeroid) or clair - Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in abballer. The . In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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#### Page 2 - Mr. J. Harvey Knauss

response to your premarket notification submission does not affect any response to your premained inder sections 531 through 542 of the Act obrigation you might have and the product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described info recei will allow for to the FDA finding of substantial in your 510 m, pror device to a legally marketed predicate device equivalence or your donion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling if you debiro bpoor and additionally 809.10 for in vitro regulation (21 Cr. Fare over contact the Office of Compliance at (301) draghobers as additionally, for questions on the promotion and 594 4040. Thursday, and please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, (301) 39 4039. 11257 premarket notification² (21CFR 807.97) - Misbrunding by Formation on your responsibilities under the Act may ocher general in Division of Small Manufacturers Assistance at its be obcailou irem [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________ _of

510(k) Number (if known):_K980937 Device Name: N/CORE™ESP-17m

Indications For Use:

Stable Angina Poctoris .

(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, Respiratory,
and Neurological Devices
510(k) Number K980937

Prescription Use OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Continued)

(Optional Format 1-2-96)