ECP HEALTH SYSTEM, MODEL 2005

K052611 · Ecp Health, Inc. · DRN · Apr 26, 2006 · Cardiovascular

Device Facts

• Record ID: K052611
• Device Name: ECP HEALTH SYSTEM, MODEL 2005
• Applicant: Ecp Health, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Apr 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the ECP Health System Model 2005 is for the treatment of patients with: (1). Stable or unstable angina pectoris. (2). Acute myocardial infarction (3). Cardiogenic shock (4). Congestive heart failure

Device Story

ECP Health System Model 2005 is a non-invasive, microprocessor-controlled external counterpulsation device. It utilizes air cuffs applied to calves, lower thighs, and upper thighs/buttocks to provide sequential positive and negative pressure compression of vascular beds. The system includes a finger pulse oximetry function to measure and display oxygen saturation. It is intended for clinical use in treating cardiovascular conditions. The device operates by synchronizing cuff inflation/deflation with the patient's cardiac cycle to enhance blood flow and reduce cardiac workload.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and functional similarity to the predicate device.

Technological Characteristics

Microprocessor-controlled external counterpulsation system. Features three-part air cuff assembly for sequential compression of lower extremities. Includes integrated finger pulse oximetry for SpO2 monitoring. Non-invasive, positive/negative pressure operation.

Indications for Use

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

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

• S-TCT Health External Counterpulsation Device (K030587)

Submission Summary (Full Text)

{0}------------------------------------------------

KOS2611

APR 2 6 2006

510(k) Application
ECP Health System
August 22, 2005

## Attachment

# 510(k) Summary

### ECP Health, Inc. ECP Health System Model 2005

| 1. Date Prepared: | August 22, 2005 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter's Name:<br>and Address | ECP Health, Inc.<br>8416 Prairie Rose Lane<br>Fort Worth, TX 76123 |
| 3. Contact Person: | Shamon Huang, M.S.<br>Vice President<br>ECP Health, Inc.<br>Tel: [phone]<br>Fax: [phone] |
| 4. Device Name: | ECP Health System Model 2005 |
| Proprietary Name: | ECP Health System Model 2005 |
| Common Name: | External Counterpulsation Device |
| Classification Name: | Device, Counter-pulsating, External |
| 5. Predicate Device: | The ECP Health System Model 2005 is substantially<br>equivalent to S-TCT Health External Counterpulsation<br>Device (FDA granted 510(k) clearance on May 30, 2003 --<br>K030587) |
| 6. Device Description: | ECP Health System Model 2005 is a positive and<br>negative pressure integrated , non-invasive medical device<br>for performing external sequential counterpulsation. It is a<br>microprocessor-controlled system that inflates and deflates<br>three parts of air cuffs which compress vascular beds in the<br>calves, lower thighs, and upper thighs /buttocks to achieve<br>the desired therapy. |
| 7. Intended use: | The intended use of the ECP Health System Model<br>2005 is for the treatment of patients with: |

7.1

{1}------------------------------------------------

510(k) Application ECP Health System August 22, 2005

- (1). Stable or unstable angina pectoris.
- (2). Acute myocardial infarction
- (3). Cardiogenic shock
- (4). Congestive heart failure
- 8. Key difference between the current device and the predicate device:

(1): Congestive heart failure has been added to the indications for use of the device (2): Unstable angina pectoris has been added to the indications for use of the device (3): A finger pulse oximetry function has been added to measure and display oxygen saturation.

#### 9. Comparison of Technological Characteristics :

Technological and functional characteristics of the ECP Health System Model 2005 are essentially the same as those of the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo is circular and features the department's emblem in the center. The emblem consists of a stylized human figure with three arms reaching upwards, symbolizing health, services, and humanity. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2006

ECP Health Inc. c/o Mr. Shamon Huang Vice President 8416 Prairie Rose Lane Fort Worth, TX 76123

Re: K052611

ECP Health System Model 2005 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsation Device Regulatory Class: Class III Product Code: DRN Dated: March 10, 2006 Received: March 17, 2006

Dear Mr. Huang:

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.

{3}------------------------------------------------

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]. 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 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/industry/support/index.html.

Sincerely yours.

Bhimima for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Application ECP Health System August 22, 2005

#### Indications for Use Statement

### Indications for Use

K052611 510(k) Number (if known):

Device Name: ECP Health System Model 2005

Indications for Use:

The intended use of the ECP Health System Model 2005 is for the treatment of patients with:

- (1). Stable or unstable angina pectoris.
- (2). Acute myocardial infarction
- (3). Cardiogenic shock
- (4). Congestive heart failure

Prescription Use yes (Part 21 CFR 801 Subpart D)

AN D/Q R

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of (Posted November 13, 2003)

Bhumluna

n Sian-Of n of Cardiovascular I Cass 5 l Ú(k) Number