EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY

K033617 · Vasomedical, Inc. · DRN · Mar 1, 2004 · Cardiovascular

Device Facts

• Record ID: K033617
• Device Name: EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
• Applicant: Vasomedical, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EECP® devices listed in this 510(k) Premarket Notification (EECP® Therapy System Model TS4 with/ without Pulse Oximetry, Model TS3 with/without Pulse Oximetry, and Model MC-2) are non-invasive external counterpulsation devices intended for the use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock.

Device Story

System consists of control console, treatment table, and patient cuff set. Inputs: non-invasive ECG, finger plethysmograph, and oxygen saturation signals. Operation: microprocessor monitors cardiac cycle via ECG; triggers sequential inflation/deflation of pneumatic cuffs on lower extremities (calves, lower thighs, upper thighs/buttocks) during diastole. Diastolic augmentation increases coronary perfusion/venous return; rapid deflation before systole reduces afterload. Used in clinical settings by trained operators. Output: real-time display of waveforms, treatment parameters, and physiologic data; hard copy reports via printer. Benefits: reduced cardiac workload and improved coronary blood flow.

Clinical Evidence

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

Technological Characteristics

System includes air compressor, reservoir, signal module, and microprocessor. Sensing: ECG and finger plethysmography. Actuation: pneumatic cuff inflation/deflation via valve assembly. Connectivity: touch screen/keyboard interface, data storage, printer. Software: proprietary custom software for system monitoring and control.

Indications for Use

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

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

• EECP® Therapy System Model TS3 (K020857)
• EECP® Therapy System Model TS3 with Pulse Oximetry (K020857)
• Enhanced External Counterpulsation Model MC-2 (K020857)

Submission Summary (Full Text)

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KO33617

MAR - 1 2004

## Attachment VI

## 510(k) Summary

## Vasomedical, Incorporated EECP® Therapy System Model TS4 with/without Pulse Oximetry EECP® Therapy System Model TS3 with/without Pulse Oximetry Enhanced External Counterpulsation Model MC-2

| 1. | Date Prepared: | 17 November 2003 |
|----|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's Name:<br>and Address | Vasomedical, Inc.<br>180 Linden Ave.<br>Westbury, NY 11590 |
| 3. | Contact Person: | Thomas R. Varricchione, MBA, RRT<br>Vice President, Clinical, Regulatory and Quality Affairs<br>Vasomedical, Incorporated<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |
| 4. | Device Name: | EECP® Therapy System Model TS4 with/without Pulse<br>Oximetry<br>EECP® Therapy System Model TS3 with/without Pulse<br>Oximetry<br>Enhanced External Counterpulsation Model MC-2 |
| | Proprietary Names: | EECP® Therapy System Model TS4 with/without Pulse<br>Oximetry<br>EECP® Therapy System Model TS3 with/without Pulse<br>Oximetry |

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| Common Name: | Enhanced External Counterpulsation Model MC-2 |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Enhanced External Counterpulsation (EECP®) Therapy System<br>Device, Counter-pulsating, External |
| 5. Predicate Device: | The EECP® Therapy Systems listed above are substantially<br>equivalent to the EECP® Therapy System Model TS3, Model TS3<br>with Pulse Oximetry, and Enhanced External Counterpuls-ation<br>Model MC-2. FDA granted 510(k) clearance for the predicate<br>device on June 14, 2002 (K020857, corrected letter issued June<br>18, 2002). |
| 6. Device Description: | Vasomedical's EECP Therapy System Model TS3, Model TS3<br>with Pulse Oximetry and Model MC-2 have been previously<br>described to FDA. The EECP® Therapy System Model TS4<br>with/without Pulse Oximetery is comprised of three major<br>components, a Control Console, a Treatment Table, and a patient<br>Cuff Set.<br><br>The Control Console accommodates the air compressor and<br>reservoir, a signal module panel, a power module, a<br>microprocessor with touch screen/keyboard interface, data storage<br>drives and printer, and components for acquiring and processing<br>ECG, finger plethysmograph and oxygen saturation signals. The<br>signals are obtained non-invasively. The microprocessor is used to<br>operate and monitor the system by means of proprietary custom<br>software, with the operator using the touch screen/keyboard<br>interface to control its operation. The screen displays information<br>pertinent to operating the system, as well as treatment parameters<br>and patient waveforms during use. Treatment pressure is selected<br>by the operator and then monitored and maintained automatically.<br>The touch screen employs "hardware-less keys" which the<br>operator touches to select a function or execute a command and<br>the keyboard enables alphanumeric text entries. An internal hard<br>disk drive is used to store data on the system a printer is used to<br>produce hard copy of site and patient identification and<br>physiologic data. |
| 7. Intended Use: | The EECP® devices listed in this 510(k) Premarket<br>Notification (EECP® Therapy System Model TS4 with/ without<br>Pulse Oximetry, Model TS3 with/without Pulse Oximetry, and<br>Model MC-2) are non-invasive external counterpulsation<br>devices intended for the use in the treatment of patients with<br>stable or unstable angina, congestive heart failure, acute<br>myocardial infarction, or cardiogenic shock. |
| 8. Comparison of<br>Technological<br>Characteristics: | Technological and functional characteristics of the<br>devices listed in this 510(k) Premarket Notification are<br>essentially the same as those of the predicate devices. The<br>devices listed in this 510(k) Premarket Notification are<br>therefore substantially equivalent to the predicate devices. |

assembly and is set at a height convenient for both patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses.

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The electrocardiogram of the patient is detected to initiate triggering of the inflation/deflation valves at appropriate times during the cardiac cycle. External pressure is applied via a patient Cuff Set to the lower extremities of the patient in synchronization with the resting, diastolic phase of the heart cycle, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. This 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 arterial perfusion pressure and coronary arterial blood flow (diastolic augmentation), as well as venous return to the right side of the heart. 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 reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload).

Proposed changes to the to the labeled contraindications of EECP Therapy Systems are r roposed chairger to along with justification and supporting documentation in Attachments Ib through Ih.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Vasomedical, Inc. c/o Thomas R. Varricchione, MBA, RRT Vice President of Clinical, Regulatory and Quality Affairs 180 Linden Avenue Westbury, NY 11590

Rc: K033617

> Trade Name: Vasomedical Enhanced External Counterpulsation (EECP®) Systems Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: III (three) Product Code: 74DRN Dated: February 11, 2004 Received: February 12, 2004

Dear Mr. Varricchione:

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. Thomas R. Varricchione

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/dsma/dsmamain.html

Sincerely yours,

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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11 February 2004

## Indications for Use

510(k) Number (if known):

K033617

Device Name:

Vasomedical Enhanced External Counterpulsation (EECP) Systems

EECP® Therapy System Model TS4 with/without Pulse Oximetry EECP® Therapy System Model TS3 with/without Pulse Oximetry Enhanced External Counterpulsation Model MC-2

External Counter-pulsating Device

Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP ) Indications for Use: Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock

Prescription Use __ X (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)

W

**510(k) Number** /<033617.

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