EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER

K020857 · Vasomedical, Inc. · DRN · Jun 14, 2002 · Cardiovascular

Device Facts

• Record ID: K020857
• Device Name: EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
• Applicant: Vasomedical, Inc.
• Product Code: DRN · Cardiovascular
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

Device Story

Non-invasive external counterpulsation system comprising control console, treatment table, and patient cuff set. Inputs include ECG, finger plethysmograph, and oxygen saturation signals. Microprocessor-controlled pneumatic system inflates/deflates cuffs on lower extremities in synchronization with cardiac cycle; inflation during diastole increases coronary perfusion and venous return; rapid deflation before systole reduces afterload. Used in professional clinical settings by trained operators. System monitors treatment pressure via internal sensors and closed-loop control. Output includes real-time display of ECG, inflation/deflation timing, plethysmography, heart rate, pressure ratios, and oxygen saturation. Benefits include improved coronary blood flow and reduced cardiac workload, supporting treatment of heart failure and angina.

Clinical Evidence

Clinical evaluation included multi-center, single-center, and registry-based investigations. Results demonstrated clinical benefit in patients with congestive heart failure. Improvements observed in objective measures (peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power) and subjective measures (quality of life, functional ability).

Technological Characteristics

System components: control console (air compressor, microprocessor, signal module), treatment table (motorized lift, pneumatic valves), and cuff set. Materials: cotton and Lycra (Spandex) treatment pants. Sensing: ECG, finger plethysmography, pulse oximetry. Connectivity: internal data storage, printer, transferable media. Software: proprietary custom software for system monitoring and closed-loop pressure control. Standards: EN 14971-1, IEC 601-1-4, ISO 10993-1/5/10/12.

Indications for Use

Indicated for adult patients with congestive heart failure, stable or unstable angina pectoris, 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 (K003469)
• EECP® MC-2 (K940264)

Reference Devices

• NONIN® Pulse Oximeter and Carbon Dioxide Detector (K982969)
• 9303 Neonatal/Adult Vital Signs Monitor (K982776)
• MTS Option for the ESCORT® II Monitor (K970763)
• Nonin® PalmSAT®, Model 2500, Pulse Oximeter (K002690)

Submission Summary (Full Text)

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# 510(k) Summary

## JUN 1 4 2002

### Vasomedical, Inc. EECP® Therapy System Model TS3 with Pulse Oximetry

| 1. | Date Prepared: | 13 June 2002 |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Research and Regulatory Affairs<br>Vasomedical, Inc.<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |
| 4. | Device Name: | Vasomedical, Inc.<br>EECP® Therapy System Model TS3 with Pulse Oximetry<br>EECP® Therapy System Model TS3<br>Enhanced External Counterpulsation EECP® MC-2 |
| | Proprietary Name: | EECP Therapy System Model TS3 with Pulse Oximetry<br>EECP® Therapy System Model TS3<br>Enhanced External Counterpulsation EECP® MC-2 |
| | Common Name: | Enhanced External Counterpulsation EECP® MC-2<br>Enhanced External Counterpulsation (EECP®) Therapy<br>System |
| | Classification Name: | Device, Counter-pulsating, External |
| 5. | Predicate Device: | The EECP® Therapy System Model TS3 with Pulse<br>Oximetry is substantially equivalent to the EECP® Therapy<br>System Model TS3 (K003469) and, by reference, to the<br>EECP® MC-2 (K940264). |
| 6. | Device Description: | The EECP® Therapy System Model TS3 with Pulse<br>Oximetry is comprised of three major components, a<br>Control Console, a Treatment Table, and a patient Cuff Set. |

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The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set-point maintained by a closed-loop control system. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data.

The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve 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/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.

External pressure is applied via the patient Cuff Set 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

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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). 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.

The Model TS3 with Pulse Oximetry incorporates a noninvasive sensor and electronic module to acquire and process the patient's oxygen saturation. These same components functions can be used separately or simultaneously. The Nonin oxygen saturation metering device has been an added feature to the following devices:

- NONIN® Pulse Oximeter and Carbon Dioxide Detector (K982969)
- 9303 Neonatal/Adult Vital Signs Monitor (K982776)
- MTS Option for the ESCORT® II Monitor (K970763)
- Nonin® PalmSAT®, Model 2500, Pulse Oximeter with 2500C & 2500B (K002690)

Key differences between the current device and the modified device include:

- Congestive heart failure has been added to the indications for use of the device. .
- . Contraindications for left ventricular hypertrophy and cardiomyopathy have been removed from the device's labeling.
- . A pulse oximetry function has been added to measure and display oxygen saturation in adult patients in a professional setting.
- . The display has been modified to allow the operator to simultaneously display ECG, inflation/deflation time, finger plethysmography, heart rate, ratio of pressure amplitudes, ratio of area under pressure waveform, treatment time and functional oxygen saturation.
- . Modifications to the Pressure Control components to enable the operator to set the desired treatment pressure with less presses of up/down touch keys, automatic maintenance of the treatment pressure set point, and holding of the treatment pressure set point when the system is placed in "Standby" mode.
- The EECP® Therapy System Model TS3 with Pulse 7. Intended Use: Oximetry is a non-invasive external counterpulsation device intended for the use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
- Technological and functional characteristics of the 8. Comparison of

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9.

| Technological<br>Characteristics: | modified device are essentially the same as those of the<br>predicate device. Principles of operation are the same. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| . Non-clinical Tests: | Non-clinical testing on the EECP® Therapy System Model<br>TS3 with Pulse Oximetry included the following: |
| • | Software verification and validation, as follows: |
| | - functional requirements as defined in the EECP®<br>Therapy System Model TS3 with Pulse Oximetry<br>System Requirements Specification. |
| | - boundary values and stress testing as defined by<br>FDA's Guidance for the Content of Premarket<br>Submission for Medical Devices Containing<br>Software, CDRH, ODE, FDA, May, 1998. |
| | - safety requirements as identified in the safety risk<br>analysis performed in accordance with EN 14971-1,<br>Medical Device Risk Analysis, October, 1994, the<br>"Essential Requirements of the Medical Devices<br>Directives", 14 June, 1993, and IEC 601-1-4, Medical<br>Electrical Equipment Part 1: General requirements for<br>safety, 4 Collateral Standard: Programmable electrical<br>medical systems, 1996-05 |

- testing in support of validation in accordance with the FDA's 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.
- Verification of System operation, as follows: ●

- functional requirements as defined in the EECP® Therapy System Model TS3 with Pulse Oximetry System Requirements Specification to verify the performance of the modified device at the system level.

- safety requirements as identified in the safety risk analysis performed in accordance with EN 14971-1, Medical Device Risk Analysis.
- additional verification tests, as indicated, to verify performance at the component level.
- biocompatibility testing in conformity with recognized standards ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12.

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Clinical evaluation of EECP® in patients with congestive 10. Clinical Evaluation: heart failure has been performed in multi-center, single center and registry-based clinical investigations. Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems. Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUN 1 8 2002

Vasomedical, Inc. c/o Mr. Thomas R. Varricchione, MBA, RRT Vice President, Clinical Research and Regulatory Affairs 180 Linden Avenue Wesbury, NY 11590

Re: K020857

Trade Name: EECP® Therapy System Model TS3, Model TS3 with Pulse Oximetry , and Enhanced External Counterpulsation EECP® MC-2 External Counterpulsating Devices Regulation Number: 21 CFR 870.5225 Regulation Name: Device, Counter-pulsating, External Regulatory Class: Class III (three) Product Code: DRN Dated: March 15, 2002 Received: March 18, 2002

Dear Mr. Varricchione:

This letter corrects our substantially equivalent letter of June 14, 2002, regarding the trade names referenced in your submission.

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a rowe 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, do noos mat have been . You may, therefore, market the device, subject to the general controls and Cosment + e. ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . profistion, 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 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, MBA, RRT

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html.

Sincerely yours.

R. R. Till Rl. R.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# Indication for Use Statement

| 510(k) Number: | K020857 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EECP® Therapy System Model TS3 with Pulse Oximetry<br>External Counter-pulsating Device |
| Indications for Use: | Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse<br>Oximetry is a non-invasive external counterpulsation device intended for<br>use in the treatment of patients with congestive heart failure, stable or<br>unstable angina pectoris, acute myocardial infarction, or cardiogenic<br>shock. |

#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The Counter Use

(Rel 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number 12020857

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# Indication for Use Statement

| 510(k) Number: | K020857 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EECP ^® Therapy System Model TS3<br>External Counter-pulsating Device |
| Indications for Use: | Vasomedical, Inc.'s EECP ^® Therapy System Model TS3 is a non-invasive<br>external counterpulsation device intended for use in the treatment of<br>patients with congestive heart failure, stable or unstable angina pectoris,<br>acute myocardial infarction, or cardiogenic shock. |

### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Division of Cardiovascular & Respiratory Devices
510(k) Number//K020857

Over-The Counter Use

ﺘﺠﻬﺰ

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# Indication for Use Statement

| 510(k) Number: | K020857 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Enhanced External Counterpulsation EECP® MC-2<br>External Counter-pulsating Device |
| Indications for Use: | Vasomedical, Inc.'s Enhanced External Counterpulsation EECP® MC-2 is<br>a non-invasive external counterpulsation device intended for use in the<br>treatment of patients with congestive heart failure, stable or unstable<br>angina pectoris, acute myocardial infarction, or cardiogenic shock. |

#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

### Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number_KO 2085 F

Over-The Counter Use