(104 days)
Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP ) 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
Vasomedical's EECP Therapy System Model TS3, Model TS3 with Pulse Oximetry and Model MC-2 have been previously described to FDA. The EECP® Therapy System Model TS4 with/without Pulse Oximetery is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set.
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 signals are obtained non-invasively. 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 selected by the operator and then monitored and maintained automatically. 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 a printer is used to produce hard copy of site and patient identification and physiologic data.
The Treatment Table is a padded table 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.
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).
The provided text is a 510(k) summary for the Vasomedical EECP® Therapy System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics and study design elements requested in your prompt.
The document is a regulatory submission focused on establishing substantial equivalence, primarily by comparing technological characteristics and intended use to a previously cleared device. It does not include performance data or clinical study results in the manner you are asking for.
Therefore, I cannot fulfill your request for the table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because that data is not present in the provided 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 |
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| 2. | Submitter's Name:and Address | Vasomedical, Inc.180 Linden Ave.Westbury, NY 11590 |
| 3. | Contact Person: | Thomas R. Varricchione, MBA, RRTVice President, Clinical, Regulatory and Quality AffairsVasomedical, IncorporatedTelephone: (516) 997-4600Facsimile: (516) 997-2299E-mail: tvarricchione@vasomedical.com |
| 4. | Device Name: | EECP® Therapy System Model TS4 with/without PulseOximetryEECP® Therapy System Model TS3 with/without PulseOximetryEnhanced External Counterpulsation Model MC-2 |
| Proprietary Names: | EECP® Therapy System Model TS4 with/without PulseOximetryEECP® Therapy System Model TS3 with/without PulseOximetry |
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| Common Name: | Enhanced External Counterpulsation Model MC-2 |
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| Classification Name: | Enhanced External Counterpulsation (EECP®) Therapy SystemDevice, Counter-pulsating, External |
| 5. Predicate Device: | The EECP® Therapy Systems listed above are substantiallyequivalent to the EECP® Therapy System Model TS3, Model TS3with Pulse Oximetry, and Enhanced External Counterpuls-ationModel MC-2. FDA granted 510(k) clearance for the predicatedevice on June 14, 2002 (K020857, corrected letter issued June18, 2002). |
| 6. Device Description: | Vasomedical's EECP Therapy System Model TS3, Model TS3with Pulse Oximetry and Model MC-2 have been previouslydescribed to FDA. The EECP® Therapy System Model TS4with/without Pulse Oximetery is comprised of three majorcomponents, a Control Console, a Treatment Table, and a patientCuff Set.The Control Console accommodates the air compressor andreservoir, a signal module panel, a power module, amicroprocessor with touch screen/keyboard interface, data storagedrives and printer, and components for acquiring and processingECG, finger plethysmograph and oxygen saturation signals. Thesignals are obtained non-invasively. The microprocessor is used tooperate and monitor the system by means of proprietary customsoftware, with the operator using the touch screen/keyboardinterface to control its operation. The screen displays informationpertinent to operating the system, as well as treatment parametersand patient waveforms during use. Treatment pressure is selectedby the operator and then monitored and maintained automatically.The touch screen employs "hardware-less keys" which theoperator touches to select a function or execute a command andthe keyboard enables alphanumeric text entries. An internal harddisk drive is used to store data on the system a printer is used toproduce hard copy of site and patient identification andphysiologic data. |
| 7. Intended Use: | The EECP® devices listed in this 510(k) PremarketNotification (EECP® Therapy System Model TS4 with/ withoutPulse Oximetry, Model TS3 with/without Pulse Oximetry, andModel MC-2) are non-invasive external counterpulsationdevices intended for the use in the treatment of patients withstable or unstable angina, congestive heart failure, acutemyocardial infarction, or cardiogenic shock. |
| 8. Comparison ofTechnologicalCharacteristics: | Technological and functional characteristics of thedevices listed in this 510(k) Premarket Notification areessentially the same as those of the predicate devices. Thedevices listed in this 510(k) Premarket Notification aretherefore 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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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):
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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§ 870.5225 External counter-pulsating device.
(a)
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.(b)
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.