(104 days)
No
The description details a microprocessor controlling the system based on physiological signals (ECG, plethysmograph, oxygen saturation) and operator input, but does not mention any AI or ML algorithms for data analysis, decision-making, or adaptation. The control logic appears to be rule-based and pre-programmed.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock." This indicates its therapeutic purpose.
No
This device is described as a therapy system for treatment of various cardiac conditions, not for diagnosis. While it acquires physiological signals (ECG, plethysmograph, oxygen saturation) and displays patient waveforms, this information is used to operate and monitor the system during treatment, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a Control Console, Treatment Table, patient Cuff Set, air compressor, reservoir, signal module panel, power module, microprocessor, touch screen/keyboard interface, data storage drives, printer, valve assembly, and connecting air hoses. While software is mentioned as operating and monitoring the system, it is integral to the function of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Vasomedical EECP Therapy System is a non-invasive external counterpulsation device. It applies external pressure to the lower extremities and uses physiological signals (ECG, plethysmograph, oxygen saturation) obtained non-invasively.
- Intended Use: The intended use is for the treatment of various cardiac conditions by applying external pressure, not by analyzing samples from the body.
The device operates externally on the patient's body and uses physiological signals, which is characteristic of a therapeutic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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
Product codes
74DRN
Device Description
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, calves, lower thighs, upper thighs, buttocks
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
§ 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.
0
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: | |
| and Address | Vasomedical, Inc. | |
| 180 Linden Ave. | ||
| Westbury, NY 11590 | ||
| 3. | Contact Person: | Thomas R. Varricchione, MBA, RRT |
| Vice President, Clinical, Regulatory and Quality Affairs | ||
| Vasomedical, Incorporated | ||
| Telephone: (516) 997-4600 | ||
| Facsimile: (516) 997-2299 | ||
| E-mail: tvarricchione@vasomedical.com | ||
| 4. | Device Name: | EECP® Therapy System Model TS4 with/without Pulse |
| Oximetry | ||
| EECP® Therapy System Model TS3 with/without Pulse | ||
| Oximetry | ||
| Enhanced External Counterpulsation Model MC-2 | ||
| Proprietary Names: | EECP® Therapy System Model TS4 with/without Pulse | |
| Oximetry | ||
| EECP® Therapy System Model TS3 with/without Pulse | ||
| Oximetry |
1
শ
:
ਾਂ
| Common Name: | Enhanced External Counterpulsation Model MC-2 |
|---|---|
| Classification Name: | Enhanced External Counterpulsation (EECP®) Therapy System |
| Device, Counter-pulsating, External | |
| 5. Predicate Device: | The EECP® Therapy Systems listed above are substantially |
| equivalent to the EECP® Therapy System Model TS3, Model TS3 | |
| with Pulse Oximetry, and Enhanced External Counterpuls-ation | |
| Model MC-2. FDA granted 510(k) clearance for the predicate | |
| device on June 14, 2002 (K020857, corrected letter issued June | |
| 18, 2002). | |
| 6. Device Description: | 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. |
| 7. Intended 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. |
| 8. Comparison of
Technological
Characteristics: | Technological and functional characteristics of the
devices listed in this 510(k) Premarket Notification are
essentially the same as those of the predicate devices. The
devices listed in this 510(k) Premarket Notification are
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.
: 12
2
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.
3
Image /page/3/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health and Human Services. The emblem features the department's logo, which is a stylized depiction of an eagle with three wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the logo.
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.
4
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
5
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 /