(94 days)
Not Found
No
The description details a microprocessor controlling timing based on ECG signals, which is standard electronic control, not indicative of AI/ML. There are no mentions of learning, adaptation, or complex pattern recognition beyond simple timing.
Yes
The device is intended for use in the "treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock," which are medical conditions, indicating a therapeutic purpose.
No
The device description indicates it is a treatment device that inflates and deflates cuffs to encourage cardiac circulation, not to diagnose a condition.
No
The device description clearly outlines hardware components such as pneumatic pressure cuffs, an air pressure/vacuum pump, and an electrocardiogram connection, in addition to the electronic control system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The US-ECP Model IV is a non-invasive device that applies external pressure to the patient's limbs to improve blood circulation. It does not analyze any samples taken from the body.
- Intended Use: The intended use is for the treatment of specific cardiac conditions, not for diagnostic testing.
The device description clearly outlines a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The intended use of the US-ECP is for the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.
S-TCT Health, Inc.'s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.
Product codes (comma separated list FDA assigned to the subject device)
DRN
Device Description
The US-ECP is a painless, non-invasive medical device for performing external, sequential counterpulsation. Treatment is administered as the patient lies on the padded top of the device. The patient's calves, thighs, and buttocks are wrapped with specially designed adjustable pneumatic pressure cuffs, similar to blood pressure cuffs. Hoses connect the cuffs to an air pressure/vacuum pump enclosed in the device's base. The patient is also connected to an electrocardiogram to monitor the patient's heart rate. Once everything is properly in place, the device inflates and deflates the cuffs. The design of the cuffs permits significant pressure to be applied to the arteries and veins at relatively low air pressures. Timing for inflation and deflation is controlled electronically by running the patient's electrocardiogram signals through a microprocessor that monitors the entire treatment process. Each wave of pressure is electronically timed to the patient's heartbeat, so that the increased blood flow is delivered to the heart at the exact moment it is relaxing. When the patient's heart pumps again, pressure in the cuffs is released instantaneously. In short, the device pumps when the patient's heart is resting and releases pressure when the patient's heart is pumping. The intent of the treatment is to encourage cardiac circulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K030587
Attachment I
510(k) SUMMARY
S-TCT Health Inc. US-ECP
- May 27, 2003 1. Date Prepared:
- S-TCT Health Inc. 2. Submitted by: 13010 Research Blvd., Suite 103 Austin, TX 78750
-
- Contact Person: James S. Turner, Esq. Swankin & Turner 1400 16th Street, NW, Suite 330 Washington, DC 20036 Tel: (202) 462-8800 Fax: (202) 265-6564 e-mail: jim@swankin-turner.com
-
- Device Name: US-ECP
External Counterpulsation Device Common name:
Classification name: Device, Counterpulsating, External
- Predicate Device: The US-ECP is substantially equivalent to:
Vasomedical Model EECP®-MC2 (K940264), for which clearance was granted February 23, 1995.
- Description of The US-ECP is a painless, non-invasive medical device for performing external, sequential counterpulsation. the Device: Treatment is administered as the patient lies on the padded top of the device. The patient's calves, thighs, and buttocks are wrapped with specially designed adjustable pneumatic pressure cuffs, similar to blood pressure cuffs. Hoses connect the cuffs to an air pressure/vacuum pump enclosed in the device's base. The patient is also connected to an electrocardiogram to monitor the patient's heart rate. Once everything is properly in place, the device inflates and deflates the cuffs. The design of the cuffs permits significant pressure to be applied to the arteries and veins at
1
relatively low air pressures. Timing for inflation and deflation is controlled electronically by running the patient's electrocardiogram signals through a microprocessor that monitors the entire treatment process. Each wave of pressure is electronically timed to the patient's heartbeat, so that the increased blood flow is delivered to the heart at the exact moment it is relaxing. When the patient's heart pumps again, pressure in the cuffs is released instantaneously. In short, the device pumps when the patient's heart is resting and releases pressure when the patient's heart is pumping. The intent of the treatment is to encourage cardiac circulation.
| 7. Intended Use: | The intended use of the US-ECP is for the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock. |
|---|---|
| 8. Comparison of Technological Characteristics: | Technological and functional characteristics of the US-ECP are essentially the same as those of the predicate devices. Differences are speed of microprocessor (US-ECP is a faster, more current model) and cosmetic (e.g., table color). |
Signature:
Date: ________________________________________________________________________________________________________________________________________________________________________
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Gouji Gong, OMD President, S-TCT Health, Inc.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
S-TCT Health Inc. c/o James S. Turner, Esq. 13010 Research Blvd., Suite 103 Austin. TX 78750
Re: K030587
S-TCT Health External Counterpulsation (ECP) Model US-ECP Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter Pulsating Device Regulatory Class: Class III (three) Product Code: DRN Dated: April 2, 2003 Received: April 3, 2003
Dear Mr. Turner:
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
Page 2 - Mr. James S. Turner
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 (OS) 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) 594-4646. 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 vours.
J. Deatter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT C
Indications for Use Statement
510(k) Number:
Device Name:
US-ECP External Counterpulsating Device
Indications for Use:
S-TCT Health, Inc.'s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
K Q k V M
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K03058
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use