(918 days)
N/A
No
The description mentions a "microprocessor-controlled system" but does not include any terms or descriptions indicative of AI or ML, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test data sets.
Yes
The device is described as performing "external, sequential counterpulsation" to achieve "the desired therapy" for "Stable Angina Pectoris," indicating its use for treatment.
No
The device description indicates it is a "medical device for performing external, sequential counterpulsation" to "achieve the desired therapy," and the intended use is "Stable Angina Pectoris," which describes a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is a "microprocessor-controlled system that inflates and deflates three pairs of air cuffs," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Stable Angina Pectoris," which is a clinical condition treated directly on the patient.
- Device Description: The device is described as a "non-invasive medical device for performing external, sequential counterpulsation" that "inflates and deflates three pairs of air cuffs which compress vascular beds." This is a physical therapy applied to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
The NICORE™ model ESP-1™ is a therapeutic device that applies external pressure to the patient's limbs. This falls under the category of a medical device used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
Currem Indication for use includes patients with: Stable Angina Pectoris
Product codes
DRN
Device Description
The NICORE™ model ESP-1™ is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calves, lower thighs, and 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K980937, Vasomedical Model EECP-MC2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 5 2000
NICORE, Inc. Manufacturing Division
5415 NW 24" Sc. . Suite 102 . Margate, FL 33063 . 954-977-8420
PREMARKET NOTIFICATION [510(k)] SUMMARY
- Submitted by:
SRS International® Corporation Suite 1000, 1625 K St., NW Washington, DC 20006 202-223-0157 Telephone: 202-835-8970 Fax:
-
Contact Person: Michael G. Farrow, Ph.D.
-
Name of the Device:
| a. Trade Name: | NICORETM ESP-1TM |
|---|---|
| b. Common Name: | External Couterpulsation Device |
| c. Classification Name: | Counterpulsation Device, External |
4. Legally Marketed Device for which we are claiming substantial equivalence:
Vasomedical Model EECP-MC2
5. Description of the Device:
The NICORE™ model ESP-1™ is a proprietary, non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs which compress vascular beds in the calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.
- Intended Use of the Device: Currem Indication for use includes patients with:
Stable Angina Pectoris
** This is a modified version of page 251 of the original 510(k) submission (K98-0937).
Modified by: Garrett Bates Vice President of Research & Development NICORE, Inc.
Signature:
Date: 3 - 2 - 9 9
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2000
Michael G. Farrow, Ph.D. Official Correspondent J-Mar Leasing, Inc. SRS International Corporation C/O 1625 K Street, N.W. Suite 1000 Washington, DC 20006
K980937 Re : Nicore™ Model ESP™-1 External Counterpulsation Device Regulatory Class: III (three) Product Code: DRN Dated: December 1, 1998 Received: December 2, 1998
Dear Dr. Farrow:
We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encebure, or any 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 In accordinos with one may, therefore, market the device, subject to the general controls provisions of the Act. The general controls ene golloral 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 (Premarket Approval), it may be subject to such echeroid) or clair - Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in abballer. The . In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
2
Page 2 - Mr. J. Harvey Knauss
response to your premarket notification submission does not affect any response to your premained inder sections 531 through 542 of the Act obrigation you might have and the product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described info recei will allow for to the FDA finding of substantial in your 510 m, pror device to a legally marketed predicate device equivalence or your donion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling if you debiro bpoor and additionally 809.10 for in vitro regulation (21 Cr. Fare over contact the Office of Compliance at (301) draghobers as additionally, for questions on the promotion and 594 4040. Thursday, and please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 39 4039. 11257 premarket notification² (21CFR 807.97) - Misbrunding by Formation on your responsibilities under the Act may ocher general in Division of Small Manufacturers Assistance at its be obcailou irem (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page__________________________________________________________________________________________________________________________________________________________________________ _of
510(k) Number (if known):_K980937 Device Name: N/CORE™ESP-17m
Indications For Use:
Stable Angina Poctoris .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K980937
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Continued)
(Optional Format 1-2-96)