(85 days)
Vasomedical Model EECP-MC2
Vasomedical Model EECP-MC2
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a microprocessor-controlled system for inflating and deflating cuffs based on pulse pressure wave measurements, which is a deterministic control process, not AI/ML.
Yes
The device is described as providing "external counterpulsation (ECP) therapy" and is "indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction." These are all therapeutic applications.
No
The device is described as a non-invasive medical device used for performing external, sequential counterpulsation (ECP) therapy. Its intended use and device description focus on treatment, not diagnosis. The performance studies measure physiological responses to the therapy (diastolic augmentation, amplitude and area ratios), but this is to assess the efficacy of the treatment, not to diagnose a condition.
No
The device description explicitly states it is a "non-invasive medical device for performing external, sequential counterpulsation" and describes physical components like "air cuffs" and a "microprocessor-controlled system that inflates and deflates". This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the NICORE Model NCP-1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide external counterpulsation (ECP) therapy for treating various cardiovascular conditions. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description clearly states it's a "non-invasive medical device for performing external, sequential counterpulsation" by inflating and deflating air cuffs on the patient's limbs. This is a physical treatment method.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The NICORE Model NCP-1 does not involve the analysis of such specimens.
The device is a therapeutic medical device, not a diagnostic one that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Current Indications for use includes treatment of patients with:
- Stable and unstable angina pectoris .
- Acute myocardial infarction .
- Cardiogenic shock ●
- . Congestive Heart Failure
The NICORE Model NCP-1 is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.
Product codes
DRN
Device Description
The NICORE Model NCP-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 muscles of the calves, thighs, and 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, thighs, and 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
A clinical study was completed to compare the NCP-1 device with the predicate. The study used nine healthy volunteers, average age 44 (range 29-59). Following screening, the subjects were randomly assigned to each device in an alternating manner and the sequential readings were taken at treatment pressures of 0.15 KPa, 0.20, 0.25, 0.30, 0.35, and 0.40 KPa. After a 90-minute rest, the subjects underwent final treatment on the other brand of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. The study used nine healthy volunteers, average age 44 (range 29-59). Data collected included the degree of diastolic augmentation. This was measured as a ratio of peak diastolic to peak systolic pressure, as determined by measurement and calculation of the amplitude and area of the representation of the patient's pulse pressure wave. The mean for the amplitude ratio on the NICORE device was 1.50, as compared to the Vasomedical device of 1.51. The mean for the area ratio on the NICORE device was 1.84 and on the Vasomedical device was 1.82. The means for the two ratios are within one standard deviation of the overall mean of the combined data. The combined amplitude ratio overall mean for both devices was 1.50 at one standard deviation of 0.62; for the area relation for both devices, the combined overall mean was 1.83, at one standard deviation of 0.82.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean amplitude ratio: NICORE device 1.50, Vasomedical device 1.51.
Mean area ratio: NICORE device 1.84, Vasomedical device 1.82.
Combined amplitude ratio overall mean for both devices: 1.50 at one standard deviation of 0.62.
Combined area ratio overall mean for both devices: 1.83, at one standard deviation of 0.82.
Predicate Device(s)
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
4897 W. Waters Avenue, Suite J Tampa, Florida 33634 Tel: (813) 901-0019 Fax: (813) 901-0415
DEC (1 4 2002
Premarket Notification [510(k)] Summary
- Submitted by: NICORE, Inc. 4897 W. Waters Ave., Suite J Tampa, FL 33634 Telephone: (813) 901-0019 Fax: (813) 901-0415
-
- Contact person: Jeff Mogilewicz Quality Assurance Manager
3. Name of the Device
- NICORE Model NCP-1 External Counterpulsation Device a. Trade Name:
- External Counterpulsation Device (ECP) b. Common Name:
- c. Classification Name: Counter-pulsating 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 NCP-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 muscles of the calves, thighs, and buttocks to achieve the desired therapy.
6. Intended use of the Device:
Current Indications for use includes treatment of patients with:
- Stable and unstable angina pectoris .
- Acute myocardial infarction .
- Cardiogenic shock ●
- . Congestive Heart Failure
1
7. Summary Comparison of Technological Characteristics to Predicate Device
Technological characteristics of this device which are similar to those of the predicate include: The number of major components (four); the triggering mechanism (patient's ECG R-wave); manual controls; non-PC based; emergency system power down; external strip chart recorder; circuit boards; maximum pressure used for treatment.
Technological characteristics of this device which are different than the predicate include: Through-hole circuit board versus a handwired/soldered board; patient's call button; operator's console displays more data simultaneously; pressure cuffs are vacuum deflated; treatment surface is contoured for safety and comfort; safety interlock requiring external ECG signal before treatment can start; air pump and air supply hoses are housed within the treatment table.
8. Discussion of Clinical Tests
Prior to marketing approval of the NCP-1 a clinical study was completed to compare the NCP-1 device with the predicate. The study used nine healthy volunteers, average age 44 (range 29-59). Following screening, the subjects were randomly assigned to each device in an alternating manner and the sequential readings were taken at treatment pressures of 0.15 KPa, 0.20, 0.25, 0.30, 0.35, and 0.40 KPa. After a 90-minute rest, the subjects underwent final treatment on the other brand of the device.
Data collected included the degree of diastolic augmentation. This was measured as a ratio of peak diastolic to peak systolic pressure, as determined by measurement and calculation of the amplitude and area of the representation of the patient's pulse pressure wave. The mean for the amplitude ratio on the NICORE device was 1.50, as compared to the Vasomedical device of 1.51. The mean for the area ratio on the NICORE device was 1.84 and on the Vasomedical device was 1.82. The means for the two ratios are within one standard deviation of the overall mean of the combined data. The combined amplitude ratio overall mean for both devices was 1.50 at one standard deviation of 0.62; for the area relation for both devices, the combined overall mean was 1.83, at one standard deviation of 0.82
9. Summary of Conclusions Drawn from Clinical Tests
Based on the testing performed on the test subjects, data analysis of the results indicates that the two sets of data obtained from the NICORE and Vasomedical devices belong to the same population and are therefore substantially equivalent,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
C 04 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NICORE, Inc. c/o Mr. Jeff Mogilewicz Quality Assurance Manager 4897 W. Waters Avenue, Suite J Tampa, FL 33634
Rc: K023016
Trade Name: NICORE Model NCP-1 External Counterpulsation Device Regulation Number: 21 CFR 870.5225 Regulation Name: External Counterpulsation Device Regulatory Class: Class III (three) Product Code: DRN Dated: September 6, 2002 Received: September 10, 2002
Dear Mr. Mogilewicz:
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. Iisting 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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Jeff Mogilewicz
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Qutur
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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510(k) Number (if known): K023016
Device Name: NICORE Model NCP-1 External Counterpulsation Device
Indications For Use: The NICORE Model NCP-1 is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Oatter
510(k) Number K023016
(Optional Format 3-10-98)
X Prescription Use