(93 days)
Not Found
No
The description details a microprocessor-controlled system with a closed-loop control for pressure and operator-set timing based on ECG. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive learning. The system appears to be based on pre-programmed logic and operator input.
Yes
The device is described as an External Counterpulsation Device (ECP) with indications for treating various cardiac conditions like angina, myocardial infarction, cardiogenic shock, and congestive heart failure. Its mechanism of action, involving controlled compression and decompression of vascular beds to improve blood flow and reduce cardiac workload, directly addresses a medical condition, which is the definition of a therapeutic device.
No
The device is described as a treatment device that inflates and deflates cuffs to compress vascular beds, aiming to achieve therapeutic effects like increasing coronary perfusion and reducing cardiac workload. Its stated purpose is "therary" (therapy). While it processes patient data (ECG, plethysmograph, pressure) to control the treatment, its primary function is not to diagnose conditions but to apply a physical intervention.
No
The device description clearly outlines multiple hardware components including a Control Console, Treatment Bed, patient Cuffs, air compressor, valves, and a motorized lifting mechanism, in addition to the software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications listed (Stable Angina Pectoris, Unstable Angina Pectoris, Acute Myocardial Infarction, Cardiogenic Shock, Congestive Heart Failure) are all clinical conditions related to the cardiovascular system. IVDs are used to diagnose diseases or conditions in vitro (outside the body) using samples like blood, urine, or tissue.
- Device Description: The device description clearly outlines a system that applies external pressure to the patient's body (calves, thighs, buttocks) to influence blood flow. This is a physical intervention, not an in vitro diagnostic test.
- Mechanism of Action: The description explains how the device inflates and deflates cuffs to augment diastolic pressure and reduce afterload. This is a therapeutic mechanism, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens outside the body, which are hallmarks of IVD devices.
The device is an External Counterpulsation (ECP) device, which is a therapeutic device used to treat certain cardiovascular conditions.
N/A
Intended Use / Indications for Use
- ACS Model NCP-2 External Counterpulsation Device is a non-invasive external Counterpulsation device intended for the use in the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock or congestive heart failure.
Product codes (comma separated list FDA assigned to the subject device)
DRN
Device Description
The ACS Model NCP-2 External Counterpulsation Device (ECP) is comprised of three major components, a Control Console, a Treatment Bed, and a set of patient Cuffs. The device 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 therary.
The Control Console is comprised of a signal amplifier module, a power module, a microprocessor control module, a keyboard control panel with trackball, a Liquid Crystal Display (LCD) panel, and a Personal Computer (PC) with storage drives, data entry QERTY keyboard, network card, and printer. Control console input and data from the ECG, finger plethysmograph, and the pressure/vacuum transducers are processed by the microprocessor to control the valve timing and pressure delivered to the cuffs. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set point maintained by a closed-loop control system. Valve inflation and deflation timing is also set by the operator based on the relative position of the R-wave of the patients ECG.
The PC is used to enter patient demographics, record pre and post-treatment data, and process data acquired by the microprocessor module to display user feedback for the ECP treatment on the LCD showing treatment parameters and patient waveforms during use.
An internal hard disk drive is used to store data on the system, a CD/DVD drive is used to record data onto removable media, and a printer is used to produce hard copy of a report that includes all of the pertinent treatment data for individual treatments and a session summary of all treatment data collected for 35 or more days.
The Treatment Bed accommodates the air compressor, a pressure and vacuum reservoir, inflation and deflation valves and a motorized lifting mechanism for the mattress assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation and deflation valves that open and close on command to inflate or deflate the patient Cuffs with air. The valve manifold assembly is connected to the air compressor and pressure/vacuum reservoir components via connecting air hoses. External pressure is delivered to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation.
When the heart is in its relaxed state during the diastolic period, 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 perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return, 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 re-conforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased after-load).
Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calves, thighs, buttocks, lower extremities
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)
Non-clinical testing on the ACS Model NCP-2 External Counterpulsation Device included:
- Software verification and validation, including:
- Functional requirements as defined in the NCP (ESP) System Requirements Specification.
- Boundary values and stress testing as defined by FDA's Guidance for the Content of Premarket Submission for Medical Devices Containing Software, CDRH, ODE, FDA, May, 1998.
- Safety requirements as identified safety risk analysis performed in accordance with EN 1497 1 - 1 Medical Device Risk Analysis, October, 1994, the "Essential Requirements of the Medical Devices Directives", 14 June, 1993, and IEC 601-1-4, Medical Electrical Equipment Part 1 : General requirements for safety. 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
- Testing in support of validation in accordance with the FDA's General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11,2002, and IEC 601-1-4, Medical Electrical Equipment Part 1: General requirements for safety, 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
- Verification of System operation, including:
- Functional requirements as defined in the NCP (ESP) System Requirements Specification to verify the performance of the device at the system level.
- Safety requirements as identified in the safety risk analysis performed in accordance with EN 1497 1 - 1, Medical Device Risk Analysis.
- Additional verification tests, as indicated, to verify performance at the component level recognized standards ISO 10993-1, ISO 10993-5, IS010993-10 and IS0 10993-12.
Clinical Evaluation: An Independent Review Board has overseen the clinical investigation of the External Counterpulsation Device. Results have demonstrated substantial equivalence to the predicate device.
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
K042413
DEC - 9 2004
000758
APPLIED CARDIAC SYSTEMS INC. NCP-2 510 (k) Summary
| 1. Date Prepared: | 24 August 2004 |
|---|---|
| 2. Submitter's Name: | |
| and Address | Applied Cardiac Systems, Inc. |
| 22912 El Pacifico Drive | |
| Laguna Hills, CA 92653 | |
| 3. Contact Person: | R. Ben Ghadimi |
| Senior Vice President of Regulatory Affairs | |
| Applied Cardiac Systems, Inc. | |
| Telephone: (949) 855-9366 | |
| Facsimile: (949) 581-1009 | |
| E-mail: bghadimi@acs.occoxmail.com | |
| 4. Device Name: | ACS Model NCP-2 External Counterpulsation Device |
| Proprietary Name: | ACS Model NCP-2 External Counterpulsation Device |
| Common Name: | External Counterpulsation Device (ECP) |
| Classification Name: | Device, Counter-pulsating, External |
| 5. Predicate Device: | Nicore NCP (ESP) External Counterpulsation Device |
| K980937 and by reference K023016 (adding Congestive | |
| heart failure to the indications for use of the device) |
6. Device Description:
The ACS Model NCP-2 External Counterpulsation Device (ECP) is comprised of three major components, a Control Console, a Treatment Bed, and a set of patient Cuffs. The device 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 therary
1
000759
The Control Console is comprised of a signal amplifier module, a power module, a microprocessor control module, a keyboard control panel with trackball, a Liquid Crystal Display (LCD) panel, and a Personal Computer (PC) with storage drives, data entry QERTY keyboard, network card, and printer. Control console input and data from the ECG, finger plethysmograph, and the pressure/vacuum transducers are processed by the microprocessor to control the valve timing and pressure delivered to the cuffs. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set point maintained by a closed-loop control system. Valve inflation and deflation timing is also set by the operator based on the relative position of the R-wave of the patients ECG.
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
The PC is used to enter patient demographics, record pre and post-treatment data, and process data acquired by the microprocessor module to display user feedback for the ECP treatment on the LCD showing treatment parameters and patient waveforms during use.
An internal hard disk drive is used to store data on the system, a CD/DVD drive is used to record data onto removable media, and a printer is used to produce hard copy of a report that includes all of the pertinent treatment data for individual treatments and a session summary of all treatment data collected for 35 or more days.
The Treatment Bed accommodates the air compressor, a pressure and vacuum reservoir, inflation and deflation valves and a motorized lifting mechanism for the mattress assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation and deflation valves that open and close on command to inflate or deflate the patient Cuffs with air. The valve manifold assembly is connected to the air compressor and pressure/vacuum reservoir components via connecting air hoses. External pressure is delivered to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation.
When the heart is in its relaxed state during the diastolic period, 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 perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return, 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 re-conforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased after-load).
Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.
2
- ACS Model NCP-2 External Counterpulsation Device is a non-7. Intended Use: invasive external Counterpulsation device intended for the use in the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock or congestive heart failure.
8. Comparison of Technological and functional characteristics :
Characteristics of the ACS Model NCP-2 External Counterpulsation Device are identical to the predicate device; Nicore Model NCP (ESP) (K9809770 and (K023016). Principles of operation are identical.
-
- Non-clinical Tests: Non-clinical testing on the ACS Model NCP-2 External Counterpulsation Device included the following:
> Software verification and validation, as follows:
- Functional requirements as defined in the NCP (ESP) System 트 Requirements Specification.
- Boundary values and stress testing as defined by FDA's Guidance 트 for the Content of Premarket Submission for Medical Devices Containing Software, CDRH, ODE, FDA, May, 1998.
- Safety requirements as identified safety risk analysis performed in I accordance with EN 1497 1 - 1 Medical Device Risk Analysis, October, 1994, the "Essential Requirements of the Medical Devices Directives", 14 June, 1993, and IEC 601-1-4, Medical Electrical Equipment Part 1 : General requirements for safety. 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
- Testing in support of validation in accordance with the FDA's 롤 General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11,2002, and IEC 601-1-4, Medical Electrical Equipment Part 1: General requirements for safety, 4 Collateral Standard: Programmable electrical medical systems, 1996-05.
3
000761
> Verification of System operation, as follows:
- Functional requirements as defined in the NCP (ESP) System Requirements Specification to verify the performance of the device at the system level.
- 트 Safety requirements as identified in the safety risk analysis performed in accordance with EN 1497 1 - 1, Medical Device Risk Analysis
- . Additional verification tests, as indicated, to verify performance at the component level recognized standards ISO 10993-1, ISO 10993-5, IS010993-10 and IS0 10993-12.
10. Clinical Evaluation:
An Independent Review Board has overseen the clinical investigation of the External Counterpulsation Device. Results have demonstrated substantial equivalence to the predicate device.
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Applied Cardiac Systems, Inc. c/o Mr. R. Ben Ghadimi Senior Vice President of Regulatory Affairs 22912 El Pacifico Drive Laguna Hills, CA 92653
Re: K042413
ACSTM Model NCP-2 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class III (three) Product Code: DRN Dated: November 22, 2004 Received: November 26, 2004
Dear Mr. Ghadimi:
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.
5
Page 2 - Mr. R. Ben Ghadimi
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) you may obtain. 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,
Duwa R. lacluner
(1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K042413
Device Name: Device, Counterpulsating, External
Indications For Use:
Current indications for use of the ACS™ Model NCP-2 are:
- . Stable Angina Pectoris
- . Unstable Angina Pectoris
- Acute Myocardial Infarction .
- Cardiogenic Shock .
- Congestive Heart Failure
Predicate Indication for Use
Taken from Predicate literature (See also, Predicate Labeling, Section C)
"The Nicore™ Model NCP (ESP) External Counterpulsation System is a non-invasive external counter pulsation device for the treatment of patients suffering from stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock, and congestive heart failure."
Prescription Use Yes (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)
Duma P. Voelker
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non of Cardiovascular Devices
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