(176 days)
The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
ECP-MC3 is the most updated designed External Counter Pulsation System for non-invasive treatment of certain cardiovascular and other ischemia related diseases. The ECP-MC3 system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastole begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.
The provided text describes the 510(k) premarket notification for the "External Counter Pulsation System; Model ECP-MC3". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device's efficacy through clinical trials or detailed performance metrics against defined acceptance criteria typically seen for AI/ML devices. As such, the standard information requested for AI/ML device acceptance criteria and study design is not present in this document.
Here's a breakdown of why this document doesn't contain the requested information:
- Device Type: The ECP-MC3 is an External Counterpulsation System, a mechanical medical device, not an AI/ML diagnostic or therapeutic device.
- Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile, or if there are differences, they do not raise new questions of safety or effectiveness. This is different from the rigorous performance testing and clinical trials often required for novel or AI/ML-driven devices.
- Focus of Testing: The non-clinical testing mentioned focuses on reliability, pressure control timing, pressure range accuracy, electrical safety, electromagnetic compatibility (EMC), and software verification/validation. These are standard engineering and safety tests for this type of device, not an assessment of AI algorithm performance.
- Lack of AI/ML Specifics: There is no mention of algorithms, machine learning models, training data, ground truth establishment, expert readers, or MRMC studies, which are all pertinent to AI/ML device evaluations.
Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and reported performance, nor can I detail the specifics of an AI/ML study (sample size, experts, adjudication, MRMC, standalone performance, training data) because this information is not applicable to or contained within the provided 510(k) summary for the ECP-MC3 device.
The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." and "Clinical performance is not deemed necessary." This further emphasizes that direct performance measurement against clinical outcomes or a specific ground truth, as would be expected for an AI/ML device, was not part of this regulatory submission.
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September 10, 2019
Vamed Medical Instrument Co., Ltd % Jet Li Regulation Manager Guangzhou KEDA Testing Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, 510060 Cn
Re: K190683
Trade/Device Name: External Counter Pulsation System; Model ECP-MC3 Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class II Product Code: DRN Dated: September 1, 2019 Received: September 5, 2019
Dear Jet Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190683
Device Name
External Counterpulsation System; Model ECP-MC3
Indications for Use (Describe)
The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 870.5225, and there were no prior submissions for the subject device.
1. Submitter Information
Sponsor: Vamed Medical Instrument Co., Ltd
Address: 1 of 8 Floor, 2# Building, No. 60, Langbao West Road, Chancheng District, Foshan City,
GuangDong, P. R. China.
Contact Person: Ji Ma
Title: General Manager
Phone: +86-757-83817601
E-mail: mj@vamed.com.cn
Application Correspondent: Jet Li
Company: Guangzhou KEDA Biological Technology Co., Ltd
E-mail: med-jl @foxmail.com
Phone: 86-18588874857
Address: 6F, No. 1 TianTairoad, Science City, LuoGang District, GuangZhou City, China
2. Subject Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | External Counterpulsation System |
| Model: | ECP-MC3 |
| Classification Name: | External counter-pulsating device |
| Review Panel: | Cardiovascular |
| Product Code: | DRN |
| Regulation Number: | 21 CFR 870.5225 |
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Regulation Class:
3. Predicate De vice Information
- Primary Predicate Device
Sponsor: Chongqing Psk Sci-tech Devolpment Co., Ltd.
2
510K number: K130439
Trade/Device Name: External Counterpulsation Device with SP02 Monitoring
Model: P-ECP/TI
Regulation Number: 21 CFR 870.5225
Repletion Name: External Counter-Pulsating Device
Regulatory Class: Class II
Product Code: DRN
- Secondary Predicate Device Sponsor: Xtreem Pulse, LLC Device Name: External Counter-Pulsation Device Model: PureFlow Classification Name: External counter-pulsating device 510(k) number: K173483 Review Panel: Cardiovascular Product Code: DRN Regulation Number: 21 CFR 870.5225
Device Description 4.
ECP-MC3 is the most updated designed External Counter Pulsation System for non-invasive treatment of certain cardiovascular and other ischemia related diseases.
The ECP-MC3 system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastole begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and
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raising cardiac output.
The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel.
Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.
5. IntendedUse
The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
Non clinical testing: 6.
The following performance data were provided in support of the substantial equivalence determination.
Reliability test : >
The device was evaluated for reliability for lifetime of three years, based on information provided by the manufacturer estimated use conditions according to CFR21 sec. 870.5225.
> Performance Testing before and after reliability test
Performance of subject device was evaluated according to CFR21 sec. 870.5225 for below testing item:
Pressure Control Timing Testing
The device was evaluated for synchronization of therapy with the appropriate phase of cardiac cycle or functionality of alarms per the special control in 21 CFR 870.5225. The Trigger Mechanism (R- wave trigger), Trigger range and External trigger ratio were tested and met the acceptance criteria (comparing to predicate device).
Pressure Range Accuracy Testing
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Pressure was set for each device, and the actual pressure was measured to check if accuracy is verified.
Referenced standard used was GB 10035-2017 Air-bagtype sequential external counter-pulsation device. The measurement Pressure difference was less than +/- 10% from the set pressure value.
A Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device, and was found to comply with IEC 60601-1 and 60601-1-2.
And the device was also evaluated to comply with IEC60601-1-6 for General Requirements For Usability; and IEC60601-1-8 General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems
Detail standard lists is as below items:
- -IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012
- -IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- -IEC 60601-1-6 Edition 3.1 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC 60601-1-8: 2006 (Second Edition) + Am.1: 2012 Medical Electrical Equipment Part -1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems
Software Verification and Validation Testing >
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.
7. Clinical Testing
Clinical data were not required in this submission to support a finding of substantial equivalence.
Comparison to Predicate Device 8.
Compare with predicate device, the subject device is very similar in design principle, intended
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use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device( Primary ) | PredicateDevice (Secondary) | Verdict |
|---|---|---|---|---|
| Manufacturer | Vamed Medical InstrumentCo., Ltd | Chongqing Psk Sci-tech Devolpment Co.,Ltd | Xtreem Pulse, LLC | -- |
| K number | K190683 | K130439 | K173483 | |
| Product Name | External CounterpulsationSystemECP-MC3 | ExternalCounterpulsationDevice P-ECP/TI | External Counter-Pulsation DevicePureFlow | -- |
| Classification Name | External counter-pulsatingdevice | External counter-pulsating device | External counter-pulsating device | |
| Regulation Class | 2 | 2 | 2 | |
| Regulation Number | 21 CFR 870.5225 | 21 CFR 870.5225 | 21 CFR 870.5225 | |
| Indications for Use | The ECP-MC3 device isintended for the treatment ofchronic stable angina that isrefractory to optimal anti-anginal medical therapy andwithout options forrevascularization. In addition,it is intended for use inhealthy patients to provideimprovement in vasodilation,and increased blood flow. It isintended for use under theoversight of a healthcareprofessional. | The intended use ofthe ECP device is toprovide externalcounterpulsation(ECP) therapy, and isindicated for use inthe treatment ofstable or unstableangina pectoris,congestive heartfailure, cardiogenicshock and acutemyocardial infarction. | The Pure FlowExternal Counter-Pulsation device isintended for thetreatment of chronicstable angina that isrefractory to optimalanti-anginal medicaltherapy and withoutoptions forrevascularization. Inaddition, it isintended for use inhealthy patients toprovideimprovement invasodilation,increased VO2, andincreased bloodflow. It is intendedfor use under the | SENote 1 |
| Elementsof | Subject Device | Predicate Device | Predicate | Verdict |
| Comparison | ( Primary ) | Device(Secondary) | ||
| oversight of ahealthcareprofessional. | ||||
| Device DesignTriggeringMechanism | R-Wave trigger for inflation | R-Wave trigger forinflation | T-Wave trigger forinflation and P-Wavedeflation timing | SE |
| Microprocessor | Windows Based | Windows Based | Windows Based | SE |
| Emergency Systempower-down | Patient Emergency StopButton | Patient EmergencyStop Button | Red-EmergencyStop Button | SE |
| Maximum pressureused fortreatment/timersettings | 50kPa0 to 120min, defaulted as60min | 0-350mmHg0 to 60min | 4.0 psi(=27.58kPa)Timer: 1-60 minutes(Single minuteincrements) | SE |
| CounterpulsationDuty | 1:1 or 1:2 to choose | 1:1 or 1:2 | 1:1 or 1:2 | SE |
| Cuff system | the Calf Cuff, the Lower ThighCuff and the Upper Cuff | the Calf Cuff, theLower Thigh Cuff andthe Upper Cuff | Nylon fabric cuffs,three parts, calf,thigh and buttocks. | SE |
| Major components | Counterpulsation Bed, Cuffkits, ECG Cable, IntegratedFinger Sensor | Counterpulsation Bed.Cuff kits, ECG Cable,Integrated FingerSensor , SPO2 | Base Unit, Air-Tubes, EKC, SPO2,EKG and three Cuffs | SENote 2 |
| Voltage/Hz/Wattage | AC 120V60Hz | AC 120V60Hz | 100-240V50/60HZ | SENote 3 |
| Dimension/Weight | 2160×810×650(mm)255kg | 2070mmX1120mmX1100mm204KG | 1250mmX700mmX500mm120KG | SENote 3 |
| OperatingEnvironment | Temperature: 10 | Temperature:10~30℃Relative Humidity: ≤80% | Temperature: 10℃ to30°C ( 50°F - 86°F)Humidity: 30% to | SENote 3 |
| Elementsof | Subject Device | Predicate Device | Predicate | Verdict |
| Comparison | ( Primary ) | Device(Secondary) | ||
| AtmosphericPressure:86kPa~106kPa | 75% RH (non-condensing)Barometric Pressure:80kPA to 100kPA | |||
| FDA-Recognized Standards | ||||
| Electrical safety,EMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2IEC 60601-1-6 | SE |
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Note 1
Although there is little difference for illustration about the indication for use, the description of the predicate device is more specified, yet their meanings are the same. This difference does not affect the safety and effectiveness.
Note 2
Although the subject device does not provide with SPO2, since it is not provided with the function for monitoring SPO2; but the treatment is supervised by the qualified physician, so for the subject device's intended use, SPO2 is not mandatory and it will not affect the safety and effectiveness.
Note 3
Although the device design and part of functional parameters between the predicate device and subject device are different, they are both complied with IEC 60601-1. So the minor differences on such parameters do not affect the safety and effectiveness.
9. Summary for clinical test
Clinical performance is not deemed necessary.
10. Conclusion
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The subject device External Counterpulsation System has all features of the predicate device for intended use.
Through the reliability testing, it demonstrate that the subject device is as effective and performs as well as the predicate device in its lifetime; And through the performance testing, the device was tested and demonstrated for its synchronization of therapy and pressure control accuracy.
The non- clinical tests demonstrate that subject device is as safe, as effective, and performs as well as the predicate device(s). Thus, the subject device is substantially equivalent to the predicate device.
11. Summary Prepared Date
17 July. 2019
§ 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.