(29 days)
The External Counterpulsation System, Soulaire 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.
The External Counterpulsation System, Soulaire device has similar design to the External Counterpulsation System Model ECP-MC3.
The Soulaire 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 diastde 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.
This FDA 510(k) summary does not contain information about acceptance criteria or specific study results for the Soulaire External Counterpulsation System.
The document indicates that the Soulaire device is a modification of a previously cleared predicate device (ECP-MC3, K190683). The modifications described are primarily related to external structure (adding storage drawers, a keyboard tray, an integrated cool air outlet), changes in dimensions and weight, and a software company logo change.
Crucially, the document states that these modifications did not result in changes to the technological characteristics or performance of the device. Therefore, the submission leverages performance and electrical testing from the previous submission (K190683) and concludes that "Clinical performance is not deemed necessary."
This means:
- Acceptance criteria and reported device performance: Not applicable from this document, as no new performance data was generated for the modified device. The document asserts that the modified device's performance is equivalent to the predicate.
- Sample size for test set and data provenance: No new test set data or studies are presented.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted or reported in this document.
- Standalone (algorithm only) performance: Not applicable, as this device is not an algorithm-only diagnostic device. It's a therapeutic medical device for physical counterpulsation.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In essence, the Soulaire device's clearance is based on its similarity to a previously cleared device, with the argument that the minor changes do not impact safety or effectiveness. Therefore, no new clinical or performance studies were provided for this specific 510(k) submission. To understand the original acceptance criteria and studies for the predicate device (ECP-MC3, K190683), one would need to refer to its 510(k) submission documentation.
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August 28, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vamed Medical Instrument Co., Ltd. % Jet Li Regulation Manager Guangzhou Keda Biological Tech Co., Ltd. 6F, No. 1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong 510060 China
Re: K202108
Trade/Device Name: External Counterpulsation System, Soulaire Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class II Product Code: DRN Dated: July 27, 2020 Received: July 30, 2020
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
for Fernando Aguel Assistant Director Division of Circulatory Support, Structural and Vascular Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
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@vesselmed.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 TianTai road, Science City, LuoGang District, GuangZhou City, China
2 Subject Device Information
Type of 510(k) submission: Special 510(k): Device Modification Common Name: External Counterpulsation System , Soulaire Classification Name: External counter-pulsating device Review Panel: Cardiovascular Product Code: DRN Regulation Number: 21 CFR 870.5225 Regulation Class: 2
3 Legally marketed device (predicate device) Information
Common Name: External Counterpulsation System Model: ECP-MC3 510(K) Number: K190683 Classification Name: External counter-pulsating device Review Panel: Cardiovascular Product Code: DRN Regulation Number: 21 CFR 870.5225 Regulation Class: 2
4 Device Description
The External Counterpulsation System, Soulaire device has similar design to the External
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Counterpulsation System Model ECP-MC3.
The Soulaire 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 diastde 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.
5 Indication for Use
The External Counterpulsation System, Soulaire 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.
6 Complied Standards
External Counterpulsation System, Soulaire complies with the following FDA recognized consensus standards:
- ANSI/AAMI ES60601-1:2005 + A1:2012, C1:2009 and A2:2010 Medical Electrical 区 Equipment - Part 1: General Requirements for Safety
- 区 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
- മ IEC 60601-1-6 Edition 3.1 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- 区 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
- Guidance for the Content of Premarket Submissions for Software Contained in 区 Medical Devices.
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7 Device modification description
All the modifications of subject device are shown in the following table as below, and no other changes were made to legally existing predicate device.
| Item | Designmodification | Before modification(K190683) | After modification |
|---|---|---|---|
| Labeling | Model name | ECP-MC3 | Soulaire |
| Software | Company logo | Image: Amed MEDICAL logo | Image: S2 logo |
| Devicedesign | Add 3 storagedrawers | Image: Storage drawers before modification | Image: Storage drawers after modification |
| Add keyboardtray | |||
| Integrated Coolair outlet | Image: Cool air outlet before modification | Image: Cool air outlet after modification | |
| Dimensions | 2160x810x650(mm) | 2240x940x970(mm) | |
| Weight | 255kg | 300kg |
8 Performance Testing
As the modifications of subject device as below, results in no technological characteristics changes, the tests and data utilized to demonstrate the substantial equivalence of the predicate devices are suitable for use in the assessment of the subject devices.
As there have been no changes to the performance of the subject devices from the predicate devices, this submission leverages performance and electrical testing provided in previous submissions.
9 Biocompatibility
All the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing. No biocompatibility test report is provided in this submission.
Clinical performance 10
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Clinical performance is not deemed necessary.
11 Comparison with predicate device
Compare with predicate device (External Counterpulsation System ECP-MC3 (K190683)), the subject device (External Counterpulsation System, Soulaire) is very similar in design principle, intended 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.
| Item | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Vamed Medical Instrument Co., Ltd | Vamed Medical Instrument Co., Ltd | -- |
| K number | TBD | K190683 | -- |
| Product Name | External Counterpulsation System,Soulaire | External Counterpulsation SystemECP-MC3 | -- |
| Regulation &Classification | External counter-pulsating deviceDRNClass 221 CFR 870.5225 | External counter-pulsating deviceDRNClass 221 CFR 870.5225 | Same |
| Indications for Use | The External CounterpulsationSystem, Soulaire device is intendedfor the treatment of chronic stableangina that is refractory to optimalanti-anginal medical therapy andwithout options for revascularization.In addition, it is intended for use inhealthy patients to provideimprovement in vasodilation, andincreased blood flow. It is intendedfor use under the oversight of ahealthcare professional. | The ECP-MC3 device is intended forthe treatment of chronic stableangina that is refractory to optimalanti-anginal medical therapy andwithout options for revascularization.In addition, it is intended for use inhealthy patients to provideimprovement in vasodilation, andincreased blood flow. It is intendedfor use under the oversight of ahealthcare professional. | SE |
| Device design | |||
| TriggeringMechanism | R-Wave trigger for inflation | R-Wave trigger for inflation | Same |
| Microprocessor | Windows Based | Windows Based | Same |
| Emergency Systempower-down | Patient Emergency Stop Button | Patient Emergency Stop Button | Same |
| Maximum pressureused fortreatment/timersettings | 50kPa0 to 120min, defaulted as 60min | 50kPa0 to 120min, defaulted as 60min | Same |
| CounterpulsationDuty | 1:1 or 1:2 to choose | 1:1 or 1:2 to choose | Same |
| Cuff system | the Calf Cuff, the Lower Thigh Cuffand the Upper Cuff | the Calf Cuff, the Lower Thigh Cuffand the Upper Cuff | Same |
| Major components | Counterpulsation Bed, Cuff kits, ECG | Counterpulsation Bed, Cuff kits, ECG | Same |
| Cable, Integrated Finger Sensor | Cable, Integrated Finger Sensor | ||
| Voltage/Hz/Wattage | AC 120V60Hz | AC 120V60Hz | Same |
| Dimension | 2240x940x970(mm) | 2160x810x650(mm) | SE |
| Weight | 300kg | 255kg | Note 1 |
| OperatingEnvironment | Temperature: 10 | Temperature: 10 | Same |
| FDA-Recognized Standards | |||
| Electrical safety,EMC | IEC 60601-1, IEC 60601-1-2, IEC60601-1-6, IEC 60601-1-8 | IEC 60601-1, IEC 60601-1-2, IEC60601-1-6, IEC 60601-1-8 | Same |
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Note 1
Although the dimension and weight of subject device are little difference to the legally existing predicate device, the modification of subject device is only about the external structure and company logo in software, not involved with technical specifications, so the difference does not affect the substantial equivalence.
Conclusion
The subject device (External Counterpulsation System, Soulaire) has all features of the predicate device for intended use. Thus, the subject device is as safe and effective as the predicate device.
12 Summary Prepared Date:
05 May. 2020
§ 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.