Enhanced External Counter Pulsation Device Plus Omay-A

K191955 · Omay(Guangzhou)Med Technologies Co., Ltd. · DRN · Aug 5, 2020 · Cardiovascular

Device Facts

• Record ID: K191955
• Device Name: Enhanced External Counter Pulsation Device Plus Omay-A
• Applicant: Omay(Guangzhou)Med Technologies Co., Ltd.
• Product Code: DRN · Cardiovascular
• Decision Date: Aug 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OM-A 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.

Device Story

Computer-controlled external counterpulsation system; applies sequential pneumatic pressure to lower extremities (calves, thighs, buttocks) synchronized with cardiac cycle. Inputs: ECG signals (R-wave detection) via electrodes. Operation: Sequential inflation during diastole increases coronary perfusion/venous return; rapid deflation before systole reduces vascular impedance/cardiac workload. Used in clinical settings under healthcare professional oversight. Output: Hemodynamic augmentation (diastolic pressure increase, systolic unloading). Benefits: Improved coronary blood flow and reduced cardiac workload for angina patients.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10) and electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Computer-controlled pneumatic system; Windows-based microprocessor. Components: Base unit, air tubes, ECG/SpO2 sensors, inflatable cuffs. Pressure range: 5-350 mmHg. Connectivity: ECG/SpO2 monitoring. Safety standards: IEC 60601-1, IEC 60601-1-2. Biocompatibility: ISO 10993-5, ISO 10993-10. Triggering: R-wave detection.

Indications for Use

Indicated for patients with chronic stable angina refractory to optimal medical therapy without revascularization options, and for healthy patients to improve vasodilation and blood flow. Used under healthcare professional oversight.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• External Counterpulsation Device with SPO2 Monitoring Model: P-ECP/TI (K130439)

Reference Devices

• External Counterpulsation System Model: ECP-MC3 (K190683)

Submission Summary (Full Text)

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August 5, 2020

Omay(Guangzhou)Med Technologies Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen. 518067 Cn

Re: K191955

Trade/Device Name: Enhanced External Counter Pulsation Device Plus Omay-A Regulation Number: 21 CFR 870.5225 Regulation Name: External counter-pulsating device Regulatory Class: Class II Product Code: DRN Dated: July 6, 2020 Received: July 6, 2020

Dear Kevin Wang:

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.

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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); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191955

### Device Name

Enhanced External Counter Pulsation Device Plus Omay-A

### Indications for Use (Describe)

The OM-A 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) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

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# 510(K) Summary

### Prepared in accordance with the requirements of 21 CFR Part 807.92

### Prepared Date: 2019/11/05

#### 1. Submission sponsor

Name: Omay (Guangzhou) Med Technologies Co., Ltd. Address: Room 302, 3F, No. 600-1, Guangshan 2nd Road, Tianhe Dist. Guangzhou, China. Contact person: Peixian Su Title: General Manager E-mail: [e-mail] Tel: [phone]

#### 2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd. Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: [e-mail]

Tel: [phone]

| Trade/Device Name | Enhanced External Counter Pulsation Device Plus Omay-A |
|-------------------|--------------------------------------------------------|
| Model | OM-A |
| Common Name | External Counter-Pulsation Device |
| Regulatory Class | Class II |
| Classification | 870.5225 / Device, Counter-Pulsating, External / DRN |
| Submission type | Traditional 510(K) |

#### 3. Subject Device Information

#### Predicate Device 4.

1) Primary Predicate Device Sponsor: Chongqing Psk Sci-tech Development Co., Ltd. Trade/Device Name: External Counterpulsation Device with SPO2 Monitoring Model: P-ECP/TI 510(k) #: K130439

2) Reference Device Sponsor: Vamed Medical Instrument Co., Ltd. Device Name: External Counterpulsation System Model: ECP-MC3 510(k) #: K190683

#### 5. Device Description

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Enhanced External Counterpulsation Device Plus OM-A is a computer-controlled system that applies external pressure via cuffs to the patient's lower extremities in synchronization with the patient's cardiac cycle. When the heart is in its relaxed state (diastole), pressure is applied sequentially; distal to proximal, from the lower legs (calves) to the lower thighs and then the upper thighs and buttocks, to propel blood back to the heart. The consequence is an increase in arterial blood pressure during diastole (diastolic augmentation) resulting in increased coronary perfusion pressure and coronary blood flow. Compression of the extremities also results in an increase in venous return to the heart. Just before the heart ejects blood (systole), air is released rapidly from all the cuffs simultaneously to release the externally applied pressure, allowing the compressed vessels to recover to their normal shape, thereby reducing vascular impedance. As a result, arterial pressure during systole is reduced (systolic unloading), as is cardiac workload. The patient's calves, lower thighs and buttocks are wrapped with cuffs containing air bladders. The patient's ECG is monitored via conventional, high-quality electrodes and detection of the R-wave is used to signal the System when to command sequential inflation of the cuffs. The start and duration of inflation, as well as the start of deflation, are adjustable by the Operator, within limits determined by the System. An algorithm is used to prevent the start of inflation during ejection of blood from the heart and to end inflation and begin deflation prior to the occurrence of the next heartbeat. The pressure applied by the cuffs is also adjustable by the Operator from 150mmHg to 300mmHg (for a patient with a heart rate of 60 bpm). The device also utilizes the following cleared components:

ECG/EKG and SpO2: K123711

#### 6. Intended use & Indication for use

The OM-A 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.

| Features | Subject Device | Primary Predicate Device | Conclusion |
|--------------------------------|------------------------------------------------|-------------------------------------------------|------------|
| | OM-A | K130439 P-ECP/TI | |
| Applicant | Omay (Guangzhou) Med<br>Technologies Co., Ltd. | Chongqing PSK Sci-tech<br>Development Co., Ltd. | / |
| Classification<br>n Regulation | 21CRF 870.5225 | 21CRF 870.5225 | Same |
| Product<br>Code | DRN | DRN | Same |
| Common<br>name | Counter-Pulsating, External | Counter-Pulsating, External | Same |
| Triggering<br>Mechanism | R-Wave trigger | R-Wave trigger | Same |

#### 7. Comparison to the Predicate Device

## Comparison to Primary Predicate Device under K130436

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| Features | Subject Device<br>OM-A | Primary Predicate Device<br>K130439 P-ECP/TI | Conclusion |
|-----------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------|
| Microproces<br>sor | Windows Based | Windows Based | Same |
| Emergency<br>System<br>power-down | Red | Red | Same |
| Pressure<br>setting | Setting range:<br>5mmHg to 350mmHg<br>Setting step: 1mmHg<br>Error: ± 10mmHg | Setting range: 1kPa~50kPa<br>Setting step: 1kPa<br>Error: ± 2kPa | Different<br>(1) |
| Treatment<br>time | Setting range: 1min~45min | Setting range: 1min~60min | Different<br>(2) |
| Cuff system | Three parts, calf, thigh and<br>buttocks. | Three parts, calf, thigh and<br>buttocks. | Same |
| Dimension/<br>Weight | 2000mm × 800mm × 700mm,<br>180kg | 2070mm × 1120mm × 1100mm,<br>220kg | Different<br>(3) |
| Major<br>components | Base Unit, Air-Tubes, ECG<br>SPO2 and three Cuffs | Base Unit, Air-Tubes, ECG SPO2<br>and three Cuffs | Same |
| Operating<br>Environment | 10°C ~30°C;<br>Relative humidity: less than<br>85%;<br>Atmospheric pressure:<br>70kPa~106kPa | 10°C ~30°C;<br>Relative humidity: less than 85%;<br>Atmospheric pressure:<br>70kPa~106kPa | Same |
| Safety and<br>EMC | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Same |

Justifications for differences between proposed device and the primary predicate device are shown as below:

Different (1) Pressure setting: The subject device's range of pressure is within predicate device. The error is less than predicate device. Thus, this difference will not cause any safety and effectiveness issues. Different (2) Treatment time: The subject device's range of treatment time is within predicate device. Thus, this difference will not cause any safety and effectiveness issues.

Different (3) Dimension/Weight: This feature is not related to clinical use and it is only a design consideration. Thus, this difference will not cause any safety and effectiveness issues.

Comparison to Reference Device under K190683

| Features | Subject Device<br>OM-A | Reference Device K190683 ECP-<br>MC3 | Conclusion |
|-----------|------------------------|--------------------------------------|------------|
| Applicant | Omay (Guangzhou) Med | Vamed Medical Instrument Co., | / |

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| Features | Subject Device<br>OM-A | Reference Device K190683 ECP-<br>MC3 | Conclusion |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification<br>n Regulation | Technologies Co., Ltd.<br>21CRF 870.5225 | Ltd.<br>21CRF 870.5225 | Same |
| Product<br>Code | DRN | DRN | Same |
| Common<br>name | Counter-Pulsating, External | Counter-Pulsating, External | Same |
| Indication<br>for use | The OM-A device is intended for<br>the treatment of chronic stable<br>angina that is refractory to<br>optimal anti-anginal medical<br>therapy and without options for<br>revascularization. In addition, it<br>is intended for use in healthy<br>patients to provide improvement<br>in vasodilation, and increased<br>blood flow. It is intended for use<br>under the oversight of a<br>healthcare professional. | The ECP-MC3 device is intended<br>for the treatment of chronic stable<br>angina that is refractory to optimal<br>anti-anginal medical therapy and<br>without options for<br>revascularization. In addition, it is<br>intended for use in healthy patients<br>to provide improvement in<br>vasodilation, and increased blood<br>flow. It is intended for use under the<br>oversight of a healthcare<br>professional. | Same |

#### Performance Data 8.

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the OM-A was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

- . Cytotoxicity
- o Sensitization
- Irritation .

The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.

## Non-clinical data

The OM-A Enhanced External Counter Pulsation Device Plus Omay-A have been tested according to the following standards:

- . IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-

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Part 1: General requirements for basic safety and essential performance

- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
The test was selected to show substantial equivalence between the subject device and the predicate.

### Clinical data

Clinical data were not required in this submission to support a finding of substantial equivalence.

#### 9. Conclusion

We conclude that the information provided in this submission is sufficient to demonstrate that the OM-A Enhanced External Counter Pulsation Device is substantially equivalent to the predicate device which is currently marketed for the same intended use.