(380 days)
No
The description mentions a "computer-controlled system" and an "algorithm" for timing cuff inflation/deflation based on the ECG R-wave. While this involves computation and logic, it does not describe the characteristics of AI or ML, such as learning from data or complex pattern recognition beyond simple timing synchronization. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as being "intended for the treatment of chronic stable angina" and "to provide improvement in vasodilation, and increased blood flow," which are all therapeutic claims.
No
The "Intended Use / Indications for Use" section states that the device is "intended for the treatment of chronic stable angina," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly details hardware components such as cuffs with air bladders, a computer-controlled system, and ECG/EKG and SpO2 monitoring components, which are physical parts of the device, not just software.
Based on the provided information, the OM-A device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of chronic stable angina by applying external pressure to the lower extremities. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system that applies external pressure to the patient's body based on their cardiac cycle. It uses physiological signals (ECG) to control the application of this pressure. This is a physical therapy/treatment device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The OM-A device does not fit this description.
N/A
Intended Use / 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. 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.
Product codes
DRN
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities (calves, lower thighs, upper thighs and buttocks)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under the oversight of a healthcare professional
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)
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, 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- Part 1: General requirements for basic safety and essential performance and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5225 External counter-pulsating device.
(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
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: omay@eecpcn.com Tel: +86-020-37092519
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: kevin@chonconn.com
Tel: +86-755 33941160
| 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.
-
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
-
Reference Device Sponsor: Vamed Medical Instrument Co., Ltd. Device Name: External Counterpulsation System Model: ECP-MC3 510(k) #: K190683
5. Device Description
4
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 | ||
| Technologies Co., Ltd. | Chongqing PSK Sci-tech | ||
| Development Co., Ltd. | / | ||
| Classification | |||
| n Regulation | 21CRF 870.5225 | 21CRF 870.5225 | Same |
| Product | |||
| Code | DRN | DRN | Same |
| Common | |||
| name | Counter-Pulsating, External | Counter-Pulsating, External | Same |
| Triggering | |||
| Mechanism | R-Wave trigger | R-Wave trigger | Same |
7. Comparison to the Predicate Device
Comparison to Primary Predicate Device under K130436
5
| Features | Subject Device
OM-A | Primary Predicate Device
K130439 P-ECP/TI | Conclusion |
|-----------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------|
| Microproces
sor | Windows Based | Windows Based | Same |
| Emergency
System
power-down | Red | Red | Same |
| Pressure
setting | Setting range:
5mmHg to 350mmHg
Setting step: 1mmHg
Error: ± 10mmHg | Setting range: 1kPa50kPa45min | Setting range: 1min~60min | Different
Setting step: 1kPa
Error: ± 2kPa | Different
(1) |
| Treatment
time | Setting range: 1min
(2) |
| Cuff system | Three parts, calf, thigh and
buttocks. | Three parts, calf, thigh and
buttocks. | Same |
| Dimension/
Weight | 2000mm × 800mm × 700mm,
180kg | 2070mm × 1120mm × 1100mm,
220kg | Different
(3) |
| Major
components | Base Unit, Air-Tubes, ECG
SPO2 and three Cuffs | Base Unit, Air-Tubes, ECG SPO2
and three Cuffs | Same |
| Operating
Environment | 10°C 30°C;106kPa | 10°C
Relative humidity: less than
85%;
Atmospheric pressure:
70kPa30°C;106kPa | Same |
Relative humidity: less than 85%;
Atmospheric pressure:
70kPa
| Safety and
EMC | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
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
OM-A | Reference Device K190683 ECP-
MC3 | Conclusion |
|-----------|------------------------|--------------------------------------|------------|
| Applicant | Omay (Guangzhou) Med | Vamed Medical Instrument Co., | / |
6
| Features | Subject Device
OM-A | Reference Device K190683 ECP-
MC3 | Conclusion |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification
n Regulation | Technologies Co., Ltd.
21CRF 870.5225 | Ltd.
21CRF 870.5225 | Same |
| Product
Code | DRN | DRN | Same |
| Common
name | Counter-Pulsating, External | Counter-Pulsating, External | Same |
| 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. | 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. | 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-
7
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.