(164 days)
Not Found
No
The description focuses on mechanical compression and does not mention any AI/ML terms or functionalities.
Yes
The device is intended for the temporary relief of minor muscle aches and pains and for temporary increase in circulation, which are therapeutic claims. Its mechanism of simulating kneading and stroking of tissues also points to a therapeutic function.
No
The document describes the device's function as providing temporary relief for muscle aches and increasing circulation through compression therapy, not for diagnosing any conditions.
No
The device description explicitly states it consists of a "leg sleeve and control device working together as one unit," indicating hardware components beyond just software. The performance studies also include hardware-related testing like biocompatibility, electrical safety, EMC, and seam strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health." This describes a physical therapy or therapeutic device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device works by applying external pressure to the limbs using inflatable garments. This is a mechanical action, not a process involving the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any of the typical components of an IVD.
Therefore, the Overlapped Compression Therapy device falls under the category of a physical therapy or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Overlapped Compression Therapy is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in pood health. The Overlapped Compression Therapy simulates kneading and stroking of tissues by using an inflatable garment.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The Overlapped Compression Therapy consists of leg sleeve and control device working together as one unit. The Overlapped Compression Therapy mainly forms the circulating pressure on the limbs and tissues by repeatedly inflating and deflating the multi cavity chambers in sequence, and evenly, orderly and properly extrudes the distal end of the limbs to the proximal end of the limbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot Calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and/or clinical setting
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 Overlapped Compression Therapy is patient contacting, therefore biocompatibility data is required.
In accordance with ISO 10993, it is surface devices that contact intact skin for a prolonged duration and the appropriate testing is Cytotoxicity, Skin Irritation and Sensitization. The subject device conducted and passed all biocompatibility testing.
Per FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", software verification and validation testing was conducted, and documentation was provided. Verification of the Overlapped Compression Therapy was conducted to ensure that the product works as designed. Validations was conducted to check the design and performance of the product.
The Overlapped Compression Therapy has been tested for conformance with the following electromagnetic compatibility and electrical safety standards.
- ANSI / AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2014 (Fourth Edition) Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
To establish the substantial equivalence of the Overlapped Compression Therapy, XINYI conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
In addition, XINYI has conducted testing to ensure the subject device meet relevant consensus standards.
- IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC60601-1-6: 2013-10 Medical electrical equipment Part 1-6: General requirements ● for basic safety and essential performance - Collateral standard: Usability
Accuracy testing for pressure and time to ensure that the device can achieve the intended maximum pressure and maintain it for the intended treatment time.
Seam strength testing to ensure that the seams of the device do not burst if maximum pressure is exceeded in the device.
Failure mode testing to indicate how the device mitigates the risk of over-pressurization if there is a software failure and the device starts to exceed maximum intended pressure.
Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical studies are not necessary to establish the substantial equivalence of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2022
Huizhou XINYI Technology Co., LTD. Jason Ye Manager Regulatory Affairs, Technical Regulation Department Area (Building 3), Changbu Village Xinwei, Huiyang District Huizhou, Guangzhou 516200 China
Re: K221862
Trade/Device Name: YY-A02-B Overlapped Compression Therapy Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 5, 2022 Received: December 5, 2022
Dear Jason Ye:
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
1
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,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221862
Device Name
YY-A02-B Overlapped Compression Therapy
Indications for Use (Describe)
The Overlapped Compression Therapy is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in pood health. The Overlapped Compression Therapy simulates kneading and stroking of tissues by using an inflatable garment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K221862
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the Overlapped Compression Therapy is provided below.
1. SUBMITTER
| Applicant: | Huizhou XINYI Technology Co., LTD |
|---|---|
| Area (Building 3), Changbu Village, Xinwei, Huiyang District, Huizhou | |
| city, Guangdong Province, P.R.China | |
| Tel: +86 752 3533308 / +8618320209888 | |
| Fax: +86 752 3522225 | |
| Contact: | Jason Ye |
| Title: Quality Manager | |
| Phone: +86 18129657928 | |
| Fax: +86 752 3522225 | |
| E-mail: 13728650049@163.com | |
| Date Prepared: | October 10, 2022 |
2. DEVICE
| Device Common Name: | Overlapped Compression Therapy |
|---|---|
| Device Trade Name: | YY-A02-B Overlapped Compression Therapy |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation: | 21 CFR 890.5650 |
| Primary Product Code: | IRP |
| Regulatory Class: | Class 2 |
| Panel: | Physical Medicine |
3. PREDICATE DEVICE
Predicate Device: K193354 - Air Compression Therapy Device (Shenzhen Dongjilian Electronics Co., Ltd.)
4. DEVICE DESCRIPTION
The Overlapped Compression Therapy consists of leg sleeve and control device working together as one unit. The Overlapped Compression Therapy mainly forms the circulating pressure on the limbs and tissues by repeatedly inflating and deflating the multi cavity chambers in sequence, and evenly, orderly and properly extrudes the distal end of the limbs to the proximal end of the limbs.
The donning instructions are shown below:
- The tracheal interface is marked 'L' and 'R', please wear correctly.
4
Image /page/4/Picture/0 description: The image shows a diagram of how to put on compression stockings. The diagram shows a person holding the top of the stocking and pulling it down over their leg. The diagram also shows a close-up of the toe of the stocking, which is marked with an "L". The diagram is simple and easy to understand.
Image /page/4/Figure/1 description: In the image, a person is shown putting on a compression stocking. The stocking is being held open by two hands, and the person's leg is being inserted into the stocking. The stocking has a reinforced toe and heel, and the letter "R" is visible on the toe of the stocking. The stocking appears to be a medical device used to improve circulation in the legs.
Right Leg Sleeve
Left Leg Sleeve
-
- Wear the warps on your legs correctly.
Image /page/4/Figure/4 description: The image shows a diagram of how to put on compression stockings. The diagram shows a person's leg with a compression stocking being pulled up over it. The stocking is being held by two hands, one on each side. The letter "L" is in the bottom right corner of the image.
- Wear the warps on your legs correctly.
Image /page/4/Figure/5 description: In the image, a hand is shown holding a bandage. The bandage is being rolled up by the fingers of the hand. The bandage is white and has a grid pattern on it. An arrow is pointing to the right, indicating the direction in which the bandage is being rolled.
- Fix all the velcros according to your size, don't wrap too tight.
Image /page/4/Figure/7 description: The image shows three diagrams of a leg being wrapped with a bandage. The first diagram shows hands wrapping the bandage around the leg, starting from the ankle and moving upwards. The second diagram shows the bandage partially wrapped around the leg, and the third diagram shows the bandage fully wrapped around the leg.
5. INTENDED USE/INDICATIONS FOR USE
The YY-A02-B Overlapped Compression Therapy is intended to be used in a home and/or clinical setting for:
The Overlapped Compression Therapy is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Overlapped Compression Therapy simulates kneading and stroking of tissues by using an inflatable garment.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Both the predicate device and subject device are indicated for the temporary relief of minor muscle
5
aches and pains and for temporary increase in circulation to the treated areas.
In conclusion, the minor differences of the indications for use do not change the fundamental intended use of the YY-A02-B Overlapped Compression Therapy
Technological Comparisons
Table below compares the key technological features of the subject device to the predicate device. The features in gray are features which are different between the predicate device and the subject device.
6
| Comparison | Subject device
(K221862) | Primary Predicate device
(K193354) | Comparison |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Huizhou XINYI Technology Co., LTD | Shenzhen Dongjilian Electronics Co.,Ltd. | N/A |
| 510(K) number | K221862 | K193354 | N/A |
| Model name | YY-A02-B | S9019 | N/A |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Type of compression | Air pressure massage | Air pressure massage | Same |
| Indications for Use (IFU) | The Overlapped Compression Therapy is
indicated for the temporary relief of minor muscle
aches and pains and for temporary increase in
circulation to the treated areas in people who are
in good health. The Overlapped Compression
Therapy simulates kneading and stroking of
tissues by using an inflatable garment. | The Air Compression Therapy Device is indicated
for the temporary relief of minor muscle aches
and pains and for temporary increase in
circulation to the treated areas in people who are
in good health. The Air Compression Therapy
Device simulates kneading and stroking of tissues
by using an inflatable garment. | Same |
| Mode of compression | Mode 1 Sequence:
Starting with the foot chamber as progressing up
the chamber for gradually rises to the
predetermined air pressure level, then
decompresses the air pressure drops, then the calf
chamber function working. Once the calf section
decompresses, the cycle begins again. | Mode 1:
Starting with the foot chamber and progressing up
the thigh chamber, each section compresses and
the pressure gradually rises to the pre-determined
air pressure level, then decompresses and the air
pressure drops. Once the thigh section
decompresses, the cycle begins again. | Same |
7
Image /page/7/Picture/0 description: The image shows two modes of operation for a compression device, likely for massage or medical purposes. Mode 1 illustrates a pressure sequence, while Mode 2, labeled as 'Circulation,' allows users to select a specific area for massage, such as the foot or calves, with adjustable pressure settings ranging from 50 mm-Hg to 210 mm-Hg. Mode 2 involves a sequential compression starting from the foot and progressing up the thigh, followed by simultaneous decompression of all sections.
8
| | Mode 3 Whole:
Which is that the foot and calf are massaged at the
same time after selecting the massage pressure(50
mm-Hg/ 90 mm-Hg /130 mm-Hg/170 mm-
Hg/210 mm-Hg). The foot and calf muscle were
massaged through progress-up/decompresses
action, which can relax or reduce the fatigue and
soreness of calf and foot muscles
(1) | Mode 3:
include two stage, stage 1: it work according to
the method of mode 1, after the stage 1 is
completed, it go to stage 2(working according to
the method of mode 2) without interruption time
until finish the stage 2, then enter next cycle
without interruption Mode1→ Mode2
The pressure sequence of mode 3 combines mode
1 and mode 2 | Same |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Level of air pressure and
pressure range | Level 1: 50mmHg
Level 2: 90mmHg
Level 3: 130mmHg
Level 4: 170mmHg
Level 5: 210mmHg | 3 levels settings:
low level:150mmHg
Mid level:185mmHg
High Level: 215mm | Similar
Note 1 |
| Pressure error range | ±10mmHg | ±25mmHg | Different
Note 2 |
| Compression cycle time | 8s-1 min 45s | Range of 25 sec to 3 min 40 sec | Similar
Note 3 |
| Anatomical locations of
applications | Foot Calf | Low limbs (Foot, calf and upper leg) | Similar
Note 4 |
| Sleeve materials | Polyester | Nylon with a Polyurethane laminate | Different
Note 5 |
| Number of air chambers | 2 Chambers | 3 Chambers | Different
Note 6 |
| | | | |
| Inflation & deflation time | Inflation time:≤20s | Inflation time:3-30s | Similar |
| | Deflation time:7s | Deflation time:1-5s | Note 7 |
| Power consumption | 8W | 12W | Different |
| | | | Note 8 |
| Transportation
environment | Temperature:-20℃ to 70℃(-4°F to 158°F | Temperature: -20°C~55°C | Different |
| | Humidity:0% to 90% RH | Humidity:5%-90% non-condensing | Note 9 |
| | Atmospheric Pressure:50kPa to 106kPa | Atmospheric Pressure:75kPa-106kPa | |
| Standards complied with | ES60601-1 | ES 60601-1 | Same |
| | IEC60601-1-2 | IEC60601-1-2 | |
| | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | |
| | IEC60606-1-11 | IEC 60601-1-11 | |
| Weight | 2.3 pounds | 4.6 pounds | Different |
| | | | Note 10 |
| Recommended treatment | | | Same |
| time | 20 minutes | 20 minutes | |
9
10
Similarity and Difference
The YY-A02-B Overlapped Compression Therapy has been compared with the Air Compression Therapy Device. The subject device has same intended use and principle of operation, similar technological characteristics as that of predicate device. Although there are several specifications that are different between the subject device and predicate device, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate devices do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in safety and performance claims.
Note 1: The level of air pressure and pressure range is different. the level of air pressure of the subject is 5 level and the predicate device is 3 level. The minimum air pressure (0 mmHg) of subject device is the same as the predicate device. the air pressure of subject device (210 mmHg) is within the range of the predicate device. Additionally, the subject device conforms to ANSI/AAMI ES60601-1 and ISO 14971, so the small differences do not affect the safety and effectiveness. Although the "air pressure level /compression levels" of subject device is different to the predicate devices, but they output air pressure range are similar, so the pressure level different do not affect the safety and effectiveness
Note 2: The subject device has a smaller pressure error range than the predicate device. So the small difference do not affect the safety and effectiveness.
Note 3: Although the "Cycle time" of subject device is different the predicate devices, but the range of cycle time is less than predicate device. So the small difference do not affect the safety and effectiveness
Note 4: The "anatomical locations of applications" of the subject device is different. It not contains the upper leg. The small difference do not affect the safety and effectiveness.
Note 5: Although the "sleeve materials" of the subject device is different from the predicate device, but the subject device complies with the requirements of the biocompatibility standards. So the difference do not affect the safety and effectiveness.
Note 6: Although the "Number of chambers" of subject device is different to the predicated device, but due to the chamber number only determines the applicable treatment site, while the "applicable treatment site" and "Indications for Use" of subject device is within the range of predicated device. So the differences do not affect the safety and effectiveness.
Note 7: Although the "Inflation & deflation time" of subject device if different to the predicated device. For the safety: the subject device has compliance with IEC 60601-1 and ISO 14971 standards. And the subject device has designed the pressure sensor to protection the over-pressure, so the subject device was safety. For the effectiveness: since the treatment mode, treatment pressure and cycle time of the subject device is similar to the predicate devices, so we can be considered that
11
the subject device and predicate device had similar effectiveness. Based on the above analysis, can be considered the small difference will not affect the safety or effectiveness issue
Note 8: Although the "power consumption" of the subject device is different than the predicate devices, they both comply with ANSI/AAMI ES60601-1, so the difference does not affect the safety and effectiveness.
Note 9: Although the "Transportation environment" of the subject device is different than the predicate devices, they comply with ANSI/AAMI ES60601-1, so the difference does not affect the safety and effectiveness.
Note 10: Although the "Weight" between the predicate devices and subject device is different, they are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness
Substantial Equivalence Conclusion
In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.
To establish the substantial equivalence of the Overlapped Compression Therapy, XINYI conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
In addition, XINYI has conducted testing to ensure the subject device meet relevant consensus standards.
PERFORMANCE DATA 7.
Biocompatibility Testing
The Overlapped Compression Therapy is patient contacting, therefore biocompatibility data is required.
In accordance with ISO 10993, it is surface devices that contact intact skin for a prolonged duration and the appropriate testing is Cytotoxicity, Skin Irritation and Sensitization. The subject device conducted and passed all biocompatibility testing.
Software Verification and Validation Testing
Per FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", software verification and validation testing was conducted, and documentation was provided. Verification of the Overlapped Compression Therapy was conducted to ensure that the product works as designed. Validations was conducted to check the design and performance of the product.
Electrical safety and electromagnetic compatibility (EMC)
The Overlapped Compression Therapy has been tested for conformance with the following electromagnetic compatibility and electrical safety standards.
- ANSI / AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential
12
performance
- IEC60601-1-2:2014 (Fourth Edition) Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
Bench Testing
To establish the substantial equivalence of the Overlapped Compression Therapy, XINYI conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
In addition, XINYI has conducted testing to ensure the subject device meet relevant consensus standards.
- IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC60601-1-6: 2013-10 Medical electrical equipment Part 1-6: General requirements ● for basic safety and essential performance - Collateral standard: Usability
Accuracy testing for pressure and time to ensure that the device can achieve the intended maximum pressure and maintain it for the intended treatment time.
Seam strength testing to ensure that the seams of the device do not burst if maximum pressure is exceeded in the device.
Failure mode testing to indicate how the device mitigates the risk of over-pressurization if there is a software failure and the device starts to exceed maximum intended pressure.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
8. CONCLUSION
Based on the detailed comparison between the predicate device and the subject device, the performance testing and conformance with applicable standards, the Overlapped Compression Therapy can be found substantially equivalent to the predicate device.