(145 days)
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Air compression leg massager HY-1117A is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
The provided document is a 510(k) Pre-market Notification for a medical device called "Air compression leg massager HY-1117A". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study for a novel device. Therefore, the document does not describe:
- Specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy).
- A "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or algorithm performance study.
- Sample sizes for test or training sets for an AI/algorithm.
- The number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Types of ground truth for an AI/algorithm.
- How ground truth for a training set was established.
Instead, the document focuses on demonstrating that the subject device is similar enough to a predicate device (Air Compression Therapy Device, K193354) by comparing their indications for use, technological characteristics, and conformance to recognized safety standards. The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable", indicating that no such studies were conducted for this submission.
The "acceptance criteria" in this context refer to meeting recognized safety and performance standards for a device of its class, and demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what is provided, framed in the context of your request to the extent possible:
1. A table of (implied) acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in a typical quantitative performance metric table. Instead, it compares the subject device's characteristics against those of a predicate device to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it is "substantially equivalent" to the predicate.
| Characteristic / "Acceptance Criteria" Category | Subject Device Performance (Air compression leg massager HY-1117A) | Predicate Device Performance (Air Compression Therapy Device, K193354) | Discussion of Differences (if any and impact on safety/effectiveness) |
|---|---|---|---|
| Indications for Use | Temporarily relieve minor muscle aches/pains, temporarily increase circulation to treated areas in healthy people (home use, OTC). | Temporarily relieve minor muscle aches/pains, temporarily increase circulation to treated areas in healthy people. Simulates kneading and stroking. | Same |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation Class | Class II | Class II | Same |
| Product Code | IRP | IRP | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 0-240mmHg | 0~240mmHg | Same |
| Treatment time | 15 minutes | 20 minutes | Similar. "the difference of treatment time would not raise adversely impact on safety and effectiveness." |
| Applicable Standards | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10 | ES 60601-1, IEC60601-1-2, ISO 10993-5, ISO 10993-10, IEC 60601-1-11 | Similar |
| Mode of compression | Sequential | Sequential/ Peristaltic | Same |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same |
| Power consumption | 24W | 12W | Similar |
| Dimensions (WHD) | 111624.9inch | 10.2×5.9×25.6inch | Similar |
| Housing materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of chambers | 3 | 3 | Same |
| Work mode | Six modes (F1, F2, F3, M1, M2, M3) | Mode 1: Sequential compression foot to thigh; Mode 2, Mode 3 (details provided for these modes) | "Although the subject device provides 6 kinds of work mode, the Mode F1, F2, F3, M1, M2, M3 are the similar with predicate device (K193354), while the subject device just have difference about inflatable order of the different chambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness." |
| Safety feature | Button on display allows user to stop/pause therapy | Button on display allows user to stop/pause therapy | Same |
| Technology | Compressor and valve system inflates chambers sequentially | Compressor and valve system inflates chambers sequentially | Same |
Study that proves the device meets the acceptance criteria:
The "study" to demonstrate acceptability in this 510(k) submission is a comparison to a predicate device (K193354) and conformance to recognized consensus standards. The document explicitly states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This means no new clinical trials or animal studies were conducted. The device's safety and effectiveness are supported by its substantial equivalence to the predicate device and demonstration of meeting fundamental electrical safety, electromagnetic compatibility, home healthcare environment requirements, and biocompatibility standards.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical or algorithmic performance test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical massager, not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/algorithm context. The "ground truth" for this submission is that the predicate device is legally marketed and generally considered safe and effective for its intended use, and the subject device shares sufficient characteristics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
January 18, 2022
Xiamen High Top Electronic Technology Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China
Re: K212713
Trade/Device Name: Air compression leg massager HY-1117A Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 5, 2022 Received: January 5, 2022
Dear Sam Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K212713
Device Name
Air compression leg massager HY-1117A
Indications for Use (Describe)
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
| 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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| Type of Submission | Traditional |
|---|---|
| Date Prepared | June 25, 2021 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen High Top Electronic Technology Co., Ltd. |
| Address | F2-5 No. 118 Siming Park, Tong'an Industrial Zone,Xiamen, Fujian, China |
| Tel | 86-15359228717 |
| 181492777@qq.com | |
| Contact Person | Liangsan Zhao |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong NewDistrict, Shanghai, China |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
| Device Identification | |
| Trade Name | Air compression leg massager HY-1117A |
| Regulation Number | 21 CFR 890.5650 |
| Classification Name | Massager, Powered Inflatable Tube |
| Device Classification | Class II |
| Panel | Physical Medicine |
| Product Code | IRP |
| Previous Submissions | None |
| Indications for Use |
Air compression leg massager HY-1117A is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Device Description
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Air compression leg massager HY-1117A is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
Predicate and Reference Device Information
| Sponsor | Shenzhen Dongjilian Electronics Co., Ltd. |
|---|---|
| Trade/Device Name | Air Compression Therapy Device |
| 510(K) number | K193354 |
| Regulation Number | 21 CFR 890.5650 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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Table 6A: Summary of Comparison
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device name | Air compression leg massager HY-1117A | Air Compression Therapy Device | N/A |
| 510(k)number | K212713 | K193354 | N/A |
| Manufacturer | Xiamen High Top Electronic TechnologyCo., Ltd. | Shenzhen Dongjilian ElectronicsCo., Ltd. | N/A |
| Productregulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classificationname | Massager, Powered Inflatable Tube | Massager, Powered InflatableTube | Same |
| Regulationclass | 2 | 2 | Same |
| Product code | IRP | IRP | Same |
| Indications foruse | Air compression leg massager HY-1117A isintended for home to temporarily relieveminor muscle aches and/or pains, and totemporarily increase circulation to thetreated areas in people who are in goodhealth. | The Air Compression TherapyDevice is indicated for thetemporary relief of minor muscleaches and pains and fortemporary increase in circulationto the treated areas in people whoare in good health. The AirCompression Therapy Devicesimulates kneading and strokingof tissues by using an inflatablegarment. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 0-240mmHg | 0~240mmHg | Same |
| Treatmenttime | 15 minutes | 20 minutes | SimilarThe treatment time of subject device is smaller thanpredicate device (K193354), so the difference oftreatment time would not raise adversely impact onsafety and effectiveness. |
| Standard | ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012, IEC 60601-1-2, IEC60601-1-11, ISO 10993-5, ISO 10993-10 | ES 60601-1;IEC60601-1-2;ISO 10993-5:ISO 10993-10;IEC 60601-1-11 | Similar |
| Mode ofcompression | Sequential | Sequential/ Peristaltic | Same |
| Power source | 100~240V 50/60Hz | 100~240V 50/60Hz | Same |
| Powerconsumption | 24W | 12W | Similar |
| Dimensions(WHD) | 111624.9inch | 10.2×5.9×25.6inch | Similar |
| Photo | Image: Leg compression sleeves and controller | Image: Handheld controller | Similar |
| Similar | |||
| Housingmaterials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number ofchambers | 3 | 3 | Same |
| Work mode | Six modes:Full leg 1(F1)Full leg 2(F2)Full leg 3(F3)Separate part 1(M1)Separate part 2(M2)Separate part 3(M3) | Mode 1:Starting with the foot chamberand progressing up the thighchamber, each sectioncompresses and the pressuregradually rises to thepre-determined air pressure level,then decompresses and theair pressure drops.Once the thigh sectiondecompresses, the cycle beginsagain.Mode 1 follows this pressuresequence: | Although the subject device provides 6 kinds ofwork mode, the Mode F1, F2, F3, M1, M2, M3 arethe similar with predicate device (K193354), whilethe subject device just have difference aboutinflatable order of the different chambers. Thetreatment pressure range are the same underdifferent work modes, so the difference of pressurerange would not raise adversely impact on safetyand effectiveness. |
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Image /page/8/Picture/1 description: The image shows a diagram of a compression garment and text describing the garment's modes of operation. Mode 2 starts with the foot chamber and progresses up the thigh, with each section compressing and the pressure gradually rising to the pre-determined air pressure level. All three sections then decompress simultaneously and the air pressure drops, then the cycle begins again. Mode 3 is also mentioned in the text.
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| include two stage, stage 1: itwork according to the method ofmode 1, after the stage 1 iscompleted, it go to stage2(working according to themethod of mode 2) withoutinterruption time until finish thestage 2, then enter next cyclewithout interruption .Mode1 $\rightleftharpoons$ Mode2The pressure sequence of mode 3combines mode 1 and mode 2 | |||
|---|---|---|---|
| Safety feature | Button on display allows user to stop orpause therapy session at any time | Button on display allows user tostop or pause therapy session atany time | Same |
| Technology | Compressor and valve system whichsequentially inflates inflatable chambers | Compressor and valve systemwhich sequentially inflatesinflatable chambers | Same |
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Summary of the technological characteristics of the device
The device meets all the applicable technical requirements of : IEC 60601-1-11: 2015 - Medical electrical equipment - Part 1-11: 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 IEC 60601-1-2: 2014 - Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
Conclusion
Based on the indications for use, technological characteristics, and non-clinical performance data, "Air compression leg massager HY-1117A (K212713)" is as safe, as effective, and performs as well as the legally marketed predicate devices, "Air Compression Therapy Device (K193354)". Therefore, the subject device is substantially equivalent to the predicate device.
§ 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).