(140 days)
POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).
POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body. Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.
The provided document is a 510(k) summary for the "Compressible Limb and Circulation Therapy System, Model POWER-Q2300". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Based on the information provided in this 510(k) summary, the device under review is a physical medical device (a massager) aiming for "temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation". It is NOT an AI/ML-enabled diagnostic or therapeutic device. Therefore, many of the typical acceptance criteria and study components requested in the prompt (such as accuracy metrics for an AI model, ground truth establishment by experts, MRMC studies, training/test set sample sizes for AI, etc.) are not applicable to this type of device.
The "study that proves the device meets the acceptance criteria" for a physical device like this primarily involves non-clinical performance testing to ensure it adheres to recognized standards for safety and essential performance, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an attempt to answer the prompt based only on the provided document, highlighting which aspects are applicable and which are not:
Acceptance Criteria and Device Performance for POWER-Q2300
As this is a physical medical device and not an AI/ML model, the acceptance criteria are based on meeting recognized medical electrical equipment standards and demonstrating comparable performance to a predicate device for its intended physical function.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Non-Clinical Testing) | Reported Device Performance (from "Non-Clinical Testing" section) | Notes |
|---|---|---|
| Electrical Safety and Essential Performance Compliance with IEC 60601-1:2005+A1:2012, ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012 | "The device has been tested and met the requirements of the following standards: IEC 60601-1:2005+A1:2012, ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012" | Standard electrical safety and performance requirements for medical devices. |
| Usability Compliance with IEC 60601-1-6 Edition 3.1 2013-10, IEC 62366-1 Edition 1.0 2015-02 | "The device has been tested and met the requirements of the following standards: IEC 60601-1-6 Edition 3.1 2013-10, IEC 62366-1 Edition 1.0 2015-02" | Standards related to the safe and effective use of the device. |
| Home Healthcare Environment Safety Compliance with IEC 60601-1-11 Edition 2.0 2015-01 | "The device has been tested and met the requirements of the following standards: IEC 60601-1-11 Edition 2.0 2015-01" | Specific requirements for devices used in home settings. |
| Electromagnetic Compatibility (EMC) Compliance with IEC 60601-1-2 Edition 4.0 2014-02 | "The device has been tested and met the requirements of the following standards: IEC 60601-1-2 Edition 4.0 2014-02" | Ensures the device operates correctly without interference and doesn't cause excessive electromagnetic disturbances. |
| Software Life Cycle Process Compliance with IEC 62304 Edition 1.1 2015-06 | "The device has been tested and met the requirements of the following standards: IEC 62304 Edition 1.1 2015-06" | Applies to the software components of the device. |
| Physical Performance Testing (Pressure Accuracy, Seam Strength, Fail Mode) | "Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed." | Specific functional tests for the device's mechanical operation. No specific numerical thresholds are provided in this summary. |
| Indications for Use Equivalence | The Indications for Use for POWER-Q2300 are "identical" to the predicate device (Rapid Reboot Compression Therapy System). | "POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading and stroking of tissues by using an inflatable garment (cuff)." |
| Operational Parameters Comparability | Pressure Range: 20-200 mmHg (Subject Device) vs. 0-200 mmHg (Predicate Device). "Pressure range of subject device is smaller than that of predicate device." Treatment Time: 15 and 30 minutes (Subject Device) vs. 10, 20, or 30 minutes with option to add 10 mins (Predicate Device). "Minor difference." Number of inflatable segments: 4 (Identical). Modes of Compression: 4 modes, visually similar/identical to predicate's 2 modes. | Operational parameters are compared to the predicate, with minor reported differences not raising new safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of AI/ML testing. For this physical device, "testing" refers to non-clinical laboratory verification against engineering standards. The document states: "Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed." It does not specify sample sizes for these tests, as they would typically involve engineering samples tested to specific physical and electrical standards, not a "test set" of patient data.
Data provenance: Not applicable. There is no patient data or clinical data used for regulatory submission, as explicitly stated: "No clinical testing was performed."
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not Applicable. As there was no clinical testing performed and no AI/ML component, there was no need for expert ground truth establishment using patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is relevant for clinical studies or AI algorithm validation with uncertain ground truth. For this physical device, regulatory clearance relied on non-clinical engineering tests and comparison to a predicate device.
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. This device is a physical massager, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. There is no AI algorithm to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable for clinical ground truth. The "ground truth" for this device's performance validation is its adherence to recognized engineering standards (IEC, ANSI/AAMI) for electrical safety, EMC, usability, and specific physical performance parameters (pressure accuracy, seam strength, fail mode). There is no "patient-specific" ground truth required for this type of device clearance by FDA.
8. The sample size for the training set
Not Applicable. This device does not use an AI or machine learning model, and therefore has no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no AI model or training set, there is no ground truth establishment for a training set.
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September 14, 2021
Wonjin Mulsan Co., Ltd. HaYong Jung QMR 89. Geomdan-ro. Seo-gu Incheon, 22653 Republic of Korea
Re: K211283
Trade/Device Name: Compressible Limb and Circulation Therapy System, Model POWER-02300 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 24, 2021 Received: August 31, 2021
Dear HaYong Jung:
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 (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,
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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) K211283
Device Name
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
Indications for Use (Describe)
POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).
| 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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510(K) Summary
[as required by 21 CFR 807.02]
| Date Prepared: | Sep. 8, 2021 |
|---|---|
| Submitter: | Wonjin Mulsan Co., Ltd.89, Geomdan-ro, Seo-gu, Incheon, 22653, Republic of KoreaTel: 82-32-816-0552, Fax: 82-32-816-0557Establishment Registration Number: 3006797972Contact Person: HaYong JungEmail: wonjin@wonjininc.com |
| Trade Name: | Compressible Limb and Circulation Therapy SystemModel POWER-Q2300 |
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation Number: | 890.5650 |
| Product Code: | IRP |
| Classification: | Class II |
| Predicate Device: | Rapid Reboot Compression Therapy System which was cleared formarketing under K182668 |
Device Description
POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body.
Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.
Indications for Use
POWER-Q2300 is intended for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading and stroking of tissues by using an inflatable garment (cuff).
| Item | Description |
|---|---|
| Operation Mode | 4 modes such as Mode A, Mode B, Mode C, and Mode D |
| Pressure Range | 20 mmHg to 200 mmHg |
| Operation Time | 15 and 30 minutes |
| Rest Time | Adjustable at interval of 0/5/10/30 sec at modes A and BFixed at 30 sec at modes C and D |
Technologic Characteristics
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Non-Clinical Testing
The device has been tested and met the requirements of the following standards:
IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral Standard: Usability
IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for 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 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 62366-1 Edition 1.0 2015-02 Medical device – Part 1: Application of usability engineering to medical devices
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle process
Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed.
The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/ accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity. The device is intended to be used only over clothing.
Clinical Testing
No clinical testing was performed.
Conclusions
Wonjin Mulsan Co., Ltd. believes that all applicable items of information specified in this submission have been supplied in full. The enclosed non-clinical data demonstrate that the subject device described herein raises no new questions concerning safety or effectiveness and may therefore be properly considered by the Agency as substantially equivalent to the predicate device that has previously been legally distributed in interstate commerce in the United States.
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Comparison with Predicate Devices
| Item | Subject Device | Predicate Device | Differences Discussion |
|---|---|---|---|
| Model | POWER-Q2300 | Rapid Reboot Compression Therapy System | NA |
| Manufacturer | Wonjin Mulsan Co., Ltd. | Rapid Reboot Recovery Products, LLC | NA |
| Classification | Class II Device, IRP (21 CFR 890.5650) | Class II Device, IRP (21 CFR 890.5650) | NA |
| 510(k) number | K182668 | NA | |
| Indications for use | POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading and stroking of tissues by using an inflatable garment (cuff). | The Rapid Reboot Compression Therapy System 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 Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment. | Identical |
| Prescriptive or OTC | OTC | OTC | Identical |
| Environment of Use | Clinics, hospital, athlete training, and home environments | Clinics, hospital, athlete training, and home environments | Identical |
| Power Source(s) | 110-120VAC, 50/60Hz | 110VAC, 60Hz | Minor difference |
| Weight | 3.1 kg | 2.63 kg (5.8 pounds) | Minor difference |
| Dimensions (W x H x D) | 290 x 260 x 172 mm | 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5") | Minor difference |
| Device pressure range | 20-200 mmHg | 0-200 mmHg | Pressure range of subject device is smaller than that of predicate device. |
| Treatment Time | User can select operation time from 15 and 30 minutes. | User determines therapy time. Choose from 10, 20, or 30 minute session time, with option | Minor difference |
| to add additional 10 minutes toany therapy time. | |||
| Number ofinflatableappliancesegments | 4 | 4 | Identical |
| Anatomicalsite | Leg (including of foot, calf,knee, upper leg)Hip (including of upper leg,glutes, hips, lower lack)Arm (including of entire arm,shoulder)Half-Leg (including of foot,calf, knee) | Leg (including of foot, calf,knee, upper leg)Hip (including of upper leg,glutes, hips, lower lack)Arm (including of entire arm,shoulder, upper chest and back) | Identical excepthalf-leg |
| Mode ofcompression | 4 modes (Mode A, Mode B,Mode C and Mode D) | 2 modes (Sequential andPeristaltic) | Refer to thevisualdescriptionbelow. |
| Mode ofcompression(visualdescription) | Image: Mode A | Image: Mode A | Mode A ofPOWER-Q2300is similar toMode A of thepredicate. |
| Image: Mode B | Image: Mode A | Mode B ofPOWER-Q2300is identical toMode A of thepredicate. | |
| Image: Mode C | Image: Mode B | Mode C ofPOWER-Q2300is identical toMode B of thepredicate. | |
| Image: Mode D | Image: Mode AImage: Mode B | Mode D ofPOWER-Q2300is a combinationof Mode B andMode C, and isidentical to acombination ofMode A andMode B of thepredicate. | |
| Appearanceand size ofCuffs | Leg | Leg | Minordifference |
| Image: Leg cuffs | Image: Leg cuffsX-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"Image: Leg cuff | Minor difference | |
| Image: Leg cuff with dimensions310940 | |||
| Medium: 310x940mmLarge: 390x990 | |||
| HipImage: Hip cuff | HipImage: Hip cuffRegular:26" x 32"Large: 26"35"Image: Hip cuff | Minordifference | |
| Image: Hip cuff with dimensions530720 | |||
| 530x720mm | |||
| ArmImage: Arm cuff | ArmImage: Arm cuffsRegular: 18" x 38"Long: 18" x 44"Image: Arm cuff | Minordifference | |
| Image: Arm cuff with dimensions255870 | |||
| Medium: 255x870mmLarge: 330x895mm | |||
| Half-Leg | None | Minordifference | |
| Otheraccessories | Image: Half-LegImage: Half-Leg with dimensions 300, 700300x700mmExtension zipperImage: Extension zipper with dimensions 120, 900Medium: 120x900mmLarge: 150x950mmDouble hoseImage: Double hoseLength: 1,430mmSingle hoseImage: Single hoseLength: 1,320mmBlocked jackImage: Blocked jack with dimensions 47.1, 13.9, 53.853.8x47.1x13.9mm | "Not publicly available in theofficial 510K Summary" | Minordifference |
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§ 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).