(148 days)
The WS™ THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The WS™ THERAPY UNIT (Model # TY-101 series), is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3 ~ 25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net or the emitter to prevent fire or direct touch by the user. The entire unit is mounted on base that is easy to move. The device uses 110 Vac as power source. it meets the related requirement of IEC 60601-1 Electrical Safety.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for the WS™ THERAPY UNIT (Model # TY-101 series).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Standards Conformance | Conformance to applicable electrical safety and electromagnetic compatibility standards. | The device conforms to IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) and related standards. The device uses 110 Vac as a power source and meets the related requirements of IEC 60601-1 Electrical Safety. |
| Intended Use Equivalence | Same intended use as a legally marketed predicate device. | The WS™ THERAPY UNIT (Model # TY-101 series) has the same intended use as the predicate device, the TDP CQ-27 Heat Lamp (K003538). Both are for temporary relief of minor muscle and joint pain/stiffness, minor joint pain with arthritis, temporary increase in local circulation, muscle relaxation, muscle spasms, minor sprains/strains, and minor muscular back pain. |
| Technological Characteristics | Similar technological characteristics to a legally marketed predicate device, with no new safety/effectiveness questions raised by differences. | The WS™ THERAPY UNIT has similar technological characteristics to the TDP CQ-27 Heat Lamp. Bench testing demonstrated that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. The device description notes an IR emitter with an emission spectrum from 3 ~ 25 microns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific "test set" in the context of clinical performance or data analysis. The evaluation relies on:
- Conformance to recognized standards (IEC 60601-1, IEC 60601-1-2) which are typically assessed through bench testing and documentation.
- A comparison to a predicate device based on intended use and technological characteristics, supported by bench testing.
Therefore, there is no mention of a "test set" in terms of patient data, sample size, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or available from the provided text. As noted above, there's no mention of a clinical "test set" and subsequently no need for expert ground truth establishment for such a set.
4. Adjudication Method for the Test Set
This information is not applicable or available from the provided text, as there is no described clinical "test set" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. The device is evaluated primarily through compliance with standards and substantial equivalence to a predicate device based on its intended use and technological characteristics ("bench testing").
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable. The WS™ THERAPY UNIT is an infrared heating device, not an AI/algorithm-driven diagnostic or treatment system. Its performance isn't measured in terms of an algorithm operating "standalone."
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, outcomes data) is not applicable here. The device's "truth" or effectiveness is established through its compliance with safety and performance standards relevant to infrared heating lamps, and its substantial equivalence to a predicate device. The performance claims (e.g., "temporary relief of minor muscle and joint pain") are based on the established effectiveness of the device type, not on a specific clinical study with a defined "ground truth" for this particular submission.
8. Sample Size for the Training Set
This information is not applicable or available from the provided text. The device is not an AI/machine learning product that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or available from the provided text, as the device is not an AI/machine learning product requiring a "training set" with ground truth.
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JUL 1 8 2008
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 2F, No. 4, Lane 130, Mincyuan Rd., Sindian City, TaipeiCounty 231, Taiwan |
| Phone: | +886-2-8219-2005 |
| Fax: | +886-2-8219-2009 |
| Contact: | Miss Ruth Pui / Overseas sales Administrator |
| 2. Device Name : | |
| Trade Name: | WS ™ THERAPY UNIT,Model # TY-101 series |
| Common Name: | Infrared Heating Lamp |
| Classification name | Lamp, Infrared |
| 3. DEVICE CLASS | WS™ THERAPY UNIT (Model # TY-101 series) have beenclassified asRegulatory Class: IIProduct Code: ILYPanel : Physical MedicineRegulation Number: 21CFR 890.5500 |
| 4. Predicate Device: | The predicate device is the• TDP CQ-27 Heat Lamp (K003538) marketed byLhasa OMS, Inc.. |
| 5. Device Description: | The WS™ THERAPY UNIT (Model # TY-101 series), isan infrared heating system which emits topical heat to thehuman body for therapeutic applications. It consists of anIR emitter (Emission spectrum ranges from 3 ~ 25microns.), a control box, a supporting arm to allow foradjustment of the emitter locations, and a protection net orthe emitter to prevent fire or direct touch by the user. Theentire unit is mounted on base that is easy to move. Thedevice uses 110 Vac as power source . it meets the relatedrequirement of IEC 60601-1 Electrical Safety. |
| 6. Intended Use: | The WS TM THERAPY UNITS, TY-101N and TY-101F, may beused for the temporary relief of minor muscle and jointpain and stiffness, the temporary relief of minor joint painassociated with arthritis, the temporary increase in localcirculation where applied, and relaxation of muscles. Inaddition, the lamp may also help muscle spasms, minorsprains and strains, and minor muscular back pain. |
Section 4 – 510(k) Summary REV.【B1】 Page 1 of 2
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- The device conforms to applicable standards includes IEC 7. Performance 60601-1, IEC 60601-1-2 & related standards----etc. Summary:
8. Conclusions:
The WS™ THERAPY UNIT (Model # TY-101 series) has the same intended use and similar technological characteristics as the TDP CQ-27 Heat Lamp (K003538) marketed by Lhasa OMS, Inc.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ws™ THERAPY UNIT (Model # TY-101 series) is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WS Far IR Medical Technology Corporation % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 N Boldt Drive Flagstaff, Arizona 86001
JUL 1 8 2008
Re: K080465
Trade Name: WS Far Infrared Therapy Unit, Model # TY-101 Series Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: May 27, 2008 Received: May 27, 2008
Dear Ms. Reich:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jennifer Reich
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K#080465
Device Name: WSTM THERAPY UNIT, Model # TY-101 series WS Far IR Medical Technology Co., Ltd.
Indications for Use:
The WS™ THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of cemporal y increason, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Page 1 of 1
(Division Sign Off) Division of General, Restorative, and Neurological Devices
510(k) Number
N/A