The HW-1000 Infrared Therapy System is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.

Device Description

The HW-1000 Infrared Therapy System is an effective, drug-free and non-invasive device which can deliver 850-950nm infrared energy through light emitting diodes (LED) mounted in the therapy pads (the same as light panels, but different expressions). Each pad has 66 diodes.

The device consists of mainframe, which contains the user interface panel, the power supply, and the output jack used to connect pad to provide output. and therapeutic pads. When working, the plug of therapeutic pads is connected with the output jack of mainframe and the therapy pads are fixed on the surface of skin directly with matched bandages to provide heating.

AI/ML Overview

This document is a 510(k) premarket notification for the "Infrared Therapy System (Model: HW-1000)". It focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance against them is not provided in this regulatory submission.

However, based on the provided text, we can infer some "acceptance criteria" through comparison with the predicate device and the results of a clinical test for effectiveness and non-clinical tests for safety.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

As specific, quantified acceptance criteria for performance are not explicitly stated (e.g., "device must achieve X% pain relief in Y% of patients"), this table will present the comparative characteristics and the conclusions drawn from the tests.

Acceptance Criteria (Inferred)	Reported Device Performance
Clinical Effectiveness: Achieve temporary relief of minor muscle/joint pain/stiffness, minor arthritis pain, muscle spasm; temporary increase in local blood circulation; temporary relaxation of muscles. (Aligned with intended use of predicate device)	Clinical test (test group with power output vs. control group without power output) showed "far better curative effect" in the test group, ensuring "effectiveness and safety." While specific quantitative metrics (e.g., pain score reduction) are not provided in this summary, the conclusion is that the device is effective for its intended use. The device also shares the same therapeutic temperature range (40-45°C) with the predicate device, which is "accepted by FDA" and implies similar therapeutic effects.
Device Temperature Range: Maintain a therapeutic device temperature range.	Device temperature: 40-45°C. This range is stated as being "accepted by the FDA" and is "the same" as the predicate device.
Skin Surface Temperature Range: Achieve a therapeutic skin surface temperature range.	Skin surface temperature: 40-45°C. This range is confirmed by self-inspection tests and is "accepted by the FDA" and is "the same" as the predicate device.
Biocompatibility: Materials in patient contact are biocompatible.	Tested according to "relevant ISO 10993 Standard" (specifically ISO 10993-5:2009/(R) 2014 for in vitro cytotoxicity and ISO 10993-10:2010 for irritation and skin sensitization). This demonstrates compliance with recognized standards.
Electrical Safety: Comply with electrical safety standards.	Tested according to AAMI / ANSI ES60601-1:2005/(R)2012 and its amendments (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod). This demonstrates compliance with recognized standards.
Electromagnetic Compatibility (EMC): Comply with EMC standards.	Tested according to IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. This demonstrates compliance with recognized standards.
Photobiological Safety: Comply with photobiological safety standards.	Tested according to IEC 62471 First edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. This demonstrates compliance with recognized standards.
Risk Management: Application of risk management processes.	Tested according to ISO 14971 Second Edition 2007-03-01, Medical Devices - Application Of Risk Management To Medical Devices. This demonstrates compliance with recognized standards.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for the clinical test mentioned in "Attachment O Clinical Evaluation Report". The summary only refers to "test group" and "control group".
Data Provenance: The company is Beijing Huatai Healthcare Technology Co., Ltd. located in P.R. China. The clinical test was "sponsored" by this company. The specific country of origin for the clinical data is not mentioned, but it can be inferred to be China. It is a prospective clinical test as it was done to evaluate the effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary. The clinical test evaluated "curative effect," but the methodology for assessing this effect (e.g., patient questionnaires, physician assessment, imaging) and the number/qualifications of experts involved in determining "ground truth" are not detailed.

4. Adjudication method for the test set

This information is not provided in the summary.

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

No, an MRMC comparative effectiveness study was not performed. This is an infrared therapy device, not an imaging or diagnostic AI device. The clinical study mentioned compared a treatment group with the device (power output) to a control group without the device (no power output). It did not involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a direct therapeutic device, not an algorithm. Its performance is measured by its direct therapeutic effect, not by an algorithm's output. The clinical test described is essentially a standalone performance evaluation of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical test, the "ground truth" was the "curative effect" observed in patients. While not explicitly defined, this would typically involve patient-reported outcomes (e.g., pain scores, stiffness levels) and potentially clinician assessments. More specific details (e.g., a validated pain scale) are not provided in the summary.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML algorithm that requires a training set. The clinical test described served as a validation of the device's therapeutic effect.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2014

Beijing Huatai Healthcare Technology Company, LTD. % Ms. Helen Nan Wenzhou Cytech Information Service Company, LTD. Room 302, Number 21 Building, Kaiyu Garden, Xishan South Road Wenzhou, 325000, Zhejiang China

Re: K142340

Trade/Device Name: Infrared Therapy System (Model: HW-1000) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: October 29, 2013 Received: November 5, 2014

Dear Ms. Nan:

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. 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 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

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Page 2 - Ms. Helen Nan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K142340

Device Name

Infrared Therapy System (Model: HW-1000)

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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北京澳尔华泰科技有限公司
Beijing Huatai Healthcare Technology Co., Ltd.

Section 5 510(k) Summary

(As required by 21 CFR 807.92(a))

5.1 Submitter Information

· Company: Beijing Huatai Healthcare Technology Co.,Ltd.
· Address: Rm.216, No.2 Building, No.18, Qinghe Anningzhuang East Road.Haidian District, Beijing City, 100085, P.R. China
・Phone: 086-10-62931963
・ Fax: 086-10-82781040
· Contact: Bingxian Zheng, General Manager
· Date: October 29, 2013.

5.2 Device Information

· Trade/Proprietary Name: Infrared Therapy System;
· Common Name: Infrared Lamp;
Model: VPT-I:
· Classification: Device Class: 2

Review Panel: Physical Medicine Name: Lamp, Infrared, Therapeutic Heating Regulation Number: 21 CFR 890.5500 Product Code: ILY

· Predicate Device: GIGALaser 1801 Submitted by PowerMedic ApS:
K Number: K134017

· Device Description:

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., Ltd.

• Intended Use:

Item	Subject Device	Predicate Device
Intended Use	Intended to emit energyin the near infraredspectrum to providetopical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm; thetemporary increase inlocal blood circulation;and for the temporaryrelaxation of muscles.	Intended to emit energyin the visible and nearinfrared spectrum toprovide topical heatingfor the purpose ofelevating tissuetemperature for atemporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm; thetemporary increase inlocal blood circulation;and for the temporaryrelaxation of muscles.
Design Principle	NIR (near-infrared)Therapy	Same
Energy Source	LED	Same
Skin Contact Mode	Direct Contact	Same
Power Supply	100-240Vac50-60Hz	Unknown
Device Temperature	40-45°C	Same

5.3 Comparison of Required Technology Characteristics

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Range
Skin SurfaceTemperature	40-45 °C	Same
Treatment Output	Zero, Moderate, Mild,Strong	6 treatment programswith variable outputpower levels
Treatment Time	10min±1min,20min±2min,30min±3min,40min±4min	6 treatment programswith variable exposuretimes
Patient ContactMaterial	Therapeutic Pad LowerCover - Medical PC	Unknown
Biocompatibility	Tested according torelevant ISO 10993Standard	Unknown
Electrical Safety	Tested according toIEC 60601-1	Tested according to EN60601-1
ElectromagneticCompatibility	Tested according toIEC 60601-1-2	Tested according to EN60601-1-2

Brief Summary:

First, the subject device shares almost the same intended use with the predicate device, though there is slight difference in the expression of their intended use, that is, the predicate device also boasts visible spectrum which the subject device don't have, such trivial difference will not influence the core usage of the devices, thus will not influencing the substantial equivalence comparison between the two devices.

Secondly, the two devices have similar technological characteristics, for example, they enjoy the same design principle, energy source, skin contact mode, device temperature range and skin surface temperature range. Though they are different in power supply and patient contact material, such differences have been verified by relevant FDA recognized standards - IEC 60601-1, IEC 60601-1-2 and ISO 10993, which supports that the subject device will be as safe for usage as the predicate device. And although they

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北京奥尔华泰科技有限公司
Beijing Huatai Healthcare Technology Co., Ltd.

are not identical in treatment output and time, the effectiveness of the subject device has been evaluated by the following clinical test. Moreover, the subject device share the same therapeutic temperature range with the predicate device which is accepted by FDA, which displays that they will enjoy similar therapeutic effects. All these facts show that the subject device will be as safe and effective as the predicate device, that the two devices are substantial equivalent.

5.4 Discussion of Tests Performed

· Clinical Tests:

The use of light energy to generate heat for therapeutic use has been well documented and is generally accepted alternative treatment modality for the temporary relief of pain and tissue repair.

And in order to evaluate the effectiveness of our subject device, we have sponsored the clinical test with test group receive treatment of the subject device (with power output) and the control group receive treatment of the subject device (without power output), during which no equipment failure or adverse events was discovered and the test result shows that the test group has far better curative effect than the control groups, which further ensures the effectiveness and safety of the subject device. For more details, please refer to Attachment O Clinical Evaluation Report.

· Non-Clinical Tests

The subject device was tested to evaluate its safety according to the following standards:

Electrical Safety

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1:2005, Mod). (General II (ES/EMC))

Electromagnetic Compatibility

IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))

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Image /page/8/Picture/0 description: The image shows a logo with the text "DERHUATAI" in a stylized font. The letters are colored in a gradient, starting with yellow and blue on the left, transitioning to red in the middle, and ending with black on the right. The font is bold and slightly slanted, giving the logo a dynamic appearance.

北京澳尔华泰科技有限公司
Beijing Huatai Healthcare Technology Co., Ltd.

3) Photobiological Safety

IEC 62471 First edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. (Radiology)

Biocompatibility

AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO 10993-10:2010. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)

Risk Analysis

ISO 14971 Second Edition 2007-03-01, Medical Devices - Application Of Risk Management To Medical Devices. (General I (OS/RM)) Moreover, the company has performed self-inspection test on the subject device in order to further ensure its safety and effectiveness, especially during which the device temperature and skin surface temperature has been confirmed as 40-45℃ which is accepted by the FDA. More details can be found in Attachment N Performance Self-Inspection Report.

5.5 Conclusion:

First, the subject device enjoys almost the same intended use, which forms the foundation of the substantial equivalence between the two devices. Secondly, the subject device shares similar technological characteristics with the predicate device and the differences in the technological characteristics have been either verified by the above FDA recognized standards or the company's own "Performance Self-Inspection Report", which shows that the subject device will be as safe and effective as the predicate device. Moreover, the effectiveness and safety of the subject device has also be evaluated by appropriate clinical report. All of these facts show that the differences between the two devices will not bring new safety and effectiveness concerns.

As a result, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.

Regulation Number and Section

N/A