The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.

Device Description

The FIR Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FIR Heat Therapy Systems, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical efficacy. Instead, the acceptance criteria are largely based on demonstrated equivalence to a predicate device and adherence to relevant safety and performance standards. The performance testing focuses on physical characteristics supportive of its intended use and safety.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Safety & Biocompatibility	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).	Patient contacting materials (Nylon-cotton blend pad, ABS plastic cover, Nylon Velcro fastener) are compliant with ISO 10993-1. (Note 1)
	Compliance with ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity).	Patient contacting materials are compliant with ISO 10993-5.
	Compliance with ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity).	Patient contacting materials are compliant with ISO 10993-10.
Electrical Safety	Compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety).	The power supply (6Vdc, 8W) is compliant with IEC 60601-1. (Note 2)
EMC	Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests).	The device is compliant with IEC 60601-1-2.
Infrared Spectrum	Emits within the therapeutic range of 5-15 microns, with a center around 9 microns (matching predicate).	The subject device emits the main infrared electromagnetic spectrum of 5-15 microns, with a center around 9 microns.
Therapeutic Temperature	Core temperature range of heating pad is within 40-45°C (matching predicate and FDA's generally considered therapeutic range).	The infrared energy test (Thermal Distribution Map) shows that the core temperature range of the heating pad is about 44°C.
Skin Temperature Reach	Time for skin surface to reach 40°C.	The skin temperature test shows that the time for skin surface to reach therapeutic temperature range 40°C is about 5 minutes.
	Time for skin surface to reach maximum temperature (comparable to predicate or within therapeutic range).	The skin temperature test shows that the time to reach maximum temperature 42°C is about 10 minutes. (Note: Predicate had ~44°C for Low setting, but the subject device's 41-42°C is noted as being within the 40-45°C therapeutic range.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a clinical "test set" in the sense of a patient population for evaluating clinical outcomes. The performance testing described (skin temperature, infrared energy/spectrum) appears to be laboratory-based testing of the device itself, not human subjects. Therefore, sample size and data provenance relating to human subject data are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The ground truth for the performance tests (e.g., infrared spectrum, temperature measurements) would be established by standard scientific measurement techniques and instrumentation, not expert human assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable, as there was no clinical test set requiring expert adjudication.

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 such study was conducted or mentioned. This device is a heat therapy system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This device is a physical therapy device with a direct effect, not an algorithmic diagnostic tool.

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

For the performance tests mentioned:

Infrared spectrum and energy: Ground truth would be established by calibrated scientific instruments (e.g., spectrometers, thermal cameras/sensors) and physical principles.
Temperature measurements: Ground truth would be established by calibrated thermometers or thermal probes.

8. The sample size for the training set

This information is not applicable. There is no indication of a "training set" as this device does not involve machine learning or AI models. This is a traditional medical device demonstrating substantial equivalence through standard performance testing and comparison to a predicate.

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

This information is not applicable, as there was no training set.

Summary

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K111273

NOV - 8 2011

Sponsor: Shenzhen Anpan Technology Co., Ltd. Subject Device: FIR Heat Therapy Systems Supplemental Information 3 for Response the 3d FDA Comment File No.:

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 Information

Sponsor Name: Shenzhen Anpan Technology Co., Ltd. Address: No. 44, 2nd Road, XiaKeng, TongLe Community, LongGang Town, LongGang District, 518116 Shenzhen, China Contact Person: Mr. Wang Tao (Certification Engineer) Tel: +86-755-8964 0313-862 Fax: +86-755-2570 0826 Email: wangtao3801495@126.com

Application Correspondent Information:

MEDLAB (Shenzhen) Information Service Co., Ltd. Address: Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road, Shenzhen, Guangdong, P.R. China, 518034 Contact Person: Ms. Sabrina Wei (Manager) Tel: +86-755-8308 9699 Fax: +86-755-8632 9134 Email: sabrinawei@hotmail.com

2. Subject Device Information

Type of 510(k) submission:	Traditional
Common Name:	Powered heating pad and infrared lamp
Trade Name:	FIR Heat Therapy Systems
Models:	EH-6601, EH-6603, EH-6604, EH-6605, EH-6606, EH-6607,EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613,EH-6614
Classification Name:	Powered heating pad and infrared lamp
Review Panel:	Physical Medicine
Product Code:	IRT, ILY
Regulation Number:	CFR 890.5740, 890.5500
Regulation Class:	2

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3. Predicate Device Information

Sponsor:	EAS Consulting Group LLC.
Device Name:	Thermotex Heat Therapy Systems
510(k) Number:	K092589
Product Code:	IRT, ILY
Regulation Number:	CFR 890.5740, 890.5500
Regulation Class:	2

4. Device Description

5. Intended Use

6. Conformity Standards

The manufacturer has evaluated the subject device by lab testing according to the following standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, � 1988+A1:1991+A2:1995
. IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. 2007
� ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009
. ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009
� ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1:2006

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7. Determination of Substantial Equivalence

Compare with predicate device, the subject device is very similar in design principle, intended use, indication for use, the applicable standards, infrared electromagnetic spectrum and therapeutic temperature range.

The difference for the key specifications listed in the following table will not affect the safety and effectiveness for the subject device.

Item	Predicate Device	Subject Device	Note
Device Name	Thermotex Heat TherapySystems	FIR Heat Therapy Systems	--
Design Principle	FIR (far-infrared) therapy	FIR (far-infrared) therapy	Same
Patient ContactingMaterial	Velours (nylon face cover,50/50 nylon/cotton back)	Nylon-cotton blend padABS plastic coverNylon Velcro fastener	Note 1
Energy Source	110Vac, 50W	6Vdc (4 x "AA" alkalinebatteries), 8W (maximum)	Note 2
Heating Element	Carbon black fiberglass(glass-fabric impregnated withelectric conducting plastic"PTFE-Carbon")	Carbon fibre	Note 3
InfraredElectromagneticSpectrum	5~15 microns, with centeraround 9 microns	5~15 microns, with centeraround 9 microns	Same
TherapeuticTemperature Range	40~45 °C	40~45 °C	Same
Approximate SkinTemperature	44 °C (for Low setting)	41~42 °C	--
Time to MaximumTemperature	--	10 minutes	Note 4
Time to ReachTherapeuticTemperature Range	--	5 minutes
RecommendedTreatment Time	30-45 minutes	30-45 minutes	Same

Note 1:

Although the patient contacting material of subject device is different from the predicate device, both of them are complied with ISO 10993-1. So this difference will not raise any safety or effectiveness issue.

Note 2:

Although the power supply of subject device is different from the predicate device, both of them are complied with IEC 60601-1. So this difference will not raise any safety or effectiveness issue.

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Note 3:

Carbon black fiberglass is an E-Glass that is woven and dyed black to look like a 3K Twill Weave carbon fiber. The carbon black fiberglass does not have the strength properties of a real carbon fiber. But their far infrared thermal specification is similar, so this difference will not raise any safety or effectiveness issue,

Note 4:

Although Approximate Skin Temperature and Time to Reach Temperature Range of predicate device are different from the predicate device, they are both in the FDA generally considering therapeutic temperature range 40-45°C, so this difference will not raise any safety or effectiveness issue.

8. Performance Testing

We have provided the performance tests including the skin temperature test and the infrared energy and spectrum test to support the safety and effectiveness of the subject device.

The spectrum test shows that the subject device emits the main infrared electromagnetic spectrum 5~15 microns, with center around 9 microns.

The infrared energy test (Thermal Distribution Map) shows that the core temperature range of heating pad is about 44°C.

The skin temperature test shows that the time for skin surface to reach therapeutic temperature range 40°C is about 5 minutes; the time to reach maximum temperature 42°C is about 10 minutes.

9. Conclusion

The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject devices are substantially equivalent to the predicate devices.

10. Summary Prepared Date: 3 November 2011

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Shenzhen Anpan Technology Co., Ltd. % MEDLAB (Shenzhen) Information Service Co., Ltd. Ms. Sabrina Wei 11900 Dulongpre Apt. 207 Street Montreal, Quebec Canada H4J 0A1

NOV - 8 2011

Re: K111273

Trade/Device Name: FIR Heat Therapy Systems, models: EH-6601, EH-6603, EH-6604, EH-6605, EH-6606, EH-6607, EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613, EH-6614 Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: IRT, ILY

Dated: October 19, 2011

Received: October 26, 2011

Dear Ms. Wei:

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

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Page 2 - Ms. Sabrina Wei

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson

Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sponsor: Shenzhen Anpan Technology Co., Ltd. FIR Heat Therapy Systems Subject Device: 510(k) submission report (V1.0), Chapter 3 File No.:

Chapter 3. Indications for Use . .

Indications for Use

-- •

510(k) Number (if known):

Device Name: FIR Heat Therapy Systems, models: EH-6603, EH-6604, EH-6604, EH-6606, EH-6607, EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613, EH-6614

Indications for Use:

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) (Division Sign-Old)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surgers and Restorative Devices and Restorative Devices

510(k) Number K111273

Report by Shenzhen Anpan Technology Co., Ltd.

Page 3-1

Regulation Number and Section

§ 890.5740 Powered heating pad.

(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.