The infrared lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Device Description

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating. Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display. The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.

AI/ML Overview

The provided 510(k) summary describes a therapeutic heating device (Infrared Lamp) and its equivalency to existing predicate devices. The "acceptance criteria" in this context are not explicitly defined as specific numerical targets for performance metrics (like sensitivity/specificity for a diagnostic device). Instead, the acceptance criteria are implicitly that the device's performance, particularly its heating capability, is similar to or better than a legally marketed predicate device and that it meets relevant safety standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Device delivers topical heating adequate to elevate tissue temperature for therapeutic purposes.	Subject Device (FIR 51, SN-51): Skin temperature can rise to 40°C within 5 minutes and maintain this temperature for at least 10 minutes in a 15-minute treatment session (at 30cm, 35cm, and 40cm distances). When compared against the predicate device (TDP CQ-27 Heat Lamp), both devices achieved a temperature range of 41-45°C, which is stated as an "effective therapy temperature range."
Device complies with relevant electrical safety and electromagnetic compatibility (EMC) standards.	Device is manufactured to comply with: - IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995)- IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests; Edition 2.1)- UL 60601-1, first edition, 2003, deviations to IEC 60601-1.
The difference in intended use (prescription vs. OTC) for the FIR 51, SN-51 model (K110721 vs K102149) does not raise new questions of safety and effectiveness.	The labeling of the subject device (K110721) is "readable and understandable for over-the-counter use." The difference does not raise new questions of safety and effectiveness, leading to a substantial equivalence determination.
The differences in technological characteristics (e.g., wavelength) between the FIR 51, SN-51 and the TDP CQ-27 Heat Lamp do not raise new questions of safety and effectiveness.	The subject device uses 600 nm - 2000 nm infrared (Near-infrared and Short-wavelength infrared), while the predicate uses 2 to 25 microns (Long-wavelength infrared and Far infrared). The submission claims that "The different wavelength will not affect the effectiveness of device." It also argues the subject device might have "less" burn risk due to visible heating. A comparison test showed both devices achieve the therapeutic temperature range of 41-45°C. Risk management report shows all risks are under control.
The device maintains safety when used by layperson users (for OTC use).	"As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested." (Refers to the prior model K102149.) The new device passes safety testing and the risk management report indicates controlled risks.

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

Test Set (Performance Testing): The description refers to "a person" for the performance testing of the subject device. This implies a very limited sample size, possibly n=1, or at most a very small convenience sample. It does not specify a statistically significant sample size.
Data Provenance: The testing was conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. It appears to be prospective testing specifically for this submission, not retrospective data.

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

This device is a therapeutic heating device, not a diagnostic device that requires expert consensus for "ground truth" on medical findings. The "ground truth" for its performance is objective physical measurement (temperature increase).
No experts are mentioned as establishing ground truth in the traditional sense for diagnostic accuracy.

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

Not applicable. The performance testing involved direct temperature measurement using an electronic thermometer, not subjective interpretation requiring 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

Not applicable. This is a therapeutic physical device, not an AI-assisted diagnostic tool involving human "readers."

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

Not applicable. This is a therapeutic physical device, not an algorithm. Its performance is inherent to its physical operation.

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

The "ground truth" for the device's performance is objective physical measurement:
- Skin temperature increase measured by an electronic thermometer.
- Compliance with international electrical safety and EMC standards.
- Comparison of heating efficacy against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. As a physical therapeutic device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and standards, not data training.

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

Not applicable, as there is no training set for this type of device.

Summary

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K110721/

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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

Submitter's Information 1.0

Establishment Registration Name:

MAR 3 0 2011

Foshan Gaunying Electronics Co., Ltd.

4F, #4 Industry Country, Cheng Nan Park of Foshan Hi-tech Industrial Development Zone Foshan, Guangdong, China 528000

Contact Person of the Applicant:

Mrs. Ladi Lee GM

Foshan Gaunying Electronics Co., Ltd.

4F, #4 Industry Country, Cheng Nan Park of Foshan Hi-tech Industrial Development Zone Foshan, Guangdong, China 528000

Tel: +86-757-8310 7610 Fax: +86-757-8310 7621 Email: xhli@fseagle.com.cn

Device Information 2.0

Type of 510(k) submission:	Traditional
Device Common Name:	Infrared Lamp
Trade Name:	Infrared Lamp
Model:Classification name:	FIR 51, SN-51lamp, infrared, therapeutic heating
Review Panel:	Physical Medicine
Product Code:	ILY
Regulation Class:	Class II
Regulation Number:	21CFR 890.5500

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3.0 Predicate Device Information

Sponsor:	Lhasa Medical, Inc
Device:	TDP CQ-27 Heat Lamp
510(K) Number:	K003538
Sponsor:	Foshan Gaunying Electronics Co., Ltd.
Device:	Infrared Lamp Model FIR 51, SN-51
510(K) Number:	K102149

4.0 Device description

Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display.

The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.

5.0 Intended Use

The Infrared Lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

6.0 Performance Summary

Testing of the Infrared Lamp (Model#: FIR 51, SN-51) includes functional performance testing and electrical safety testing. The device is manufactured to comply with the following international standards:

IEC 60601-1. Medical Electrical Equipment Part 1: General Requirements . for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). (General)
UL 60601-1, first edition, 2003, deviations to IEC 60601-1 .

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7.0 Non-clinical data

We conduct a performance testing with the subject device. For the subject device, let a person at the distance 30cm, 35cm and 40cm, set the treatment time at 15 minutes, and then we use an electronic thermometer to measure the temperature of skin temperature every minutes. The testing result shows that the skin temperature can rise to 400 within 5 minutes which means that the subject device can maintain skin temperature at least 10 minutes in one treatment time (15 minutes).

8.0 Comparison to predicate device and conclusion

Compare with predicate device Gaunying Infrared Lamp Model FIR 51, SN-51 8.1 (K102149)
The subject device and the predicate device is exactly the same product, except that predicate device is intended for prescription use, while subject device is intended for over-the-counter use.

The difference between subject device and predicate device is in the labeling. The labeling of subject device is readable and understandable for over-the-counter use.

So, the difference does not raise new questions of safety and effectiveness. The Infrared Lamp (Model#: FIR 51 and SN-51), is substantially equivalent to the predicate device.

Compare with predicate device TDP CQ-27 Heat Lamp made by Lhasa Medical, 8.2 Inc (K003538)
Compared with predicate device TDP CO-27 Heat Lamp made by Lhasa Medical, Inc (K003538), the device Infrared Lamp (Model#: FIR 51 and SN-51) has same intended use with the predicate device. Although, there is a little different technological characteristics;

The infrared wavelength used in subject device and predicate device is deferent. The subject device uses 600 nm - 2000 nm infrared, which belongs to Nearinfrared (0.75-1.4 um) and Short-wavelength infrared (1.4-3 um). The predicate device use 2 to 25 microns, which belongs to Long-wavelength infrared (8-15 um) and far infrared (15-1,000 um).

The human visible light is in wavelength 400–700 nm. So the subject device heating can be seen when it is working. The predicate device heating is not visible when it is working. That means the possibility of burns risk for subject device is less than the predicate device.

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Whatever Near-infrared, Short-wavelength infrared, Long-wavelength infrared and Far infrared, they all can heat and therapy disease. The different wavelength will not affect the effectiveness of device.

We conduct a comparison testing with the subject device and predicate device. For the subject device, put an electronic temperature sensor at the distance 30cm. 35cm and 40cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25°C. For the predicate device, put an electronic temperature sensor at the distance 12", 15' and 18''. Set the treatment time at 60 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25℃. The result shows that both devices can achieve the temperature range 41-45°C which is an effective therapy temperature range.

The testing report shows that Infrared Lamp (Model#: FIR 51 and SN-51) is as effective as predicate device.

The subject device and predicate device also have difference in shape, rated power, cooling means, timing controller and installation. However, analyses and testing show that the difference does not raise new questions of safety and effectiveness. The new device passes the safety testing, and the risk management report shows all the risks are under control.

As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested.

So, the difference does not raise new questions of safety and effectiveness. The Infrared Lamp (Model#: FIR 51 and SN-51), is substantially equivalent to the predicate device

9.0 Submission date: Dec 20, 2010

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

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

Foshan Gaunying Electronics Co., Ltd. % Intertek Testing Services NA, Inc. Mr. William J. Sammons 2307 E. Aurora Road / Unit B7 Twinsburg, OH 44087

MAR 3 0 201

Re: K110721

Trade/Device Name: Gaunying Infrared Lamp (Model # FIR 51. SN-51) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 14, 2011 Received: March 15, 2011

Dear Mr. Sammons:

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 - Mr. William J. Sammons

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Al. B. Rh
for

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

Enclosure

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Statement of Indications for Use

510(k) Number (if known):

Device Name: Infrared Lamp Model: FIR 51, SN-51

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

signature

Page 1 of l

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

510(k) Number K11072/

Section 4, Page 1 of 1

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.