Bashan TDP Heat Lamp is 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 the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

Bashan TDP Heat Lamp is used to provide topical heating to the body. It is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 5 to 25 microns, 110 volt power, 250 watts. It includes timer, safety fuses.

AI/ML Overview

The provided text describes a 510(k) summary for the "Bashan TDP Heat Lamp," comparing it to predicate devices. This document focuses on demonstrating substantial equivalence to legally marketed devices, primarily through adherence to recognized standards and comparison of features. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement.

However, based on the provided text, I can extract information related to safety and performance testing that serves as the basis for claiming substantial equivalence.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., target specificity or sensitivity) that a study would aim to meet for a diagnostic device. Instead, the "acceptance criteria" appear to be met by compliance with recognized electrical safety and electromagnetic compatibility standards, and by showing similar characteristics and intended use to predicate devices. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate devices.

Feature/Criterion	Acceptance Criteria (Implied by Standards/Predicate Devices)	Reported Device Performance
Safety & Essential Performance	Compliance with AAMI/ANSI ES60601-1	Bashan TDP Heat Lamp meets AAMI/ANSI ES60601-1.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Bashan TDP Heat Lamp meets IEC 60601-1-2.
Home Healthcare Environment	Compliance with IEC 60601-1-11 (for OTC use)	Bashan TDP Heat Lamp meets IEC 60601-1-11.
Output Parameters	Verification of output parameters	Performance test report conducted to verify output parameters. Result indicates "safe and effective."
Intended Use/Indications	Comparable to predicate devices	"temporary relief of minor muscle and joint pain and stiffness, ... temporary increase in local circulation ... relaxation of muscles. ... muscle spasms, minor sprains and strains, and minor muscular back pain." (Matches predicate devices).
Operating Timer	Predicate devices have various ranges or unspecified	Up to 60 minutes (Difference from predicate's "Up to 95 minutes" noted, but deemed not to affect safety/effectiveness).
Skin Temperature	Effective skin temperatures between 40 ~ 45 ℃ at 8" ~ 12" distance	Models TDP-124D & TDP-124F: 20cm: 45°C; 25cm: 42°C; 30cm: 40°C. Models TDP-166D & TDP-166F: 20cm: 45°C; 25cm: 43°C; 30cm: 41°C. (Difference noted, but deemed not to affect safety/effectiveness).
Usability	Users' ability to comprehend labeling and operate as intended, with no safety issues.	500 eligible device users successfully operated the device with no safety issues reported.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions 500 eligible device users for the usability study.
The data provenance is not explicitly stated as "country of origin," but the submitter, Chongqing YUHE Medical Instruments Co., Ltd., is based in Chongqing, China. The study appears to be a prospective usability study where participants interacted with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For the usability study, the document does not specify "experts" establishing ground truth in the sense of clinical reviewers. Instead, the "ground truth" for usability was likely derived from the successful interaction of the 500 device users with the product and its labeling, and the absence of reported safety issues. There were no clinical experts mentioned in evaluating the usability outcomes.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical adjudication process described for the usability study. The determination of "successfully operated" and "no safety issues" likely came directly from the observed outcomes of the 500 users.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is an infrared heat lamp for pain relief, not a diagnostic imaging device typically associated with MRMC studies to assess reader interpretations. The study conducted was a usability study and performance testing against standards.

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

No, a standalone "algorithm only" performance study was not done. This device is a physical therapeutic device, not an AI or algorithm-based product.

7. The Type of Ground Truth Used

Usability Study: The "ground truth" was derived from directly observed user performance and self-reported issues (or lack thereof) during the study. Successful operation and absence of safety issues reported by the 500 users served as the "ground truth" for usability.
Performance Tests: The "ground truth" for performance (e.g., output parameters, skin temperature) was established through measurement against predefined engineering specifications and recognized electrical safety and performance standards.

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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

February 14, 2017

Chogqing Yuhe Medical Instruments Co., Ltd. Liu Yong General Manager No.104-8 City Garden Mid Road, Shapingba District Chongqing, 400038 CN

Re: K162590

Trade/Device Name: Bashan TDP Heat Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: January 2, 2017 Received: January 9, 2017

Dear Liu Yong:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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/ResourcesforYou/Industry/default.htm. 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

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,

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162590

Device Name Bashan TDP Heat Lamp

Indications for Use (Describe)

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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Sponsor:	Chongqing YUHE Medical Instruments Co., Ltd.
Subject Device:	Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F
File No.:	510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

Chapter 5. 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Company Name: Chongqing YUHE Medical Instruments Co., Ltd. Establishment registration number: Applying Address: No.104-8 City Garden Mid Road, Shapingba District, Chongqing, China Name of contact person: Liu Yong Title: General Manager Tel: +86-23-65462778 Fax: +86-23-65462778 Email: 191513131@qq.com

Application Correspondent:

Contact Person: Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com

2. Subject Device Information:

Type of 510(k) Submission: Traditional Common Name: Infrared lamp Trade Name: Bashan TDP Heat Lamp Models: TDP-124D, TDP-166D, TDP-124F, TDP-166F Classification Name: lamp, infrared, therapeutic heating Review Panel: Physical Medicine Product Code: ILY Regulation Number: 21CFR890.5500 Regulation Class: 2

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Sponsor:	Chongqing YUHE Medical Instruments Co., Ltd.
Subject Device:	Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F
File No.:	510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

3. Predicate Device Information:

Predicate Device 1:

510(K) Number: K081720 Company Name: Prime Herbs Corporation Trade Name: Precision TDP Lamp, Precision Infrared Lamp, Marvel Lamp, Marvel Lamp, Wonder Lamp Common Name: Infrared Heating Lamp Product Code: ILY

Predicate Device 2:

510(K) Number: K043558 Company Name: Chongqing Xinfeng Medical Instrument Co., Ltd. Trade Name: Xinfeng Lamp Common Name: Infrared Heating Lamp Product Code: ILY

4. Device Description

5. Intended Use / Indications for Use

6. Test Summary

Bashan TDP Heat Lamp is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

� AAMI/ANSI ES60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, Edition 2005/(R)2012 and A1:2012;
� 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, Edition 4.0, 2014;

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Sponsor:	Chongqing YUHE Medical Instruments Co., Ltd.
Subject Device:	Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F
File No.:	510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

� IEC 60601-1-11: Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0, 2015;
� The performance test report has also been conducted to verify the output parameters of the device.

The result of tests indicates that the Bashan TDP Heat Lamp is safe and effective, and the substantial equivalent performance as the legally marketed predicate device.

7. Usability Study

Usability study was conducted on 500 eligible device users. The study evaluated the users' ability to comprehend the device labeling and operate the device as intended in a safe and effective means. The study results showed that potential device users could successfully operate the device as intended with no safety issues reported.

Elements ofComparison	Subject Device	Predicate Device	Remark
Manufacturer	Chongqing YUHEMedical Instruments Co.,Ltd.	Prime HerbsCorporationChongqing XinfengMedical InstrumentCo., Ltd.	--
Device Name	Bashan TDP Heat Lamp(Models: TDP-124D,TDP-166D, TDP-124F,TDP-166F)	Precision TDP Lamp,Precision Heat Lamp,Precision InfraredLamp, Marvel Lamp,Wonder LampXinfeng Heating Lamp(Models: CQ-27, CQ-36)	--
510(k) Number	Applying	K081720 K043558	--
Product Code	ILY	ILYILY	SE
Indications forUse	Bashan TDP Heat Lampis used for the temporaryrelief of minor muscleand joint pain andstiffness, the temporaryrelief of minor joint painassociated with arthritis,the temporary increasein local circulation whereapplied, and therelaxation of muscles. Inaddition, it may also helpmuscle spasms, minor	The Precision TDPlamp, Precision HeatLamp, PrecisionInfrared Lamp, MarvelLamp and WonderLamp may be used forthe temporary relief ofminor muscle and jointpain and stiffness, thetemporary relief ofminor joint painassociated witharthritis, the temporaryBashan TDP HeatLamp is used for thetemporary relief ofminor muscle and jointpain and stiffness, thetemporary relief ofminor joint painassociated witharthritis, the temporaryincrease in localcirculation whereapplied, and therelaxation of muscles.	SE

	sprains and strains, andminor muscular backpain.	increase in localcirculation whereapplied, and therelaxation of muscles.In addition, it may alsohelp muscle spasms,minor sprains andstrains, and minormuscular back pain.	In addition, it may alsohelp muscle spasms,minor sprains andstrains, and minormuscular back pain.
Type of Use	OTC	OTC	Prescription	SE
Key Components	Heating headSwing armControl boxPedestal with extension	Heating headSwing armControl boxPedestal withextension	Heating headSwing armControl boxPedestal withextension	SE
Power InputRating	250W maximum, 50/60Hz	250W maximum, 50/60Hz	250W maximum, 50/60Hz	SE
Spectrum Range	5 ~ 25 microns	2 ~ 50 microns	5 ~ 25 microns	SE
Warming UpTime	15 minutes	--	15 minutes	SE
Total WorkingHours	1000 Hours	1200 ~ 1500 Hours	1000 Hours	SE
Operating Timer	Up to 60 minutes	--	Up to 95 minutes	SENote 1
Placement Type	Models TDP-124D &TDP-166D: desktoptype;Models TDP-124F, TDP-166F: floor type	--	Desktop type	SENote 2
Radiant PlateDiameter	TDP-124D & TDP-124F:12.4 cm;TDP-166D & TDP-166F:16.6 cm	--	16.6 cm	SENote 3
SkinTemperature	The distance from lamphead and the testingresult:(1) Models TDP-124D &TDP-124F:20cm distance: 45°C;25cm distance: 42°C;30cm distance: 40°C(2) Models TDP-166D &TDP-166F:20cm distance: 45°C;25cm distance: 43°C;30cm distance: 41°C	--	The distance from lamphead and the testingresult:8" (20cm) distance:45°C:10" (25cm) distance:43°C;12" (30cm) distance:41°C	SENote 4
ComplianceStandards	AAMI/ANSI ES 60601-1,IEC 60601-1-2,IEC 60601-1-11	IEC 60601-1,IEC 60601-1-2	IEC 60601-1,IEC 60601-1-2	SENote 5

8. Comparison to predicate device and conclusion

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Sponsor:

Subject Device:

Chongqing YUHE Medical Instruments Co., Ltd. Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F

File No.:

510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

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Sponsor:	Chongqing YUHE Medical Instruments Co., Ltd.
Subject Device:	Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F
File No.:	510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

Comparison in Detail

Note 1 - 3:

The Operating Timer, Placement Type, Inner Cover Diameter of subject devices are a little difference from predicate devices. They are both compliance with IEC 60601-1 requirements. So the difference will not raise any safety or effectiveness issue.

Note 4:

The Skin Temperature of subject devices are a little difference from predicate devices, but the effective skin temperatures are between 40 ~ 45 ℃ in 8" ~ 12" distance from lamp head. So the difference will not raise any safety or effectiveness issue.

Note 5:

The Compliance Standards of subject devices are a little difference from predicate devices, but the subject devices are also complied with home healthcare environment used device standard IEC 60601-1-11 for OTC used. So the difference will not raise any safety or effectiveness issue.

Finial conclusion:

The subject device Bashan TDP Heat Lamp (Models: TDP-124D, TDP-166D, TDP-124F, TDP-166F) has all features of predicate devices, the Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp, Wonder Lamp (K081720) and Xinfeng Heating Lamp (K043558). The differences between them do not affect the safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate devices.

9. Date of the summary prepared: February 9, 2017

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.