(14 days)
No
The summary describes a simple infrared lamp for topical heating and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on temperature output and electrical safety, not algorithmic performance.
Yes
The device is intended to provide topical heating for the temporary relief of muscle and joint pain, stiffness, and spasm, which are therapeutic claims.
No
The device is intended to provide topical heating for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation), not to diagnose medical conditions.
No
The device description clearly states it is a physical infrared lamp with a glass ceramic plate, indicating it is a hardware device. The performance studies also focus on the physical properties and effects of the lamp.
Based on the provided information, the Gaunying Infrared Lamp (Model #: FIR 51, SN-51) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This is an in vivo application, meaning it's used on a living organism.
- Device Description: The description details a lamp that emits infrared radiation for heating. This aligns with a physical therapy or medical device used externally on the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. The Gaunying Infrared Lamp operates by applying energy to the body.
N/A
Intended Use / Indications for Use
The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are 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.
Product codes
ILY
Device Description
Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). (General)
- UL 60601-1, first edition, 2003, deviations to IEC 60601-1
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 40° within 5 minutes which means that the subject device can maintain skin temperature at least 10 minutes in one treatment time (15 minutes).
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, 40cm and 45cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25°. For the predicate device, put an electronic temperature sensor at the distance 8''. 10'' and 12''. 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 device can achive the temperature range 41-45 which is an effective therapy temperature range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 5
AUG 1 3 2010
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
1.0 Submitter's Information
41
Establishment Registration Name:
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
Contact Person of the Consultant:
Mr. Stephen Ling
MEDLAB (Shenzhen) Information Service Co., LTD
Room 2706, Block A. ZhongFang JinYuan Buiding, Xinwen Road Shenzhen, Guangdong, P.R. China, 518034
TEL: +86-755-83089699 FAX: +86-755-83089760
Email: lingbensuo@gmail.com, please CC sabrinawei@hotmail.com
Section 5, Page 1 of 4
1
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Infrared Lamp |
| Trade Name: | Infrared Lamp |
| Model: | FIR 51, SN-51 |
| Classification name: | lamp, infrared, therapeutic heating |
| Review Panel: | Physical Medicine |
| Product Code: | ILY |
| Regulation Class: | Class II |
| Regulation Number: | 21CFR 890.5500 |
3.0 Predicate Device Information
| Sponsor: | Chongqing Xinfeng Medical Instrument Co., Ltd. |
|---|---|
| Device: | Xinfeng Heating Lamp, including 3 different models CQ-27, CQ-36 and CQ-55A |
| 510(K) Number: | K043558 |
4.0 Device description
Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
5.0. Intended Use
The Infrared Lamp are 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 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment
2
1:2004)). (General)
- UL 60601-1, first edition, 2003, deviations to IEC 60601-1
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 40□ 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
Compared with predicate device Xinfeng CQ-27, CQ-36 and CQ-55A Heating Lamps made by Chongqing Xinfeng Medical Instrument Co., Ltd. (K043558), 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 5 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.
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, 40cm and 45cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 250. For the predicate device, put an electronic temperature sensor at the distance 8''. 10'' and 12''. Set the treatment time at 60 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 250. The result shows that both device can achive the temperature range 41-45 which is an effective therapy temperature range.
The testing report shows that Infrared Lamp (Model#: FIR 51 and SN-51) is as
3
Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 5
effective as predicate device.
The new device pass the safety testing, and the risk management report shows all the risk are under control.
So, the deference 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.
Submission date: Oct 21, 2009 9.0
.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
AUG 1 3 2010
Re: K102149
Trade/Device Name: Gaunying Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 29, 2010 Received: July 30, 2010
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
5
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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely vours.
Mark A. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 4
Statement of Indications for Use
510(k) Number (if known):
AUG 1 3 2010
Device Name: Infrared Lamp Model: FIR 51, SN-51
Indications For Use:
1
The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are 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.
Prescription Use X (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)
Yurly A. Egorov
(Division Sign-Off)
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102149
Section 4, Page 1 of 1