(203 days)
The Gaunying Infrared Lamp ( Model #: IL50) 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.
Gaunying Infrared Lamp (Model#: IL50) 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.
Here's an analysis of the Gaunying Infrared Lamp (Model IL50) based on the provided 510(k) summary, aiming to answer your specific questions.
Important Note: This device is a basic therapeutic heating lamp. The acceptance criteria and testing described are for physical performance and safety, not for diagnostic accuracy or complex AI performance metrics like those seen in medical imaging.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Heat Output: Maintain temperatures above 40°C for at least 10 minutes within a 15-minute cycle. | - Maintained >40°C for at least 10 minutes. - Sensor (skin) temperature never exceeded 45°C. |
| Temperature Homogeneity/Consistency (implied by predicate comparison) | Device "tracks temperature readings" of the predicate device, indicating comparable heat output. | |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, UL 60601-1 standards. | Device is "manufactured to comply" with these standards. (No specific test results detailed, but compliance is stated). |
| Usability | Operating Instructions (OI) are clear and allow safe and effective operation by lay people. | Initial study showed questions, but revised OI led to no difficulties for a new study group. Concluded OI clear and effective. |
| Equivalence to Predicate | Similar intended use and comparable performance (specifically heat output characteristics). | Same intended use. Wavelength difference considered not to affect effectiveness. Bench test showed temperature readings tracked predicate device. Concluded "as safe and effective as the predicate device" and "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Performance Test: 2 devices (Gaunying Infrared Lamp Model IL50).
- Data Provenance: Not explicitly stated, but implies internal bench testing conducted by the manufacturer, likely in China (where the company is based). This is a retrospective evaluation of a manufactured product.
- Usability Test: An initial group of 10 people (5 females, 5 males). A second group of 10 people for re-testing.
- Data Provenance: Not explicitly stated, but implies internal testing by the manufacturer. This would be a prospective user study.
- Comparison Temperature Test: Not explicitly stated, but assumed to be 1 subject device (IL50) and 1 predicate device (Xinfeng Heating Lamp).
- Data Provenance: Not explicitly stated, but implies internal bench testing. This is a retrospective evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There are no "experts" in the traditional sense of medical specialists establishing ground truth for this type of device. The ground truth for functional performance (temperature output) is based on instrument measurements (digital temperature sensor) and engineering specifications (e.g., target temperature ranges).
For the Usability Test, the "ground truth" was an observable measure of user comprehension and ability to operate the device based on the Operating Instructions, observed by the study facilitators. No specific "experts" in usability were mentioned, but the observers effectively served this role.
4. Adjudication Method for the Test Set
- Functional Performance Tests: No explicit adjudication method described. The results are quantitative measurements from instruments. The two devices in the initial heat output test tracked "near 100%", implying consistency without needing further adjudication.
- Usability Test: The adjudication was based on direct observation of user interaction and their verbal feedback/questions. The Operating Instructions were revised based on this feedback. The re-test observed a lack of difficulties, effectively adjudicating the revised instructions as clear. There's no "2+1" or similar method, as it's a qualitative observation of user behavior.
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. This device is an infrared lamp for therapeutic heating, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The functional performance and comparison tests were standalone in the sense that they evaluated the device's physical output (heat generation) directly through measurement, without human intervention affecting its output. The "algorithm" here is the device's internal mechanism for generating infrared light and heat. Its performance was measured intrinsically.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Functional Performance:
- Instrumental Measurements: Digital temperature sensor readings served as the primary ground truth for heat output.
- Engineering/Physiological Specifications: The desired effective temperature (>40°C) and the safety threshold (<45°C) are based on physiological understanding and safety standards.
- Usability: Direct Observation of User Interaction and Feedback.
- Equivalence: Comparative Instrumental Measurements against a legally marketed predicate device.
8. The Sample Size for the Training Set
This type of medical device (an infrared heating lamp) does not involve machine learning or AI, and therefore, there is no training set in the computational sense. The device is engineered to meet specific physical output parameters.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
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510(K) SUMMARY
JAN - 5 2011
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:
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 (US Agent/Official Correspondent) of the Applicant:
Mr. Guenter Ginsberg (President)
Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135, USA Tel: 239 948 2001 Fax: 239 948 2002 Email: g.ginsberg@gmx.net
. Device Information
Type of 510(k) submission: Traditional Device Common Name: Infrared Lamp Infrared Lamp Trade Name: IL50 Model: lamp, infrared, therapeutic heating Classification name: Physical Medicine Review Panel: ILY Product Code: Class II Regulation Class: 21CFR 890.5500 Regulation Number:
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2.0 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 |
3.0 Device description
Gaunying Infrared Lamp (Model#: IL50) 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.
4.0 Intended Use
The Gaunying Infrared Lamp (Model #: IL50) 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.
Performance Summary 5.0
Testing of the Infrared Lamp (Model#: IL50) 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 .
- Performance Bench Tests: .
Two (2) devices were tested for heat output at distances of 30, 35 and 40cm from the infrared source. Temperatures were recorded every one (1) minute, up to 15 minutes, using a digital temperature sensor. The test results concluded that the Infrared Lamp (Model#: IL50) was able to maintain temperatures above 40° C (the desired effective temperature) at least 10 minutes of the 15 minutes cycle time. The tests also showed that the temperature at the sensor (skin) never exceeded a temperature of 45° C. Both devices used for this test tracked each near 100%.
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Usability Test:
A group of 10 people were selected, 5 females and 5 men with different ages and educational backgrounds. They were given the Operating Instructions (OI) to read and study before using the subject device. The test group had no problem operating the device, but had questions and clarifications about some statements in the OI. The OI was changed accordingly. A new study group of 10 people were tested and observed. Nobody had any difficulties understanding the OI and operating the device. It was concluded that the Operating Instructions are clear and have enough information and warnings that lay people should not have any difficulties understanding the instructions and operating the device safely and effectively.
6.0 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#: IL50) 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 Near-infrared (0.75-1.4 µm) and Short-wavelength infrared (1.4-3 um). The predicate device use 5 to 25 microns, which belongs to Longwavelength infrared (8-15 µm) and far infrared (15-1,000 µm).
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.
Comparison Temperature Test:
A bench test was set up to compare the heat output of the predicate device with the subject device. Temperatures were recorded for both devices at distances of 30, 35, and 40 cm and at 1 minute intervals up to 55 minutes. The results show that the Gaunying Infrared Lamp (the subject) tracks the temperature readings of the Xingfing Heating Lamp (the predicate device) and is therefore equivalent in performance to 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. The testing report shows that Infrared
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Gaunying Infrared Lamp IL50 510(K) Files: Section 5
Lamp (Model#: IL50) is as safe and effective as the predicate device.
So, the difference does not raise new questions of safety and effectiveness. The Infrared Lamp (Model#: IL50), is substantially equivalent to the predicate device.
7.0 Submission date:
June 16, 2010
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest wings and a body. The bird is oriented diagonally, moving from the upper right to the lower left of the image. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Foshan Gaunying Electronics Co., Ltd. % Media Trade Corporation Mr. Guenter Ginsberg 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
JAN - 5 2011
Re: K101693
Trade/Device Name: Gaunying Infrared Lamp, Model IL50 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: December 10, 2010 Received: December 10, 2010
Dear Mr. Ginsberg:
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. Iisting 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
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Page 2 – Mr. Guenter Ginsberg
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Sincerely yours,
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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pg 1 of 1
Statement of Indications for Use
510(k) Number (if known): K101693
Device Name: Gaunying Infrared Lamp Model: IL50
JAN - 5 2011
Indications For Use:
The Gaunying Infrared Lamp ( Model #: IL50) 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.
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)
Neil P. Olken
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Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101693
Section 4, Page 1 of 1
§ 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.