(157 days)
The Thermotex 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.
The Thermotex 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 nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
The provided submission for the Thermotex Heat Therapy Systems (K092589) does not contain detailed acceptance criteria or a specific study proving the device meets particular numerical performance targets that would typically be seen in studies for AI/ML-based medical devices. This submission is for an electrically-powered pad that generates infrared radiation, a type of device where performance is generally demonstrated through bench testing and animal studies to ensure safety and function, rather than diagnostic accuracy or effectiveness against a specific disease outcome in humans with statistical metrics.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the submission for this physical medical device (infrared heating pad) does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or quantitative clinical outcomes data typically found for diagnostic or treatment AI algorithms. Instead, the "performance" discussed relates to its technological characteristics and safety.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Infrared Radiation Capability | Demonstrated during laboratory bench testing. |
| Safety (General) | Demonstrated during laboratory bench testing and animal studies. |
| Heat Control Functionality | User-controlled 3-position switch for heat maintenance. |
| Substantial Equivalence to Predicate | The manufacturer stated that technological differences do not raise new questions of safety and effectiveness, supported by preclinical bench and animal testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a human clinical test set for diagnostic performance. The submission refers to "laboratory bench testing" and "animal studies." No specific numbers for animals or test configurations are provided.
- Data Provenance: The studies were described as "laboratory bench testing" and "animal studies." No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though preclinical studies are typically prospective by nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a therapeutic heating pad, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. Ground truth for its performance would entail measuring physical parameters (e.g., temperature, infrared output) and observing physiological responses in animal models, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as there is no human test set requiring adjudication in the context of diagnostic or treatment efficacy evaluation that would typically use methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the impact of AI/ML on human reader performance, typically in imaging diagnostics. This device is not an AI/ML diagnostic tool, nor does it assist human readers in interpretation.
6. Standalone (Algorithm Only) Performance Study
No. This is not an algorithm-only device. It is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for this type of device would be based on:
- Physical measurements: During bench testing to confirm infrared output, temperature control, and electrical safety.
- Physiological observations: In animal models to assess safety (e.g., tissue damage) and potentially the intended therapeutic effect (e.g., local circulation increase, muscle relaxation - though specific metrics are not detailed).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML 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 an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The submission indicates that the Thermotex Heat Therapy Systems' performance and safety were demonstrated through:
- Laboratory Bench Testing: This testing was used to evaluate infrared radiation capability and overall safety. It likely involved measuring the device's physical output (e.g., wavelength, intensity of IR radiation) and confirming its electrical and mechanical safety features.
- Animal Studies: These studies were conducted to further demonstrate the safety of the device. Animal models are often used to assess potential for thermal injury, tissue response, and possibly to observe physiological effects in vivo that are relevant to its indications for use (e.g., local circulatory changes, if measured).
The overall goal of these studies, as stated by the manufacturer, was to demonstrate that "the technological differences between the Thermotex Heat Therapy Systems and the predicate device do not raise new questions of safety and effectiveness." The FDA's 510(k) clearance (K092589) confirms that, based on the submitted information (including the preclinical bench and animal testing), the device was found to be substantially equivalent to its predicate device (BIO-MAT 2000, K072534) for its stated indications for use. This substantial equivalence determination implies that the device met the necessary safety and effectiveness standards relevant to its classification as a Class II device.
{0}------------------------------------------------
ATTACHMENT E
510(k) SUMMARY
| 510(k): | K092589 |
|---|---|
| Trade Name: | Thermotex Heat Therapy Systems |
| Sponsor: | EAS Consulting Group LLC.1940 Duke Street, Suite 200Alexandria, VA 22314Fax- 703.684.4428 |
| Device Generic Name: | Electric Heating Pad and Infrared Lamp |
| Classification: | CFR 890.5740 Class II |
JAN 2 8 2010CFR 890.5500 Class II
IRT, ILY Product Code:
Product Description:
The Thermotex 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 nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
Indications for Use:
The Thermotex 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.
Predicate Devices:
The Thermotex Heat Therapy Systems is substantially equivalent to BIO-MAT 2000 (K072534) - Rich Way International Inc.
Technological Characteristics
The Thermotex Heat Therapy Systems are electrically-powered pads that generate infrared radiation to apply heat to affected body areas. The user can control the pad's heat mrarou raintente to the body by means of a 3-position switch. The manufacturer has evaluated the pad's performance during laboratory bench testing and animal studies to demonstrate infrared radiation capability and its safety.
{1}------------------------------------------------
Substantial Equivalence
The Thermotex Heat Therapy Systems have the same intended use and indications for use as its predicate device. The manufacturer has conducted preclinical bench and animal testing with the Thermotex heat pads. The information from laboratory and animal testing documents that the technological differences between the Thermotex Heat Therapy Systems and the predicate device do not raise new questions of safety and effectiveness.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Thermotex Therapy Systems, Ltd. % EAS Consulting Group LLC Mr. Eduardo March 1940 Duke Street, Suite 200 Alexandria, Virginia 22314
JAN 2 8 2010
Re: K092589
Trade/Device Name: Thermotex Heat Therapy Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, IRT Dated: January 25, 2010 Received: January 26, 2010
Dear Mr. March:
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
{3}------------------------------------------------
Page 2 - Mr. Eduardo March
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,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Thermotex Heat Therapy Systems
Page _______ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K092589
Device Name: THERMOTEX HEAT THERAPY SYSTEMS
Indications for Use:
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associaed with arthritis, muscle spasms, minor strains and sprains and minor muscular back air: muscular relaxation; and the temporary increase of local circulation where wained.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND / OR
Over-the -Counter Use × (PART 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| (Division Sign-Off) | FOR M. MELKERSON |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K092589 |
§ 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.