(200 days)
The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called the "Diowave Laser System." This type of document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a clinical trial report or a more extensive technical submission for an AI/ML powered device.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, ground truth establishment) is not present in this document.
Here's what can be extracted based on the provided text:
- Device Name: Diowave Laser System
- Regulation Number: 21 CFR 890.5500
- Regulation Name: Infrared lamp
- Regulatory Class: Class II
- Product Code: ILY
- Indications for Use: The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Explanation for missing information:
The FDA 510(k) process for a device regulated as an "Infrared lamp" (product code ILY) largely relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (e.g., wavelength, power output, safety features) and intended use. It does not generally require the submission of detailed clinical performance studies, especially those involving AI/ML algorithms, human reader studies, or complex ground truth establishment, which are more common for novel diagnostic or AI-powered devices. The clearance indicates that the device's performance is considered acceptable because it is similar to existing, approved devices for the stated indications.
To answer your specific questions in the format requested, with the understanding that most information is not available from this document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document, as it relies on substantial equivalence to a predicate device. | Not specified in this document, as it relies on substantial equivalence to a predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable/Not mentioned. The 510(k) clearance for this type of device does not typically require a test set of this nature.
- Data provenance: Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/Not mentioned.
- Qualifications of experts: Not applicable/Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not mentioned.
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
- MRMC study: Not applicable/Not mentioned. This device is not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect size: Not applicable/Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: Not applicable/Not mentioned. This device is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable/Not mentioned. The 510(k) for this device relies on demonstrating equivalence to predicate devices, not on a ground truth for diagnostic accuracy.
8. The sample size for the training set
- Sample size for training set: Not applicable/Not mentioned. This device is not an AI/ML powered device requiring a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Not mentioned.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 23, 2012
Technological Medical Advancements, Incorporated (TMA) = % Dr. Bruce Coren 1209 North Flagler Drive West Palm Beach, Florida 33401
Re: K121363
Trade/Device Name: Diowave Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: November 20, 2012 Received: November 11, 2012
Dear Dr. Coren:
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 vour 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Dr. Bruce Coren
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,
David Krause
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K121363
Device Name: Diowave Laser System
Indications for Use:
The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Prescription Use ਨ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off Division of Surgical Devices 510(k) Number: K121363
§ 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.