BIOLIGHT BIODYNAM by BIOLIGHT AB

The Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

Device Description

The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

AI/ML Overview

This is an FDA Premarket Notification (510(k)) K130866 for the Biolight Biodynam device, an infrared lamp. This document primarily focuses on the substantial equivalence determination and regulatory compliance, and as such, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a specific study proving device performance.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Not available in this document. This 510(k) summary only states that the device provides "topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue." It does not provide quantitative acceptance criteria (e.g., specific temperature ranges, pain reduction scales, or timeframes) or direct performance data from a clinical study to meet those criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not available in this document. This document does not describe a clinical study or a test set.

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):

Not available in this document. This document does not describe a clinical study or the establishment of ground truth by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not available in this document. This document does not describe a clinical study or an adjudication method.

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:

Not applicable and not available in this document. The Biolight Biodynam is an infrared lamp for pain relief, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable and not available in this document. As an infrared lamp, this device does not involve an algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not available in this document. This document does not describe a clinical study or the type of ground truth used.

8. The sample size for the training set:

Not applicable and not available in this document. This document describes a medical device (infrared lamp), not an algorithm that would require a training set.

9. How the ground truth for the training set was established:

Not applicable and not available in this document. This document describes a medical device (infrared lamp), not an algorithm that would require a training set with established ground truth.

In summary: This 510(k) document is a regulatory approval letter based on "substantial equivalence" to a predicate device. It primarily addresses the device's indications for use and regulatory classification, not the detailed performance data or clinical study results that would be required to answer most of your questions. To obtain such information, one would typically need to review the specific clinical trials or performance studies submitted by the manufacturer to the FDA, which are generally not part of the publicly available 510(k) decision letter itself.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 25, 2013

Biolight Ab Attn: Par Olausson Lido Warfvinges Vag 26 SE-112 51 Stockholm Sweden

Re: K130866

Trade Name: Biolight Biodynam Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: IL Y Dated: September 25, 2013 Received: September 27, 2013

Dear Mr. Olausson Lido:

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

{1}------------------------------------------------

Page 2 - Mr. Olausson Lido

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K130866

Device Name: Biolight Biodynam

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Regulation Number and Section

N/A