The indicated use of the Nanobeam 940 is to emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Device Description

DavaRay's Nanobeam 940 is a near-infrared light device used for therapeutic purposes. The proposed classification for the new device is Class II. The Nanobeam 940 falls within the definition of a "Sec. 890.5500 Infrared Lamp" Class II device.

AI/ML Overview

This 510(k) premarket notification for the Nanobeam 940 device does not include detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or a data analysis of performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices, which is a common pathway for Class II medical devices like the Nanobeam 940 (an Infrared Lamp).

The documentation does not contain:

A table of acceptance criteria and reported device performance.
Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for a performance study.

Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices. This means that the device's safety and effectiveness are established by showing it is as safe and effective as, and performs similar functions to, existing devices already on the market.

Based on the provided text, here's what can be inferred:

1. Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or reported device performance metrics are provided in the document.
The implicit "acceptance criteria" for the 510(k) pathway is that the new device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness profile.
The "reported device performance" is essentially that the Nanobeam 940 emits energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, etc., similar to its predicates.

2. Sample Size and Data Provenance:

Not applicable / Not provided. The submission does not detail a clinical or performance study with a test set. Substantial equivalence is often demonstrated through comparison of device specifications, materials, and intended use, rather than a de novo clinical trial for every 510(k) submission.

3. Number of Experts and Qualifications:

Not applicable / Not provided. No ground truth establishment is described for a performance study.

4. Adjudication Method:

Not applicable / Not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable / Not provided. This type of study would be relevant for devices involving image interpretation or diagnostic aid, which the Nanobeam 940 is not.

6. Standalone Performance Study:

Not applicable / Not provided. While the device operates "standalone" in the sense that it functions without human-in-the-loop interpretation, a formal "standalone performance study" (as typically understood in AI/software medical devices) was not conducted or described. The performance is assessed in comparison to its predicates.

7. Type of Ground Truth Used:

Not applicable / Not provided.

8. Sample Size for the Training Set:

Not applicable / Not provided. This device is hardware for therapeutic purposes, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not provided.

Summary of the Study (or lack thereof) Proving Acceptance Criteria:

The "study" proving the Nanobeam 940 meets acceptance criteria, in the context of this 510(k) submission, is the assessment of substantial equivalence to predicate devices.

Predicate Devices Identified:
- BioBeam 940 (K042813)
- MedLight 630 Pro (K042813)
- LumiWave 1X4 (K051816)
Basis for Equivalence: The Nanobeam 940 is considered substantially equivalent because its intended use (temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation where heat is indicated) is the same as the predicate devices, and it operates by emitting Near-IR spectrum energy, similar to its predicates, which were approved through the 510(k) exemption process. The regulatory classification for all these devices is Class II, "Infrared Lamp."

In essence, the "proof" is that the device is technologically and functionally similar to devices already found safe and effective by the FDA. No de novo performance study with specific metrics, test sets, or ground truth establishment is described within this 510(k) summary.

Summary

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

K073681

510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

1. Applicant

DavaRay Inc. 2232 S. Main St. #422 Ann Arbor, MI 48103

DEC 0 9 2008

Contact Person: David J. Arndt, President DavaRay, Inc. Phone Number: (734) 276-5366 Fax Number: (734) 677-7791 Email: davidjarndt(@sbcglobal.net

2. Device Name

Nanobeam 940

3. Predicate Device

The Nanobeam 940 is similar to the BioBeam 940 (K042813), the MedLight 630 Pro (K042813) and the LumiWave 1X4 (K051816). We consider the Nanobeam-940 to be substantially equivalent to these three devices which were approved for market through the 510(k) exemption process.

4. Intended Use of the Device

5. Description of the Device

Thank you for your review of our application,

David J. Arndt

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DavaRay, Inc. % Mr. David J. Ardnt President 2232 S. Main Street, #422 Ann Arbor, Michigan 48103

DEC 0 9 2008

Re: K073681

Trade/Device Name: Nanobeam 940 Regulation Number: 21 CFR 890.5550. Regulation Name: Infared Lamp Regulatory Class: II Product Code: ILY Dated: November 19, 2008 Received: November 24, 2008

Dear Mr. Ardnt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Mr. David J. Ardnt

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Milkeran

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use 510(k) Number (if known): K073681/S001 Device Name: Nanobeam 940

Indications for Use:

Prescription Use _XXX AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation Page 1 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K073681/S001 DavaRay, Inc.

510(k) Number

Regulation Number and Section

N/A