(347 days)
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No
The summary describes a near-infrared light device for therapeutic purposes and makes no mention of AI or ML technology.
Yes
The device description explicitly states, "DavaRay's Nanobeam 940 is a near-infrared light device used for therapeutic purposes." Additionally, its intended use for relieving pain, stiffness, and promoting relaxation and blood circulation aligns with therapeutic functions.
No
The device is described as emitting energy for therapeutic purposes, specifically for pain relief and increased blood circulation, not for diagnosing conditions. It is classified as an "Infrared Lamp" for therapeutic use.
No
The device description explicitly states it is a "near-infrared light device" and falls under the classification of an "Infrared Lamp," which are hardware devices that emit light.
Based on the provided information, the Nanobeam 940 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for therapeutic purposes on the human body (temporary relief of pain, stiffness, etc.). IVD devices are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose diseases or conditions.
- Device Description: It's described as a "near-infrared light device used for therapeutic purposes" and classified as an "Infrared Lamp," which is a physical therapy device, not an IVD.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or any of the typical functions of an IVD device.
Therefore, the Nanobeam 940 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
ILY
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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
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.
5. Description of the Device
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.
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.
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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
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Indications for Use 510(k) Number (if known): K073681/S001 Device Name: Nanobeam 940
Indications for Use:
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.
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