(72 days)
Not Found
No
The summary describes a simple infrared therapy probe with an on/off switch and basic software to drive the energy source. There is no mention of AI, ML, image processing, or any complex data analysis that would suggest the use of such technologies.
Yes
The device is intended to treat various physical ailments by providing topical heating, and its stated indications for use align with the definition of a therapeutic device.
No.
The device's stated Intended Use is for therapeutic purposes (topical heating for temporary relief of aches, pains, and stiffness), not for identifying or investigating a disease, injury, or other condition.
No
The device description explicitly states the D890 is an "infrared therapy accessory probe" and contains an "infrared energy source," indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a therapeutic application of infrared therapy for pain relief and increased blood circulation. This is a treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description confirms it's an infrared therapy probe used for delivering energy to the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in the body
- Diagnosis or monitoring of diseases based on sample analysis
Therefore, the Solaris D890™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
Product codes
ILY
Device Description
The Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY: DYNATRONICS CORPORATION 7030 Park Centre Drive Salt Lake City UT 84121 Phone: (800) 874-6251; (801) 568-7000; Fax: (801) 568-7711
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- DEVICE NAME (Trade/common, and classification): Solaris D890™ Therapy Probe.
| Classification: | Class II |
|---|---|
| Regulation Nos.: | 890.5500 |
| Product Codes: | ILY |
-
- PREDICATE DEVICES:
Solaris D880 Infrared Probe -- Cleared under K031329
- PREDICATE DEVICES:
-
PERFORMANCE STANDARDS: The Solaris D890 conforms to the applicable 3. requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).
-
- DESCRIPTION: The Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.
-
- INTENDED USE/INDICATIONS FOR USE: The Solaris D890 provides infrared therapy for the following allowed claims:
Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
The Intended Use/Indications For Use stated herein are identical to the cleared indications for the predicate device.
1
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- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Solaris D890 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device. Therefore, the proposed Solaris D890 is substantially equivalent to the Solaris D880 Infrared Probe, cleared under K031329
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- SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices. They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and verified/validated to applicable standards/guidance documents. The Solaris D890 is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program.
Signed: Ronald J. Hatch
Ronald J. Hatch, VP Operations/RA DYNATRONICS CORPORATION
Dated: 3/9/04
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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 stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 2 2004
Mr. Ronald J. Hatch Vice President Operations and Regulatory Affairs Dynatronics Corporation 7030 Park Centre Drive Salt Lake City, Utah 84121
Re: K040729
Trade/Device Name: Solaris™ D8907M Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 10, 2004 Received: March 22, 2004
Dear Mr. Hatch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have a nowe 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 for use outstan to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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). and Cosmeter For (10) in 10 (110) the general controls provisions of the Act. The r ou may, ateres provisions of the Act include requirements for annual registration, listing of general conable 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 thay or babyer to an a legulations, 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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or any I edetar baked and sequirements, 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 form in the quality of Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ronald J. Hatch
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provoost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
K040729
Device Name:
Solaris™ D890™ Therapy Probe
Indications For Use:
Infrared therapy to provide topical heating for:
Temporary increase in blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis
K Prescription Use (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 CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________