(72 days)
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 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.
The provided FDA 510(k) summary for the Solaris D890™ Therapy Probe does not contain information about a study that establishes acceptance criteria or reports device performance in the way a clinical study would for a novel medical device.
Instead, this submission leverages the substantial equivalence pathway, which means the device's safety and effectiveness are established by demonstrating its similarity to a legally marketed predicate device, the Solaris D880 Infrared Probe (K031329).
Therefore, many of the requested fields regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable or not explicitly detailed in this type of submission.
Here's how the provided information relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (NA)
The 510(k) summary does not define specific performance acceptance criteria for clinical outcomes or efficacy endpoints. Instead, the acceptance is based on the device conforming to applicable regulatory standards for electronic and light-emitting products, and being substantially equivalent to the predicate device in terms of technology, intended use, and indications for use.
The "reported device performance" in this context refers to the device's technical specifications and how they align with regulatory requirements and the predicate device, rather than performance data from a clinical trial.
| Acceptance Criteria Type (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Conformance to 21 CFR sections 1010 (Electronic Products: General) | Device conforms to applicable requirements. |
| Conformance to 21 CFR sections 1040.10 & 1040.11 (Light-Emitting Products) | Device conforms to applicable requirements. |
| Technical Characteristics (similar to predicate) | "Shares the same or similar basic characteristics" as predicate. |
| Intended Use/Indications for Use (same as predicate) | "Identical to the cleared indications for the predicate device." |
| Safety & Effectiveness (similar to predicate) | "No substantive differences between the products... Similar to technologies used in other similar medical devices." |
| Quality Management System | Developed and documented under Dynatronics' mature Quality Management System (21 CFR Part 820). |
| Design/Change Control | Developed under design/change control, verified/validated to applicable standards. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (NA)
No clinical test set or data provenance is detailed in this 510(k) summary. The submission relies on establishing substantial equivalence to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable (NA)
No clinical test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not Applicable (NA)
No clinical test set requiring an adjudication method is described in this 510(k) summary.
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 (NA)
This device is an infrared therapy probe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (NA)
This device is an infrared therapy probe and does not involve a standalone algorithm for performance testing.
7. The Type of Ground Truth Used
Not Applicable (NA)
As no clinical study or test set requiring ground truth is detailed, no specific type of ground truth is mentioned. The "ground truth" for this submission revolves around regulatory compliance and technical similarity to the predicate device.
8. The Sample Size for the Training Set
Not Applicable (NA)
No training set for an algorithm is described in this 510(k) summary as it is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not Applicable (NA)
As no training set is described, the method for establishing its ground truth is not applicable.
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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).
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- 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.
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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
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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
Page 1 of
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.