(70 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 Dynatron® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy. Components: System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays. Infrared pad, model Dynatron Xp, for administering IR therapy. Hand-held infrared probe, model D405, for administering IR therapy. Accessories such as power cord.
The provided text is a 510(k) premarket notification for the Dynatron® Solaris™ Series of infrared therapy devices. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness. Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details will not be found in this document.
The document explicitly states:
- "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 are verified/validated to applicable standards/guidance documents."
This indicates that the manufacturer is relying on the established safety and effectiveness of the predicate device (Dynatron® Solaris™ D705 and accessory D880 IR Probe, cleared under K031329) and adherence to general performance standards and regulations.
Therefore, I cannot extract the requested information as it is not contained within this 510(k) submission.
What can be extracted is information related to the device itself and its regulatory status:
| Category | Description / Response |
|---|---|
| 1. A table of acceptance criteria and the reported device performance | Not applicable. This document is a 510(k) submission for substantial equivalence. It does not present specific acceptance criteria or new clinical performance data for the device. Instead, it asserts the device's substantial equivalence to a predicate device, implying that its performance is comparable to that already accepted for the predicate device. The performance standard mentioned is general: "The Dynatron Solaris Series of devices conform to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General)." |
| 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) | Not applicable. No clinical test set data is presented or referenced to demonstrate performance, as this is a 510(k) submission relying on substantial equivalence to a predicate device. |
| 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 applicable. No clinical test set data is presented, and therefore, no expert-established ground truth is mentioned. |
| 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set | Not applicable. No clinical test set data is presented, and therefore, no adjudication method is mentioned. |
| 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. This device is an infrared therapy device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant to this type of device. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not applicable. This device is an infrared therapy device, not an AI algorithm. Its performance is related to its physical function of providing topical heating. |
| 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) | Not applicable. No new clinical ground truth development is presented for this substantial equivalence submission. The effectiveness is based on the known therapeutic effects of infrared therapy and the predicate device. |
| 8. The sample size for the training set | Not applicable. No machine learning or AI training set is relevant or mentioned for this device. |
| 9. How the ground truth for the training set was established | Not applicable. No machine learning or AI training set is relevant or mentioned for this device. |
Summary of Device and Regulatory Context (from the provided text):
- Device Name: Dynatron® Solaris™ Series (models Dyntron X3, Xp, D405); Infrared therapy.
- Intended Use/Indications For Use: Topical heating via infrared therapy for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
- Predicate Device: Dynatron® Solaris™ D705 and accessory D880 IR Probe (cleared under K031329).
- Basis for SE: The devices share the same or similar basic characteristics, features, and intended use as the predicate.
- Safety and Effectiveness Rationale: No substantive differences from the predicate, similar to other currently used medical devices, developed under Dynatronics' Quality Management System, and verified/validated to applicable standards/guidance documents.
- Regulatory Class: Class II, Product Code ILY.
- FDA Determination Date: July 25, 2005.
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Kosizel
SUMMARY OF SAFETY AND EFFECTIVENESS
DYNATRONICS CORPORATION SUBMITTED BY: 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): Dynatron® Solaris™ Series (model numbers Dyntron X3, Xp, D405); Infrared therapy.
| Classification: | Class II |
|---|---|
| Regulation Nos .: | 890.5500 |
| Product Codes: | ILY |
2. PREDICATE DEVICE:
Dynatron® Solaris™ D705 and accessory D880 IR Probe Cleared under K031329 (October 22, 2003)
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- PERFORMANCE STANDARDS: The Dynatron Solaris Series of devices conform to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General).
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- DESCRIPTION: The Dynatron® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy.
Components:
System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays.
Infrared pad, model Dynatron Xp, for administering IR therapy.
Hand-held infrared probe, model D405, for administering IR therapy.
Accessories such as power cord.
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Kosi261
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- INTENDED USE/INDICATIONS FOR USE: The Dynatron X3 device, including models Dynatron Xp and D405, provide topical heating via infrared therapy 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
- INTENDED USE/INDICATIONS FOR USE: The Dynatron X3 device, including models Dynatron Xp and D405, provide topical heating via infrared therapy for:
The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices.
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- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Dynatron Solaris X3, Dynatron Xp, and D405, offer topical heating for treatment of selected medical conditions. They share the same or similar basic characteristics, features and intended use as the predicate and, therefore, are substantially equivalent to the Dynatron D705 and the D880 infrared probe (applicable 'K' number listed above).
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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 are verified/validated to applicable standards/guidance documents. The products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program.
Signed: Ronald J. Hald
Dated: May 13, 2005
Ronald J. Hatch, VP Operations/RA DYNATRONICS CORPORATION
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the left side of the logo. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2005
Mr. Ronald J. Hatch VP Operations/Regulatory Affairs Dynatronics Corporation 7030 Park Centre Drive Salt Lake City, Utah 84121
Re: K051261
Trade/Device Name: Dynatron® X3, Dynatron® Xp IR Light Pad, D405 IR Light Probe Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 12, 2005 Received: May 16, 2005
Dear Mr.Hatch:
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. Ronald J. Hatch
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter natification. The FDA finding of substantial equivalence of your device to a legally premated 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 it you atence of Compliance at (240) 276-0115. 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 other general mionmational 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,
Eun A
Miriam C. Provost, Ph.D Acting 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): K051261_______________________________________________________________________________________________________________________________________
Device Name: Dynatron® X3 Dynatron® Xp IR Light Pad D405 IR Light Probe
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
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Ko51261
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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.