(156 days)
Intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
The DPL ™ Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The device is comparable in design, technology, and output to the Dermillume HR 1000 infrared lamp product. The lamps are contained in two panels on a desk stand. The panels are detachable for use individually or as a pair on the body. The product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes.
The provided 510(k) summary for the DPL™ Therapy System (K081570) describes a medical device, an infrared lamp, and its substantial equivalence to a predicate device. However, this document does not contain the typical "acceptance criteria" or a detailed "study that proves the device meets the acceptance criteria" in the way one would expect for a more complex diagnostic or AI-driven device.
Instead, the submission largely relies on demonstrating substantial equivalence to a predicate device (Dermillume Red HR 1000, 510(k) K051681) and compliance with relevant electrical safety and electromagnetic compatibility standards. The "clinical studies" mentioned are more about verifying the therapeutic heating effect and safety rather than statistical performance against specific diagnostic metrics.
Here's an attempt to extract and interpret the requested information based on the provided text, making it clear where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (an infrared lamp for therapeutic heating) and the provided document, the "acceptance criteria" are primarily related to safety, therapeutic effect (skin temperature elevation), and substantial equivalence to a predicate device. Performance is framed in terms of achieving therapeutic heat safely.
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Safety: Device conforms to electrical safety standards. | Conforms to IEC 60601-1-1:2000. Safe temperatures were maintained for the duration of the treatment time. No adverse effects or complications encountered. |
| Safety: Device conforms to electromagnetic compatibility. | Complies to EN 60601-1-2:2001. |
| Effectiveness: Therapeutic heat is attained. | Clinical studies demonstrate that therapeutic heat is attained for male and female subjects. |
| Performance: Comparable to predicate device. | The DPL™ Therapy System is safe, as effective, and performs comparably to the predicate device (Dermillume Red HR 1000, K051681). It furnishes therapeutic heating comparable to the predicate. Device takes 8 minutes to reach target temperature on skin. |
| Operational: Automatic timed cycle. | Product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "male and female subjects" for clinical studies but does not provide a specific number for the test set or any breakdown.
- Data Provenance: Not specified. It's listed under "Clinical studies demonstrate," but there's no information about the country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not provided. This device is an infrared lamp for therapeutic heating. The "ground truth" here is not an expert consensus on interpreting images or diagnoses, but rather objective physiological measurements (e.g., skin temperature, absence of burns/adverse events) and patient-reported outcomes (e.g., pain relief, muscle relaxation). The submission does not detail the personnel involved in collecting or assessing this.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Since there's no expert interpretation of data needing consensus, an adjudication method like 2+1 or 3+1 is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically for evaluating diagnostic performance of human readers, sometimes with and without AI assistance. This document describes an infrared therapy device, not a diagnostic tool, and involves no "human readers" in the context of interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infrared lamp, a physical therapy device, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The Type of Ground Truth Used
- Physiological measurements and safety observations: The "ground truth" seems to be based on objective measurements like skin temperature elevation reaching "therapeutic heat" and the absence of adverse effects or complications. It would also implicitly involve the device successfully delivering infrared light.
- Patient-reported outcomes (implied): While not explicitly stated as "ground truth," the intended use (relaxation, relief of aches/pains) implies that some form of subjective feedback on these outcomes would have been assessed in the "clinical studies."
8. The Sample Size for the Training Set
- Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable / Not provided. As there's no AI component or training set, this question is not relevant.
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510(k) Summary
| Submitted by: | LED Technologies, LLC1460 Conifer TrailElizabeth, CO 80107USA | Phone: 303-646-5480Fax: 303-646-9239Email: rferguson@led-technologies.com | NOV - 7 2008 | |
|---|---|---|---|---|
| Contact Person: | Lewis WardL.W. Ward and Associates, Inc.4655 Kirkwood CourtBoulder, CO 80301USA | Phone: 303-530-3279Fax: 303-530-4774Email: lwward@qwest.net | ||
| Date Prepared: | 10-27-08 | |||
| Device Trade Name: | Infrared Lamp | |||
| Classification Name: | Regulation Number: 21 CFR 890.5500Regulation Name: Infrared Lamp | Regulation Class: IIProduct Code: ILY | ||
| Intended Use: | Intended for the relaxation of muscles and relief of musclespasms; temporary relief of minor muscle and joint aches,pains, and stiffness; temporary relief of minor pain andstiffness associated with arthritis; and to temporarilyincrease local blood circulation. | |||
| TechnologicalCharacteristics: | The DPL TM Therapy System is a compact infrared lamp fortherapeutic heating. It delivers infrared light to the skin resulting in asafe elevation of the skin temperature for therapeutic effects. Thedevice is comparable in design, technology, and output to theDermillume HR 1000 infrared lamp product. The lamps are containedin two panels on a desk stand. The panels are detachable for useindividually or as a pair on the body. The product has an automatic17-minute timed cycle which may be repeated by activating the ONcycle. Device takes 8 minutes to reach target temperature on skin.Total time for treatment is 17 minutes. | |||
| Substantial Equivalence: | The DPL TM Therapy System is substantially equivalent to theDermillume Red HR 1000 device, 510(k) K051681. The DPL TM TherapySystem furnishes therapeutic heating comparable to the predicate. | |||
| Test Data: | The device conforms to the electrical safety requirements established inIEC 60601-1-1:2000 and complies to the electromagnetic compatibilityrequirements in EN 60601-1-2:2001. Clinical studies demonstrate thattherapeutic heat is attained for male and female subjects. Safe temperatureswere maintained for the duration of the treatment time. No adverse effects atcomplications were encountered. The DPL System's device is safe, aseffective, and performs comparable to the predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LED Technologies, LLC % L.W. Ward Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
NOV - 7 2008
Re: K081570
Trade/Device Name: DPL™ Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 29, 2008 Received: November 3, 2008
Dear Mr. Ward:
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. Lewis Ward
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 Pestmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance arvers 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 M. Mckeen
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):
Device Name: DPI,™ Therapy System
Indications for Use:
Intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use X (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 (ODE)
Neel R. Ople firxm
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K081570
§ 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.