(130 days)
The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.
The PowerLaser is a hand-held, battery operated, non-invasive, low level infrared therapeutic laser lamp. A separate battery charger can recharge the battery when it is removed from the PowerLaser. PowerLaser is a medical device, which is delivered packed with battery charger and complete labeling for the user.
The provided text is a 510(k) summary for the PowerLaser device. It outlines the device description, its intended use, and its substantial equivalence to other legally marketed infrared lamps. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document is a regulatory submission for premarket notification, focusing on demonstrating that the PowerLaser is substantially equivalent to previously cleared devices based on its intended use, design, and adherence to safety standards. It does not include the results of performance studies as one might find in a clinical trial report or a detailed engineering verification and validation document.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This information is not present in the 510(k) summary. Acceptance criteria and device performance results from specific studies are typically detailed in separate sections of a full 510(k) submission or in technical reports, which are not included here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific test sets or studies that would involve a sample size.
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)
- Cannot be provided. No test sets or ground truth establishment are discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test sets or adjudication methods are discussed.
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
- Cannot be provided. The device is an infrared lamp, not an AI or imaging diagnostic device that would typically involve a multi-reader multi-case study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The device is a physical therapeutic lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth is discussed.
8. The sample size for the training set
- Cannot be provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no training set or ground truth for it is relevant or discussed.
What is present in the document:
- Intended Use/Indications for Use: The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.
- Substantial Equivalence: The device claims substantial equivalence to the PowerLaser 90 (K030692) and the Vectra Genisys Laser System (K040662).
- Device Description: A hand-held, battery-operated, non-invasive, low-level infrared therapeutic laser lamp.
- Compliance: Demonstrates compliance to relevant safety standards, EMC standards, and standards for low-level infrared laser equipment.
To get the information requested, you would need to consult a more detailed technical file or clinical study report associated with the PowerLaser, if such documents exist and are publicly available. The 510(k) summary itself focuses on regulatory justification for marketing, not detailed performance metrics from a study.
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510(k) Summary As required by section 807.92(c)
| Submitted by: | PowerMedic ApSKanalstraede 2DK-4300 HolbaekDenmarkTel: +45 5944 0832Fax: +45 5944 2911E-mail: ag@powermedic.dkWebsite: www.powermedic.dk | JUL - 2 2007 |
|---|---|---|
| Contact Person: | Arne Grinsted | |
| Prepared On: | Monday, January 08, 2007 | |
| Classification Name: | Lamp, Infrared | |
| Common Name: | Infrared Laser | |
| Proprietary Name: | PowerLaser | |
| Classification: | The device satisfies the 21 CFR definition of a ClassII infrared lamp as follows: |
| RegulationNumber | ClassificationNumber | ProductNomenclature | Identification / Classification |
|---|---|---|---|
| 890.5500 | ILY | Lamp, Infrared | A device that emits energy atinfrared frequencies(approximately 700 nanometers)to 50,000 nanometers to providetopical heating |
| Establishment registration: | Owner / Operator No.: 9052408. |
|---|---|
| US Representative: | PowerMedic US Inc. |
| Development: | PowerMedic ApS has developed the device. |
| Production: | PowerMedic ApS is manufacturing and packagingthe device. |
| Reason for the 510(k): | The Product has never been marketed in USAbefore. However the PowerLaser 90 has beenmarketed in the USA since 2003. |
- I
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Substantial Equivalence: The PowerLaser is substantially equivalent to other infrared lamps currently in commercial distribution such as the PowerLaser 90 which was the subject of 510(k) number K030692 and the Vectra Genisys Laser System which was the subject of 510(k) number K040662. The PowerLaser has the equivalent intended use (i.e. pain relief). Device Description: The PowerLaser is a hand-held, battery operated, non-invasive, low level infrared therapeutic laser lamp. A separate battery charger can recharge the battery when it is removed from the PowerLaser. PowerLaser is a medical device, which is delivered packed with battery charger and complete labeling for the user. Special Controls: The PowerLaser as well as the battery charger demonstrates compliance to relevant safetystandards, EMC standards and standards for low level infrared laser equipment. Statement of Indications for use: The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
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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 & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and head. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.
DEC 112008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
PowerMedic ApS % Arne Grinsted Kanalstraede 2 DK-4300 Holback Denmark
Re: K070516 Trade/Device Name: PowerLaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: February 8, 2007 Received: February 13, 2007
Dear Arne Grinsted:
This letter corrects our substantially equivalent letter of July 2, 2007.
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 (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 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 mav 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 - Arne Grinsted
This letter will allow you to continue 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 (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 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/dsma/dsmamain.html.
Sincerely yours,
NulR.P.Qydm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image contains a logo with the words "POWER MEDIC" stacked on top of each other. Below the words is the phrase "HEALING TECHNOLOGY". To the left of the words is a square with a stylized hand inside of it. The hand has four fingers and a thumb.
Indications for Use
510(k) Number (if known): 070516
Device Name: PowerLaser
Indications for Use:
The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.
Image /page/4/Picture/6 description: The image shows a form with two options: "Prescription Use" and "Over-The-Counter Use." The "Prescription Use" option is marked with an "X", indicating that it is selected. The text below each option provides a reference to the relevant section of the Code of Federal Regulations (CFR), specifically 21 CFR 801 Subpart D for prescription use and 21 CFR 801 Subpart C for over-the-counter use.
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number 4670516
§ 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.