(358 days)
The AIRNERGY+® Stream is indicated for use to emit energy to provide topical heating for the purposes of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary relief of minor arthritis pain and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where applied.
Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology. The device electrical and mechanical design is for use and convenience of the users. The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm.
The provided text is a 510(k) summary for the AIRNERGY+® STREAM device, which is an infrared lamp. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific performance metrics against pre-defined acceptance criteria as would be found for more complex devices or novel technologies.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) is not present in the provided document.
Here's an analysis of what can be extracted and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The general "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate device in terms of intended use and technology, and proving safety and effectiveness.
- Reported Device Performance:
- "Tests have proven that the AIRNERGY+® is safe and effective with respect to its intended use and does not depict any risk to the user."
- "Performance data has proven that it performes safe and effectively with respect to its intended use."
- "It conforms to applicable ISO standards."
- "It has the same indication for use and same technology as the predicate devices."
Summary Table (based on available information):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe for intended use | "Tests have proven that the AIRNERGY+® is safe...and does not depict any risk to the user." "Performance data has proven that it performes safe..." |
| Effective for intended use | "Tests have proven that the AIRNERGY+® is...effective with respect to its intended use." "Performance data has proven that it performes safe and effectively with respect to its intended use." |
| Conforms to standards | "It conforms to applicable ISO standards." (Specifically mentions IEC 60601-1 and IEC 60601-1-2 as voluntary standard compliance). |
| Substantially equivalent to predicate in intended use | "It has the same indication for use...as the predicate devices." (Intended use is to emit energy for topical heating for temporary relief of minor muscle and joint pain, arthritis pain, muscle spasm, relieving stiffness, promoting muscle relaxation, and temporarily increasing local blood circulation.) |
| Substantially equivalent to predicate in technology | "Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology." "The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "tests" and "performance data" but does not specify the nature, sample size, or provenance of these tests/data. This is typical for infrared lamps seeking 510(k) clearance, where substantial equivalence often relies on electrical, mechanical, and emission characteristic testing rather than human clinical trials.
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/Not provided. This type of information is relevant for AI/imaging devices involving expert review for ground truth. The AIRNERGY+® STREAM is an infrared lamp, and its safety and effectiveness assessment would not typically involve expert clinical adjudication in this manner for a 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. See point 3.
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
- No, not done/Not applicable. This is a medical device, but it is an infrared lamp for topical heating, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided in detailed form. For an infrared lamp, "ground truth" would relate to its physical properties (e.g., wavelength emission, temperature output), electrical safety, and potentially biocompatibility, along with demonstrating that these properties are consistent with devices already on the market with the claimed intended uses. The document states "Tests have proven..." but does not detail the nature of these tests or their 'ground truth' methodologies beyond referencing compliance with IEC standards.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI learning system.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This device is not an AI learning system.
In summary: The provided 510(k) summary for the AIRNERGY+® STREAM is for an infrared lamp, a physical medical device. The 'study' referred to is a demonstration of substantial equivalence to predicate devices, supported by compliance with electrical safety and performance standards (IEC 60601-1, IEC 60601-1-2) and general "tests" and "performance data" validating its safety and effectiveness for its intended use. It does not involve the type of clinical trial data, AI performance metrics, or ground truth establishment relevant for AI-powered diagnostic or assistive technologies.
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| 510 (k) Summary of safety and effectiveness | |
|---|---|
| Applicant: | natural energy solutions AGReisertstraße 2153773 Hennef, GermanyPhone No.: +49 (22 42) 9330-0Fax No.: +49 (22 42) 9330-30E-mail: info@nes-ag.comSEP - 5 2006 |
| Establishment registration number | 3004139830 |
| Name of contact | Dr. Martina Günderoth, MBAEisenhutweg 1584036 Kumhausen-Preisenberg, GermanyPhone No.: ++49 871 430 8378Fax No.: ++49 871 430 8379E-mail: mguenderoth@onlinehome.de |
| Proprietary name | AIRNERGY+®STREAM |
| Common name | AIRNERGY STREAM |
| Classification name | Infrared lamp. |
| Code of Federal Regulations | 21 CFR 890.5500 |
| Regulatory Class | Class II |
| Device panel / product code | Physical medicine / ILY |
| Predicate device | There are several infrared lamps known in the market. One ofthese is the Acubeam of Light Force Therapy, Inc. (K 022888). |
| Description of device | Like the predicate devices the AIRNERGY+® Stream is a lampthat has the same indication for use and equivalent technology. |
| 510(k) Summary | AIRNERGY+® Stream |
| The device electrical and mechanical design is for use andconvenience of the users. The red light is generated by LEDs(light emitting diodes) at a wave range between 600 and 650nm. | |
| Intended use | The AIRNERGY+® Stream is indicated for use to emit energy toprovide topical heating for the purposes of elevating tissue tem-perature for temporary relief of minor muscle and joint pain, tem-porary relief of minor arthritis pain and muscle spasm, relievingstiffness, promoting relaxation of muscle tissue, and to tempora-rily increase local blood circulation where applied. |
| Voluntary standardcompliance | - IEC 60601-1- IEC 60601-1-2 |
| Tests have proven that the AIRNERGY+® is safe and effectivewith respect to its intended use and does not depict any risk tothe user. | |
| Conclusions | The AIRNERGY+® Stream is designed, labeled, and verified forperformance and safety. Performance data has proven that itperformes safe and effectively with respect to its intended use.It conforms to applicable ISO standards.It has the same indication for use and same technology as thepredicate devices. |
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Natural Energy Solutions AG, Hennef/Germany 1.4/0806
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Natural Energy Solutions AG, Hennef/Germany 1.4/0806
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natural Energy Solutions AG % C.R.C. Martina Gunderoth, MBA Regulatory Affairs Manager Eisenhutweg 15 84036 Kumhausen-Preisenberg Germany
SEP - 5 2006
Re: K052492
Trade/Device Name: AIRNERGY+® STREAM Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 20, 2006 Received: June 27, 2006
Dear Dr. Gunderoth:
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 (OS) 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 - Martina Gunderoth, MBA
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 (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/industry/support/index.html.
Sincerely y
Tor
Mark N. Mölke
Mark N. Melkerson Director C 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): 1 < 0 / 2 492
Device Name:_AIRNERGY+® STREAM
Indications For Use:
The A/RNERGY+® Stream is indicated for use to emit energy to provide topical heating for the purposes of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary relief of minor arthritis pain and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where applied.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K052494 |
|---|---|
| --------------- | --------- |
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