(194 days)
The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.
The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength.
The provided 510(k) summary for the Axiom BioLaser LLLT Series-1 details regulatory information and declares substantial equivalence to a predicate device, the Erchonia PL2000. It does not contain information about acceptance criteria, device performance, clinical study design, or ground truth establishment.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) summary explicitly states that the substantial equivalence is due to the technical aspects of both devices (Axiom BioLaser LLLT Series-1 and Erchonia PL2000) being "Significantly equivalent," leading to the "same treatment For the intended use of providing temporary relief of minor chronic neck And shoulder pain of musculoskeletal origins." This suggests FDA clearance was based on equivalence to a legally marketed predicate device rather than a new clinical study demonstrating specific performance metrics against acceptance criteria.
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510 (K) Summary
| Device Classification Name | Lamp, Non-heating forAdjunctive use in pain therapy |
|---|---|
| Regulation Number | 890.5500 |
| 510(k) Number | K030622 |
| Device Name | The Axiom BioLaser LLT Series - 1 |
| Applicant | Axiom Worldwide9423 Corporate Lake DriveTampa, Florida 33634 |
| Contact | James J. Gibson |
| Product Code | NHN |
The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength. The Axiom BioLaser LLT Series - 1 is substantially equivalent to the Erchonia PL2000 with an output power of no more than 5 mW and with a 635 nm wavelength. The wavelength although they differ, do not substantially effect the Transmission through the skin. The technical aspects of both devices are Significantly equivalent, therefore, achieving the same treatment For the intended use of providing temporary relief of minor chronic neck And shoulder pain of musculoskeletal origins.
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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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with three parallel lines above them. The lines and profiles are black, and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
Mr. James J. Gibson President Axiom Worldwide 9423 Corporate Lake Drive Tampa, Florida 33634
Re: K030622
Trade/Device Name: Axiom BioLaser LLLT Series-1 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: June 10, 2003 Received: June 11, 2003
Dear Mr. Gibson:
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. James J. Gibson
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. Provost
for 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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510(k) Number (if known): 长0 3 06 22
Device Name: Axiom BioLaser LLLT Series-1
Indications For Use:
Intended Use
The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _______
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number Ka030622
§ 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.