(88 days)
ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
The system will produce a 980nm infrared and a 650 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 650 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 650 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
The provided text is a 510(k) summary for the ALT Laser, Model AVI HPLL-12. This document is a premarket notification for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing outcomes for the device itself.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is about regulatory clearance based on substantial equivalence, not a clinical or performance validation study as might be conducted for a novel device or AI algorithm.
Here's a breakdown of the requested information based on the provided text:
Description of Acceptance Criteria and Proving Device Meets Criteria
The provided document does not describe acceptance criteria in the traditional sense of performance metrics for a study proving a device's effectiveness. Instead, it aims to demonstrate "Substantial Equivalence" to a legally marketed predicate device (ALT Laser, Model VTR75, K031612). The "acceptance criteria" here implicitly revolve around demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission for a laser device (infrared lamp), the "performance" is described in terms of its intended function and technological characteristics, not in terms of diagnostic accuracy or treatment efficacy metrics typically found in AI device studies.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (from K091285) |
|---|---|
| Intended Use: Device performs as intended for its specified medical indication. | Intended Use: "ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue." This is identical to the predicate device's intended use. |
| Technological Characteristics: Device has similar operational principles and safety features as the predicate. | Technological Characteristics: Produces 980nm infrared and 650nm red visible laser light in overlapping patterns. The 650nm visible light acts as an indicator, locking out the 980nm infrared light if absent (safety feature). "The intended use and technological characteristic of the two devices do not vary significantly." "The light at infrared wavelengths is therapeutic in nature and although the output of infrared energy varies between devices this difference only impacts the amount of time to attain the therapeutic thermal effect of the infrared energy." |
| Safety: Device is as safe as the predicate, with no new safety concerns. | Safety: Comprehensive warnings and cautions are listed, similar to what would be expected for a Class II infrared laser. The aiming laser lockout mechanism is described as a safety feature. The document states, "The safety and effectiveness of the Avicenna Laser Technology, Inc.'s ALT Laser, Model AVI HPLL-12 infrared device is comparable to that of the Avicenna's ALT Laser Model VTR 75 device." |
| Effectiveness: Device is as effective as the predicate. | Effectiveness: "The light at infrared wavelengths is therapeutic in nature and although the output of infrared energy varies between devices this difference only impacts the amount of time to attain the therapeutic thermal effect of the infrared energy. Therefore, the operational differences and output between the predicate device ALT Laser VTR 75 and ALT Laser, Model AVI HPLL-12 does not present a significant effect in the therapeutic outcome." |
Regarding specific AI study questions (samples, experts, adjudication, MRMC, standalone):
The provided text describes a laser device (infrared lamp), not an AI/ML powered medical device. Therefore, the following information is not applicable or not available in this submission.
2. Sample size used for the test set and the data provenance: Not applicable. This is a claim of substantial equivalence for a physical device, not an AI algorithm evaluated on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert evaluation for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is demonstrating that the device's technical specifications and intended use align with its predicate.
8. The sample size for the training set: Not applicable. This is not an AI/ML device trained on data.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device trained on data.
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Section 5: 510k) Summary
The Summary of Safety and Effectivenes on the ALT Laser, Model AVI awailson available and represented the time the time the alterations of the conclusions or recommendations set forth.
| Applicant | Avicenna Laser Technology, Inc.Bruce Coren, DVM, MS.9822 East Washington Street, Suite 6Chagrin Falls, Ohio 44023JUL 2 8 2009 |
|---|---|
| Telephone | (561) 722 - 1153 |
| Facsimile | (561) 820 - 9646 |
| Date | April 24, 2009 |
| Name | ALT Laser, Model AVI HPLL-12 |
| Classification | Infrared Lamp, 21 CFR 890.5500 |
| Predicate: | ALT Laser, Model VTR75, K031612 market clearance date December 11,2003 |
| Description | The system will produce a 980nm infrared and a 650 nm red visible laserlight in overlapping patterns. The two types of light will be mixed suchthat the visible 650 nm light becomes a reasonable indicator of theinvisible infrared 980nm light. The 650 nm visible aiming laser light willbe sensed and if the light is absent, it will lock out the infrared 980nm lightand alert the operator. |
| Intended Use | ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infraredspectrum to provide topical heating for use when heat is indicated in thetemporary relief of minor muscle and joint pain, muscle spasm, pain andstiffness associated with arthritis, and promoting relaxation of the muscletissue. |
| Contraindications | Do not apply infrared light to abdominal or lumbosacral points inpregnant females. Do not apply infrared light to the epiphyseal lines in children. Do not apply infrared light to the thorax or over the pacemaker itselfin patients with pacemakers. Do not apply infrared light over the thyroid gland, ovaries andtesticles. Do not apply infrared light to patients who are taking drugs that haveheat or light sensitive contraindications, such as but not limited tocertain types of steroids |
| Warning | Do not use in the presence of flammable solvents or anesthetics. Never look directly into the laser light source or at scattered laser lightfrom any reflective surfaces. Never sight down the beam into thesource. Direct eye contact with the output beam from the laser will causeserious damage and possible blindness. Avoid direct exposure to the laser light. The intensity of the beam caneasily cause flesh burns or ignite clothing. Never look directly into the beam or at a specular reflection evenwhile wearing protective eyewear. |
| Caution | Always wear laser safety eyewear, which is optically dense at the wavelength of operation. Limit access to the laser to qualified users who are familiar with laser safety practices and who are aware of the dangers involved. As a precaution against accidental exposure to the output beam or its reflection, those using the system should wear laser safety glasses as required by the wavelength being generated. Use the laser in an enclosed room. Laser light will remain collimated over long distances and therefore prevents a potential hazard if not confined. Post warning signs in the area of the laser beam to alert those present. Advise all those using the laser of these precautions. It is good practice to operate the laser in a room with controlled and restricted access. Always wear laser safety eyewear, which is optically dense at the wavelength of operation. Use safety interlocks to restrict access to laser areas and prevent unauthorized use of the laser. Post warning signs for class IV laser products. |
| SubstantialEquivalencyInformation | The light at infrared wavelengths is therapeutic in nature and although the output of infrared energy varies between devices this difference only impacts the amount of time to attain the therapeutic thermal effect of the infrared energy. Therefore, the operational differences and output between the predicate device ALT Laser VTR 75 and ALT Laser, Model AVI HPLL-12 does not present a significant effect in the therapeutic outcome. |
| TechnologicalCharacteristics | The intended use and technological characteristic of the two devices do not vary significantly. The safety and effectiveness of the Avicenna Laser Technology, Inc.'s ALT Laser, Model AVI HPLL-12 infrared device is comparable to that of the Avicenna's ALT Laser Model VTR 75 device. |
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ku91280 510(k) SUMMARY, continue
The Summary of Safety and Effectiveness on the ALT Laser, Model AVI HPLL-12 reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2009
Avicenna Laser Technology, Inc. % Bruce R. Coren, DVM, MS President 9822 East Washington Street, Suite 6 Chagrin Falls, Ohio 44023
Re: K091285
Trade/Device Name: ALT Laser, Model AVI HPLL-12 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: June 19, 2009 Received: July 6, 2009
Dear Dr. Coren:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Bruce R. Coren, DVM, MS
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 yours
Chlare Buchup
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indication for Use Summary
510(k) Number (if known): K091285
Device Name: _ _ _ _ _ _ _ _ _ _ _ ALT Laser, Model AVI HPLL-12
Indications For Use:
ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DuilR.Oale for mken
(Division Sign-Off) Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K091285
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _
- 11A-
§ 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.