(88 days)
No
The description focuses on laser technology and safety features based on light sensing, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue," which are therapeutic applications.
No
The "Intended Use / Indications for Use" states that the device is for "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," which are all therapeutic purposes, not diagnostic.
No
The device description explicitly mentions producing and sensing laser light, which are hardware components. The intended use also describes emitting energy, which is a physical action performed by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating for the temporary relief of pain and muscle issues. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the emission of laser light for heating purposes. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection of specific analytes
- Diagnostic claims
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.)
In summary, the ALT Laser, Model AVI HPLL-12 is a therapeutic device that uses laser energy for pain relief and muscle relaxation, not a device used to diagnose diseases or conditions by examining samples from the human body.
N/A
Intended Use / 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.
Product codes
ILY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 6
Chagrin Falls, Ohio 44023
JUL 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 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. |
| 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. |
| Contraindications | Do not apply infrared light to abdominal or lumbosacral points in
pregnant females. Do not apply infrared light to the epiphyseal lines in children. Do not apply infrared light to the thorax or over the pacemaker itself
in patients with pacemakers. Do not apply infrared light over the thyroid gland, ovaries and
testicles. Do not apply infrared light to patients who are taking drugs that have
heat or light sensitive contraindications, such as but not limited to
certain 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 light
from any reflective surfaces. Never sight down the beam into the
source. Direct eye contact with the output beam from the laser will cause
serious damage and possible blindness. Avoid direct exposure to the laser light. The intensity of the beam can
easily cause flesh burns or ignite clothing. Never look directly into the beam or at a specular reflection even
while 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. |
| Substantial
Equivalency
Information | 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. |
| Technological
Characteristics | 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. |
1
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.
2
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
3
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
4
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 _
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