(62 days)
No
The 510(k) summary describes a simple infrared heat lamp system with a control unit and a treatment probe. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on functional and electrical safety testing, not algorithmic performance.
Yes
The device description explicitly states, "The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device.
No
The device is described as a therapeutic device intended to provide topical heating for pain relief and increased blood circulation, not for diagnosing medical conditions.
No
The device description explicitly states the system is comprised of a Control Unit and a handheld treatment probe, which are hardware components.
Based on the provided information, the APOLLO IR Heat Lamp System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This involves direct interaction with the patient's body.
- Device Description: The description confirms it's a non-invasive, hand-held therapeutic device that delivers infrared energy to the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The APOLLO IR Heat Lamp System does not involve the analysis of any such specimens.
Therefore, the APOLLO IR Heat Lamp System falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the 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 promoting relaxation of muscle.
Product codes
ILY
Device Description
The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
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)
Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023621, K033923, K040729, K001179, K052647, K032787
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
MAR 2 ] 2006
510k Notification APOLLO IR Heat Lamp System January 10, 2006
APPENDIX B
510(k) PREMARKET NOTIFICATION SUMMARY
(per 21 CFR 807.92)
APOLLO IR Heat Lamp System
I. Applicant:
Apollo Physical Therapy Products International 818 North Idaho St. San Mateo, CA 94401
January 10, 2006 Date Prepared:
II. Device Name
Proprietary Name: APOLLO IR Heat Lamp System Common / Usual Name: Infrared Lamp Infrared Lamp (21 CFR 890.5500) Classification Name: Product Code: ILY
Intended Use of the Device III.
The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the 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 promoting relaxation of muscle.
IV. Predicate Devices
Predicate devices to the APOLLO IR Heat Lamp System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), Thor International, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase Systems (K052647) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process.
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V. Description of the Device
The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
Summary of the technical characteristics of the APOLLO IR Heat Lamp VI. System to the referenced predicate devices
The APOLLO IR Heat Lamp System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
VII. Testing
Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the APOLLO IR Heat Lamp System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2006
Apollo Physical Therapy Products International c/o Texas Applied Biomedical Services Ms. M. Joyce Heinrich 12101-A Cullen Boulevard Houston, Texas 77047-2951
Re: K060134
Trade/Device Name: Apollo IR Heat Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: January 10, 2006 Received: January 24, 2006
Dear Ms. Heinrich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared. 310(x) pe device is substantially equivalent (for the indications ferenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Ac. (71ct) that do nov requesable to the general controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 a0010) ins. Existing major regulations affecting your device can Inay be subject to subli additional comise of the 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease of advised that i Dris issualite over device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any I cucral statutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 007); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. M. Joyce Heinrich
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wif anon you to ogen tinding of substantial equivalence of your device to a legally premaince nonification "Thesults 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 ir you desire specific as not any and (240) 276-0120. 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 other general informational 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/industry/support/index.html.
Sincerely yours,
.mll
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Notification APOLLO IR Heat Lamp System January 10, 2006
APPENDIX A
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): Pending
Device Name:
APOLLO IR Heat Lamp System
Indications for Use:
The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the 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 promoting relaxation of muscle.
Prescription Use: X (Part 21 CFR 801 Subpart D)
.
AND/OR
Over the Counter Use: _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODpE) Concurrence of C
(Division Sign Off Division of General, Restorative. and Neurological Devices
510(k) Number_K060(34