(62 days)
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.
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.
The APOLLO IR Heat Lamp System's 510(k) premarket notification (K060134) does not contain a study that proves the device meets specific acceptance criteria in the way described by your request. Instead, it relies on a demonstration of substantial equivalence to predicate devices already cleared by the FDA.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not specify quantitative acceptance criteria or provide performance metrics in the format of a clinical study with results alongside those criteria. The clearance is based on equivalence to predicate devices and functional/safety testing, not on achieving specific clinical performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" of patient data for performance evaluation in the usual sense. The "testing" mentioned refers to functional performance and electrical safety of the device itself, not evaluation on a dataset representing patient cases or outcomes.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There is no clinical study described that would require experts to establish ground truth for a test set of patient data.
4. Adjudication Method
Not applicable. As no clinical study on patient data is described, adjudication methods are irrelevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The APOLLO IR Heat Lamp System is a physical therapy device that emits infrared energy, not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI algorithm; it's a physical therapy device. Thus, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
Not applicable. Since no clinical study on patient data is described for performance evaluation, there is no "ground truth" established in that context. The "truth" demonstrated for the device's functionality is its ability to emit infrared energy and comply with safety standards.
8. Sample Size for the Training Set
Not applicable. As this device is not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Device Acceptance and "Study" Information from the Document:
Instead of a clinical study proving acceptance criteria, the 510(k) process for the APOLLO IR Heat Lamp System relies on the following:
- Intended Use Equivalence: The device is intended to emit infrared energy for topical heating, temporary relief of pain and stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation. This intended use is stated to be similar to that of predicate devices.
- Technical Characteristic Equivalence: The APOLLO IR Heat Lamp System and the listed predicate devices (e.g., Meditech International Inc BioFlex Professional Therapy System, Thor International, Ltd. DDII Laser System) are all classified as "Infrared Lamps" (21 CFR 890.5500) and utilize infrared/visible laser diodes for topical heating. The submission states the device has "similar functional and performance characteristics" to these predicates.
- Functional and Safety Testing: The document states:
- "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."
- "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."
Conclusion:
The "acceptance criteria" for the APOLLO IR Heat Lamp System, as presented in the 510(k) notification, are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and by confirming functional and electrical safety through standard testing. There is no clinical study, patient dataset, or AI performance evaluation described in this documentation. The FDA clearance (K060134) letter confirms that the device was found substantially equivalent to predicate devices for its stated indications for use.
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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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
§ 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.