(286 days)
The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.
The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.
This is a 510(k) premarket notification for a medical device (K090008) which often relies on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically associated with novel or high-risk devices.
Based on the provided document, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance & 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 & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No specific acceptance criteria or performance metrics table is provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence.
- No MRMC comparative effectiveness study or standalone AI algorithm performance study was performed or reported. This device is an infrared therapeutic heating lamp, not an AI-powered diagnostic or assistive technology.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The submission does not describe a clinical study or a test set in the context of evaluating diagnostic or algorithmic performance. The device is an infrared lamp.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" to establish for a test set in this context, as it's not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The device is an infrared lamp for therapeutic heating; it does not generate diagnostic data for which "ground truth" would be established. The "ground truth" here would be the physical properties and safety of the device itself.
8. The sample size for the training set & 9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires training data or a training set.
Summary of Device Acceptance and Supporting Information from the Document:
The acceptance of the Tända Restore System is based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance criteria from a clinical trial.
Here's the relevant information provided:
- Device Name: Tända Restore™
- Intended Use: An over-the-counter device for temporary relief of minor aches and pains in muscles and joints, and whenever recommended by a licensed medical professional for hot applications. It aims to emit energy in the infrared spectrum to provide topical heating for elevating/maintaining tissue temperature, temporary relief of minor muscular pain, joint pain & stiffness, muscle relaxation, improved range of motion, and temporary increase in local blood circulation.
- Regulatory Status: Class II medical device, Product Code ILY, Regulation Number 890.5500 (Infrared Lamp).
Basis for Acceptance (Substantial Equivalence):
- Predicate Devices:
- Comparison of Technological Differences: The document states: "The intended use and technological characteristics of the Tanda Restore are virtually identical to the combined intended uses and technological characteristics of the listed equivalent predicate devices. Any differences between the Tanda Restore System and the equivalent devices have no significant influence on the safety or effectiveness of the Tanda Restore System."
- Additional Safety Data:
- The Tända Restore System underwent certification to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
- Testing and analysis demonstrated compliance to ISO 10993 (Biological evaluation of medical devices - Biocompatibility).
Conclusion based on the provided document:
The FDA determined the Tända Restore™ device to be substantially equivalent to its predicate devices, primarily based on its shared intended use, similar technological characteristics (infrared lamp emitting 870 nm), and compliance with recognized safety and biocompatibility standards (IEC 60601-1 and ISO 10993). There was no need for clinical trial-based acceptance criteria or performance metrics as it's a therapeutic heating lamp demonstrating equivalence, not a novel diagnostic tool.
§ 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.