(108 days)
The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
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Temporary relief of minor joint pain associated with arthritis.
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The temporary increase in local circulation where applied.
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Relaxation of muscle.
The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:
- (1) Main assembly
- (2) 5-Ball Projector
- (3) Remote Control
- (4) Accessories
Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.
This document is a 510(k) Premarket Notification from Nuga Medical Co., Ltd. for their device, the N5-1. The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy in the way an AI/software device typically would.
Therefore, many of the details requested in your prompt (such as acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not provided in this regulatory document. This submission focuses on comparing the N5-1's design, technological characteristics, and intended use to a previously cleared predicate device to show that it does not raise new questions of safety or effectiveness.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The intended use of the N5-1 should be substantially equivalent to the predicate device, providing muscle relaxation and topical heating for: - Temporary relief of minor muscle and joint pain and stiffness. - Temporary relief of minor joint pain associated with arthritis. - Temporary increase in local circulation where applied. - Relaxation of muscle. | The N5-1's intended use is identical to the predicate device (NM-7000): "to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. - Temporary relief of minor joint pain associated with arthritis. - The temporary increase in local circulation where applied. - Relaxation of muscle." |
| Technological Characteristics Equivalence (General) | Design, function, and technical characteristics should be similar to the predicate device and not raise new safety/effectiveness concerns. | The N5-1 is stated to be similar to the predicate device (NM-7000) with regard to design, function, and technical characteristics. Key differences (music player, size, components, mode set-up) are explicitly stated not to raise new safety and effectiveness issues. |
| Material (Internal/External Projector) | Ceramic material for heating elements. | Both the N5-1 and the predicate device use Tourmanium ceramic for the emission source, and ceramic for the internal and external projector materials. |
| Temperature Range | 40 - 60°C (104 - 140°F) | Both the N5-1 and the predicate device operate within the temperature range of 40 - 60°C (104 - 140°F). |
| Safe Working Load | 170 kg | Both the N5-1 and the predicate device have a safe working load of 170 kg. |
| Electrical Safety | Compliance with AAMI ES60601-1. | The N5-1 "complies with the electrical safety ... requirements established by the standards AAMI ES60601-1". |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | The N5-1 "complies with the ... electromagnetic compatibility requirements established by the standards ... IEC 60601-1-2". |
| Software Validation | Software designed and developed according to a software development process, verified and validated, and in accordance with FDA guidance for "MODERATE level of concern software." | Software was designed and developed according to a software development process and was verified and validated. It is deemed "MODERATE level of concern software." |
| Biocompatibility | No direct patient contact for device parts (no biocompatibility testing needed). | The N5-1 "does not contain any parts which be contacted with the body of patient directly." Therefore, biocompatibility testing was not performed based on this criteria. |
2. Sample size used for the test set and the data provenance:
- This document is for a physical therapy device, not an AI/software device that processes data for diagnosis or treatment decisions. Therefore, there is no "test set" in the context of data for an algorithm.
- The safety and performance are evaluated through engineering tests (electrical safety, EMC) and comparison to a predicate device. Clinical studies were explicitly stated as not being necessary or performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" in the context of an algorithm's performance requiring ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable.
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:
- No. This is not an AI-assisted diagnostic or therapeutic device that requires human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical therapy device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of an AI/software device's performance. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., AAMI ES60601-1, IEC 60601-1-2) and demonstrating substantial equivalence to a legally marketed predicate device with the same intended use and similar technological characteristics.
8. The sample size for the training set:
- Not applicable. There is no AI training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI training set.
Summary of the Study:
The document describes a non-clinical study primarily focused on demonstrating substantial equivalence to a predicate device (K111329, NM-7000) for regulatory clearance. This is done by comparing:
- Intended Use: The N5-1's intended use is identical to the predicate device.
- Technological Characteristics: The N5-1 is shown to have similar design, function, and technical characteristics (e.g., emission source, temperature range, safe working load) to the predicate device. Minor differences are identified and argued not to raise new safety or effectiveness concerns.
- Performance via Standards Compliance: Electrical safety and electromagnetic compatibility (EMC) were tested against recognized standards (AAMI ES60601-1 and IEC 60601-1-2, respectively). The device "complies" with these standards.
- Software Validation: The device's software (classified as "MODERATE level of concern") was designed, developed, verified, and validated according to a software development process and FDA guidance.
- Biocompatibility: No biocompatibility testing was performed as the device does not have direct patient contact.
Conclusion: Based on this comparison and compliance with engineering standards, NUGA MEDICAL Co., Ltd. concludes that the N5-1 is substantially equivalent to the predicate device. No clinical studies were deemed necessary or performed for this submission.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).