(234 days)
The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
The HONKON-Slimming I+ and HONKON-Slimming III+ are the non-invasive body shaping product to combine four different technologies including IR (infrared), Bi-Polar RF (radio-frequency) and mechanical tissue manipulation using pulsed vacuum and massage rollers. The combination of the IR and vacuum coupled RF technologies causes deep heating of the connective tissue including the fibrous septae which in turn promotes an increase in local cellular reduction. The additional mechanical tissue manipulation of the device causes an immediate increase in circulation and lymphatic drainage, both essential components for healthy skin structure.
The HONKON-Slimming I+ and HONKON-Slimming III+ can output infrared light with wavelength 700-2000nm, the infrared light can penetrate whole skin tissue. The infrared light has the effect to expand blood vessels, temporary improvement of local blood circulation; At the same time, this spectrum has a good efficacy for temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
The HONKON-Slimming I+ and HONKON-Slimming III+ can output 1MHz frequency, produce RF energy from X, Y and Z directions in the subcutaneous tissue. Temperature of skin tissues becomes higher, Enzyme activity was enhanced so that fat cells can be fully released within the triglyceride; Triglycerides in the fat under the action of enzymes, cracking into fatty acids and glycerol.
Massage rollers has obvious mechanical compression to skin tissues. Meanwhile, deep negative pressure gives skin and muscles full relaxation and rest. Maximum 8kg negative pressure can absorb all skin tissues into the gap between the bipolar RF tips, ensure RF energy can reach fat layers.
Based on this,the HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
This document is a 510(k) Summary for a medical device called the "Slimming Treatment Device" (models HONKON-Slimming I+ and HONKON-Slimming III+). It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
The document does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite or thigh circumference). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technical specifications, safety, and regulatory compliance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined as pass/fail thresholds for clinical performance but rather as demonstrating substantial equivalence to the predicate devices across various technical and safety parameters. The "Reported Device Performance" in this context refers to the device's technical specifications and the results of non-clinical safety tests.
| Item | Acceptance Criteria (Demonstrates SE to Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Intended Use | Similar indications to predicate devices: relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and temporary reduction of thigh circumferences. | The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thigh circumferences. |
| Regulatory Information | Classification (Class II), Product Code (NUV, ISA), Regulation Number (21 CFR 878.4810) are substantially equivalent. | Classification: II; Product Code: NUV, ISA; Regulation Number: 21 CFR 878.4810 |
| RF Output Energy | The device's RF output energy is considered safe and effective, and performs as well as the predicate device based on non-clinical tests (IEC 60601-2-2). (Predicate devices have up to 50W and up to 150W respectively.) | 40-400W |
| RF Output Frequency | The device's RF output frequency is substantially equivalent to predicate devices (Predicate 1: 0.8 MHz, 1.7 MHz, 2.45 MHz; Predicate 2: N.A.). | 1MHz |
| Max. RF output energy density | The device's max RF output energy density is substantially equivalent to predicate devices (Predicate 1: 78.125W/cm2, 4.76W/cm2, 33.33W/cm2; Predicate 2: 115.38W/cm2, 6.67W/cm2, 12 W/cm2, 9.38W/cm2). | XF-I+:12.14W/cm²; XF-VII+:27W/cm² |
| Infrared energy | The device's infrared energy is considered safe and effective, and performs as well as the predicate device based on non-clinical tests (IEC 60601-1) for the risk of heat. (Predicate 1: N.A.; Predicate 2: Up to 3.3W). | XF-I+ & XF-VII+: I: 5W II: 7W III: 8W IV: 9W V: 10W |
| Infrared wavelengths | The device's infrared wavelengths are substantially equivalent (Predicate 1: N.A.; Predicate 2: 850nm). | 700-2000nm |
| Max. IR output energy density | The device's max IR output energy density is substantially equivalent (Predicate 1: /; Predicate 2: 2.54W/cm², 0.44W/cm², 0.26W/cm², 0.21W/cm²). | XF-I+:0.30W/cm²; XF-VII+:0.67W/cm² |
| Vacuum | The device's vacuum mechanism is substantially equivalent (both predicates use "Pulsed"). | Pulsed (-0.08Mpa -- -0.01Mpa) |
| Mechanical Massage | The device's mechanical massage feature is substantially equivalent (Predicate 1: Yes; Predicate 2: N.A.). | Yes |
| Treatment Area | Differences in treatment area size are not considered to affect safety and effectiveness. | XF-I+: 3294 mm²; XF-VII+: 1482mm² |
| Electrical Safety | Compliance with IEC 60601-1 (all devices). | The proposed devices were tested to demonstrated to comply with IEC 60601-1. |
| EMC | Compliance with IEC 60601-1-2 (all devices). | The proposed devices were tested to demonstrated to comply with IEC 60601-1-2. |
| Biocompatibility | No toxicity (ISO 10993-5), No irritation (ISO 10993-10), No sensitization (ISO 10993-10) for patient contact materials, demonstrably equivalent to predicate devices. | Cytotoxicity: No toxicity (ISO 10993-5); Irritation: Applied sample did not induce irritation to skin. (ISO 10993-10); Sensitization: The test article showed no signification evidence of causing skin sensitization in the guinea pig. (ISO 10993-10) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set sample size or data provenance (country, retrospective/prospective) for clinical effectiveness. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility) and comparisons to existing predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or test set with expert-established ground truth was performed for this submission. The "ground truth" for the substantial equivalence claim relies on regulatory standards and the specifications of the predicate devices.
4. Adjudication method for the test set
Not applicable, as no clinical study or test set requiring adjudication was performed.
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
Not applicable. This device is a physical therapeutic device, not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical therapeutic device, not an algorithm. Its operation involves human application.
7. The type of ground truth used
For the purpose of this 510(k) submission, the "ground truth" is largely:
- Regulatory Standards: Compliance with established international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-5, -10) for safety and performance.
- Predicate Device Specifications: The accepted safety and effectiveness profiles of the legally marketed predicate devices (Reaction™ System K090221 and VelaShape K122579). The proposed device's specifications are compared to these predicates to demonstrate similarity.
8. The sample size for the training set
Not applicable. As no clinical study was conducted. There is no "training set" in the context of device efficacy for this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no training set was used or described.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.