(245 days)
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
The proposed device is a type of the most advanced electromagnetic noninvasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.
The provided document is a 510(k) summary for the HI-EMT MAGSHAPE device. It outlines the device details, intended use, comparison to a predicate device, and conclusions regarding substantial equivalence. However, it explicitly states:
"No clinical study is included in this submission." (Page 7)
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective. The acceptance criteria discussed are related to non-clinical tests (e.g., electrical safety, EMC) and performance specifications compared to the predicate device.
Here's an analysis of the information that is available, and what is missing based on your request:
Information Available from the Document:
1. A table of acceptance criteria and the reported device performance:
The document provides "Performance Comparison" (Tables 2 and 3) which effectively serves as a comparison of the proposed device's specifications against those of the predicate device. While not explicitly labeled "acceptance criteria," the predicate device's specifications represent the benchmark for equivalence.
| Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (HI-EMT MAGSHAPE) | Remark |
|---|---|---|
| Product Code: NGX | NGX | Same |
| Regulation Number: 21 CFR 890.5850 | 21CFR 890.5850 | Same |
| Indications for Use: | Same as predicate | Same |
| - Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. | ||
| - Strengthening, Toning and Firming of buttocks, thighs and calves. | ||
| - Improvement of muscle tone and firmness, for strengthening muscles in arms. | ||
| Principle of Operation: Initiating action potential of nerves results in muscle contraction. | Initiating action potential of nerves results in muscle contraction. | Same |
| Type of use: Prescription use | Prescription use | Same |
| Electronic Protection Class: Class II, Type BF | Class I, Type B | Similar (Note 1 - differences don't raise new safety/effectiveness issues) |
| User Interface: Touch screen | Touch screen | Same |
| Type of Energy: Magnetic field | Magnetic field | Same |
| Magnetic Field Intensity: BTL 299-6: 0.5 - 1.8 T ±20%, BTL 299-7: 0.7 - 2.0 T ±20% | 0-2 T | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Pulse Repetition Rate: 1-150 Hz | F1:1-10Hz, F2:1-100Hz | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Pulse Duration: BTL 299-6: 280 ± 20% µs, BTL 299-7: 190 ± 20% µs | 300 µs | Similar (Note 2 - differences don't raise new safety/effectiveness issues) |
| Selection of parameters (Intensity, Time): Yes | Yes | Same |
| Therapy Time: Up to 60 min | Up to 60 min | Same |
| Energy Source: 100-240 V AC, 50-60 Hz | AC110V, 60Hz | Similar (Note 1 - differences don't raise new safety/effectiveness issues) |
| System Dimensions (D × W × H): 580 × 580 × 1380 mm (23 × 23 × 55 in) | MSP001: 5204401240mm, MSP002: 5304001140mm, MSP003: 5504001140mm (Tolerance: ≤ ±5%) | Similar (Note 3 - appearance differences don't affect effectiveness/performance) |
| Ambient Temperature: -10°C ~ +55°C | + 16°C ~ + 35°C | Similar (Note 4 - passed accelerated aging test) |
| Relative Humidity: 10% to 85% | 80%, No Condensation | Similar (Note 4 - passed accelerated aging test) |
| Environmental Specifications: For indoor use only | For indoor use only | Same |
| Electrical safety: Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC: Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Missing Information (as per your request, due to no clinical study):
- Sample sized used for the test set and the data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established from experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
- 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 not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this device is not an algorithm-only product.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth used as no clinical study was performed for this submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
- The sample size for the training set: Not applicable, no training set as no machine learning or AI models are mentioned.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2023
Beijing Sano Laser S&T Development Co., Ltd % Heather Wang Consultant Microkn Medical Technology Service (Shanghai) Co.,Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai (Shanghai Jing'an HUAFA Center) Shanghai, 200435 China
Re: K230024
Trade/Device Name: HI-EMT MAGSHAPE Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 25, 2023 Received: July 25, 2023
Dear Heather Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230024
Device Name HI-EMT MAGSHAPE
Indications for Use (Describe)
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K230024
1. Contact information
1.1. Applicant
Applicant Name: Beijing Sano Laser S&T Development Co., Ltd.
Address: Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi
District, Beijing, China.
Contact Person: Hongbo Zhang
Title: Manager
Tel: +86 10 53006037-830
Email: alex(@sanolasers.com
Date prepared: Dec. 15, 2022
1.2. Consultant
Company: Microkn Medical Technology Service (Shanghai) Co.,Ltd.
Address: Room 901, No. 889, Pinglu Road, Jing'an District,
Shanghai (Shanghai Jing'an HUAFA Center)
Contact Person: Heather. Wang
Telephone: +86 13166194697
Email: heather.wang@microkn.com
2. Device information
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- Trade Name: HI-EMT MAGSHAPE .
- Classification Name: Stimulator, Muscle, Powered, for Muscle Conditioning ●
- Model(s): SHE-MSP003, SHE-MSP002, SHE-MSP001 ●
- Classification: II ●
- Product Code: NGX ●
- Regulation Number: 21 CFR 890.5850 .
3. Indications for Use
- . Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves. ●
- Improvement of muscle tone and firmness, for strengthening muscles in ● arms.
4. Legally Marketed Predicate Device
Product name: BTL 799-2L
510(k) Number: K190456
Product Code: NGX
Manufacture: BTL Industries, Inc.
5. Description of the device
The proposed device is a type of the most advanced electromagnetic.noninvasive treatment machine (with attachments). It is used for muscle
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tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc.
Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.
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The main components of proposed device shown in Table 1.
| Components | Functions | Applied to |
|---|---|---|
| Handle | Deliver Electromagnetic Field Energy toBody Part to be Treated | ALL Models |
| Color Touch Screen | User Interface and System Used forControl | ALL Models |
| Air Switch | Protect the System | ALL Models |
| KEY Switch | Start the System | ALL Models |
Table 1 Main Components of Proposed Device
6. Non-Clinical Test conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1 Medical electrical device Part1: General requirements for ● basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment- Part 1-2: General . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
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7. Clinical Test Conclusion
No clinical study is included in this submission.
8. Substantially Equivalent (SE) Comparison
The HI-EMT MAGSHAPE has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 2), performance specifications (Table 3).
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Item | HI-EMTMAGSHAPEK230024 | BTL 799-2LK190456 | Remark |
| ProductCode | NGX | NGX | Same |
| RegulationNumber | 21CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indicationsfor Use | • Improvement ofabdominal tone,strengthening of the | • Improvement ofabdominal tone,strengthening of the | Same |
| Item | Proposed DeviceHI-EMTMAGSHAPE | Predicate DeviceBTL 799-2L | Remark |
| abdominal muscles,development offirmer abdomen.• Strengthening,Toning and Firmingof buttocks, thighsand calves.• Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms. | abdominal muscles,development offirmer abdomen.• Strengthening,Toning and Firmingof buttocks, thighsand calves.• Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms. | ||
| Principle ofOperation | Initiating actionpotential of nervesresults in musclecontraction. | Initiating actionpotential of nervesresults in musclecontraction. | Same |
| Type of use | Prescription use | Prescription use | Same |
| Proposed Device | PredicateDevice | ||
| Item | HI-EMTMAGSHAPE | BTL 799-2L | Remark |
| Electronic ProtectionClass | Class I, Type B | Class II, TypeBF | SimilarNote 1 |
| User Interface | Touch screen | Touch screen | Same |
| Type of Energy | Magnetic field | Magnetic field | Same |
| Magnetic Field Intensity | 0-2 T | BTL 299-6applicator:0.5 - 1.8T±20%BTL 299-7applicator:0.7 - 2.0T±20% | SimilarNote 2 |
| Pulse Repetition Rate | F1:1-10HzF2:1-100Hz | 1-150 Hz | SimilarNote 2 |
| Pulse Duration | 300 μs | BTL 299-6applicator: | SimilarNote 2 |
| Proposed Device | PredicateDevice | ||
| Item | HI-EMTMAGSHAPE | BTL 799-2L | Remark |
| $280 \pm 20% \mu s$BTL 299-7applicator:$190 \pm 20% \mu s$ | |||
| Selection ofparameters (Intensity,Time) | Yes | Yes | Same |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Energy Source | AC110V, 60Hz | 100-240 V AC,50-60 Hz | SimilarNote 1 |
| System Dimensions(D × W × H) | MSP001: 520 *440 * 1240mm,Tolerance: ≤ ±5%MSP002: 530 400 1140mm,Tolerance: ≤ ±5%MSP003: 550 * | 580 × 580 ×1380 mm(23 × 23 × 55in) | SimilarNote 3 |
| Item | Proposed Device | Predicate Device | Remark |
| HI-EMT MAGSHAPE | BTL 799-2L | ||
| 400 * 1140mm,Tolerance: $\leq \pm 5%$ | |||
| Ambient Temperature | + 16°C ~ + 35°C | -10°C ~ +55°C | SimilarNote 4 |
| Relative Humidity | 80%, NoCondensation | 10% to 85% | SimilarNote 4 |
| EnvironmentalSpecifications | For indoor useonly | For indoor useonly | Same |
Table 2 General Comparison
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Table 3 Performance Comparison
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Note 1
The proposed device HI-EMT MAGSHAPE has minor difference on Electronic Protection Class and Energy Source with the predicate device BTL 799-2L, but the proposed device had passed IEC 60601-1 and IEC 60601-1-2 test codes, so these differences don't raise any new safety and effectiveness issues.
Note 2
The proposed device HI-EMT MAGSHAPE has differences on stimulation parameter with the predicate device BTL 799-2L. The differences do not raise new question of safety and or effectiveness.
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Note 3
The proposed device HI-EMT MAGSHAPE has minor difference on System Dimensions with the predicate device BTL 799-2L, but differences on appearance design will not affect the effectiveness and performance of the product and will not increase the risk of the product. So, it doesn't raise any new safety and effectiveness issues.
Note 4
The proposed device HI-EMT MAGSHAPE has minor difference on Ambient Temperature and Relative Humidity with the predicate device BTL 799-2L, but the proposed device had passed the accelerated aging test, so the difference won't raise any new safety and effectiveness issues.
Safety comparison has been done to validate the EMC specification and safety of the device (Table 4).
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| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Electricalsafety | Comply with IEC60601-1 | Comply with IEC60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
Biocompatibility Consideration:
The skin contacting element is Acrylonitrile butadiene styrene (ABS). The biocompatibility of the device was assessed in accordance with FDA's 2020 Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'"
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9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).