(238 days)
The NuEra Tight Family, EMS Model, is intended for:
- 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.
NuEra Tight Family, EMS Model, is a family of devices designed to:
- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.
This document is a 510(k) summary for the NuEra Tight Family, EMS Model, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially in terms of clinical performance, cannot be fully extracted as such a study is not part of this 510(k) submission. This document primarily addresses safety, electrical compatibility, and functional equivalence to a predicate device already on the market.
However, I can extract information related to the performance data presented within the context of demonstrating substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria for clinical efficacy or the reported performance of the device against such criteria. Instead, it focuses on demonstrating compliance with safety and technical standards and functional equivalence to a predicate device.
The performance data provided relates to:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety | In compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-10/A1. |
| Software Verification and Validation | Software verification was conducted to FDA regulations, standards, and guidance document requirements. Results conclude the software has met these requirements. |
| Functional Testing (Technical Specifications) | Functional tests performed confirmed alignment with device technical specifications. |
| Biocompatibility | Assessed in accordance with ISO 10993-1:2018 and FDA guidance. The device has no contact with patient skin. |
| Risk Management | In compliance with ISO 14971. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This 510(k) summary does not describe any clinical study with a "test set" of patients or data provenance in the context of clinical performance. The testing mentioned (electrical safety, software, functional) is laboratory or engineering-based.
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. This information pertains to clinical performance evaluations, which are not detailed in this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 powered muscle stimulator, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device for muscle stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe clinical ground truth establishment. For the technical performance aspects:
- Electrical Safety & EMC: Compliance with international standards (IEC 60601 series).
- Software V&V: Compliance with FDA regulations, standards, and guidance.
- Functional Testing: Device technical specifications served as the "ground truth" for these tests.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI-driven device.
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December 31, 2020
Bios s.r.l. Maurizio Bianchi Head of QA/RA Via Guido Rossa 10/12 Vimodrone, MI 20090 Italy
Re: K201239
Trade/Device Name: NuEra Tight Family, EMS Model Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 5, 2020 Received: October 8, 2020
Dear Maurizio Bianchi:
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.
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
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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-devices/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 (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201239
Device Name NuEra Tight Family, EMS Model
Indications for Use (Describe)
| The NuEra Tight Family, EMS Model, is intended for: | |
|---|---|
| ----------------------------------------------------- | -- |
-
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
| Contact Details | |
|---|---|
| 510(k) Number | K201239 |
| 510(k) Type | Traditional |
| Applicant Information | Bios s.r.l.Via Guido Rossa, 10/1220090 Vimodrone (MI) – Italy |
| Contact | Dr Eliana Russo |
| Date Prepared | 24 June 2020 |
| Device Name(s): | NuEra Tight Family, EMS Model |
| Model Refs | APMD151 |
| Common Name | Powered Muscle Stimulator |
| Regulatory Class | Class II |
| Product Codes | NGX |
| Regulation Names | Stimulator, muscle, powered, for muscle conditioning |
| Predicate Device for EMS Treatments | |||
|---|---|---|---|
| K190456 | NGX, 890.5850 | Powered Muscle Stimulator (BTL 799-2L) | BTL Industries, Inc. |
Device Description
NuEra Tight Family, EMS Model, is a family of devices designed to:
- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.
Indications for Use
The NuEra Tight Family, EMS Model, is intended for:
- . Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- ı Strengthening, toning and firming of buttocks, thighs and calves;
- . Improvement of muscle tone and firmness, for strengthening muscles in arms.
Predicate Device Comparison
The product specification, functionality, indications for use, and treatment parameters of the NuEra Tight Family, EMS Model, are the same or very similar to the legally marketed predicate and reference devices.
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For the electromagnetic stimulation function, the subject device and predicate device have many identical, similar or substantially equivalent properties or features. No differences that could affect safety or effectiveness have been identified, as indicated in Table 1.
| Table 1: Predicate device comparison table – NuEra Tight Family, EMS Model – Electromagnetic Stimulation | |||
|---|---|---|---|
| Feature | Subject device | Predicate device | Similarity |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios S.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Product Code | NGX - Stimulator, Muscle, Powered | NGX - Stimulator, Muscle, Powered | Same |
| Regulation | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indications for Use | The NuEra Tight Family (EMS Model) is intended:• for improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;• for strengthening, toning and firming of buttocks, thighs and calves;• for improvement of muscle tone and firmness, for strengthening muscles in arms. | BTL 799-2L is indicated to be used for:• 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. | Same |
| Principle of action | Initiating action potential of nerves results in muscle contraction. | Initiating action potential of nerves results in muscle contraction. | Same |
| Clinical use | Prescription Use | Prescription Use | Same |
| Electrical Protection | Class I type BF | Class I type BF | Same |
| User Interface | Touch Screen | Touch Screen | Same |
| Firmware Controlled | Yes | Yes | Same |
| Type of energy | Magnetic Field | Magnetic Field | Same |
| Number of outputs | 2 | 2 | Same |
| Number of magneticcoils in the applicator | 1 | 1 | Same |
| Magnetic Field Intensity | Large HP: 0.5 – 1.8 T ± 20% | BTL 299-6 applicator: 0.5 - 1.8 T ± 20% | Same |
| Small HP: 0.7 – 2.0 T ± 20% | BTL 299-7 applicator: 0.7 - 2.0 T ± 20% | Same | |
| Pulse Repetition Rate | 1-150 Hz | 1-150 Hz | Same |
| Pulse Duration | Large HP: 280 ± 20% µs | BTL 299-6 applicator: 280 ± 20% µs | Same |
| Small HP: 190 ± 20% µs | BTL 299-7 applicator: 190 ± 20% µs | Same | |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Characteristics | Bios Device | Predicate Device | Notes |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios s.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Power Source(s)- Method of LineCurrent IsolationPatient LeakageCurrent- Normal condition- Single fault condition | IEC 60601-1 compliant< 0,1 μΑ< 5 μΑ | IEC 60601-1 compliant< 0,1 μΑ< 5 μΑ | N/A |
| Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (µA) | N/A | N/A | No electrodes.Applicators arenot connectedto patient. |
| Number of OutputModes | 1 | 1 | N/A |
| Number of OutputChannels- Synchronous orAlternating? | 2Synchronous | 2Synchronous | No electrodes.Applicators arenot connectedto patient. |
| - Method of ChannelIsolation | N/A | N/A | |
| Regulated Current orRegulated Voltage? | Regulated voltage | Regulated Voltage | N/A |
| Software /Firmware/MicroprocessorControl? | Yes | Yes | N/A |
| Automatic OverloadTrip? | N/A | N/A | No electrodes.Applicators arenot connectedto patient. |
| Automatic No-LoadTrip? | N/A | N/A | No electrodes.Applicators arenot connectedto patient. |
| Automatic Shut Off? | No | Not available | N/A |
| Patient OverrideControl? | Yes | Not available | N/A |
| Indicator Display:- On/Off Status?- Low Battery?- Voltage/CurrentLevel? | YesN/ANo | YesN/ANo | N/A |
| Timer Range (minutes) | Up to 30 minutes | Up to 30 minutes | N/A |
| Compliance withVoluntary Standards?(If yes, specify) (If yes,specify) | N/A | N/A | N/A |
| Compliancewith 21 CFR 898? | N/A | N/A | N/A |
| Weight | 100 kg | Not available | N/A |
| Dimensions (in.) [W xH x D] | 1350x560x710 mm(53x22x28 in) | 580x1380x580 mm (23x55x23 in) | N/A |
| Housing Materials andConstruction | Steel and Injection MoldedPlastics | Steel and Injection Molded Plastics | N/A |
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Table 2: Basic Unit Characteristics
This section is intended to describe basic unit characteristics. The parameters listed are assumed to be independent of the selected output mode. If this is not the case, or if the information is not applicable to the device, an explanation should be provided. If a specific parameter is not applicable (N/A), this should be noted.
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| Table 3: Output Specifications | |||
|---|---|---|---|
| An output mode is defined (for reporting purposes) as aversion of a waveform produced by the unit. For example,biphasic symmetrical, biphasic asymmetrical, andmonophasic would all be considered separate outputmodes. A copy of the following information should becompleted for each output mode. If a specific parameter isnot applicable (N/A), this should be noted. | |||
| Unique output mode.No electrical output delivered to the body for this EMStechnology | |||
| Characteristics | Bios Device | Predicate Device | Notes |
| Waveform (e.g.,pulsed monophasic,biphasic) | Biphasic | Biphasic | N/A |
| Shape (e.g.,rectangular, spike,rectified sinusoidal) | Sinusoidal | Sinusoidal | N/A |
| Maximum OutputVoltage (specify units) | N/A | N/A | No electrodes.Applicators arenot connectedto patient. |
| Maximum OutputCurrent (specify units) | N/A | N/A | No electrodes.Applicators arenot connectedto patient. |
| Pulse Width (specifyunits) | Large HP: 280 ± 20% µs | BTL 299-6 applicator: 280 ± 20% µs | N/A |
| Small HP: 190 ± 20% µs | BTL 299-7 applicator: 190 ± 20% µs | N/A | |
| Frequency (Hz) | 1-150 Hz | 1-150 Hz | N/A |
| For interferentialmodes only:- Beat Frequency (Hz) | N/A | N/A | N/A |
| For multiphasicwaveforms only:- Symmetrical phases?- Phase Duration(include units)(state range, ifapplicable)(both phases, ifasymmetrical) | Yes | Yes | N/A |
| Net Charge (mC per pulse) | |||
| Net Charge (mC per pulse) | N/A | N/A | No electrodes.Applicators are not connected to patient. |
| Maximum Phase Charge, (mC) | N/A | N/A | No electrodes.Applicators are not connected to patient. |
| Maximum Current Density (mA/cm²) | N/A | N/A | No electrodes.Applicators are not connected to patient. |
| Maximum Average Current | N/A | N/A | No electrodes.Applicators are not connected to patient. |
| Maximum Power Density (W/cm²) (using smallest electrode conductive surface area) | N/A | N/A | No electrodes.Applicators are not connected to patient. |
| Burst Mode (i.e., pulse trains)a. Pulses per burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | N/A | N/A | N/A |
| ON Time (seconds) | N/A | N/A | N/A |
| OFF Time (seconds) | N/A | N/A | N/A |
| Additional Features (if applicable) | N/A | N/A | N/A |
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Performance Data
Electrical safety and electro-magnetic compatibility
The NuEra Tight Family, EMS Model, has been tested and is in compliance with:
- . IEC 60601-1; Medical Electrical Equipment - Part 1: 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 Disturbances - Requirements And Tests;
- IEC 60601-1-6; Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And ● Essential Performance - Collateral Standard: Usability;
- IEC 60601-2-10/A1; Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
- IEC 62304; Medical Device - Software Life Cycle Processes;
- ISO 14971; Medical Devices Application Of Risk Management To Medical Devices .
Software Verification and Validation
In addition to the electrical safety testing performed, software verification was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification was also performed on the NuEra Tight Family, EMS Model, in compliance with internal design control procedures. The results of this testing conclude the NuEra Tight Family, EMS Model, is determined to be safe and effective.
Functional Testing
Functional tests have been performed to confirm that the performance of the NuEra Tight Family, EMS Model, devices are aligned with the device technical specifications.
Biocompatibility
Based on the type and duration of body contact, existing biocompatibility data has been assessed in accordance with ISO 10993-1:2018 (FDA standards recognition # 2-258) and FDA guidance document 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff', 16 June 2016.
The NuEra Tight Family, EMS Model, has no contact with the skin of the treated patients.
Conclusion
Based upon the indications for use and known technical information provided in this pre-market notification, the NuEra Tight Family, EMS Model, devices has been shown to be substantially equivalent to currently marketed predicate and reference devices. Any differences are considered minor and do not raise new issues of the safety and effectiveness of the NuEra Tight Family, EMS Model, devices when compared to the predicate devices.
§ 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).