(66 days)
System from Slendertone is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes. Indications for used are as follows:
System-Abs, Type 390, E10/X10
- The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
System-Shorts, Type 390, E20
- Strengthening, toning and firming of the bottom and thigh region.
System-Abs and System-Shorts are the newest product offerings from Slendertone (division of Bio-Medical Research Ltd.). The products include an interchangeable, rechargeable handheld controller, which can be used with a garment from the System range, to exercise specific areas of the body. The System-Abs belt is used to exercise the abdominal muscles and the System-Shorts is used to exercise the bottom and thigh muscles.
The overall product consists of a garment (shorts for System-Shorts and belt for System-Abs), control unit, a pack of adhesive backed gel based electrodes (6 for System-Shorts and 3 for System-Abs), battery charger and instruction manual.
System is a two-channel EMS product and offers 7 programs to the user of the belt and 4 programs to users of the shorts. Electrodes are applied to the inner surface of the garment to cover the silver studs and the garment is fitted (sizing options are given for a best fit) using the hook and loop patches. Each System garment contains an ID chip, which is programmed to determine the different model types and treatment parameters and is connected to the electronic controller unit via a lead and connector. The control unit generates the required stimulation signals and the garment connects these signals to the skin electrodes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit.
There is no current passed from side to side. Because the user has no access to the wiring or connectors within the garment, he/she cannot alter the current path and so the possibilities for misuse are greatly reduced.
The product cannot be used whilst in charge mode.
Materials:
(Belt): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Foam -- 100% Polyurethane
(Shorts): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Non-Elastic Hook and Loop - 100% Polyethylene, Foam - 100% Polyurethane, Stitch String - 100% Nylon.
This document is a 510(k) summary for muscle stimulator devices (System-Abs and System-Shorts). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove device performance against those criteria.
Therefore, the requested information elements related to specific acceptance criteria, a study proving performance against them, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or not provided in this document.
However, I can extract information regarding the clinical and non-clinical tests that were performed to support substantial equivalence, which is a form of demonstrating safety and effectiveness.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as new, quantitative performance criteria for the proposed devices. The acceptance criteria for this submission revolve around demonstrating substantial equivalence to the predicate devices and compliance with relevant safety standards.
- Reported Device Performance: The document does not present new performance data for improvement of muscle tone or strengthening from the proposed devices themselves. Instead, it relies on the clinical information submitted for the predicate devices to support the stated Indications for Use.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No new clinical studies were conducted for the proposed devices. The submission leverages previous clinical information.
- Data Provenance: The clinical information is from the original predicate submissions (K010335 for Slendertone Flex, Type 512, and K022855 for Slendertone Flex Bottom and Thigh Toning System, Type 511). The document does not specify whether these predicate studies were retrospective or prospective, or their country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No new clinical studies or ground truth establishment processes are described for the proposed devices.
4. Adjudication Method:
- Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is not relevant to a muscle stimulator device and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
- Not applicable. These are physical muscle stimulator devices, not AI algorithms.
7. The Type of Ground Truth Used:
- For the predicate devices' clinical information, the "ground truth" would have been objective measurements of muscle tone/strength improvement or subjective assessments by participants or clinicians. The document does not detail the specific methodology for ground truth establishment for the predicate studies.
8. The Sample Size for the Training Set:
- Not applicable. No "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of what was reported to demonstrate safety and effectiveness for the proposed devices in this 510(k) submission:
- Clinical Tests:
- Non-Clinical Tests:
- The proposed devices (System-Abs and System-Shorts) were designed and independently tested to comply with several international electrical safety and electromagnetic compatibility (EMC) standards:
- EN 60601-1-2:2001 (Medical electrical equipment - EMC)
- CISPR 22:2003 & CFR 47 Part 15:2005 (Radio disturbance characteristics)
- DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995 (General requirements for safety)
- IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995 (General requirements for safety)
- DIN EN 60601-2-10; IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators)
- Battery Charger complies with IEC 60950 and UL 1950 (Safety standards for information technology equipment, which the charger falls under).
- The proposed devices (System-Abs and System-Shorts) were designed and independently tested to comply with several international electrical safety and electromagnetic compatibility (EMC) standards:
- Risk Management:
- A risk management plan was carried out according to EN ISO 14971:2001.
- Quality System:
- Bio-Medical Research Ltd. is registered to IS EN ISO 13485:2003 (Quality management systems for medical devices).
- CE Mark:
- The devices are CE marked in Europe and comply with the Medical Device Directive 93/42/EEC.
Conclusion:
This 510(k) submission primarily demonstrates substantial equivalence through a comparison of technological characteristics to predicate devices and adherence to recognized safety and EMC standards. It explicitly states that no new clinical studies were performed for the proposed devices, relying instead on the clinical evidence of the predicate devices. Therefore, a direct answer to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of new clinical performance data is not provided in this document.
§ 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).