(136 days)
The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.
Revitive IX (OTC) is indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.
Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.
The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.
The provided text describes the Revitive IX (OTC) device and its substantial equivalence to predicate devices, focusing on safety and performance, but it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.
The document is a 510(k) summary for an Over-The-Counter (OTC) powered muscle stimulator (Revitive IX), and typically these submissions demonstrate substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria for an AI algorithm.
However, I can extract the information that is present concerning performance testing and usability studies:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, the document does not explicitly list "acceptance criteria" in the typical sense of a target performance metric for an AI system (e.g., sensitivity, specificity, AUC). Instead, it refers to compliance with safety and biocompatibility standards and successful usability testing.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Biocompatibility | ISO 10993-5 (in vitro cytotoxicity): Complied and functioned as intended, results as expected. |
| ISO 10993-10 (irritation and skin sensitization): Complied and functioned as intended, results as expected. | |
| Safety & Essential Performance (General) | BS EN 60601-1 (Medical electrical equipment): Complied and functioned as intended, results as expected. |
| Electromagnetic Compatibility (EMC) | BS EN 60601-1-2 (Medical electrical equipment - EMC): Complied and functioned as intended, results as expected. |
| Safety (Nerve and Muscle Stimulators Specific) | EN 60601-2-10 (Nerve and muscle stimulators safety): Complied and functioned as intended, results as expected. |
| Safety (Home Healthcare Environment) | BS EN 60601-1-11 (Home healthcare environment requirements): Complied and functioned as intended, results as expected. |
| Usability/Human Factors (for OTC use) | Usability study: Established that the Revitive IX (OTC) device, as labeled, is safe and effective in the hands of the intended population and suitable for Over-The-Counter use. |
| Substantial Equivalence (Overall Safety & Effectiveness) | Performance data (including the above) demonstrates the Revitive IX (OTC) is as safe and effective as the predicate devices. |
The following information is NOT present in the provided text, as it pertains to AI/algorithm performance studies which are not described for this device.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable (N/A) as no AI performance study is described.
- 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): N/A.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A.
- 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: N/A.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A.
- The sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
Summary of what is available from the document:
The document describes performance data primarily related to meeting established medical device safety, EMC, and biocompatibility standards (e.g., ISO and EN standards). A usability study was also conducted to demonstrate safe and effective operation by intended users in a home environment for OTC use, following FDA human factors draft guidance. The device is a "Powered Muscle Stimulator" and the "software included in the device controls the pulses generated by the device to stimulate the muscle." However, this software is for device function control, not for an AI-driven diagnostic or treatment recommendation system that would typically have the AI-specific performance metrics requested. The submission is a 510(k) for substantial equivalence, implying that its safety and effectiveness are established by comparison to existing legally marketed predicate devices, supported by compliance with relevant standards and usability testing.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol of three human profiles facing right, with flowing lines representing the concept of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Actegy, Ltd % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, DC 20004
Re: K143207
Trade/Device Name: Revitive IX (OTC) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: November 7, 2014 Received: November 7, 2014
Dear Dr. Smith,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Revitive IX (OTC)
Indications for Use (Describe)
- . To temporarily increase local blood circulation in healthy leq muscles.
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- . For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (leqs) due to strain from exercise or normal household duties.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Actegy's Revitive IX (OTC)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK
| Phone: | +44(0) 1344 636 940 |
|---|---|
| Facsimile: | +44(0) 8452 255 612 |
| Contact Person: | Angela Glover |
|---|---|
| Date Prepared: | March 18, 2015 |
Name of Device and Name/Address of Sponsor
Revitive IX (OTC) - Model: RIX
- Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK
Common or Usual Name
Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device
Classification Name
Powered muscle stimulator for muscle conditioning, 21 C.F.R. § 890.5850, product code NGX/NUH
Predicate Devices
OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager - PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354)
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Device Description
The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.
Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.
The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.
Intended Use / Indications for Use
The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.
Revitive IX (OTC) is indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
Technological Characteristics
The Revitive IX (OTC) is a mid-frequency (20-53Hz) Electrical Muscle Stimulator providing pulsed symmetrical biphasic, rectangular and bipolar waveforms utilizing Conductive Footpads & Self Adhesive Cutaneous Electrodes and rocker feature. The device provides an output current of 10-14mA@500Ω r.m.s. and maximum output voltage of 32V@500Ω. Intensity is controlled via the user
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interface in 1-99 incremental steps. The duration of the treatment session can be set between 1 and 60 minutes.
Performance Data
Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted in accordance with the following standards:
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|---|---|
| ISO 10993-10 | Biological evaluation of medical devices. Tests for irritation and skin sensitization |
| BS EN 60601-1 | Medical electrical equipment. General requirements for basic safety and essential performance |
| BS EN 60601-1-2 | Medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests |
| EN 60601-2-10 | Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
| BS EN 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. |
In all instances, the Revitive IX (OTC) functioned as intended and the results observed were as expected.
A Usability study was conducted to determine that the intended users can identify they are appropriate users of the device and to assess whether they can operate the device in a safe and effective manner based on their reading and following the directions for use contained in the device labeling. The Revitive IX (OTC) summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011). In summary, it was established that the Revitive IX (OTC) device, as labeled, is safe and effective in the hands of the intended population and therefore is suitable for Over-The- Counter use.
Substantial Equivalence
The Revitive IX (OTC) is as safe and effective as its predicate devices. The Revitive IX (OTC) has the same technological characteristics, and principles of operation and similar indications and intended uses, as its predicate devices. The differences in Indications between the Revitive IX (OTC) and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX (OTC) is as safe and effective as the predicate devices and is suitable for Over-The- Counter use. Thus, the Revitive IX (OTC) is substantially equivalent.
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Actegy Ltd's
REVITIVE IX (OTC)
Substantial Equivalence Chart
| OTC TENS Electronic Pulse | ||||
|---|---|---|---|---|
| Revitive IX (OTC) | OTC EMS Stimulator | Massager - PL009 | Revitive IX (Rx) | |
| Candidate | Primary Predicate | Secondary Predicate | Secondary Predicate | |
| 510(k) Number | TBD | K133965 | K122744 | K123354 |
| Device Name, Model | REVITIVE IX (OTC), RIX | OTC EMS Stimulator, MT1001 | OTC TENS Electronic PulseMassager - PL009 | REVITIVE IX (RX), RIX |
| Product Code: | NGX/NUH | NGX | NUH/NGX | IPF |
| Intended Use | Intended for electrical stimulation ofthe lower leg and other muscles forvarious indications | Intended for electricalstimulation of the lower leg forvarious indications | Intended for electricalstimulation of tired and soremuscles | Intended for electricalstimulation of the lower leg forvarious indications |
| Indications for Use | To temporarily increase local bloodcirculation in healthy leg muscles.To stimulate healthy muscles in orderto improve and facilitate muscleperformance.For temporary relief of painassociated with sore and achingmuscles in the shoulder, waist, back,upper extremities (arms) and lowerextremities (legs) due to strain fromexercise or normal household duties. | The OTC EMS stimulatorMT1001 is intended tostimulate healthy muscles ofthe lower extremity in order totemporarily increase localblood circulation and tostimulate healthy muscles inorder to improve and facilitatemuscle performance. | To be used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, neck,upper extremities (arm) andlower extremities (leg) due tostrain from exercise or normalhousehold activities. | 1. Relaxation of musclespasms:2. Prevention or retardation ofdisuse atrophy:3. Increasing local bloodcirculation:4. Muscle re-education:5. Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis;and6. Maintaining or increasingrange of motion. |
| Technological Characteristics | Mid Frequency (20-53Hz) ElectricalMuscle Stimulator providing pulsedsymmetrical biphasic, rectangular andbipolar waveforms utilizingConductive Footpads & Self AdhesiveCutaneous Electrodes and rockerfeature | Mid Frequency (10-36Hz)Electrical Muscle Stimulatorproviding pulsed symmetricalbiphasic, rectangular andbipolar waveforms utilizingConductive Footpads & SelfAdhesive CutaneousElectrodes and rocker feature | Mid Frequency (1-63Hz)Electrical Muscle Stimulatorproviding pulsed monophasic,rectangular waveforms utilizingSelf Adhesive CutaneousElectrodes | Mid Frequency (20-53Hz)Electrical Muscle Stimulatorproviding pulsed symmetricalbiphasic, rectangular andbipolar waveforms utilizingConductive Footpads & SelfAdhesive CutaneousElectrodes and rocker feature |
| Accessories | Self Adhesive Cutaneous Electrodes | Self Adhesive CutaneousElectrodes | Self Adhesive CutaneousElectrodes | Self Adhesive CutaneousElectrodes |
| Revitive IX (OTC) | OTC EMS Stimulator | OTC TENS Electronic PulseMassager - PL009 | Revitive IX (Rx) | |
| Manufacturer | Actegy Ltd | Shenzhen DongdixinTechnology Co. Ltd. | Prospera Corporation | Actegy Ltd |
| Dimensions (mm) [W x H x D] | Ø360mm x 75mm | 427.3 x 416.5 x 103.7mm | 2.24 x 7.80 x 0.91in | Ø360mm x 75mm |
| Weight | 1725g (not including PSU) | 1910g (device only, excludingbatteries) | 8.21 oz | 1725g (not including PSU) |
| Power Source(s) | Power adaptorInput: 100-240V, 50/60Hz, 0.18A.Output: 5.0Vdc, 1.0A | Power adaptorInput: 100-240V, 50/60Hz,Output: 6.0Vdc, 300mAOr 6.0Vdc, 4xC batteries | 6V battery | Power adaptorInput: 100-240V, 50/60Hz,0.18A.Output: 5.0Vdc, 1.0A |
| Safety Features | Automatic Shut off, Override Control | Automatic Shut off, OverrideControl | Automatic Shut off, OverrideControl | Automatic Shut off, OverrideControl |
| Biocompatibility | Yes | Unknown | Yes | Yes |
| Number of Output Modes | 1 | 1 | 3 | 1 |
| Number of Output Channels | 2 (1 for Foot, 1 for body pads) | 3 (2 for foot, 1 for body) | 2 | 2 (1 for Foot, 1 for body pads) |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes |
| Voltage/Current Level? | Yes: 1-99 intensity indicator | Yes: 1-99 intensity indicator | Yes: 1-10 intensity dial | Yes: 1-99 intensity indicator |
| Timer Range (minutes) | 1 to 60 minutes | 1 - 99 minutes | 15 minutes | 1 to 60 minutes |
| Compliance with VoluntaryStandards? | MDD (93/42EEC), EN 60601-1,EN60601-1-2, EN 60601-1-11,EN60601-2-10 | Unknown | IEC60601-1:IEC60601-1-2;IEC60601-2-10 | MDD (93/42EEC), EN 60601-1,EN60601-1-2, EN 60601-1-11,EN60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Unknown | Yes | Yes |
| Housing Materials andConstruction | Casing/body ABS, footpads NBR | Unknown | Enclosure ABS | Casing/body ABS, footpadsNBR |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile |
| Biocompatibility | Yes | Unknown | Yes | Yes |
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§ 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).