(113 days)
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.
Indications for Use:
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion
The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery.
The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.
The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to
-
Send particular information from remote control to stimulation modules (stimulation settings)
-
Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status,
-
Transfer binary data to stimulation modules, and
-
Allow synchronization from stimulation modules to remote control clocks.
The provided documentation describes the Chattanooga Revolution Wireless, a powered muscle stimulator and transcutaneous electrical nerve stimulator (TENS) device. The information details the device's characteristics, indications for use, comparison to a predicate device (Vectra Neo), and performance testing conducted for its 510(k) premarket notification.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail values. Instead, the document discusses compliance with recognized standards and successful completion of various tests. The reported device performance is presented as a confirmation of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | The device was tested and found to comply with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, a recognized standard for medical electrical equipment. |
| Electromagnetic Compatibility (EMC) | The device was tested and found to comply with IEC 60601-1-2 Edition 3:2007-03, a recognized standard for electromagnetic compatibility in medical electrical equipment. |
| Nerve and Muscle Stimulator Specific Safety | The device was tested and found to comply with IEC 60601-2-10 Edition 2.0 2012-06, a recognized standard for the basic safety and essential performance of nerve and muscle stimulators. |
| FCC Radio Frequency Compliance | The device was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249. |
| Software Verification | The device's software was verified in accordance with FDA's guidance document: General Principles of Software Validation, January 11, 2002. The testing demonstrated that the software meets its design requirements. Also complies with IEC 62304 First Edition 2006-05 (Medical Device Software - Software Life Cycle Processes). |
| Usability/Human Factors | Usability/Human Factors testing was performed, demonstrating that established requirements for usability were met, and the design is appropriate for intended users and use environment. The study "substantiates the acceptability of the use-related risks." Complies with IEC 60601-1-6 Edition 3.0 2010-01 (Usability) and IEC 62366:2007, Ed. 1 (Application of Usability Engineering). |
| Wireless Coexistence | The performance was evaluated in an environment with other Chattanooga Revolution Wireless devices and other 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements. |
| Risk Management | Complies with ISO 14971:2007 (Medical Devices - Application of Risk Management). |
| Electrode Lead Wires & Patient Cables | Complies with 21 CFR 898 (Performance standard for electrode lead wires and patient cables). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests (e.g., electrical safety, software verification, usability). There is also no mention of data provenance (e.g., country of origin, retrospective/prospective). The tests described are primarily engineering verification and validation studies rather than clinical trials with human participant data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the performance testing primarily involves engineering compliance with standards and functional verification, the concept of "ground truth" established by experts in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for these tests would be the specifications outlined in the recognized standards themselves, and the expertise would lie with the engineers and testers performing the measurements and assessments against those standards. No specific number or qualifications of such experts are provided beyond implied expertise in regulatory and engineering compliance.
4. Adjudication Method for the Test Set
As the studies described are compliance-based engineering tests and not clinical studies requiring expert consensus on complex outcomes, an explicit adjudication method like "2+1" or "3+1" is not mentioned or relevant. Compliance is typically determined by whether the device's performance meets the defined parameters of the relevant standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The device is a physical therapy device (stimulator), and the evaluation focuses on its safety and performance against established standards and a predicate device, not on assessing the improvement of human readers (e.g., doctors interpreting scans) with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The device itself is a physical medical device, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance studies are for the integrated device system.
7. Type of Ground Truth Used
The "ground truth" for the performance testing is implicitly defined by:
- Recognized Standards: Such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 14971.
- Design Requirements: For the software verification and usability testing, the device's own design requirements serve as the ground truth against which performance is measured.
- FCC Regulations: For radio frequency compliance.
There is no mention of pathology, clinical outcomes data, or expert consensus (in a diagnostic context) as ground truth.
8. Sample Size for the Training Set
This information is not provided. The document describes premarket notification for a physical medical device, not an AI/ML product that typically involves a "training set." The software verification mentioned refers to traditional software engineering verification, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The ground truth for the device's design and functionality is established through engineering specifications, regulatory standards, and intended use definitions.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
DJO, LLC Lorri Trotter Regulatory Affairs Manager 1430 Decision Street Vista. California 92081
Re: K153696
Trade/Device Name: Chattanooga Revolution Wireless Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF; GZJ Dated: March 11, 2016 Received: March 14, 2016
Dear Ms. Trotter:
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
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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 devicerelated 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,
Michael J.Hoffmann -A
- for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153696
Device Name Chattanooga Revolution Wireless
Indications for Use (Describe)
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.
Indications for Use:
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitted by: | DJO, LLC |
|---|---|
| 1430 Decision Street | |
| Vista, CA 92081 | |
| Contact Person: | Lorri Trotter |
| Regulatory Affairs Manager | |
| (760)734-3049 | |
| Date Summary Prepared: | April 11, 2016 |
| Trade Name: | Chattanooga® Revolution Wireless |
| Classification Name: | Powered muscle stimulator (21 CFR 890.5850);Transcutaneous electrical nerve stimulator for pain relief(21 CFR 5890) |
| Product Code: | IPF, GZJ |
| Regulatory Class: | Class II |
| Predicate Device: | Vectra Neo (K132284) |
Device Description:
The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an
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electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery.
The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.
The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to
-
Send particular information from remote control to stimulation modules (stimulation settings)
-
Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status,
-
Transfer binary data to stimulation modules, and
-
Allow synchronization from stimulation modules to remote control clocks.
Indications for Use:
The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.
Indications for Use:
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy -
- -Maintaining or increasing range of motion
- Re-educating muscles -
- Relaxation of muscle spasms -
- -Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery -
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain -
- Post-surgical and post-trauma acute pain -
- As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm -
- Increasing local blood circulation -
- -Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion -
Programs:
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The Chattanooga Revolution Wireless provides 14 programs: Trigger Point, Acute Pain, Chronic Pain, Muscle Pump Cycle, Muscle Pump Continuous, Increase ROM (Range of Motion), Decrease Muscle Tone, Fast Twitch Function, Muscle Atrophy, Slow Twitch Function, VMS-FR Dynamic 2 Channel, VMS-FR Dynamic 4 Channel, VMS-FR Static 2 Channel, and VMS-FR Static 4 Channel.
Comparison to the Predicate Device: Includes Table
The indications for use for the Revolution Wireless USA are a subset of those for the predicate device the Vectra Neo Clinical Therapy System. The predicate device has additional features, functions, and applications that are not included in the Revolution Wireless. Therefore, we are comparing the Revolution Wireless only to those functions of the predicate that are applicable.
The technological characteristics of the two devices are very similar for the comparable functions, but there are a few differences. The following table summarizes the similarities and differences between the technological characteristics of the two devices. The power sources of the two devices differ (Revolution is battery powered) and output specifications differ slightly between the two devices, but the Chattanooga Revolution Wireless conforms to required standards, and small differences in output do not raise any issues of safety or effectiveness. The Revolution Wireless differs from the predicate in that it communicates wirelessly with the stimulation modules, but the design of the wireless feature is identical to that of the Compex Wireless USA (K143551).
| Basic Device Characteristics – Comparison with Predicate Device | |||
|---|---|---|---|
| Characteristic | New Device | Predicate Device | Similar/ Different |
| 510(K) NumberDevice Name, Model | ChattanoogaWireless PRO | K132284Vectra Neo ClinicalTherapy System | Different |
| Manufacturer | DJO, LLC | DJO, LLC | Similar |
| Prescription/OTC | Prescription | Prescription | Similar |
| Where used | Physician office,physical therapyClinic, Hospital,Nursing Home, PostAcute Care,Chiropractic Clinic | Physician office,physical therapyClinic, Hospital,Nursing Home, PostAcute Care,Chiropractic Clinic | Similar |
| Target population | Adult Population | Adult Population | Similar |
| Anatomical library | Yes | Yes | Similar |
| Audio Indicator | Yes | Yes | Similar |
| Connection of device to electrodes | Stimulation Moduleis directly connectedto the custom maleSNAP assembled inthe electrode. UserInterface (LCD andbuttons) is physicallyseparated (Remote | With cablesincluding pins toconnect to electrodespins. There is 1 cableper channel with amaximum of 4channels | Different |
| Characteristic | New Device | Predicate Device | Similar/Different |
| Control) andcommunicateswirelessly with up tofour (4) stimulationmodules.Stimulation safetyremains fullymanaged byStimulation Moduleelectronic circuititself. | |||
| Power Source (s) | Rechargeable battery | 100-240V~, 2.6-1.0A, 47-63Hz | Different |
| Method of Line Current Isolation | NABattery operateddevice | Independenttransformer isolated | Different |
| Electrical Type | NABattery operateddevice | Type BF | Different |
| Patient Leakage Current - NormalCondition (μΑ) | NABattery operateddevice | <100uA patientleakage | Different |
| Patient Leakage Current - SingleFault Condition (μΑ) | NABattery operateddevice | <300uA line leakage | Different |
| Number of Output Modes | Muscle stimulator:Electrodes | Muscle stimulator:ElectrodesUltrasound:applicatorsEMG:electrodesLaser: applicator | Different |
| Number of Output Channels | 4 | 0, 2, or 4 | Similar |
| Synchronous or Alternating | See OutputSpecifications Below | See OutputSpecifications Below | |
| Method of Channel Isolation | Each channel is themiddle of a H Bridge.Except when it isactivated, eachchannel is always inhigh impedance state | Throughtransformers andopto-couplers | Different |
| Regulated Current or RegulatedVoltage (output signals only) | Regulated current onall channels | Configurable foreither constantvoltage or constantcurrent, see OutputSpecifications below. | Similar |
| Software/Firmware/MicroprocessorControl | Yes | Yes | Similar |
| Characteristic | New Device | Predicate Device | Similar/Different |
| Automatic No-Load Trip | Yes | Yes | Similar |
| Automatic Shut Off | Yes, On/off switch | Yes | Similar |
| Patient Override Control | Yes | Yes | Similar |
| Indicator Display | Similar | ||
| - On/Off Status | Yes | Yes | |
| - Low Battery | Yes | No battery | |
| - Voltage/Current level? | Yes, unit [miliAmps] | Yes, unit [mA] | |
| Timer Range (Minutes) | Yes, unit [minutes]Max 30 [minutes] | 0-60 [minutes] | Different |
| Compliance with 21 CFR 898? | Yes21CFR 898-Performance standardfor electrode leadwires and patientcables. | 21CFR 898-Performancestandard forelectrode lead wiresand patient cables. | Similar |
| Weight | Remote: 0.24 lbswith battery | Device: 20.7 lbs | Different |
| Stimulation Module:0.11 lbs per module | Module: 1 lbs | Different | |
| Docking Station: 3lbs | Device + CartAccessory: 48.9 lbs | Different | |
| Dimension (in.) [W x H x D] | Remote: 11 x 7 x 2cm | Device: [15.89 x20.05 x 15.89] | Different |
| Stimulation Module:2x(6 x 2) cm | Module: [11.12 x1.43 x 6.34] | Different | |
| Docking Stationtablet: 14x27x3 [cm] | Device + Cart:[23.94 x 52.85 x26.19] | Different | |
| OUTPUT SPECIFICATIONS | |||
| VMS Symmetrical Biphasic Waveform | |||
| Shape | Rectangular | Rectangular | Similar |
| Maximum Output Voltage (± 10%) | 60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ | 57 V @ 500 Ω200 V @ 2 kΩ100V @ 10 kΩ(open lead detectedabove 10[mA]) | Different |
| Maximum Output Current (± 10%) | 120 mA @ 500 Ω90 mA @ 2 kΩ18 mA @ 10 kΩ | 114 mA @ 500 Ω100 mA @ 2 kΩ10 mA @ 10 kΩ(open lead detectedabove 10[mA]) | Different |
| Pulse Width | 300 to 400 [μs](microseconds) | 20 to 400 [μs](microseconds) | Different |
| Frequency | 1 to 100 Hz | 1 - 200 [Hz] | Different |
| Net Charge [μC/pulse] | 0 [μC] @ 500ΩExcitation pulse fullycompensated | 0 [μC] @ 500Ω | Similar |
| Characteristic | New Device | Predicate Device | Similar/Different |
| Maximum Phase Charge [µC] | 48 [µC] @ 500Ω | 45.6 [µC] @ 500Ω | Different |
| Maximum Current (RMS) Density(mA/cm2) | 2.1mA/cm2 | 2.4 mA/cm2 | Different |
| Maximum Power Density[mW/cm²] | 36 [mW/cm²] @ 500Ω | 55 [mW/cm²] @ 500Ω | Different |
| ON Time (seconds) | 1 - 10 [sec] | 1 - 60 [sec] | Different |
| OFF Time (seconds) | 3 - 50 [sec] | 1 - 60 [sec] | Different |
| Additional Features (if applicable) | 100 [µs](microseconds) | 100 [µs](microseconds) | Similar |
| VMS-FR Waveform | |||
| Shape | Rectangular | Rectangular | Similar |
| Maximum Output Voltage (± 10%) | 60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ | 57 V @ 500 Ω200 V @ 2 kΩ100V @ 10 kΩ(open lead detected above 10[mA]) | Different |
| Maximum Output Current (± 10%) | 120 mA @ 500 Ω90 mA @ 2 kΩ18 mA @ 10 kΩ | 114 mA @ 500 Ω100 mA @ 2 kΩ10 mA @ 10 kΩ(open lead detected above 10[mA]) | Different |
| Pulse Width | 200 to 300 [µs](microseconds) | 20 to 400 [µs](microseconds) | Different |
| Frequency | 35 - 80 Hz | 20 - 80 [Hz] | Different |
| Net Charge [µC/pulse] | 0 [µC] @ 500ΩExcitation pulse fullycompensated | 0 [µC] @ 500Ω | Similar |
| Maximum Phase Charge [µC] | 36 [µC] @ 500Ω | 45.6 [µC] @ 500Ω | Different |
| Maximum Current (RMS) Density(mA/cm2) | 1.34mA/cm2 | 1.52 mA/cm2 | Different |
| Maximum Power Density[mW/cm²] | 14.4 [mW/cm²] @ 500Ω | 22 [mW/cm²] @ 500Ω | Different |
| Burst Mode (i.e. pulse trains) | N/A, no burst modea) Pulses per burstb) Bursts per secondc) Burst duration (seconds)d) Duty Cycle[Line (b) x Line (c)] | VMS burst | Different |
| ON Time (seconds) | 1 - 10 [sec] | 1 - 60 [sec] | Different |
| OFF Time (seconds) | 3 - 50 [sec] | 1 - 60 [sec] | Different |
| Additional Features (if applicable) | 100 [µs](microseconds) | 100 [µs](microseconds) | Similar |
| Interphase interval | (microseconds) | (microseconds) |
Rasic Device Characteristics - Comparison with Predicate Device
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Performance Testing:
Electrical Safety and Electromagnetic Compatibility: The Chattanooga® Revolution Wireless was tested and found to comply with recognized standards for electrical safety and electromagnetic compatibility.
FCC Radio Frequency Testing: The Chattanooga® Revolution Wireless was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249.
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.
Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.
Wireless Coexistence Testing: The performance of Chattanooga® Revolution Wireless was evaluated in an environment with other Chattanooga® Revolution Wireless device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.
Standards:
| RecognitionNo. | Standard | Description |
|---|---|---|
| 19-4 | AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 AndA2:2010/(R)2012 (ConsolidatedText) | Medical Electrical Equipment - Part1: General Requirements for BasicSafety and Essential Performance(IEC 60601-1, Mod.) |
| 19-1 | IEC 60601-1-2 Edition 3:2007-03 | Medical Electrical Equipment - Part1-2: General Requirements for BasicSafety and Essential Performance –Collateral Standard: ElectromagneticCompatibility – Requirements andTests |
| 17-11 | IEC 60601-2-10 Edition 2.0 2012-06 | Medical Electrical Equipment -- Part2-10: Particular Requirements forthe Basic Safety and EssentialPerformance of Nerve and MuscleStimulators |
| 5-85 | IEC 60601-1-6 Edition 3.0 2010-01 | Medical Electrical Equipment - Part |
The Chattanooga Revolution Wireless conforms to the following standards.
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| 1-6: General Requirements for BasicSafety and Essential Performance –Collateral Standard: Usability | ||
|---|---|---|
| N/A* | IEC 62366:2007, Ed. 1* Ed. 1 was used because it is citedin IEC 60601-1-6 Ed. 3.0. | Medical Devices - Application ofUsability Engineering to MedicalDevices |
| 13-8 | IEC 62304 First Edition 2006-05 | Medical Device Software - SoftwareLife Cycle Processes |
| 5-40 | ISO 14971:2007 | Medical Devices - Application ofRisk Management to MedicalDevices |
Conclusion:
Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Chattanooga Revolution Wireless is as safe and effective as, and substantially equivalent 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).