(29 days)
The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).
Indications for Use:
- As an NMES device, indications are for the following conditions:
- Relaxation of muscle spasms
- Retardation or prevention of disuse atrophy
- Increasing local blood circulation
- Re-educating muscles
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
The CyMedica e-vive™ System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The e-vive™ system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.
The e-vive device is equipped with a goniometer (Class I, 510(k) Exempt), which is intended to measure and record joint range of motion.
e-vive™ electrical stimulation technology is based on the electrical stimulation technology developed for CyMedica QB1™ system. K150413. The e-vive™ electrotherapy programs are delivered to the patient directly by a User Interface controller integrated in a conductive garment. The stimulation programs are managed wirelessly using a mobile application developed for use on smart phones or tablets that interact with the User Interface controller.
The e-vive™ system are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.
In NMES mode, the e-vive™ system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The evive™ NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.
In NMES mode, the e-vive™ system consists of a knee conductive garment with an incorporated Controller, docking receptacle, range of motion sensor, three electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.
As a TENS device, the e-vive TENS treatment is a safe and effective method of providing a drug-free method of pain relief. Patients with recurring pain, can utilize the e-vive TENS treatment program for immediate and long-term pain relief.
The e-vive™ TENS system consists of a conductive garment with an incorporated Controller. docking receptacle, two electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.
The e-vive electrogoniometer (battery powered goniometer) is capable of measuring and recording the joint range of motion by using two sensors to detect the knee range of motion. One sensor is located on the Controller board and the second sensor is located within the sensor pod, on a small electronic board. The sensor pod is contained within the conductive garment below the knee area opening. The sensor pod is connected wirelessly to the Controller using a BLE connection. The sensor data from the sensor pod and the Controller sensor is conveyed to the mobile device real time. The sensors can detect the knee extension/flexion angles, and associated range of motion angle through the use of the e-vive mobile app when initiated by the patient or healthcare provider.
The e-vive™ System incorporates a Bluetooth Low Energy, BLE 4.1 connection module to enable wireless communication and can be paired with a Bluetooth enabled mobile device running the e-vive™ App, available from the App stores. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.
The Controller is connected to the conductive garment via a 16-pin interface. The Controller contains the primary safety controls for operation of the device and a push button is available for switching the unit on or off. The power button remains active and can be used in the event of loss of Bluetooth connection to power on/off the device or start/stop stimulation while performing stimulation sessions. The e-vive™ system contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and Bluetooth™ activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
The document provided is a 510(k) Summary for the CyMedica e-vive™ System, which focuses on demonstrating substantial equivalence to a predicate device (QB1 NMES & TENS System K150413) rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding a study design (sample size, expert qualifications, adjudication, MRMC study, standalone performance) is not available in these documents.
However, the document does list various non-clinical performance data and standards compliance to demonstrate safety and effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document implicitly uses compliance with recognized standards and substantial equivalence to a predicate device as its acceptance criteria. No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided for efficacy, as this is a non-clinical submission.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 | Complies (Tested) |
| Compliance with IEC 60601-2-10:2012 | Complies (Tested) | |
| Compliance with IEC 60601-1-11:2015 | Complies (Tested) | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014, 4th Edition | Complies (Tested) |
| Compliance with BLE module wireless standards (FCC 47CFR PT 15-C, RSS 210, ICES 003, ETSI EN 300 328, ETSI EN 301 489-1, ETSI EN 301 489-17) | Met all specified requirements (Certified by supplier) | |
| Software | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) | Validated, meets design requirements |
| Compliance with IEC 62304:2006 | Validated | |
| Usability/Human Factors | Compliance with IEC 60601-1-6:2010 | Complies (Tested), results support instructions |
| Compliance with IEC 62366:2007 | Complies (Tested), results substantiate risk acceptability | |
| Biocompatibility | Compliance with ISO 10993-1:2009 | Tested |
| Compliance with ISO 10993-5:2009 | Tested | |
| Compliance with ISO 10993-10:2010 | Tested | |
| Risk Management | Compliance with ISO 14971:2007 | Tested |
| Battery Safety | Compliance with IEC 62133:2012 | Complies (Tested) |
| Functional Equivalence | Substantial equivalence to predicate device (QB1 System, K150413) in intended use, design, materials, and functional characteristics for NMES and TENS. | Demonstrated through comparison of technical characteristics and compliance with guidance document (FDA Final Guidance Document for Powered Muscle Stimulator 510(k), June 9, 1999). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes non-clinical bench testing and compliance with standards, not a clinical study with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as this was a non-clinical submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this was a non-clinical submission.
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:
- No, an MRMC study was not done. This device is an electrotherapy device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that the device's electrical stimulation output parameters were tested independently to ensure they fall within safe and effective ranges as per relevant standards (IEC 60601-2-10). The goniometer's accuracy in measuring range of motion was also assessed independently. This could be considered standalone performance for the specific functions of stimulation delivery and goniometry.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the electrical safety and performance parameters, the "ground truth" was defined by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC, ETSI) and an FDA guidance document for powered muscle stimulators.
- For the goniometer, the ground truth would be accepted methods of measuring flexion/extension angles.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a training set in the traditional sense. The software validation involved testing against design requirements.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).