(23 days)
Not Found
No
The description focuses solely on the physical and electrical properties of a disposable electrode for electrical muscle stimulation. There is no mention of any computational or algorithmic components, let alone AI/ML.
No.
The device (Motive™ Electrode) is described as a conductive and adhesive interface between the user's skin and an electrical muscle stimulator, and its intended use is to deliver electrical stimulation therapy when connected to a muscle stimulator. However, the electrode itself does not provide the therapeutic effect; it only facilitates the delivery of stimulation from an external muscle stimulator, which is the therapeutic device.
No
The device is described as an "interface" between the user's skin and an "electrical muscle stimulator" for "electrical stimulation therapy." It delivers electrical impulses to muscles, indicating a therapeutic rather than diagnostic function.
No
The device description clearly details physical components like gel pads, a PET sheet, silver ink traces, and a magnetic connector housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a conductive interface between the user's skin and an electrical muscle stimulator for electrical muscle stimulation therapy. This is a direct interaction with the body for therapeutic purposes, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical interface (electrodes) for delivering electrical impulses to muscles. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely electrical stimulation through the skin.
- Performance Studies: The performance studies focus on electrical, mechanical, and biocompatibility testing related to skin contact and electrical conductivity, not on the accuracy or reliability of diagnostic information derived from biological samples.
Therefore, the Motive Electrode falls under the category of a medical device used for therapy (electrical muscle stimulation), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated.
The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads.
The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thigh covering the quadriceps muscles
Indicated Patient Age Range
adults of 22 years of age and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification of the Motive Electrode include electrical and mechanical tests to show that it meets its target specifications over a range of operating and storage conditions. Verification and performance testing further demonstrate that it meets user needs as reflected in the functional specification.
To demonstrate the safety, the Motive device was tested per the following standards:
- ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
A biocompatibility test was conducted on the patient contacting materials per the following standards. The test results were acceptable, and the materials were considered biocompatible.
- ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices- Part 10: Tests for skin irritation and sensitization
Accelerated aging shelf-life testing was performed to ensure that the Motive Electrode performs as intended over the course of its labeled shelf-life.
The electrical tests demonstrated the electrodes impedance measurements were acceptable and electrodes performed effectively and safely in delivering transmitting electrical stimulation to the user's tissue. The electrical tests also demonstrated that the Motive Electrode's Maximum Current Density and Maximum Average Power Density were acceptable and similar to the predicate device, ASCEND Electrode.
Mechanical testing demonstrated that the electrodes maintained the mechanical integrity for different lavers and components of the electrode sheet.
Visual evaluation demonstrated that the Motive Electrodes were intact and interfaced with the muscle stimulator.
Verification and performance testing further demonstrate that the Motive Electrodes meet user's needs as reflected in the product specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 22, 2023
CyMedica Orthopedics, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K230533
Trade/Device Name: Motive™ Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 27, 2023 Received: February 27, 2023
Dear Prithul Bom:
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.
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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 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-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 Advice (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.
Tushar Bansal -S
for Heather Dean, Ph.D 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230533
Device Name Motive(TM) Electrode
Indications for Use (Describe)
The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator.
Motive Electrode is intended for adults of 22 years of age and older.
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 Motive™ Electrode CyMedica Orthopedics, Inc.
1 Regulatory Information
| 1.1 Trade/Proprietary Name: | Motive™ Electrode | |
|---|---|---|
| 1.2 Common Name: | Electrode, Cutaneous | |
| 1.3 Regulation Names & Numbers: | Cutaneous Electrode, 21 CFR 882.1320 | |
| Product Codes: | ||
| Code- GXY; Electrode, Cutaneous | ||
| 1.4 Classification: | Class II | |
| 1.5 Manufacturer Name: | CyMedica Orthopedics, Inc. | |
| 2120 East 6t Street, Suite 8 | ||
| Tempe, AZ 85288 | ||
| Telephone (480) 664-1282 | ||
| FAX (866) 296-2772 |
1.6 Predicate Device Information:
Trade name - ASCEND Electrode, NeuroMetrix, Inc. Common name - Electrode, Cutaneous Code - GXY; Electrode, Cutaneous Classification name - Cutaneous Electrode, 21 CFR 882.1320 510(k) Number – K140586
These devices are reviewed by the Neuromodulation and Physical Medicine Devices (DHT5B).
Submission Information 2
Submission Number:
Date:
Contact:
February 15, 2023
Kereshmeh Shahriari 2120 East 6th Street, Suite 8 Tempe, AZ 85288 kereshmeh@cymedicaortho.com
4
Telephone (480) 664-1282 FAX (866) 296-2772
3 Intended Use/Indications for Use
The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.
4 Device Description
The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated.
The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads.
The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.
Summary of Non-Clinical/ Bench Studies 5
Verification of the Motive Electrode include electrical and mechanical tests to show that it meets its target specifications over a range of operating and storage conditions. Verification and performance testing further demonstrate that it meets user needs as reflected in the functional specification.
To demonstrate the safety, the Motive device was tested per the following standards:
- ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices- Part 10: Tests for ● irritation and skin sensitization
6 Biocompatibility Testing
The patient contacting materials in the Motive™ Electrode include a conductive hydrogel used in the form of gel pads. The hydrogel is placed on a Polyethylene Terephthalate (PET) backing liner. PET is a known biocompatible material. The hydrogel is medical grade, self-adhering, and biocompatible. The gel pads (hydrogel) are skin contacting. A biocompatibility test was conducted on the patient contacting materials per the following standards. The test results were acceptable, and the materials were considered biocompatible.
- ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro .
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cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices- Part 10: Tests for skin irritation and sensitization
7 Shelf-Life
The Motive Electrode has a 6-month shelf life. Accelerated aging shelf-life testing was performed to ensure that the Motive Electrode performs as intended over the course of its labeled shelf-life.
8 Summary of Non-Clinical/ Bench Studies
Verification of the Motive Electrode included electrical and mechanical tests. The electrical tests demonstrated the electrodes impedance measurements were acceptable and electrodes performed effectively and safely in delivering transmitting electrical stimulation to the user's tissue. The electrical tests also demonstrated that the Motive Electrode's Maximum Current Density and Maximum Average Power Density were acceptable and similar to the predicate device, ASCEND Electrode.
Mechanical testing demonstrated that the electrodes maintained the mechanical integrity for different lavers and components of the electrode sheet.
Visual evaluation demonstrated that the Motive Electrodes were intact and interfaced with the muscle stimulator.
Verification and performance testing further demonstrate that the Motive Electrodes meet user's needs as reflected in the product specification.
9 Comparison of Technological Characteristics with the Predicate Device
The predicate device for Motive Electrode is ASCEND Electrode manufactured by NeuroMetrix, Inc., 510(k) NUMBER K140586. The Motive Electrode and ASCEND Electrode have the same intended use. Both are intended as disposable. single-patient for multiple application use electrodes with an adhesive conductive hydrogel interface to deliver treatment from an electrical stimulator to the User's skin. Both are multi-layer electrode sheet designs housing multiple individual electrodes in a pre-defined geometry. Both are substantially equivalent in composition and material, consisting of flex silver pads or traces printed onto a plastic film base sheet.
The primary difference between the two devices is that the Motive Electrode consists of three electrodes compared to the ASCEND Electrode's four electrodes. The shape and surface area of the Motive Electrodes are within range of the predicate ASCEND Electrodes. The individual predicate ASCEND Electrodes contain a smaller surface area (36 by 46 mm, surface area of 1656 mm²). In contrast, the smallest Motive Electrode contains a larger surface area (50.8 mm diameter circle, surface area of 2026 mm²).
Table 1 compares design details of the Motive Electrode to the predicate ASCEND Electrode:
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Table 1: Motive Electrode and predicate ASCEND Electrode comparison
| | Subject Device
Motive Electrode
CyMedica Orthopedics,
Inc.
510(k), K230533 | Predicate Device
ASCEND Electrode,
NeuroMetrix, Inc.
510(k), K140586 | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Intended Use | The Motive™ Electrode is
intended for use as a
disposable, conductive, and
adhesive interface between the
user's skin and an electrical
muscle stimulator. | The ASCEND Electrode is
intended for use as disposable,
conductive, adhesive interface
between the user's skin and a
transcutaneous electrical nerve
stimulator. | N/A |
| Number of
Electrodes | 3, two rectangular and one
circular | Not publicly available | Any differences do not raise
any issue in equivalency of
both as it relates to safety or
efficacy. |
| Sterile | Non-sterile | Non-sterile | N/A |
| Single-Patient
Use | Yes | Yes | N/A |
| Number of
applications | Multiple | Not publicly available | N/A |
| Shelf life | 6 months | Not publicly available | N/A |
| Technical Characteristics | | | |
| Substrate | Polyethylene terephthalate
(PET) film | Not publicly available | N/A |
| Conductor | Conductive silver ink traces | Not publicly available | N/A |
| Conductive
interface | Medical grade conductive
hydrogel | Not publicly available | N/A |
| Connector | Pogo pin connector array | Not publicly available | Any differences do not raise
any issue in equivalency of
both as it relates to safety or
efficacy. |
| Overall
Dimensions | 15.6 x 21.8 cm, total area 211
cm², includes three electrodes | Not publicly available | Any differences do not raise
any issue in equivalency of
both as it relates to safety or
efficacy. |
| Conductive
Surface
Dimensions | Two rectangular pads 5.1 x
10.2 cm and one circular pad
5.1 cm diameter, total area
124.5 cm² | Not publicly available | Any differences do not raise
any issue in equivalency of
both as it relates to safety or
efficacy. |
10 Conclusion
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the Motive Electrode is as safe, as effective, and performs as well as the predicate device.