Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode

K222528 · Well-Life Healthcare Limited · KPI · Dec 29, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222528
• Device Name: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
• Applicant: Well-Life Healthcare Limited
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. Electromyographic (EMG) sensing of the pelvic floor muscles.

Device Story

Well-Life Probe Electrode (Model: SA) consists of vaginal and rectal probes used for pelvic floor muscle rehabilitation. Probes are lightweight cylinders with stainless steel conductive rings/plates; designed for single-patient, repeated intermittent use (up to 300 sessions). Device acts as a passive interface; it does not generate or control electrical power. It connects to an external electrical stimulator to deliver stimulation or capture EMG signals. Used in home or clinical settings by patients or clinicians. Output is electrical stimulation to muscles or EMG feedback to the user/clinician to guide rehabilitation. Benefits include improved neuromuscular control and treatment of urinary incontinence.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993-1, -5, -10, -12), accelerated aging (ASTM F1980-16), tensile strength (ANSI AAMI EC53), and electrical safety/performance (ANSI AAMI NS4, IEC 60601-1).

Technological Characteristics

Passive electrode probe; stainless steel electrodes; ABS and PVC housing. Dimensions vary by model. Connectivity: wired connection to external stimulator. No internal energy source. Reusable; cleaned with soap and water. Standards: ISO 10993 (biocompatibility), ANSI AAMI NS4 (stimulators), ASTM F1980 (aging), IEC 60601-1 (safety), ANSI AAMI EC53 (cables).

Indications for Use

Indicated for patients requiring pelvic floor muscle rehabilitation or neuromuscular control restoration for the treatment of urinary incontinence. Includes vaginal and rectal probe use for pelvic musculature electromyographic feedback or electrical stimulation.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Predicate Devices

• LIFE-CARE VAGINAL PROBE, LIFE-CARE ANAL PROBE (K122194)

Reference Devices

• TensCare Ltd. Perfect PFE (K191312)

Submission Summary (Full Text)

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December 29, 2022

Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No. 168. de St., Jhonghe District New Taipei City, 235 Taiwan

Re: K222528

> Trade/Device Name: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HIR Dated: November 17, 2022 Received: November 30, 2022

Dear Jenny Hsieh:

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.

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica K. Nguyen -S

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K222528

#### Device Name

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)

Indications for Use (Describe)

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include

Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483,

SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Type of Use (Select one or both, as applicable)

X 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

| Type of Submission: | Traditional |
|----------------------|---------------------------------------------------------------------------|
| Preparation date: | 12/28/2022 |
| Submitter: | Well-Life Healthcare Ltd. |
| Address: | 6F. No.168, Lide St., Jhonghe District, New Taipei<br>City, 23512, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Jenny Hsieh<br>([e-mail]) |
| Registration number: | 3006850006 |

# 4. Identification of the device:

| 510(K) No | K222528 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Well-Life Probe Electrode for Stimulation/EMG<br>Probe (Model: SA) |
| Common or usual name: | Incontinence Stimulation/EMG Electrode<br>Probe |
| Model: | Vaginal Probe:<br>SA-2876, SA-25145, SA-20100, SA-3478, SA-<br>2687<br>Rectal Probe:<br>SA-1483, SA-19108, SA-1563, SA- 2486 |
| Classification name: | Nonimplanted Electrical Continence Device |
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI & HIR |

# 5. Identification of the Predicate and Reference Devices:

| Predicate Device: | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) No | K122194 |
| Predicate Device Name: | LIFE-CARE VAGINAL PROBE, LIFE-CARE<br>ANAL PROBE. The predicate has not been subject<br>to a design-related recall. |
| Model: | Everyway Incontinence Stimulation Electrode,<br>model PR-02/02A, PR-03/03/A, PR-04/04A, PR-<br>10A, PR-11A, PR-14A, for Life-Care Vaginal<br>Probe & PR-06/06A, PR-12A, PR-13/13A for Life-<br>Care Anal Probe. |

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| Classification name: | Nonimplanted Electrical Continence Device |
|------------------------|-------------------------------------------|
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI & HIR |

| Reference Device: | |
|------------------------|-----------------------------------------------------------------------------------------------|
| 510(K) No | K191312 |
| Reference Device Name: | TensCare Ltd. Perfect PFE |
| Model: | Vaginal Probe:<br>Liberty Loop Vaginal Probe (X-VPL)<br>Electrical Stimulator:<br>Perfect PFE |
| Classification name: | Nonimplanted Electrical Continence Device |
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI |

#### 6. Intended Use and Indications for use of the Subject Device:

## Intended Use

Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. Electromyographic (EMG) sensing of the pelvic floor muscles.

#### Indications for use

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

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#### 7. Description of the Device:

Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.

Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).

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| Elements of<br>Comparison | Subject Device | Predicate Device | Reference Device | Remark |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510K number | K222528 | K122194 | K191312 | ------ |
| Device Name | Well-Life Probe<br>Electrode for<br>Stimulation/EMG<br>Probe Model: SA<br>Vaginal Probe:<br>SA-2876, SA-25145,<br>SA-20100, SA-3478, SA-<br>2687<br>Rectal Probe (Rectal<br>Probe):<br>SA-1483, SA-<br>19108, SA-1563,<br>SA-2486 | Vaginal Probe:<br>PR-02/ PR-02A, PR-03/<br>PR-03A, PR-04/ PR-<br>04A.<br>PR-10A, PR-11A, PR-<br>14A<br>Anal Probe:<br>PR-06/06A, PR-12A,<br>PR-13/13A | Vaginal Probe:<br>Liberty Loop Vaginal<br>Probe (X-VPL)<br>Electrical Stimulator:<br>Perfect PFE | |
| Product Code | KPI & HIR | KPI & HIR | KPI | Same as Predicate |
| Prescriptive or<br>Over-the-<br>Counter (OTC) | OTC and RX | RX | OTC and RX | Instructions are<br>equivalent to<br>K191212 and<br>include information<br>for suitable<br>stimulator<br>selection |
| Regulation No | 21 CFR Part 876.5320 | 21 CFR Part 876.5320 | 21 CFR Part 876.5320 | Same as Predicate |
| Indications<br>for Use | Well-Life Probe<br>Electrode for<br>Stimulation/EMG Probe<br>(Model: SA) include<br>Vaginal Probe SA-2876,<br>SA-25145, SA-20100,<br>SA-3478, SA-2687 &<br>Rectal Probe SA-1483,<br>SA-19108, SA-1563,<br>SA-2486 are intended to<br>provide<br>electromyographic<br>feedback from pelvic<br>musculature or electrical<br>stimulation to pelvic<br>musculature for the<br>purpose of rehabilitation<br>of week pelvic floor<br>muscles and restoration<br>of neuromuscular<br>control during the<br>treatment of urinary<br>incontinence. | The everyway<br>incontinence stimulation<br>electrode, model pr-<br>02/02a, pr-03/03a, pr-<br>04/04a, pr-10a, pr-11a, pr-<br>14a for life-care vaginal<br>probe & pr-06/06a, pr-<br>12a, pr-13/13a for life-<br>care anal probe are<br>intended to provide<br>electromyographic<br>feedback from pelvic<br>musculature or electrical<br>stimulation to pelvic<br>musculature for the<br>purpose of rehabilitation<br>of weak pelvic floor<br>muscles and restoration of<br>neuromuscular control<br>during the treatment of<br>urinary incontinence. | Perfect PFE is intended<br>to provide electrical<br>stimulation and<br>neuromuscular re-<br>education for the purpose<br>of rehabilitation of weak<br>pelvic floor muscles for<br>the treatment of stress,<br>urge and mixed urinary<br>incontinence in women<br>and to maintain urinary<br>continence in women. | Same as Predicate |
| Intended Use | Electrical stimulation of<br>the pelvic floor muscles<br>for the treatment of<br>urinary incontinence.<br>EMG sensing of the<br>pelvic floor<br>muscles. | Electrical stimulation of<br>the pelvic floor muscles<br>for the treatment of<br>urinary incontinence.<br>EMG sensing of the<br>pelvic floor muscles. | Perfect PFE is intended<br>to provide electrical<br>stimulation and<br>neuromuscular<br>reeducation for the<br>purpose of rehabilitation<br>of weak pelvic floor<br>muscles for the treatment<br>of stress, urge and mixed<br>urinary incontinence in<br>women and to maintain<br>urinary continence in<br>women. | Same as Predicate |
| Contact<br>Duration | Intermittent mucosal<br>contact<30 min/ session-<br>Stim<1 hour/session-<br>EMG not exceeding 1hr<br>combined | Intermittent mucosal<br>contact<30 min/ session-<br>Stim<1 hour/session-<br>EMG not exceeding 1hr<br>combined | Unknown | Same as Predicate |
| Product Type | Probe only | Probe only | Probe + Electrical<br>Stimulator | Same as Predicate |
| Electrode<br>Placement | Vaginal<br>Rectal<br>(Anal) | Vaginal<br>Anal | Vaginal | Same as Predicate |
| Usage<br>Conditions | Reusable-Single Patient | Reusable-Single Patient | Reusable-Single Patient | Same |
| Electrode<br>Material | Stainless steel | Stainless steel | Stainless Steel | Same |
| Frequency<br>(Hz) | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 50Hz | No energy transmission | Max: 50Hz | Equivalent to<br>Predicate |
| Pulse Width | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 300 us | No energy transmission | Max: 300us | Equivalent to<br>Predicate |
| Maximum<br>Output<br>Voltage (V) | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 45V 500Ω | No energy transmission | 45V @500Ω | Equivalent to<br>Predicate |
| Maximum<br>Output<br>Current (A) | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 90mA<br>@500Ω | No energy transmission | 90mA @500Ω | Equivalent to<br>Predicate |
| Max R.M.S<br>Power<br>Density (W-<br>r.m.s/cm²) | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 0.25 W/cm²<br>@500Ω | No energy transmission | 0.014 W /cm² @500Ω | Equivalent to<br>Predicate |
| Max R.M.S<br>Current<br>Density (mA-<br>r.m.s/cm²) | No energy transmission<br>However, the<br>specifications of the<br>matched Electrical<br>stimulator must be<br>smaller than 2 mA /cm²<br>@500Ω | No energy transmission | 0.318 mA/cm² @500Ω | Equivalent to<br>Predicate |
| Electrode<br>Area (Single-<br>Electrode) | Vaginal<br>SA-2876: 7.62 cm²<br>SA-25145: 7.87 cm²<br>SA-20100: 6.25 cm²<br>SA-3478: 4.25 cm²<br>SA-2687: 6.12 cm²<br>Rectal<br>SA-1483: 1.93 cm²<br>SA-19108: 3.77 cm²<br>SA-1563: 2.17 cm²<br>SA-2486 2.85 cm² | Vaginal<br>PR-02A: 7.65 cm²<br>PR-03A: 7.87 cm²<br>PR-04A: 6.25 cm²<br>PR-10A: 6.25 cm²<br>PR-11A: 6.25 cm²<br>PR-14A: 6.00 cm²<br>Anal<br>PR-06A: 1.93 cm²<br>PR-12A: 2.26 cm²<br>PR-13A: 3.77 cm² | Liberty Loop Vaginal<br>Probe (X-VPL): 4.24cm² | Similar/Equivalent |

# 8. Comparison of Technological Characteristics

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# 9. Statement of conformity

List of FDA-recognized voluntary consensus standards cited in this submission.

| Recognition<br>Number | Standard Designation<br>Number and Date | Title Of Standard | Date Of<br>Recognition |
|-----------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------|
| 2-258 | ISO 10993-1<br>Fifth Edition 2018-08 | Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk<br>management process | 01/14/2019 |
| 2-245 | ISO 10993-5<br>Third Edition 2009-06-<br>01 | Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | 02/23/2016 |
| 2-296 | ISO 10993-10 Fourth<br>edition 2021-11 | Biological evaluation of medical devices -<br>Part 10: Tests for skin sensitization | 05/30/2022 |
| 2-291 | ISO 10993-23 First<br>edition 2021-01 | Biological evaluation of medical devices<br>- Part 23: Tests for irritation | 06/07/2021 |
| 17-14 | ANSI AAMI<br>NS4:2013(R)2017 | Transcutaneous Electrical Nerve<br>Stimulators 2013(R)2017 | 01/14/2019 |
| 14-497 | ASTM F1980-16 | Standard Guide for Accelerated Aging of<br>Sterile Barrier Systems for Medical<br>Devices | 12/23/2016 |
| 5-114 | IEC 62366-1<br>Edition 1.0 2015-02 | Medical devices - Part 1: Application of<br>usability engineering to medical devices | 12/23/2016 |
| 19-4 | IEC 60601-1:2005,<br>MOD | Medical electrical equipment- Part 1:<br>General requirements for basic safety and<br>essential performance | 07/09/2014 |
| 3-129 | ANSI AAMI<br>EC53:2013/(R)2020 | ECG trunk cables and patient leadwires | 06/07/2021 |

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## 10. Non-Clinical Testing Summary:

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

- 1) Biocompatibility Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5 Third Edition 2009-06-01), sensitization (ISO 10993-10 Fourth edition 2021-11), irritation (ISO 10993-10 Fourth edition 2021-11) and Sample preparation and reference materials (ISO 10993-12 Fourth Edition 2012-07-01).
- 2) Recommendations and requirements outlined in the FDA guidance "Design Considerations for Devices Intended for Home Use," 21 CFR Part 801, and 21 CFR Part 809.10 were followed. A comparison to the instructions of the reference device which have been validated for OTC use were conducted to support OTC instructions in the labeling. Based on the similarity of the Well-Life Probe Electrode to the predicate and reference devices with respect to design, indications for use, cleaning instructions, and labeling materials, additional usability testing was determined not to be necessary.
- 3) Recommendations and requirements outlined in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed for reprocessing and cleaning instructions in the labeling.
- 4) Performance Bench Testing was performed to verify the performance to specifications of the proposed device and included the following:
- Performance Bench testing was performed to verify the performance to specifications with ANSI AAMI NS4:2013(R)2017.
- ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" was followed for accelerated aging of the subject device. After accelerated aging, functional performance testing was conducted on aged samples to support the proposed shelf life of 2 years.
- Testing was performed to verify the performance to specifications of the proposed device to subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD to comply with 21 CFR 898. Electromagnetic Compatibility (EMC) and Electrical Safety Testing beyond subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD was not determined to be necessary because the subject device is an individual component of an electrical system that does not generate or control electrical power, similar to the predicate device.
- Performance Testing Bench- Tensile strength of cable connection test per ANSI AAMI EC53:2013/(R)2020 related test methods for lead wire strength of cable connection test to ensure the safety of related electrical connection of products.

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# 11. Conclusion:

After comparison and evaluation, the subject device "Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)" has many of the features and technological characteristics of the predicate device, and performance testing supports that any differences do not impact safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.