MiniStim MS-IVB Peripheral Nerve Stimulator

K143095 · Halyard Health, Inc. · BXN · Mar 24, 2015 · Anesthesiology

Device Facts

• Record ID: K143095
• Device Name: MiniStim MS-IVB Peripheral Nerve Stimulator
• Applicant: Halyard Health, Inc.
• Product Code: BXN · Anesthesiology
• Decision Date: Mar 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

The Ministim MS-IVB is a battery-powered peripheral nerve stimulator for monitoring the effects of skeletal muscle relaxants.

Device Story

MiniStim MS-IVB is a handheld, battery-powered peripheral nerve stimulator used by anesthesiologists or nurse anesthetists in clinical settings. It delivers electrical stimulus pulses to monitor the depth of neuromuscular blockade during surgery. The device features selectable stimulus modes: Twitch, Tetanus (50Hz/100Hz), Train of Four, and Double Burst. It uses a Texas Instruments MSP430G2553IPW20 processor to control pulse timing and duration. The clinician observes the patient's muscle twitch response to determine the effectiveness of muscle-relaxant drugs. The device includes safety features such as automatic shut-off timers for pulse delivery and idle time. Output amplitude is adjustable. The device provides visual feedback via LED. It is designed to be immune to Bovie interference. By monitoring the twitch amplitude, the clinician can assess the level of muscle relaxation, helping to manage anesthesia levels and improve patient safety during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including IEC 60601 safety testing (electrostatic discharge, radiated/conducted/magnetic field immunity), software verification, user interface/functionality testing, and waveform verification.

Technological Characteristics

Handheld, battery-powered (9V alkaline) peripheral nerve stimulator. Dimensions: 2.4" W x 4.2" L x 1" H. Weight: 6 oz. Output: 0-50mA at 9.2V. Processor: Texas Instruments MSP430G2553IPW20. Stimulus modes: Twitch, Tetanus, Train of Four, Double Burst. Pulse width: 0.22ms. Rise time: <10µs. Connectivity: None. Software: Version 01.02.02.00. Sterilization: Not sterile.

Indications for Use

Indicated for monitoring the effects of skeletal muscle relaxants in patients undergoing procedures requiring general anesthesia.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

Predicate Devices

• MS-III MiniStim Peripheral Nerve Stimulator (K913184)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2015

Halyard Health, Inc. (Formerly Kimberly-Clark Healthcare) Lindsey Hedlund, MBA Regulatory Affairs Coordinator 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re: K143095

> Trade/Device Name: Ministim* Peripheral Nerve Stimulator Model MS-IVB Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: BXN Dated: December 19, 2014 Received: December 24, 2014

Dear Ms. Hedlund.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K143095

Device Name

MiniStim Peripheral Nerve Stimulator - Model MS-IVB

Indications for Use (Describe)

The Ministim MS-IVB is a battery-powered peripheral nerve stimulator for monitoring the effects of skeletal muscle relaxants.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## Section 8.0 – 510(k) Summary

| | The 510(k) Summary is being submitted in accordance with the requirements<br>of 21 CFR 807.92. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 20, 2015 |
| Applicant | Halyard Health (formerly Kimberly-Clark Health Care)<br>5405 Windward Parkway<br>Alpharetta, GA 30004 |
| Official<br>Correspondent | Lindsey Hedlund, MBA<br>Regulatory Affairs Coordinator<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | MiniStim* Peripheral Nerve Stimulator – Model MS-IVB |
| Classification<br>Name | Stimulator, nerve, battery-powered |
| Device<br>Classification<br>and Product<br>Code | Class II per 21 CFR §868.2775<br>Product Code - BXN |
| Predicate<br>Devices | The MS-III MiniStim* Peripheral Nerve Stimulator was cleared by K913184,<br>under the Life-Tech, Inc. applicant. Ownership of the 510(k) was transferred<br>to Kimberly-Clark in 2013. |

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### Section 8.0 - 510(k) Summary, Continued

Device The MS-IVB is a nerve stimulator with selectable stimulus output waveforms Description and adjustable output amplitude. The stimulus output is intended for monitoring the depth of patient muscle and nerve relaxation while

| Characteristic | MS-IVB |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|
| Power Source | 9V Alkaline Battery |
| Display | LED |
| Stimulus Modes | Twitch, Tetanus (50Hz and 100Hz), Train of Four, and Double Burst |
| Dimensions | 2.4" W x 4.2" L x 1" H |
| Weight with Battery | 6 oz |
| Current Output | Measured with load of $2K \u03a9\u00b1 10%$<br>● 0 to 50mA at 9.2 V<br>● 0 to 42mA at 7.5 V (Low Battery Alert Threshold) |

Indications for Use

The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.

Technological The technical characteristics of the MiniStim* Peripheral Nerve Stimulator Characteristics are similar to those of the predicate and currently marketed devices in design, energy source, intended use, and function. Unlike the predicate, the MS-IVB will have shut off time limits set on the Twitch and Tetanus pulse durations, as well as an idle time maximum. A comparative summary of the MiniStim* to the predicate device is provided in the following tables:

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## Section 8.0 – 510(k) Summary, Continued

| Comparison of the general features of the predicate, currently marketed, and subject devices | | |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | MS-III<br>(K913184) | MS-IVB<br>(Subject Device) |
| FDA Classification | Class II (Regulation No. 868.2775) | NO CHANGE |
| FDA Product Code | BXN | NO CHANGE |
| Common Name | Peripheral Nerve Stimulator | NO CHANGE |
| Device Trade Name | MiniStim MS-III | MiniStim MS-IVB |
| Indications for Use | Peripheral nerve stimulators are used by the<br>anesthesiologist or nurse anesthetist during<br>surgery to monitor the effectiveness of muscle-<br>relaxant drugs used in conjunction with general<br>anesthesia to reduce the overall anesthesia<br>level. In essence, the anesthesiologist observes<br>the muscle twitch generated by the stimulator to<br>determine when the twitch amplitude has<br>declined by an amount which indicates<br>effective action of the muscle relaxant drug. | The MiniStim* MS-IVB is a battery<br>powered Peripheral Nerve Stimulator<br>for monitoring the effects of skeletal<br>muscle relaxants. |
| Physical Configuration | Handheld | NO CHANGE |
| User Feedback | LED | NO CHANGE |
| User Input | Membrane Switch and Dial | NO CHANGE |
| Power Source | 9V Alkaline | NO CHANGE |
| Bovie Immunity | Not Tested | Immune |
| Level of Concern | Moderate | NO CHANGE |

### Comparison of the general features of the predicate, currently marketed, and subject devices

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## Section 8.0 – 510(k) Summary, Continued

Comparison of the physical dimensions/specifications of the predicate, currently marketed, and subject devices

| | MS-III (K913184) | MS-IVB<br>(Subject Device) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Pulse Amplitude Control | Hardware | NO CHANGE |
| Pulse timing control | Times IC (Integrated Circuit) | NO CHANGE |
| Software Version | N/A — Analog | 01.02.02.00 |
| Sterilization Requirements | Not Sterile | NO CHANGE |
| Battery | 9V alkaline battery | NO CHANGE |
| Size | 2.4" W X 4.2"L x 0.8" | 2.4" W X 4.2"L x 1" |
| Weight | 5oz including battery | 6oz including battery |
| Min Output Voltage | 0V | NO CHANGE |
| Max Output Voltage | 450 V± 10% (open circuit) | 320V ± 10% (open circuit) |
| Output Current<br>@ 9.2 V<br>●<br>@ 7.5 V (Low Battery Alert<br>●<br>Threshold) | Measured with load of 2K Ω± 10%<br>● 0 to 50mA at 9.2 V<br>● 0 to 42mA at 7.5 V (Low Battery Alert<br>Threshold) | NO CHANGE |
| Conductive Shielding | Present | Removed |
| Processor | N/A | Texas Instruments<br>MSP430G2553IPW20 |

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## Section 8.0 – 510(k) Summary, Continued

| | MS-III<br>(K913184) | MS-IVB<br>(Subject Device) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Width | 0.22 milliseconds | NO CHANGE |
| Pulse Rise Time | <10µs open circuit | NO CHANGE |
| Train of Four | The Train of Four consists of two pulses per<br>second for two seconds. The sequence is<br>automatically repeated every 10 seconds. | NO CHANGE<br>No change to the pattern. The automatic<br>repeat of the pattern was removed based on<br>user feedback. |
| Double Burst | Each Double Burst stimulus consists of 2<br>groups of 3 pulses each. The sequence is<br>automatically repeated every 10 seconds.<br>Within a group, the individual pulses are<br>separated by 20ms (50Hz rate). The second<br>group of three pulses follows the first after<br>750ms. | NO CHANGE<br>No change to the pattern. The automatic<br>repeat of the pattern was removed based on<br>user feedback. |
| Tetanus Pulse<br>Frequency | Each Tetanus Pulse consists of the optional 50<br>or 100 pulses per second while the button is<br>held. | The Tetanus feature remains the same,<br>however an additional feature of 30 second<br>time limit was included to both the 50Hz and<br>the 100Hz option to limit the pulse delivery<br>duration. |
| Twitch Pulse<br>Frequency | Each Twitch Pulse is one pulse per second.<br>It is automatically repeated every second. | The Twitch Pulse frequency remains the<br>same, however an additional feature of a 20<br>minute time limit was included for the pulse<br>delivery duration. |
| Power On/Off | Press the button to turn unit ON or OFF.<br>Indicator lights when the unit is ON and flashes<br>when the battery is ready to be replaced. | The Power On/Off remains the same,<br>however, an additional feature of an<br>automatic shut off after 20 minutes of idle<br>time was included. |

#### Comparison of the functionalities of the predicate, currently marketed, and subject devices

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# Section 8.0 - 510(k) Summary, Continued

| Summary of<br>The MiniStim* Peripheral Nerve Stimulator - Model MS-IVB underwent the<br>Non-Clinical<br>tests noted in the below table and results are indicated as well. | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|
| Test Name and Description | Pass/Fail | | | |
| IEC 60601 Safety Testing Electrostatic Discharge, | Pass | | | |
| Radiated Immunity, Conducted RD Immunity, Magnetic | | | | |
| Field Immunity | | | | |
| Software Verification | Pass | | | |
| User Interface / Functionality | Pass | | | |
| Waveform | Pass | | | |
| | Pass | | | |
| There was no clinical testing required to support the medical device as the<br>Indications for Use is equivalent to the predicate device. The substantial<br>equivalence of the device is supported by the non-clinical testing. | | | | |
| Based on the intended use, technological characteristics, performance data,<br>and nonclinical test, the subject MiniStim* Peripheral Nerve Stimulator,<br>Model MS-IVB, is substantially equivalent and is as safe and as effective as<br>the legally marketed predicate device K913184. | | | | |
| | Packaging and Labeling Verification | | | |