MiniStim MS-IVB Peripheral Nerve Stimulator

• K Number: K143095
• Device Name: MiniStim MS-IVB Peripheral Nerve Stimulator
• Manufacturer: Halyard Health, Inc.
• Date Cleared: 2015-03-24 ( 147 days)
• Product Code: BXN
• Regulation Number: 868.2775

Intended Use

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

Device Description

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

Predicate Devices

K913184

Reference Devices

K913184

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a basic nerve stimulator with adjustable parameters and does not mention any AI/ML capabilities or related performance metrics.

Therapeutic

No
The device is described as a "Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants," explicitly stating "monitoring" rather than therapy. Its purpose is to assess the depth of muscle and nerve relaxation during surgery, not to treat a condition.

Diagnostic

Yes
The device is described as a "Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants," which indicates it is used to assess a physiological state (muscle and nerve relaxation) to guide medical intervention.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "battery powered Peripheral Nerve Stimulator" and a "nerve stimulator with selectable stimulus output waveforms and adjustable output amplitude," indicating it is a hardware device that generates electrical stimuli. While it includes software verification, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to monitor the effects of skeletal muscle relaxants by stimulating peripheral nerves. This is a direct interaction with the patient's body to assess a physiological response.
• Device Description: The device description confirms it's a nerve stimulator with an output intended for monitoring muscle and nerve relaxation. This further reinforces its use in a clinical setting on a patient.
• Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not process or analyze any biological specimens.

Therefore, the MiniStim* MS-IVB is a medical device used for patient monitoring, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

BXN

Device Description

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 Ω± 10%
● 0 to 50mA at 9.2 V
● 0 to 42mA at 7.5 V (Low Battery Alert Threshold)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

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)

The MiniStim* Peripheral Nerve Stimulator - Model MS-IVB underwent the tests noted in the below table and results are indicated as well.
Test Name and Description: IEC 60601 Safety Testing Electrostatic Discharge, Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity. Result: Pass.
Test Name and Description: Software Verification. Result: Pass.
Test Name and Description: User Interface / Functionality. Result: Pass.
Test Name and Description: Waveform. Result: Pass.
Test Name and Description: Packaging and Labeling Verification. Result: Pass.
There was no clinical testing required to support the medical device as the Indications for Use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K913184

Reference Device(s)

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

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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

1

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

2

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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FOR FDA USE ONLY

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

4

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 $2K \u03a9\u00b1 10%$
● 0 to 50mA at 9.2 V
● 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:

Continued on next page

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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
(K913184)	MS-IVB
(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
anesthesiologist or nurse anesthetist during
surgery to monitor the effectiveness of muscle-
relaxant drugs used in conjunction with general
anesthesia to reduce the overall anesthesia
level. In essence, the anesthesiologist observes
the muscle twitch generated by the stimulator to
determine when the twitch amplitude has
declined by an amount which indicates
effective action of the muscle relaxant drug.	The MiniStim* MS-IVB is a battery
powered Peripheral Nerve Stimulator
for monitoring the effects of skeletal
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

Continued on next page

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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
(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
@ 9.2 V
●
@ 7.5 V (Low Battery Alert
●
Threshold) | Measured with load of 2K Ω± 10%
● 0 to 50mA at 9.2 V
● 0 to 42mA at 7.5 V (Low Battery Alert
Threshold) | NO CHANGE |
| Conductive Shielding | Present | Removed |
| Processor | N/A | Texas Instruments
MSP430G2553IPW20 |

Continued on next page

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Section 8.0 – 510(k) Summary, Continued

| | MS-III
(K913184) | MS-IVB
(Subject Device) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Width | 0.22 milliseconds | NO CHANGE |
| Pulse Rise Time |