EZstim*III Peripheral Nerve Stimulator/Nerve Locator

K162048 · Halyard Health - Irvine · KOI · Dec 5, 2016 · Anesthesiology

Device Facts

• Record ID: K162048
• Device Name: EZstim*III Peripheral Nerve Stimulator/Nerve Locator
• Applicant: Halyard Health - Irvine
• Product Code: KOI · Anesthesiology
• Decision Date: Dec 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

The EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use: (1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia. (2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

Device Story

Battery-powered, hand-held peripheral nerve stimulator/locator; delivers constant current electrical pulses to patient via lead cables. Output range (high 0.05-80mA or low 0.05-5.0mA) automatically determined by connected lead cable type. High range supports monitoring neuromuscular junction (twitch, tetanus, double-burst, train-of-four modes); low range assists needle placement for regional anesthesia. Operated by clinicians in clinical settings. Device provides visual feedback via LCD. Output current amplitude and pulse patterns controlled by user to facilitate nerve stimulation or localization. Benefits include improved accuracy in nerve block needle placement and objective monitoring of muscle relaxation levels during anesthesia.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety, EMC, software verification/validation, hardware functional testing, packaging distribution simulation (ASTM D4169-14), electrosurgery immunity, and battery life testing.

Technological Characteristics

Hand-held, battery-powered (9V) constant current stimulator. High range: 0.05-80mA; Low range: 0.05-5.0mA. High contrast LCD. Connectivity via specific patient lead cables (NSL-5 or RBW-5U). Safety/EMC standards: IEC 60601-1 (3.1 ed), IEC 60601-1-2 (4th ed). Software class: IEC 62304 Class B (Moderate Level of Concern). Non-sterile.

Indications for Use

Indicated for monitoring skeletal muscle relaxant effects during general anesthesia (high current range) and locating hypodermic needle tips near nerves for regional nerve block procedures (low current range).

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

• EZstim ES100 (K954505)

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

December 5, 2016

Halyard Health - Irvine Maria Pronina Technical Leader, Regulatory Affairs 43 Discovery, Suite 100 Irvine, California 92618

Re: K162048

Trade/Device Name: EZstim* III Peripheral Nerve Stimulator/Nerve Locator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI Dated: November 1, 2016 Received: November 2, 2016

Dear Maria Pronina:

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 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.

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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,

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

Tina Kiang, Ph.D. Acting 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) K162048

Device Name

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

Indications for Use (Describe)

The EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use:

(1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia.

(2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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43 Discovery, Suite 100 Irvine, CA 92618 USA

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## 510(k) Summary

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92

The assigned 510(k) number is:

| Submitted by: | Halyard Health<br>43 Discovery, Suite 100<br>Irvine, CA 92618 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 2026095 | |
| Contact Person: | Maria Pronina<br>Technical Leader, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Summary Prepared: | December 5, 2016 | |
| Reason for Premarket<br>Notification: | New Device | |
| Trade Name: | EZstim* III Peripheral Nerve Stimulator/Nerve Locator | |
| Common/Usual Name: | Stimulator, Nerve, Peripheral, Electric | |
| Regulation Name: | Electrical peripheral nerve stimulator | |
| Classification Regulation: | 21 CFR 868.2775 | |
| Product Code: | KOI | |
| Regulatory Class: | Class II | |
| Panel: | 73 - Anesthesiology | |
| Predicate Device: | Life-Tech, Inc. received clearance for the Electrical Peripheral<br>Nerve Stimulator, EZstim ES100 (K954505). Ownership of<br>K954505 was transferred to Halyard Health (formerly Kimberly-<br>Clark Healthcare) in 2013. | |
| Characteristic | Predicate Device | Subject Device |
| | EZstim (ES100)<br>(K954505) | EZstim* III (ES500)<br>(K162048) |
| Characteristic | Predicate Device<br>EZstim (ES100)<br>(K954505) | Subject Device<br>EZstim* III (ES500)<br>(K162048) |
| Regulation<br>Product Code | KOI | SAME |
| Manufacturer | Currently Halyard Health | SAME |
| Indications for Use | The EZstim has two indications for use:<br>(1) On the high (0-80mA) current range<br>the device is used to monitor the effects<br>of skeletal muscle relaxants during<br>general anesthesia. (2) On the low (0-<br>8mA) it is used as a nerve locator in<br>Regional Nerve Block procedures. | The EZstim* III has two (2) indications for<br>use: (1) On the high (0.05 – 80mA) output<br>current range, the device is used to monitor<br>the effects of skeletal muscle relaxants during<br>general anesthesia. (2) On the low (0.05 -<br>5.0mA) output current range, it is used as a<br>nerve Locator to help locate the tip of a<br>hypodermic needle near the nerve to which<br>local anesthesia is to be delivered in Regional<br>Nerve Block procedures. |
| Physical<br>Configuration | Hand-Held | SAME |
| Size | 3.7" (9.4cm) W x 6.2" (15.8cm) L x<br>1.4" (3.6cm) H | 3.5" (8.5 cm) W x 6.5" (16.3 cm) L x 2"<br>(5 cm) H (including knob) |
| Weight | 11.5 oz (326 g) | 9.6 oz (275gm) |
| Output Current | HIGH Range: 0 to 80 mA ± 2 mA.<br>LOW Range: 0.0 to 8.0 mA ± 0.2mA. | High Range: adjustable high current mode<br>regulated output 0.05 to 80 mA ± 5% into<br>3.74 k ohms or less<br>Low Range: adjustable current regulated 0.05<br>to 5.0 mA ± 1% into 11.5 k ohms or less |
| Stimulation<br>Categories | Double Burst, Train-of-Four, Twitch, or<br>Tetanus | SAME |
| Display | Single-line alphanumeric LCD with 16<br>characters | High contrast LCD approximately 1.0" high<br>x 2.45" wide |
| Mounting<br>Bracket | Mounting Bracket to an IV pole is<br>available as an optional accessory. | SAME |
| Expected<br>Service Life | 5 Years | SAME |
| Performance<br>Testing Data | • EMC Compatibility per "FDA<br>Reviewers Guidance for Pre-<br>market Notification Submission for<br>the anesthesiology and respiratory<br>device branch." (Based on IEC<br>801.)<br>• Software Verification and<br>Validation Testing per FDA<br>Guidance for software with Minor<br>Level of Concern<br>• Hardware mechanical and<br>functional Testing<br>• Packaging - None | • IEC 60601-1 (3.1 edition) standard for<br>safety and the IEC 60601-1-2 (4th<br>edition) standard for EMC.<br>• Software Verification and Validation<br>Testing per FDA Guidance for software<br>with Moderate Level of Concern (IEC<br>62304 Class B).<br>• Hardware mechanical and functional<br>Testing<br>• Packaging verification simulation<br>testing |
| Biocompatibility | Not Applicable (device is non-<br>patient contacting) | SAME |
| Power Source | One 9 Volt Alkaline Battery | SAME |
| Sterilization | Non-Sterile | SAME |
| Test Name and Description | Pass/Fail | |
| IEC 60601 Safety Testing Electrostatic Discharge Radiated<br>Immunity, Conducted RD Immunity, Magnetic Field Immunity<br>Description:<br>Electrical Safety and Electromagnetic Compatibility (EMC) were<br>tested and found to comply with IEC 60601-1 (3.1 Edition)<br>standard and the IEC 60601-1.2 (4th Edition) standard for EMC:<br>o Radiated Emissions<br>o Electrostatic Discharge Immunity<br>o Radiated RF Electromagnetic Fields Immunity<br>o Immunity to proximity field from RF wireless<br>communication equipment<br>o Conducted Disturbances, Induced by RF Fields Immunity<br>o Power Frequency Magnetic Fields Immunity<br>o Leakage Current<br>o Dielectric Voltage Withstand<br>o Excessive Temperature<br>o Humidity Preconditioning<br>o Abnormal Operation and Fault Conditions | Pass | |
| Software Verification | Pass | |
| Description: | | |
| The device's software has been validated in accordance with the<br>requirements set forth in the FDA Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical<br>Devices (May 11, 2005). The software validation tests<br>demonstrated that the software version meets the design<br>requirements.<br>Hardware Verification | | |
| Description:<br>Hardware Verification test was conducted to ensure that the<br>ES500 Hardware and Software system functions as intended and<br>included the following:<br>o Output current test<br>o Beeper test<br>o Battery removal test<br>o Weight test<br>o Internal temperature test<br>The Hardware Verification test demonstrates that the design<br>outputs meet the design input<br>Packaging Verification | Pass | |
| Description:<br>Packaging distribution simulation testing was conducted per<br>ASTM D4169-14 (Standard Practice for Performance Testing of<br>Shipping Containers and Systems). The ES500 went through the<br>following distribution simulation:<br>o Temperature and Humidity Conditioning<br>o Schedule A - Manual Handling (First Drop Sequence)<br>o Schedule C - Vehicle Stacking<br>o Schedule F - Loose Load Vibration<br>o Schedule E - Vehicle Vibration<br>o Schedule J - Concentrated Impact<br>o Schedule A – Manual Handling (Second Drop Sequence)<br>Electrosurgery Test | Pass | |
| Description:<br>Electrosurgery Immunity testing was successfully completed to<br>ensure the ES500 device is electrosurgery compatible, where the<br>device operates as intended in High Output Current mode. The<br>electrosurgery immunity test demonstrated that the design output<br>meets the design input requirements.<br>Battery Life Test | Pass | |
| Description: | Pass | |
| Battery Life Test was conducted to ensure the duration of single<br>9V battery to function in accordance with the established<br>acceptance criteria for the ES500 device. The battery life tests<br>demonstrated that the design output meets the design input<br>requirement. | | |
| Battery Door Seal Integrity (Adhesive) Test | | |
| Description:<br>The Battery Door Seal Integrity (Adhesive) Test was conducted<br>to ensure the adhesive gasket in the battery door compartment<br>maintains integrity after battery replacements. The battery<br>adhesive test demonstrated that the design output meets the<br>design input requirement. | Pass | |

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#### 5.1 Description of the Device

The EZstim* III (Model ES500) is both a constant current Peripheral Nerve Stimulator (HIGH output current range) and a Peripheral Nerve Locator (LOW output current range). Output current range is determined by the model of patient lead cable connected to the unit.

- . When the Halyard NSL-5 patient lead cable is connected, the unit automatically sets to the HIGH output current range (0.05 to 80 mA), with no stimulus mode selected (null mode). When the user selects a stimulus mode (i.e., 1 or 2 Hz Twitch, 50 Hz Tetanus, 100 Hz Tetanus, Double-Burst, or Train-of-Four), the unit functions as a nerve stimulator for use in monitoring the effects of skeletal muscle relaxants on the neuromuscular junction.
- . When the Halyard RBW-5U patient lead cable is connected, the unit automatically sets to the LOW output current range (0.05 to 5.0 mA). In this range, the unit functions as a nerve locator for use in regional nerve block procedures.

#### Indications for Use 5.2

EZstim* III Peripheral Nerve Stimulator/Nerve Locator is a battery powered Peripheral Nerve Stimulator / Nerve Locator with two (2) indications for use:

- (1) on the high (0.05 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia.
- (2) on the low (0.05 5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

#### 5.3 Summary of Substantial Equivalence:

The intended use, materials, performance, and technological principles of operation of the EZstim* III Peripheral Nerve Stimulator/Nerve Locator (Model ES500) are substantially equivalent to the predicate device, EZstim (Model ES100) cleared under K954505. Just as with the predicate, energy is delivered to the patient via lead cable accessories that connect to the ES500 output connectors. As with the predicate device, stimulus control functions on the ES500 allow control of the output current amplitude and electrical pulse pattern to deliver the…