(133 days)
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.
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.
The provided documentation describes the Halyard Health EZstim* III Peripheral Nerve Stimulator/Nerve Locator (Model ES500), which is a medical device. This device is not an AI/ML device, therefore, many of the requested criteria are not applicable.
Here's an analysis of the acceptance criteria and study information provided for this medical device, tailored to what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name and Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| IEC 60601 Safety Testing (Electrostatic Discharge, Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity, Radiated Emissions, Immunity to proximity field from RF wireless communication equipment, Conducted Disturbances Induced by RF Fields Immunity, Power Frequency Magnetic Fields Immunity, Leakage Current, Dielectric Voltage Withstand, Excessive Temperature, Humidity Preconditioning, Abnormal Operation and Fault Conditions) | Compliance with IEC 60601-1 (3.1 Edition) and IEC 60601-1-2 (4th Edition) | Pass |
| Software Verification (Validation in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)) | Software meets design requirements | Pass |
| Hardware Verification (Output current test, Beeper test, Battery removal test, Weight test, Internal temperature test) | Hardware and Software system functions as intended and design outputs meet design input | Pass |
| Packaging Verification (Distribution simulation testing per ASTM D4169-14: Temperature and Humidity Conditioning, Schedule A - Manual Handling (First Drop Sequence), Schedule C - Vehicle Stacking, Schedule F - Loose Load Vibration, Schedule E - Vehicle Vibration, Schedule J - Concentrated Impact, Schedule A – Manual Handling (Second Drop Sequence)) | Packaging maintains integrity during distribution simulation | Pass |
| Electrosurgery Test (Ensures device is electrosurgery compatible and operates as intended in High Output Current mode) | Device operates as intended in High Output Current mode during electrosurgery | Pass |
| Battery Life Test (Ensures duration of single 9V battery functions in accordance with established acceptance criteria for the ES500 device) | Battery life meets design input requirement | Pass |
| Battery Door Seal Integrity (Adhesive) Test (Ensures adhesive gasket in the battery door compartment maintains integrity after battery replacements) | Adhesive gasket maintains integrity after battery replacements | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of devices tested for EMC, number of software modules tested). It generally states that "testing of the EZstim* III Peripheral Nerve Stimulator/Nerve Locator was performed."
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted to demonstrate compliance with recognized standards and internal design requirements. They are presumably prospective in the sense that the tests were designed and executed specifically for this device submission. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or accredited test labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the device is a hardware medical device, and the evaluation relies on engineering and regulatory compliance testing rather than expert-derived ground truth as would be used for AI/ML diagnostic devices.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which are not relevant to the non-clinical engineering and regulatory compliance tests performed for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The EZstim* III is a peripheral nerve stimulator/locator, a hardware device with a direct physiological function, not an interpretative AI. No human reader assistance is involved in its direct function.
6. Standalone (Algorithm Only) Performance
- This question is not applicable. The device is not an algorithm; it is a physical hardware device with embedded software. The software verification test (mentioned in the table) assesses the software's functionality as part of the overall device system, but there is no "standalone algorithm" performance assessed separately from the device's hardware.
7. Type of Ground Truth Used
- The "ground truth" for the tests performed is based on engineering specifications, recognized international standards (IEC 60601-1, IEC 60601-1-2, ASTM D4169-14), and internal design input requirements. These are objective, measurable performance benchmarks rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive AI/ML models.
8. Sample Size for the Training Set
- This question is not applicable. The device is not an AI/ML algorithm that undergoes a "training phase." The "training set" concept is not relevant to its development and testing.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Image /page/3/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with two stylized sails inside, one white and one green. To the right of the circle is the word "HALYARD" in a bold, sans-serif font, also in blue.
43 Discovery, Suite 100 Irvine, CA 92618 USA
Tele: (800) 448-3569 (949) 923-9400 (949) 923-2401 Fax:
Visit us on the web at:
www.halyardhealth.com www.myON-Q.com
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 Health43 Discovery, Suite 100Irvine, CA 92618 | |
|---|---|---|
| Establishment RegistrationNumber: | 2026095 | |
| Contact Person: | Maria ProninaTechnical Leader, Regulatory AffairsPhone: 949.923.2325Fax: 678.389.9791e-mail: maria.pronina@hyh.com | |
| Date Summary Prepared: | December 5, 2016 | |
| Reason for PremarketNotification: | 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 PeripheralNerve Stimulator, EZstim ES100 (K954505). Ownership ofK954505 was transferred to Halyard Health (formerly Kimberly-Clark Healthcare) in 2013. | |
| Characteristic | Predicate Device | Subject Device |
| EZstim (ES100)(K954505) | EZstim* III (ES500)(K162048) | |
| Characteristic | Predicate DeviceEZstim (ES100)(K954505) | Subject DeviceEZstim* III (ES500)(K162048) |
| RegulationProduct Code | KOI | SAME |
| Manufacturer | Currently Halyard Health | SAME |
| Indications for Use | The EZstim has two indications for use:(1) On the high (0-80mA) current rangethe device is used to monitor the effectsof skeletal muscle relaxants duringgeneral anesthesia. (2) On the low (0-8mA) it is used as a nerve locator inRegional Nerve Block procedures. | The EZstim* III has two (2) indications foruse: (1) On the high (0.05 – 80mA) outputcurrent range, the device is used to monitorthe effects of skeletal muscle relaxants duringgeneral anesthesia. (2) On the low (0.05 -5.0mA) output current range, it is used as anerve Locator to help locate the tip of ahypodermic needle near the nerve to whichlocal anesthesia is to be delivered in RegionalNerve Block procedures. |
| PhysicalConfiguration | Hand-Held | SAME |
| Size | 3.7" (9.4cm) W x 6.2" (15.8cm) L x1.4" (3.6cm) H | 3.5" (8.5 cm) W x 6.5" (16.3 cm) L x 2"(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.LOW Range: 0.0 to 8.0 mA ± 0.2mA. | High Range: adjustable high current moderegulated output 0.05 to 80 mA ± 5% into3.74 k ohms or lessLow Range: adjustable current regulated 0.05to 5.0 mA ± 1% into 11.5 k ohms or less |
| StimulationCategories | Double Burst, Train-of-Four, Twitch, orTetanus | SAME |
| Display | Single-line alphanumeric LCD with 16characters | High contrast LCD approximately 1.0" highx 2.45" wide |
| MountingBracket | Mounting Bracket to an IV pole isavailable as an optional accessory. | SAME |
| ExpectedService Life | 5 Years | SAME |
| PerformanceTesting Data | • EMC Compatibility per "FDAReviewers Guidance for Pre-market Notification Submission forthe anesthesiology and respiratorydevice branch." (Based on IEC801.)• Software Verification andValidation Testing per FDAGuidance for software with MinorLevel of Concern• Hardware mechanical andfunctional Testing• Packaging - None | • IEC 60601-1 (3.1 edition) standard forsafety and the IEC 60601-1-2 (4thedition) standard for EMC.• Software Verification and ValidationTesting per FDA Guidance for softwarewith Moderate Level of Concern (IEC62304 Class B).• Hardware mechanical and functionalTesting• Packaging verification simulationtesting |
| Biocompatibility | Not Applicable (device is non-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 RadiatedImmunity, Conducted RD Immunity, Magnetic Field ImmunityDescription:Electrical Safety and Electromagnetic Compatibility (EMC) weretested and found to comply with IEC 60601-1 (3.1 Edition)standard and the IEC 60601-1.2 (4th Edition) standard for EMC:o Radiated Emissionso Electrostatic Discharge Immunityo Radiated RF Electromagnetic Fields Immunityo Immunity to proximity field from RF wirelesscommunication equipmento Conducted Disturbances, Induced by RF Fields Immunityo Power Frequency Magnetic Fields Immunityo Leakage Currento Dielectric Voltage Withstando Excessive Temperatureo Humidity Preconditioningo Abnormal Operation and Fault Conditions | Pass | |
| Software Verification | Pass | |
| Description: | ||
| The device's software has been validated in accordance with therequirements set forth in the FDA Guidance for the Content ofPremarket Submissions for Software Contained in MedicalDevices (May 11, 2005). The software validation testsdemonstrated that the software version meets the designrequirements.Hardware Verification | ||
| Description:Hardware Verification test was conducted to ensure that theES500 Hardware and Software system functions as intended andincluded the following:o Output current testo Beeper testo Battery removal testo Weight testo Internal temperature testThe Hardware Verification test demonstrates that the designoutputs meet the design inputPackaging Verification | Pass | |
| Description:Packaging distribution simulation testing was conducted perASTM D4169-14 (Standard Practice for Performance Testing ofShipping Containers and Systems). The ES500 went through thefollowing distribution simulation:o Temperature and Humidity Conditioningo Schedule A - Manual Handling (First Drop Sequence)o Schedule C - Vehicle Stackingo Schedule F - Loose Load Vibrationo Schedule E - Vehicle Vibrationo Schedule J - Concentrated Impacto Schedule A – Manual Handling (Second Drop Sequence)Electrosurgery Test | Pass | |
| Description:Electrosurgery Immunity testing was successfully completed toensure the ES500 device is electrosurgery compatible, where thedevice operates as intended in High Output Current mode. Theelectrosurgery immunity test demonstrated that the design outputmeets the design input requirements.Battery Life Test | Pass | |
| Description: | Pass | |
| Battery Life Test was conducted to ensure the duration of single9V battery to function in accordance with the establishedacceptance criteria for the ES500 device. The battery life testsdemonstrated that the design output meets the design inputrequirement. | ||
| Battery Door Seal Integrity (Adhesive) Test | ||
| Description:The Battery Door Seal Integrity (Adhesive) Test was conductedto ensure the adhesive gasket in the battery door compartmentmaintains integrity after battery replacements. The batteryadhesive test demonstrated that the design output meets thedesign input requirement. | Pass |
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Image /page/4/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with two triangles inside, one white and one green. To the right of the circle is the word "HALYARD" in bold, blue letters.
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 appropriate stimulus for a given application.
The following summary table compares the technological characteristics of the subject EZstim* III (Model ES500) to the predicate EZstim (Model ES100) device.
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The Indications for Use statements of the subject and predicate devices are similar and both are intended for 1) monitoring effects of skeletal muscle relaxants during general anesthesia, and 2) use as a nerve locator in Regional Nerve Block procedures. The only differences in the Indications for Use statements of the two devices are the referenced current ranges specified (i.e., The predicate device High Current Range is 0 to 80 mA, while the subject device High Current Range is 0.05 to 80 mA. The predicate device Low Current Range is 0 to 8.0 mA. while the subject device Low current range is 0.05 to 5.0 mA.) The lower limit for both the High and Low Current Ranges was changed to 0.05 mA to allow quantitative verification of this lower limit value because it's not possible to verify 0mA. The upper limit of the Low Current Range was reduced to 5.0 mA to limit nerve exposure to higher current.
Neither of these differences to details within the Indications for Use statement impact the intended use or function of the device; and do not raise different questions of safety or effectiveness of the device when used as labeled.
5.4 Summary of Non-Clinical Testing
The following testing of the EZstim* III Peripheral Nerve Stimulator/Nerve Locator was performed in accordance with the requirements of the design control guidelines and established quality assurance processes to demonstrate substantial equivalence of the subject device to the predicate device.
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Image /page/8/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green design inside, followed by the word "HALYARD" in bold, blue letters. The design inside the circle appears to be two stylized shapes, one white and one green.
5.5 Summary of Clinical Testing
No clinical testing was required or performed since substantial equivalence of the device was supported by the non-clinical testing.
Conclusion
Based on the design and results of testing, the proposed new EZstim* III Peripheral Nerve Stimulator/Nerve Locator (Model ES500) device is as safe, as effective, and performs as well as or better than the predicate. The ES500 is substantially equivalent to the predicate (Model ES100).
§ 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).