(133 days)
Not Found
No
The description focuses on electrical stimulation and hardware/software verification, with no mention of AI or ML algorithms for data analysis or decision-making.
Yes
The device is used to monitor the effects of skeletal muscle relaxants during general anesthesia and to help locate nerves for regional nerve block procedures, both of which are therapeutic interventions or support therapeutic procedures.
Yes
This device is a diagnostic device because it is used to monitor the effects of skeletal muscle relaxants during general anesthesia and to help locate the tip of a hypodermic needle near the nerve for regional nerve block procedures, both of which involve assessing a physiological state or anatomical location.
No
The device description explicitly states it is a "battery powered Peripheral Nerve Stimulator/Nerve Locator" and details hardware components like patient lead cables and a 9V battery. The performance studies also include hardware verification and battery life tests, confirming it is a physical device with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are monitoring the effects of skeletal muscle relaxants during general anesthesia and locating nerves for regional nerve blocks. Both of these are procedures performed directly on the patient's body.
- Device Description: The device is a Peripheral Nerve Stimulator/Nerve Locator that applies electrical current to the patient.
- Lack of In Vitro Activity: An IVD is a medical device that is used to examine specimens derived from the human body (such as blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing. This device does not perform any such testing on specimens outside the body.
The device is used to interact directly with the patient's nervous system and muscles, which is a characteristic of an in vivo (within the body) medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KOI
Device Description
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.
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)
IEC 60601 Safety Testing Electrostatic Discharge Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity
Description: Electrical Safety and Electromagnetic Compatibility (EMC) were tested 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 Emissions
o Electrostatic Discharge Immunity
o Radiated RF Electromagnetic Fields Immunity
o Immunity to proximity field from RF wireless communication equipment
o Conducted Disturbances, Induced by RF Fields Immunity
o Power Frequency Magnetic Fields Immunity
o Leakage Current
o Dielectric Voltage Withstand
o Excessive Temperature
o Humidity Preconditioning
o Abnormal Operation and Fault Conditions
Key Results: Pass
Software Verification
Description: The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets the design requirements.
Key Results: Pass
Hardware Verification
Description: Hardware Verification test was conducted to ensure that the ES500 Hardware and Software system functions as intended and included the following:
o Output current test
o Beeper test
o Battery removal test
o Weight test
o Internal temperature test
The Hardware Verification test demonstrates that the design outputs meet the design input
Key Results: Pass
Packaging Verification
Description: Packaging distribution simulation testing was conducted per ASTM D4169-14 (Standard Practice for Performance Testing of Shipping Containers and Systems). The ES500 went through the following distribution simulation:
o Temperature and Humidity Conditioning
o Schedule A - Manual Handling (First Drop Sequence)
o Schedule C - Vehicle Stacking
o Schedule F - Loose Load Vibration
o Schedule E - Vehicle Vibration
o Schedule J - Concentrated Impact
o Schedule A – Manual Handling (Second Drop Sequence)
Key Results: Pass
Electrosurgery Test
Description: Electrosurgery Immunity testing was successfully completed to ensure the ES500 device is electrosurgery compatible, where the device operates as intended in High Output Current mode. The electrosurgery immunity test demonstrated that the design output meets the design input requirements.
Key Results: Pass
Battery Life Test
Description: Battery Life Test was conducted to ensure the duration of single 9V battery to function in accordance with the established acceptance criteria for the ES500 device. The battery life tests demonstrated that the design output meets the design input requirement.
Key Results: Pass
Battery Door Seal Integrity (Adhesive) Test
Description: The Battery Door Seal Integrity (Adhesive) Test was conducted to ensure the adhesive gasket in the battery door compartment maintains integrity after battery replacements. The battery adhesive test demonstrated that the design output meets the design input requirement.
Key Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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).
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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.
1
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
2
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 Health
43 Discovery, Suite 100
Irvine, CA 92618 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 2026095 | |
| Contact Person: | Maria Pronina
Technical Leader, Regulatory Affairs
Phone: 949.923.2325
Fax: 678.389.9791
e-mail: maria.pronina@hyh.com | |
| Date Summary Prepared: | December 5, 2016 | |
| Reason for Premarket
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
Nerve Stimulator, EZstim ES100 (K954505). Ownership of
K954505 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 Device
EZstim (ES100)
(K954505) | Subject Device
EZstim* III (ES500)
(K162048) |
| Regulation
Product 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 range
the device is used to monitor the effects
of skeletal muscle relaxants during
general anesthesia. (2) On the low (0-
8mA) it is used as a nerve locator in
Regional Nerve Block procedures. | The EZstim* III has two (2) indications for
use: (1) On the high (0.05 – 80mA) output
current range, the device is used to monitor
the effects of skeletal muscle relaxants during
general anesthesia. (2) On the low (0.05 -
5.0mA) 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. |
| Physical
Configuration | Hand-Held | SAME |
| Size | 3.7" (9.4cm) W x 6.2" (15.8cm) L x
1.4" (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 mode
regulated output 0.05 to 80 mA ± 5% into
3.74 k ohms or less
Low Range: adjustable current regulated 0.05
to 5.0 mA ± 1% into 11.5 k ohms or less |
| Stimulation
Categories | Double Burst, Train-of-Four, Twitch, or
Tetanus | SAME |
| Display | Single-line alphanumeric LCD with 16
characters | High contrast LCD approximately 1.0" high
x 2.45" wide |
| Mounting
Bracket | Mounting Bracket to an IV pole is
available as an optional accessory. | SAME |
| Expected
Service Life | 5 Years | SAME |
| Performance
Testing Data | • EMC Compatibility per "FDA
Reviewers Guidance for Pre-
market Notification Submission for
the anesthesiology and respiratory
device branch." (Based on IEC
801.)
• Software Verification and
Validation Testing per FDA
Guidance for software with Minor
Level of Concern
• Hardware mechanical and
functional Testing
• Packaging - None | • IEC 60601-1 (3.1 edition) standard for
safety and the IEC 60601-1-2 (4th
edition) standard for EMC.
• Software Verification and Validation
Testing per FDA Guidance for software
with Moderate Level of Concern (IEC
62304 Class B).
• Hardware mechanical and functional
Testing
• Packaging verification simulation
testing |
| 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 Radiated
Immunity, Conducted RD Immunity, Magnetic Field Immunity
Description:
Electrical Safety and Electromagnetic Compatibility (EMC) were
tested 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 Emissions
o Electrostatic Discharge Immunity
o Radiated RF Electromagnetic Fields Immunity
o Immunity to proximity field from RF wireless
communication equipment
o Conducted Disturbances, Induced by RF Fields Immunity
o Power Frequency Magnetic Fields Immunity
o Leakage Current
o Dielectric Voltage Withstand
o Excessive Temperature
o Humidity Preconditioning
o Abnormal Operation and Fault Conditions | Pass | |
| Software Verification | Pass | |
| Description: | | |
| The device's software has been validated in accordance with the
requirements set forth in the FDA Guidance for the Content of
Premarket Submissions for Software Contained in Medical
Devices (May 11, 2005). The software validation tests
demonstrated that the software version meets the design
requirements.
Hardware Verification | | |
| Description:
Hardware Verification test was conducted to ensure that the
ES500 Hardware and Software system functions as intended and
included the following:
o Output current test
o Beeper test
o Battery removal test
o Weight test
o Internal temperature test
The Hardware Verification test demonstrates that the design
outputs meet the design input
Packaging Verification | Pass | |
| Description:
Packaging distribution simulation testing was conducted per
ASTM D4169-14 (Standard Practice for Performance Testing of
Shipping Containers and Systems). The ES500 went through the
following distribution simulation:
o Temperature and Humidity Conditioning
o Schedule A - Manual Handling (First Drop Sequence)
o Schedule C - Vehicle Stacking
o Schedule F - Loose Load Vibration
o Schedule E - Vehicle Vibration
o Schedule J - Concentrated Impact
o Schedule A – Manual Handling (Second Drop Sequence)
Electrosurgery Test | Pass | |
| Description:
Electrosurgery Immunity testing was successfully completed to
ensure the ES500 device is electrosurgery compatible, where the
device operates as intended in High Output Current mode. The
electrosurgery immunity test demonstrated that the design output
meets the design input requirements.
Battery Life Test | Pass | |
| Description: | Pass | |
| Battery Life Test was conducted to ensure the duration of single
9V battery to function in accordance with the established
acceptance criteria for the ES500 device. The battery life tests
demonstrated that the design output meets the design input
requirement. | | |
| Battery Door Seal Integrity (Adhesive) Test | | |
| Description:
The Battery Door Seal Integrity (Adhesive) Test was conducted
to ensure the adhesive gasket in the battery door compartment
maintains integrity after battery replacements. The battery
adhesive test demonstrated that the design output meets the
design 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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Image /page/5/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green abstract shape inside, followed by the word "HALYARD" in blue, bold letters. The abstract shape inside the circle appears to be two stylized sails or peaks, one white and one green.
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Image /page/6/Picture/0 description: The image shows the logo for Halyard. 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, possibly representing sails or stylized mountains.
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/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with a white and green abstract shape inside, followed by the word "HALYARD" in blue, bold letters. The abstract shape inside the circle appears to be two stylized sails or peaks, one white and one green.
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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).