(147 days)
The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.
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
This document is a 510(k) summary for the MiniStim* Peripheral Nerve Stimulator – Model MS-IVB, indicating it is a premarket notification for a medical device. This type of document is not designed to contain acceptance criteria and detailed study results in the typical sense of a clinical trial or algorithm performance study.
Instead, the "acceptance criteria" here refer to the device meeting various standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" that proves the device meets these criteria is a series of non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Name) | Reported Device Performance |
|---|---|
| IEC 60601 Safety Testing (Electrostatic Discharge, Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity) | Pass |
| Software Verification | Pass |
| User Interface / Functionality | Pass |
| Waveform | Pass |
| Packaging and Labeling Verification | Pass |
2. Sample size used for the test set and the data provenance
The document discusses non-clinical testing of the device itself, not a test set of data from patients. Therefore, sample size and data provenance in the context of patient data are not applicable. The "sample" would refer to the physical device(s) tested. The provenance of the testing is internal to the manufacturer (Halyard Health, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical engineering and software verification tests for the device, not a study evaluating human interpretation or a machine learning algorithm's performance against expert-established ground truth.
4. Adjudication method for the test set
This is not applicable for the same reasons as points 2 and 3. The testing involves verifying device specifications and adherence to standards, not human expert adjudication of diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This document describes a traditional medical device (peripheral nerve stimulator), not an AI/ML-driven diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" would be established engineering specifications and international standards (e.g., IEC 60601 for safety, predefined waveforms for output verification, expected software behavior).
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
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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 (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 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 requirementsof 21 CFR 807.92. | |
|---|---|
| Date Prepared | March 20, 2015 |
| Applicant | Halyard Health (formerly Kimberly-Clark Health Care)5405 Windward ParkwayAlpharetta, GA 30004 |
| OfficialCorrespondent | Lindsey Hedlund, MBARegulatory Affairs CoordinatorTel: 470-448-5441Fax: 920.225.4932Email: lindsey.hedlund@hyh.com |
| Trade Name | MiniStim* Peripheral Nerve Stimulator – Model MS-IVB |
| ClassificationName | Stimulator, nerve, battery-powered |
| DeviceClassificationand ProductCode | Class II per 21 CFR §868.2775Product Code - BXN |
| PredicateDevices | The MS-III MiniStim* Peripheral Nerve Stimulator was cleared by K913184,under the Life-Tech, Inc. applicant. Ownership of the 510(k) was transferredto 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 $2K \u03a9\u00b1 10%$● 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 theanesthesiologist or nurse anesthetist duringsurgery to monitor the effectiveness of muscle-relaxant drugs used in conjunction with generalanesthesia to reduce the overall anesthesialevel. In essence, the anesthesiologist observesthe muscle twitch generated by the stimulator todetermine when the twitch amplitude hasdeclined by an amount which indicateseffective action of the muscle relaxant drug. | The MiniStim* MS-IVB is a batterypowered Peripheral Nerve Stimulatorfor monitoring the effects of skeletalmuscle 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 AlertThreshold) | NO CHANGE |
| Conductive Shielding | Present | Removed |
| Processor | N/A | Texas InstrumentsMSP430G2553IPW20 |
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 | <10µs open circuit | NO CHANGE |
| Train of Four | The Train of Four consists of two pulses persecond for two seconds. The sequence isautomatically repeated every 10 seconds. | NO CHANGENo change to the pattern. The automaticrepeat of the pattern was removed based onuser feedback. |
| Double Burst | Each Double Burst stimulus consists of 2groups of 3 pulses each. The sequence isautomatically repeated every 10 seconds.Within a group, the individual pulses areseparated by 20ms (50Hz rate). The secondgroup of three pulses follows the first after750ms. | NO CHANGENo change to the pattern. The automaticrepeat of the pattern was removed based onuser feedback. |
| Tetanus PulseFrequency | Each Tetanus Pulse consists of the optional 50or 100 pulses per second while the button isheld. | The Tetanus feature remains the same,however an additional feature of 30 secondtime limit was included to both the 50Hz andthe 100Hz option to limit the pulse deliveryduration. |
| Twitch PulseFrequency | Each Twitch Pulse is one pulse per second.It is automatically repeated every second. | The Twitch Pulse frequency remains thesame, however an additional feature of a 20minute time limit was included for the pulsedelivery duration. |
| Power On/Off | Press the button to turn unit ON or OFF.Indicator lights when the unit is ON and flasheswhen the battery is ready to be replaced. | The Power On/Off remains the same,however, an additional feature of anautomatic shut off after 20 minutes of idletime was included. |
Comparison of the functionalities of the predicate, currently marketed, and subject devices
Continued on next page
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Section 8.0 - 510(k) Summary, Continued
| Summary ofThe MiniStim* Peripheral Nerve Stimulator - Model MS-IVB underwent theNon-Clinicaltests 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 theIndications for Use is equivalent to the predicate device. The substantialequivalence of the device is supported by the non-clinical testing. | ||||
| Based on the intended use, technological characteristics, performance data,and nonclinical test, the subject MiniStim* Peripheral Nerve Stimulator,Model MS-IVB, is substantially equivalent and is as safe and as effective asthe legally marketed predicate device K913184. | ||||
| Packaging and Labeling Verification |
§ 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).