The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are intended to be connected to a nerve monitoring unit, such as the Neurosign 100 Nerve Monitor, which requires a standard 1.5mm DIN 42802 touch proof connector, in order to provide an electrical path by which electrical impulses may pass from the monitoring unit to the patient, thus effecting nerve stimulation to assist its user in locating and identifying motor nerves.

Device Description

The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are surface electrodes used to stimulate nerves during various surgical procedures. They may be used on the surface of the skin, or on the surface of surgically exposed tissue, and as such, they are not intended nor designed to be inserted into tissue.

AI/ML Overview

This 510(k) premarket notification for the Kirwan Disposable Nerve Stimulator Probes (Models: 41-3400, 41-3401, 41-302, and 41-3403) describes a device that is substantially equivalent to legally marketed predicate devices. As such, the study focuses on demonstrating this equivalence rather than establishing novel acceptance criteria through a standalone performance study as would be required for a new technology.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a device demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily met through compliance with recognized standards and a demonstration that the device's design, materials, and function are virtually identical to the predicates. There aren't specific quantitative performance metrics reported for this device in the same way one might find for a diagnostic algorithm (e.g., sensitivity, specificity).

Acceptance Criteria Category	Description of Criteria (Inferred from 510(k))	Reported Device Performance
Intended Use	The device's intended use must be the same as or very similar to the predicate devices.	The Kirwan 41-34XX Series probes are intended to connect to a nerve monitoring unit (e.g., Neurosign 100) to provide an electrical path for impulses to stimulate nerves, assisting in locating and identifying motor nerves. This is stated to be substantially equivalent to the predicate devices.
Technological Safety	The device must not introduce new technological risks or characteristics.	The device's technological safety is established by the fact that it does not contain any new technological risks or characteristics compared to the predicate devices. Its design, materials, and function are virtually identical to the predicates, with minor exceptions (handle grip, probe insulation) that were selected to enhance design without compromising substantial equivalence.
Technological Effectiveness	The device's core function and mechanism of action must be equivalent to predicates.	The device's core function (electrical stimulation for nerve localization) and energy source are identical to the predicates. The effectiveness is implicitly covered by the "virtually identical" design and function claim.
Performance	The device's performance must be substantially equivalent to predicates.	The device's performance is supported by adherence to prevailing standards and guidelines. Specifically, testing was conducted to current dielectric strength and biocompatibility requirements to assure no compromise due to minor design changes. Safety and hazard analysis determined hazard conditions to be low-to-moderate, which is acceptable. This demonstrates performance consistent with established safety and efficacy requirements for this type of device.
Compliance with Standards	The device must meet relevant national and international medical device standards.	Kirwan 41-34XX Series probes were tested and manufactured in accordance with prevailing standards and guidelines, and found to comply with: - ISO 10993-1 (Biological evaluation)- IEC 60601-1 (Medical electrical equipment)- IEC 60601-2-10 (Specific requirements for nerve and muscle stimulators)- ISO 11137 -1/2 (Sterilization - radiation sterilization)
Biocompatibility	Materials in contact with the patient must be biocompatible.	Testing for biocompatibility requirements was assured, implying compliance.
Dielectric Strength	Electrical insulation properties must meet safety standards.	Testing to current dielectric strength requirements was assured, implying compliance.
Sterilization	Sterilization methods must be validated and controlled.	Compliance with ISO 11137 -1/2 (Sterilization of health care products requirements for validation and routine control - radiation sterilization) is stated.
Hazard Analysis	Hazards associated with the device must be identified and adequately controlled.	Safety and hazard analysis determined that the hazard conditions for the 41-34XX Series of Disposable Nerve Stimulating Probes range in the low-to-moderate level and for this reason are acceptable. This indicates that identified risks are managed to an acceptable level.

Study Details

The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is not a clinical study designed to establish quantitative performance metrics of a new AI algorithm. Therefore, many standard AI/MDCAS study components are not applicable or explicitly mentioned.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not specified. This submission relies on engineering and manufacturing verification and validation, as well as comparison to predicate devices, rather than a clinical test set with patient data for performance evaluation in the context of an AI algorithm. The testing described (dielectric strength, biocompatibility) would involve material and electrical samples, not patient data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not specified. Ground truth, in the context of an AI/MDCAS device, typically refers to expert consensus, pathology, or outcomes for clinical data. This type of ground truth is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of physical and functional characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods are used to resolve discrepancies in expert-derived ground truth for clinical data, which is not part of this device submission.
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 study is not relevant for this type of device (disposable nerve stimulating probes). This device is a tool used by a clinician, not an AI diagnostic or assistive imaging tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device. It's an electrical probe used to stimulate nerves.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the testing performed (dielectric strength, biocompatibility, sterilization), the "ground truth" would be the established scientific and engineering standards and methodologies defined in the ISO and IEC standards listed. These standards define acceptable limits and procedures.
The sample size for the training set:
- Not applicable / Not specified. This device does not use machine learning, therefore, there is no training set.
How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no training set, this question is not relevant.

Summary

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K100912

Image /page/0/Picture/1 description: The image shows the logo for "KIRVAN Surgical Products". The logo features a medical symbol to the left of the word "KIRVAN" in large, bold letters. To the right of "KIRVAN" is the phrase "Surgical Products" in a smaller, stacked font. The logo is simple and professional, conveying a sense of trust and reliability.

AUG 1 9 2010

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

{as required by 21 CFR, section 807.92( c )}

FOR

Kirwan Disposable Nerve Stimulator Probes

Models: 41-3400, 41-3401, 41302, and 41-3403.

Common name: Disposable Nerve Stimulating Probe / Electrode.

Classification name: Needle electrode (§882.1350)

Product code: GXZ:

Devices Class: Class II

The Disposable Nerve Stimulator Probes are surface electrodes used to stimulate nerves during various surgical procedures. They may be used on the surface of the skin, or on the surface of surgically exposed tissue, and as such, they are not intended nor designed to be inserted into tissue.

Technological safety and effectiveness is established by the fact that these probes do not contain any new technological risks or characteristics when compared to legally marketed devices offered here as predicates. Their design, materials and function were intended to be, and are virtually identical to the predicates. The

Kirwan Surgical Products, LLC 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario, Director of Regulatory Affairs Date prepared: 8/19/2010

Page 1 of 2

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exceptions being the handle grip pattern and the probe insulation (where applicable), both were selected to enhance the design without compromising their substantial equivalence in regards to intended use, technological safety and effectiveness and performance. Testing to current dielectric strength and biocompatibility requirements assured that there was no compromise. Their energy source is of course identical. They are manufactured according to established standards with the technological characteristics of each probe listed on its labeling.

There are no applicable performance standards listed for these devices under Section 514 of the Food, drug and Cosmetic Act. Nonetheless, Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes have been tested and manufactured in accordance with prevailing standards and guidelines in order to assure safety and efficacy. Kirwan Disposable Nerve Stimulating Probes have been found to comply with the requirements of the applicable sections within the following standards and guidelines;

. ISO 10993-1, Biological evaluation of medical devices - Part 1: Guidance on the selection of tests.
IEC 60601-1, Medical electrical equipment. 트
IEC 60601-2-10, medical electrical equipment, Part 2; particular . requirements for the safety on nerve and muscle stimulators.
ISO 11137 -1/2, Sterilization of health care products requirements for B validation and routine control-radiation sterilization.

Safety and hazard analysis has determined that the hazard conditions for the 41-34XX Series of Disposable Nerve Stimulating Probes range in the low-tomoderate level and for this reason are acceptable.

Therefore, the Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are substantially equivalent in intended use, technological safety and effectiveness and perform as well as the following predicates:

Magstim 3600-00, 3601-00, 3602-00 and 3603-00 Disposable Probes, . Manufactured by Technomed Europe, under 510(k), K050325.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kirwan Surgical Products LLC c/o Mr. Kevin P. Prario Director of Regulatory Affairs 180 Enterprise Drive Marshfield, MA 02050

AUG 1 9 2010

Re: K100912

Trade/Device Name: 41-34XX Series of Kirwan Disposable Nerve Stimulating Probes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: Class II Product Code: GXZ Dated: July 14, 2010 Received: July 15, 2010

Dear Mr. Prario:

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.

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Page 2 - Mr. Kevin P. Prario

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. device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

R. R. Rimmer, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___

Device Name:

Models: 41-34XX Series of Kirwan Disposable Nerve Stimulating Probes.

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evauation (ODE)

Vance Davis

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

100912

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Prescription Use
(Per 21 CFR 801.109)

510(k) Number

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).