DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

K100912 · Kirwan Surgical Products, Inc. · GXZ · Aug 19, 2010 · Neurology

Device Facts

• Record ID: K100912
• Device Name: DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
• Applicant: Kirwan Surgical Products, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Aug 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

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 Story

Disposable nerve stimulating probes; connect to external nerve monitoring units (e.g., Neurosign 100) via standard 1.5mm DIN 42802 touch-proof connector. Device acts as passive electrical conduit; transmits electrical impulses from monitor to patient tissue. Used by surgeons during procedures to locate/identify motor nerves. Surface electrodes; applied to skin or surgically exposed tissue; non-invasive (no tissue insertion). Provides visual/auditory feedback to surgeon via monitor response; assists in nerve preservation/identification. Benefits include improved surgical precision and reduced risk of nerve damage.

Clinical Evidence

Bench testing only. Compliance with ISO 10993-1 (biocompatibility), IEC 60601-1 (general safety), and IEC 60601-2-10 (nerve/muscle stimulator safety). No clinical data presented.

Technological Characteristics

Surface electrode; 1.5mm DIN 42802 connector. Materials compliant with ISO 10993-1. Sterilized via radiation (ISO 11137-1/2). Passive electrical path; no internal energy source. Non-invasive design.

Indications for Use

Indicated for use by clinicians during surgical procedures to assist in locating and identifying motor nerves via electrical stimulation. Not intended for insertion into tissue; for use on skin or surgically exposed tissue surfaces.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Magstim 3600-00, 3601-00, 3602-00 and 3603-00 Disposable Probes (K050325)

Reference Devices

• Neurosign 100 Nerve Monitor

Submission Summary (Full Text)

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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 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.

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: [phone] Fax: [phone] Contact: Kevin P. Prario, Director of Regulatory Affairs Date prepared: 8/19/2010

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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 [phone] or [phone] 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:

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.

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