SURGICAL STIMULATORS

K110422 · Technomed Europe · ETN · May 26, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K110422
• Device Name: SURGICAL STIMULATORS
• Applicant: Technomed Europe
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: May 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Technomed Europe Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Story

Kartush disposable surgical stimulators are invasive, single-patient-use instruments designed for tissue dissection and monopolar nerve stimulation. The device consists of a tip, tapered shaft, handle, and connection pin, typically constructed from stainless steel. It connects to external nerve monitoring equipment via a detachable lead wire with a safety DIN 42802 connector. During surgery, the clinician uses the device to physically dissect tissue while simultaneously delivering electrical stimulation to locate and identify cranial, peripheral motor, or spinal nerve roots. The output is the delivery of electrical current to the target tissue, which helps the surgeon avoid nerve damage by identifying nerve locations. The device is used in a surgical setting by a physician or surgical team. Benefits include improved nerve identification and preservation during dissection procedures.

Clinical Evidence

Bench testing only. Testing included dimensional measurements for current density, impedance tests of tips in saline, material comparison, and dielectric strength testing of shaft and handle insulation. Results confirmed performance equivalence to the predicate device.

Technological Characteristics

Materials: Stainless steel. Energy: Electrical stimulation (monopolar). Form factor: Various tip shapes (needle, elevator, ring dissector, sickle knife, hook) with tapered shaft and handle. Connectivity: Detachable lead wire with DIN 42802 safety connector. Sterilization: Sterile, single-use. Design: Integrated 1-piece material construction for tip, shaft, handle, and pin.

Indications for Use

Indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots, in patients undergoing surgical procedures.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Medtronic Xomed Stimulus/Dissection Instruments, Ball-Tip Probes (K031003)

Reference Devices

• Disposable subdermal needle electrode (K990015)

Submission Summary (Full Text)

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## p.10 + 3 K110422

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| 510(k) Summary | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands |
| Submitted by: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands<br>Tel.: [phone]<br>Fax: [phone] |
| Contact person: | Mr. Pierre Vreuls<br>Manager Regulatory Affairs and Quality Assurance<br>E-mail: [e-mail] |
| Date: | February 11, 2011 |
| Proprietary Name: | Kartush Disposable Surgical stimulators |
| Common/usual Name: | Surgical nerve stimulator/locator |
| Classification Name: | Surgical nerve stimulator/locator is classified as class II per 21<br>CFR section 874.1820. Product code ETN. |
| Substantial Equivalence: | K031003: Medtronic Xomed Stimulus/Dissection Instruments,<br>Ball-Tip Probes |
| Device description: | Kartush Disposable surgical stimulators are invasive devices used<br>in the tissue dissection and monopolar stimulating. The<br>instruments have different tip shapes for performing different<br>dissection and stimulating procedures. The tip, tapered shaft,<br>handle and connection pin are made of 1 pieces material. The<br>instruments are designed for single-patient/multiple application<br>use.<br>The detachable lead wire has a safety DIN 42802 connector. |

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K110422 p.2 of 3

Name and model numbers new devices:

| Predicate device Medtronic<br>Xomed [K031003] | Technomed Europe surgical<br>stimulators<br>[proposed device] | New model numbers<br>[proposed device] |
|-----------------------------------------------|---------------------------------------------------------------|----------------------------------------|
| Medtronic Xomed name | Proposed device name | Internal model # |
| KSD Curved needle | Kartush Curved needle | 42301-001 |
| KSD Elevator | Kartush Elevator | 42302-001 |
| KSD Ring dissector, 3mm thin | Kartush Ring dissector, 3mm thin | 42303-001 |
| KSD Ring dissector, 2mm thin | Kartush Ring dissector, 2mm thin | 42303-002 |
| KSD Sickle knife | Kartush Sickle knife | 42304-001 |
| KSD 90° hook | Kartush 90° hook | 42305-001 |
| KSD Crabtree | Kartush Crabtree | 42306-001 |
| KSD Ring dissector, 3mm reg. | Kartush Ring dissector, 3mm reg. | 42303-003 |
| KSD Ring dissector, 2mm reg. | Kartush Ring dissector, 2mm reg. | 42303-004 |

Extension cable to connect device to appropriate equipment:

| Predicate device Medtronic | Technomed Europe surgical | New model numbers |
|----------------------------|------------------------------------------------------|-------------------|
| Xomed [K031003] | stimulators<br>[proposed device] | [proposed device] |
| Medtronic Xomed name | Proposed device name | Internal model # |
| KSD connection lead wire | Kartush 3m extension cable DIN<br>42802 to DIN 42802 | 42307-001 |

Needle electrode already released under 510(k) K990015 (no predicate needed):

| Description | Device Name | Internal model # |
|------------------|---------------------------------------|------------------|
| Needle electrode | Disposable subdermal needle electrode | 40072-001 |

Commercial sets planned with above products:

| New catalog numbers set | Technomed Europe surgical<br>stimulators | New model numbers |
|-------------------------|------------------------------------------------------|-------------------|
| Proposed catalog # set | Proposed device name | Internal model # |
| 4007-00-KT | Kartush Curved needle | 42301-001 |
| | Kartush Elevator | 42302-001 |
| | Kartush Ring dissector, 3mm thin | 42303-001 |
| | Kartush 3m extension cable DIN<br>42802 to DIN 42802 | 42307-001 |
| | Disposable subdermal needle<br>electrode | 40072-001 |
| | Kartush Ring dissector, 2mm thin | 42303-002 |
| | Kartush Sickle knife | 42304-001 |
| | Kartush 90° hook | 42305-001 |
| | Kartush Crabtree | 42306-001 |
| 4009-00-KT | Kartush Ring dissector, 3mm reg. | 42303-003 |
| | Kartush Ring dissector, 2mm reg. | 42303-004 |
| | Kartush 3m extension cable DIN<br>42802 to DIN 42802 | 42307-001 |
| | Disposable subdermal needle<br>electrode | 40072-001 |

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110422 p.3 of 3

| Intended Use: | The Technomed Europe Kartush disposable surgical stimulators<br>are indicated for tissue dissection and stimulation of cranial and<br>peripheral motor nerves for location and identification during<br>surgery, including spinal nerve roots. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to predicates: | The design, materials, chemical composition, packaging and<br>other technological characteristics of the subject device is<br>equivalent to those of the predicate devices. |
| Non-clinical data: | Technomed Europe has been bench testing the Kartush<br>disposable surgical stimulators to confirm performance<br>characteristics of this device. The bench testing consisted of<br>dimensional measurements to determine the current density,<br>impedance tests of the tips of the devices through saline, material<br>comparison and dielectric strength test of the shaft and handle<br>insulation. The conclusion of these bench tests is that the subject<br>devices are equivalent to the predicate devices. |

| Comparison of characteristics between Kartush disposable surgical stimulators and the predicate |
|-------------------------------------------------------------------------------------------------|
| device: |

| Characteristic | Predicate device Medtronic Xomed<br>[K031003] | Technomed Europe's Kartush<br>disposable surgical<br>stimulators [proposed device] |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Indications for use | Tissue dissection and stimulation of cranial<br>and peripheral motor nerves for location and<br>identification during surgery including spinal<br>nerve roots. | Same |
| Base material | Stainless steel | Same |
| Electrical insulation | Electrical insulation on all surfaces not<br>intended to provide electrical contact with the<br>patient and connection | Same |
| Distal patient contact<br>surface material | Stainless steel | Same |
| Proximal stimulator<br>connector | Yes | Yes |
| IEC 60601-1<br>protected pin design | Touch proof connector | Same |
| Patient contact<br>material | Biocompatible | Same |
| Use and delivery | Single use and sterile | Same |

Conclusion:

The comparison to the predicate devices demonstrate that the Kartush disposable surgical stimulators are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

MAY 2 6 2011

Technomed Europe c/o Pierre Vreuls Manager Regulatory Affairs Amerikalaan 71 6199 AE Maastricht Airport The Netherlands

Re: K110422

Trade/Device Name: Kartush Disposable Surgical Stimulators Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: April 18, 2011 Received: April 21, 2011

Dear Mr. Vreuls:

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

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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.

Signature

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): K110422

Kartush disposable surgical stimulators Device Name:

Indications For Use:

The Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

| Prescription Use | X |
|-----------------------------|---|
| (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

John Doucet
John Doucet

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

510(k) Number K110422