STIMULATING BUR GUARD

K063305 · Medtronic Xomed, Inc. · ETN · Nov 29, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K063305
• Device Name: STIMULATING BUR GUARD
• Applicant: Medtronic Xomed, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone. The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

Device Story

Stimulating Bur Guard is a sterile, single-use accessory for XPS 3000 Drill System and Medtronic Nerve Integrity Monitor (NIM). Device locks onto drill handpiece; features anterior opening to accept standard surgical bur/blade. Principle of operation: delivers electrical stimulating current from NIM console through the guard to the bur/blade tip to locate/identify cranial, peripheral, and spinal motor nerves during tissue/bone removal. Used in OR by surgeons. Output is electrical stimulation of nerves; allows surgeon to identify nerve proximity during drilling, preventing accidental nerve damage. Benefits patient by reducing risk of iatrogenic nerve injury during complex surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included reliability, useful life, bur/blade compatibility, current delivery, noise, temperature, current drop out, and electrical isolation. Biocompatibility testing performed per ISO 10993-1 and FDA G95-1. EMC and electrical safety testing conducted per EN 60601-1-2 and EN/IEC 60601-1.

Technological Characteristics

Sterile, single-use, monopolar nerve stimulator accessory. Materials biocompatible for limited duration (<24 hrs) contact. Connects to NIM console for energy delivery. Dimensions/form factor designed to lock onto XPS 3000 handpiece. Sterilization via ETO. No software or firmware components.

Indications for Use

Indicated for nerve monitoring during incision/removal of soft/hard tissue or bone using a standard bur/blade. Patient population includes those undergoing otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general, plastic, or orthopedic surgical procedures, including spinal applications.

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 Monopolar Stimulator Probe (K992869)

Reference Devices

• XPS 3000 Drill System (K041523)

Submission Summary (Full Text)

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K063305

## 510(k) Summary

NOV 2 9 2006

| 510(k) Owner | Medtronic Xomed, Inc<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216-0980 USA<br>904-296-9600<br>904-296-2386 (FAX) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Antoine Kouchakjy<br>Senior Regulatory Affairs Specialist<br>Medtronic Xomed, Inc |
| Date Summary Prepared | October 31, 2006 |
| Proprietary Name | Stimulating Bur Guard (Final name TBD) |
| Common Name | Stimulator, Nerve |
| Classification Name | Primary · Surgical nerve stimulator / locator<br>(21 CFR 874.1820, Product Code ETN, Class II)<br>Secondary · Drill, Surgical, ENT (electric or pneumatic) including<br>handpiece<br>(21 CFR 874.4250, Product Code ERL, Class II)<br>Secondary · Surgical instrument motors & accessories / attachments<br>(21 CFR 878.4820, Product Code HWE, Class I) |

### Marketed device claiming equivalence to:

The Stimulating Bur Guard is equivalent to the Medtronic Xomed Monopolar Stimulator Probe, K992869. The guard is also an accessory to the XPS 3000 Drill System covered under K041523.

### Device Description

The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.

#### Intended Use

When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.

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### Indications for Use

The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

| Characteristic | New Device:<br>Medtronic Xomed<br>Stimulating Guard | Predicate:<br>Medtronic Xomed Ball-Tip<br>Monopolar Stimulating<br>Probe [K992869] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | When used with both the Medtronic<br>Nerve Integrity Monitor (NIM) and<br>XPS Drill Systems, the Stimulating<br>Guard is intended to stimulate cranial<br>and peripheral motor nerves,<br>including spinal nerve roots, with a<br>standard bur / blade for location and<br>identification during the incision and<br>removal of soft and hard tissue or<br>bone. | To stimulate cranial and<br>peripheral motor nerves for<br>location and identification<br>during surgery, including<br>spinal nerve roots |
| Insulated | Yes | Yes |
| Stimulator connector | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization Method | ETO | ETO |
| Shelf Life | 3 months (initially) | 8-year |
| Single Use | Yes | Yes |
| Monopolar | Yes | Yes |

### Summary of Technological Characteristics

### Biocompatibility

The Stimulating Guard is considered biocompatible for use as an external communicating device with tissue / bone contact of limited duration (< 24 hrs). The appropriate tests were performed on all patient contacting materials according to:

- ISO 10993-1:2003, Biological evaluation of medical devices Part 1 Evaluation . and Testing
- FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for . Evaluation of Medical Devices, May 1, 1995

### Shelf Life Aging

Accelerated aging studies for the Stimulating Guard will ensure three (3) months shelf life prior to a limited market release and a minimum shelf life of one (1) year at the time of full market release. Shelf life testing will be ongoing post-launch to ultimately achieve a four (4) year shelf life.

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# KOG 3305

### Operating Life

The device is provided sterile and intended for single use. No reprocessing instructions are given. The device met the acceptance criteria for worst case use during a surgical procedure.

### Bench Testing

The device met the acceptance criteria for: Reliability and Useful life, Bur / blade Compatibility, Current delivery, Current delivery compared to 2.3mm ball tip probe, Noise, Temperature, Current drop out, Electrical Isolation

### Electromagnetic Compatibility and Electrical Safety Testing

The Stimulating Guard is not a source of electromagnetic interference in and of itself. However, the devices are evaluated for EMC as a system with the nerve monitoring and drill system consoles in accordance with EN 60601-1-2. Electrical safety testing is conducted in accordance with EN / IEC 60601-1 and electrical safety is achieved through levels of protection built within the BF Rated Consoles. Both the XPS 3000 and NIM systems are BF rated.

### Software

The device does not contain any software nor does it require any software changes to be made to the XPS Drill System or the Nerve Monitoring System (NIM)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Xomed, Inc. c/o Antoine Kouchakiy Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216-0980

NOV 2 9 2006

Re: K063305

Trade/Device Name: Stimulating Bur Guard Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: October 31, 2006 Received: November 1, 2006

Dear Mr. Kouchakjy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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### Page 2 - Antoine Kouchakjy

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychlemin IWD

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

Enclosure

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### INDICATIONS FOR USE

Kolo 3305 510(k) Number (if known):

Stimulating Bur Guard (Final name to be determined) Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the When used with bour the modified North late cranial and peripheral motor nerves, including Stimulating Dur Guard is meenated bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.

The Stimulating Bur Guard is indicated for nerve monitoring the incision and removal of The Stimulating Dur Guard is marcated bur / blade during otology, neurotology, sinus, Son and hard though of oche wad neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kenneth Baker

510(k) Number K063305

Prescription Use
(Per 21 CFR 801.109) X

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