STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

K082010 · Stryker Ireland Ltd., Instruments Division · HBF · Dec 29, 2008 · Neurology

Device Facts

• Record ID: K082010
• Device Name: STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
• Applicant: Stryker Ireland Ltd., Instruments Division
• Product Code: HBF · Neurology
• Decision Date: Dec 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4305
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick. The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

Device Story

Zyphr Disposable Cranial Perforator; mechanically powered tool; creates access holes in cranium. Used in surgical settings by neurosurgeons. Device functions as sterile, single-use cutting accessory; attaches to powered surgical drills. Provides rapid, safe bone penetration. Benefits patient by facilitating controlled cranial access for neurosurgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanically powered cranial drill bit; sterile, single-use; available in 14/11mm and 11/7mm sizes. Materials are patient-contacting; device is a mechanical cutting accessory.

Indications for Use

Indicated for creating cranial access holes. Large 14/11mm version for adults with bone thickness ≥3mm. Small 11/7mm version for adult and pediatric patients with bone thickness ≥1mm.

Regulatory Classification

Identification

Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.

Predicate Devices

• Acra-Cut Automatic Cranial Drill (Perforator) (K892866)
• Codman Disposable Perforator (K071931)

Submission Summary (Full Text)

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DEC 2 9 2008

1000 .

**stryker**®

Instruments

## 510(k) Summary

Carrigtwobill Business & Technology Park, Carrigtwohill, Co. Cork, Ireland
t: [phone] f: [phone]
www.stryker.com

| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1811755 |
| Trade Name: | Zyphr ^TM Disposable Cranial Perforator Bit |
| Common Name: | Cranial Perforator |
| Classification Name: | Drills, Burs, Trephines & Accessories (Compound, Powered) (HBF) |
| Equivalent to: | K892866 Acra-Cut Automatic Cranial Drill (Perforator)<br>K071931 Codman Disposable Perforator |
| Device Description: | The Zyphr ^TM Disposable Cranial Perforator is a mechanically powered tool<br>specifically designed to rapidly create an access hole through the skull in a<br>safe and reliable manner. |
| Indications For Use; | The Stryker Zyphr ^TM Disposable Cranial Perforator Large 14/11mm<br>(perforator) is a sterile, single use cutting accessory intended for cutting an<br>11 mm diameter access hole through the cranium of adult patients. It is<br>intended for thin bone that is at least 3mm thick. |
| | The Stryker Zyphr ^TM Disposable Cranial Perforator Small 11/7mm<br>(perforator) is a sterile, single use cutting accessory intended for cutting a 7<br>mm diameter access hole through the cranium of adult and pediatric<br>patients. It is intended for thin bone that is at least 1mm thick. |
| Substantial Equivalence<br>(SE) Rational: | The Zyphr ^TM Cranial Perforator has the same intended use as the Acra-<br>Cut Automatic Cranial Drill (Perforator) and Codman Disposable<br>Perforator. This device and the predicate devices have the same<br>technological characteristics, the same operating principles, use the same<br>patient contacting materials and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Zyphr ^TM Cranial<br>Perforator is substantially equivalent to legally marketed devices. |

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KC82010
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Submitted by:

Colette O'Connor Regulatory Specialist

Collette O'Connor

Signature

22 Decor

Date submitted:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus in its talons. The eagle is depicted in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2008

Stryker Ireland Ltd. % Ms. Colette O'Connor Carrigtwohill Business & Technology Park Carrigtwohill, Co. Cork Ireland

Re: K082010

Trade/Device Name: Zyphr Disposable Cranial Perforator Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBF Dated: November 7, 2008 Received: November 10, 2008

Dear Ms. O'Connor:

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 (Spccial 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 - Ms. Colette O'Connor

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark M. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K082010

Device Name: Zyphr TM Disposable Cranial Perforator

## Indications For Use:

The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.

The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krave for MXM

neral, Restorative and Neurological Devices

**510(k) Number** < `K062010

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