CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223

K071931 · Codman & Shurtleff, Inc. · HBF · Oct 22, 2007 · Neurology

Device Facts

• Record ID: K071931
• Device Name: CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
• Applicant: Codman & Shurtleff, Inc.
• Product Code: HBF · Neurology
• Decision Date: Oct 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4305
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Device Story

Codman Disposable Perforator is a single-use, sterile, mechanical surgical instrument designed for cranial perforation. The device consists of stainless steel inner and outer drill components and a Hudson End interface; it attaches to standard pneumatic or electric surgical driving tools. During neurosurgical procedures, the surgeon operates the drill to penetrate the skull. The device features an automatic disengagement mechanism that triggers upon completion of the perforation or when downward pressure is removed from the drill point, preventing accidental dural injury. The device is intended for use by neurosurgeons in an operating room setting. It provides a controlled, disposable solution for cranial access, reducing the risk of cross-contamination associated with reusable perforators.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel. Energy source: External pneumatic or electric surgical drill. Form factor: Pre-assembled, single-use, sterile drill with Hudson End connection. Mechanism: Mechanical automatic disengagement upon perforation completion or pressure release.

Indications for Use

Indicated for perforating the cranium in patients requiring cranial access.

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

• Codman Disposable Perforator with Hudson End (K791101A)

Submission Summary (Full Text)

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K071931

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## 510(k) Summary Codman® Disposable Perforator

# Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

OCT 2 2 2007

## Contact Person

Emily E Valerio Regulatory Affairs Specialist II Telephone Number: [phone] Fax Number: [phone]

## Name of Device

| Proprietary Name: | Codman® Disposable Perforator |
|----------------------|-------------------------------------------------------------------------|
| Common Name: | Disposable Perforator |
| Classification Name: | Powered compound cranial drills, burrs, trephines and their accessories |

## Device Classification

Powered compound cranial drills, burrs, trephines, and their accessories are Class II devices per 21 CFR § 882.4305 (84 HBF).

## Statement of Substantial Equivalence

Codman Disposable Perforators are substantially equivalent to the Codman Disposable Perforator with Hudson End (K791101A) based on the device's similarity to the predicate device in intended use, materials, design, and principles of operations.

### Indications for Use

Codman Disposable Perforators are intended to perforate the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

#### Physical Description

The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.

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K071931

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# Device Testing

Substantial equivalence for this device is based upon comparison to predicate device characteristics and performance testing. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Codman & Shurtleff, Inc. % Ms. Emily E. Valerio Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767 OCT 2 2 2007

Re: K071931

Trade/Device Name: Codman Disposable Perforators Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBF Dated: September 13, 2007 Received: September 14, 2007

Dear Ms. Valerio:

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

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Page 2 - Ms. Emily E. Valerio

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For Mark N. Melkerson Dep 0,2
10/19/95

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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K071931

P. i. o t' l

# Indications for Use

510(k) Number (if known):

Device Name:

Codman Disposable Perforators

Indications For Use:

The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE)

P.C.M.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K07197