CODMAN DURAFORM DURAL GRAFT IMPLANT

K041518 · Codman & Shurtleff, Inc. · GXQ · Jun 22, 2004 · Neurology

Device Facts

• Record ID: K041518
• Device Name: CODMAN DURAFORM DURAL GRAFT IMPLANT
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CODMAN DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

Device Story

The CODMAN DURAFORM Dural Graft Implant is a sterile, absorbable collagen sponge derived from processed bovine tendons. It serves as a dural substitute for the repair or replacement of the dura mater. The device is designed primarily as a sutureless, onlay graft, though surgeons may opt for tensionless sutures if desired. It is intended for use by surgeons in clinical settings during neurosurgical procedures. By providing a scaffold for dural repair, the implant facilitates healing and closure of the dural membrane.

Clinical Evidence

No clinical data provided; bench testing only as established in the original 510(k) submission (K033395).

Technological Characteristics

Collagen sponge material derived from processed bovine tendons. Sterile, absorbable implant. Designed as an onlay graft for sutureless or tensionless suture application.

Indications for Use

Indicated for patients requiring repair or substitution of the dura mater during surgical procedures.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• CODMAN Dural Graft Implant (K033395)

Submission Summary (Full Text)

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## K041518

### 510(k) Summary CODMAN DURAFORM Dural Graft Implant (formerly known as CODMAN Dural Graft Implant)

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

Contact Person________________________________________________________________________________________________________________________________________________________________

Elizabeth Dolan Sr. Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

### Name of Device________________________________________________________________________________________________________________________________________________________________

CODMAN DURAFORM Dural Graft Implant Proprietary Name: Dura Substitute Common Name: Classification Name: Dura Substitute

## Device Classification ________________________________________________________________________________________________________________________________________________________

Class II, per 21 CFR § 882.5910 – Dura substitute (GXQ)

### Statement of Substantial Equivalence__________________________________________________________________________________________________________________________________________

The CODMAN DURAFORM Dural Graft Implant is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to itself (K033395).

#### Indications for Use __________________________________________________________________________________________________________________________________________________________

The CODMAN DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

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# KO41518

The CODMAN DURAFORM Dural Graft Implant is a collagen sponge manufactured from processed bovine tendons. It is a sterile, absorbable implant intended for the repair of the patient's dura matter. The CODMAN Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.

#### Device Testing________________________________________________________________________________________________________________________________________________________________

No additional testing required for this special 510(k) submission. All testing submitted in original 510(k), K033395.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Ms. Elizabeth Dolan Senior Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K041518

Trade/Device Name: CODMAN DURAFORM Dural Graft Implant Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: II Product Code: GXQ Dated: June 4, 2004 Received: June 7, 2004

Dear Ms. Dolan:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave 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 for use stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to oonimores provision of 110) 233 de MCS that have been rechasined require approval of a premarket approval application (PMA). and Cosmeter Free (110) war the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 rr your de rise to such additional controls. Existing major regulations affecting your device can may or babyet to back want want 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 I lease be actives and I Drivination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I cueral statuted and equirements, including, but not limited to: registration and listing (21 comply with an the Not of LEFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Elizabeth Dolan

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieming of substantial equivalence of your device to a legally premaired notincation: "The PDF intellige of the more 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 If you desire specific acrees as [phone]. Also, please note the regulation entitled, Colliact the Office of Compunities in the notification" (21CFR Part 807.97). You may obtain Missuranting by reference to premation on your responsibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. 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): K041518

Device Name: CODMAN DURAFORM Dural Graft Implant

Indications For Use:

The CODMAN DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

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)

Miriam C. Provost

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

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