CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

K033395 · Codman & Shurtleff, Inc. · GXO · Feb 25, 2004 · Neurology

Device Facts

• Record ID: K033395
• Device Name: CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GXO · Neurology
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CODMAN Dural Graft Implant is a sterile, absorbable collagen sponge derived from processed bovine tendons. Designed as a sutureless, onlay graft for dural repair, though tensionless sutures are optional. Used by neurosurgeons in clinical settings to replace or repair dura mater. Implant acts as a scaffold for tissue healing; resorbs over time. Benefits include effective dural closure, prevention of CSF leakage, and minimization of post-operative complications like adhesions or foreign body reactions.

Clinical Evidence

Bench testing and animal study only. Bench testing compared physical/mechanical properties (thickness, tensile strength, suture retention, burst strength, surface structure) against predicate. Animal study evaluated in vivo performance, showing no significant differences in CSF leakage, infection, hydrocephalus, hemorrhage, adhesion formation, device resorption, foreign body reaction, or vascularization compared to predicate.

Technological Characteristics

Collagen sponge manufactured from processed bovine tendons. Sterile, absorbable, onlay graft. Physical properties include specific thickness, tensile strength, suture retention strength, and burst strength. Surface structure characterized by Scanning Electron Microscopy.

Indications for Use

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

Regulatory Classification

Identification

A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.

Predicate Devices

• DuraGen Dural Graft Matrix (K982180)
• Codman Bicol Collagen Sponge (preamendment)
• Codman Ehtisorb™ Dura Patch (K991413)

Submission Summary (Full Text)

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# KO33395

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## 510(k) Summary CODMAN Dural Graft Implant

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

Date: October 22, 2003

#### Contact Person

Elizabeth Dolan Senior Requlatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

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

#### Device Classification

Dura Substitutes are Class II devices per 21 CFR § 882.5910.

#### Physical Description

The CODMAN 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.

#### Indications for Use

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

### Device Testing

The CODMAN Dural Graft Implant was subjected to biocompatibility testing, physical and mechanical testing, and an animal study. Testing was

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(k) Notification: CODMAN Dural Graft Implant

conducted with consideration to FDA's "Guidance Document for Dura Substitute Devices: Guidance for Industry" (Nov. 9, 2000).

The physical and mechanical properties of the sterilized CODMAN Dural Graft Implant were tested and compared to a predicate device. Both devices performed similarly. These tests included: device thickness, tensile strength, suture retention strength, burst strength, and surface structure (Scanning Electron Microscopy).

The CODMAN Dural Graft Implant and its predicate device performed similarly in an in vivo animal study. Animals implanted with either device showed no signs of CSF leakage, infection, hydrocephalus, hemorrhage or Histopathologic samples from animals implanted with either toxicity. CODMAN Dural Graft Implant or its predicate device were similar in terms of adhesion formation, device resorption, foreign body reactions, other tissue reactions, and device vascularization.

#### Statement of Substantial Equivalence

The CODMAN Dural Graft Implant is substantially equivalent to DuraGen Dural Graft Matrix (K982180), Codman Bicol Collagen Sponge (preamendment), and Codman Ehtisorb™ Dura Patch (K991413) based on the subject device's similarity to the predicate devices in intended use, material, design, physical and functional characteristics. Physical comparisons, bench testing, an animal study and a clinical literature review demonstrate that the CODMAN Dural Graft Implant is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white emblem. The emblem features a circular border with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes. The eagle is facing to the right.

FEB 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033395

Trade/Device Name: CODMAN Dural Graft Implant Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: January 9, 2004 Received: January 12, 2004

Dear Ms. Dolan:

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 Fedcral Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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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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), pleasc 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milkerson

Cclia 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): K0333395

Device Name: CODMAN Dural Graft Implant

Indications For Use: The Codman Dural Graft Implant is intended for use in procedures
For Use: The Collection of the collection disatis dura mater is needed Indications For Ose. The Oouman Burar Starting of the patient's needed.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

and the same of the same of the same of the same of the same of the same of the states of the states and

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)

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

| 510(k) Number | K033395 |
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