(15 days)
No
The device description and intended use focus on a collagen sponge for dural repair, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an implant for repairing dura mater, not a therapeutic device that treats disease or provides therapy.
No
The device is an implantable graft for repairing dura mater, not for diagnosing conditions.
No
The device description clearly states it is a collagen sponge manufactured from processed bovine tendons, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair or substitution of the patient's dura mater." This is a surgical implant used directly on the patient's tissue.
- Device Description: The description clearly states it's a "collagen sponge manufactured from processed bovine tendons" and an "absorbable implant intended for the repair of the patient's dura matter." This describes a physical implant, not a device used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical implant used for structural repair.
N/A
Intended Use / 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.
Product codes
GXQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dura mater
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No additional testing required for this special 510(k) submission. All testing submitted in original 510(k), K033395.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).
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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: (508) 828-3262 Fax Number: (508) 828-3212
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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and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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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