(15 days)
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.
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.
The provided document K041518 is a 510(k) summary for the CODMAN DURAFORM Dural Graft Implant. It is a "Special 510(k) submission" and the key information regarding acceptance criteria and device performance is specifically described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document states: "No additional testing required for this special 510(k) submission. All testing submitted in original 510(k), K033395." Due to this, the provided document K041518 does not contain specific acceptance criteria or reported device performance for new tests. Instead, it relies on the predicate device (K033395) for its substantial equivalence claim regarding performance.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. As noted above, no new testing was performed for this special 510(k) submission (K041518). Information regarding sample size and data provenance for the original 510(k) (K033395) is not available in the provided document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Since no new testing was conducted, there was no expert review process described for establishing ground truth within this document. This kind of information would typically be found in the original 510(k) submission (K033395) if clinical or performance data was gathered requiring expert evaluation.
4. Adjudication Method for the Test Set
Not applicable. No new testing requiring adjudication was performed for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not performed as part of this 510(k) submission, as it is a special 510(k) relying on equivalence to a predicate device without new performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a dural graft implant, not an AI algorithm. Therefore, no standalone algorithm performance study was done.
7. The Type of Ground Truth Used
Not applicable. As this is a medical implant and no new performance testing was conducted, there is no discussion of ground truth in the context of an AI algorithm or diagnostic device. The substantial equivalence is based on the physical properties, intended use, and materials of the implant compared to its predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a medical implant, not an AI algorithm. Therefore, there is no training set mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device.
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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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510(k) Number_ 100 4/5/8
§ 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).