(125 days)
The CODMAN Dural Graft Implant is intended for use in procedures where the repair or substitute of the patient's dura mater is needed.
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.
The CODMAN Dural Graft Implant was evaluated through biocompatibility, physical/mechanical testing, and an animal study, with results compared to a predicate device, DuraGen Dural Graft Matrix (K982180), Codman Bicol Collagen Sponge (preamendment), and Codman Ehtisorb™ Dura Patch (K991413).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (CODMAN Dural Graft Implant) | Reported Device Performance (Predicate Device) |
|---|---|---|
| Biocompatibility | No signs of toxicity | Not explicitly stated but inferred to be acceptable given substantial equivalence claim |
| Physical and Mechanical Properties | Similar thickness, tensile strength, suture retention strength, burst strength, and surface structure | Baseline for comparison |
| In Vivo Performance (Animal Study) | No CSF leakage, infection, hydrocephalus, hemorrhage, or toxicity | No CSF leakage, infection, hydrocephalus, hemorrhage, or toxicity |
| Histopathologic Samples (Animal Study) | Similar adhesion formation, device resorption, foreign body reactions, and tissue vascularization | Baseline for comparison |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Type: This dossier describes performance testing (biocompatibility, physical/mechanical, and an animal study) rather than a clinical study with human subjects.
- Sample Size:
- Biocompatibility: Not explicitly stated, but typically involves in vitro and/or in vivo tests on cell samples or small animals.
- Physical and Mechanical Testing: Not explicitly stated, but typically involves multiple samples for each test (e.g., thickness, tensile strength, burst strength).
- Animal Study: The number of animals used is not specified.
- Data Provenance: The studies are described as "Device Testing" and "an animal study." This suggests prospective data generation specifically for the purpose of this submission. The country of origin for the studies is not specified, but the applicant, Codman & Shurtleff, Inc., is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Animal Study Adjudication: Histopathologic samples were analyzed. While not explicitly stated, it is inferred that veterinary pathologists or similar qualified experts would have assessed these samples. The number of experts is not specified.
- Physical/Mechanical Testing: These tests typically rely on standardized laboratory protocols and instrumentation, rather than expert consensus on a 'ground truth' in the same way clinical image interpretation would.
4. Adjudication Method for the Test Set:
- Animal Study: The document mentions "Histopathologic samples from animals implanted with either 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." This implies a comparison of findings, likely by qualified experts. However, a specific adjudication method (e.g., 2+1, 3+1) is not provided. It's more likely an independent assessment by pathology experts.
- Other tests: Not applicable, as these are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The evaluation involved a direct comparison of physical properties and in vivo performance in an animal model between the new device and predicate devices. This type of study is more relevant for diagnostic devices interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable as this is a medical implant, not an AI algorithm.
7. The Type of Ground Truth Used:
- Physical and Mechanical Testing: The "ground truth" was established by objective measurements against predefined specifications or benchmarks, and direct comparison to the predicate device.
- Animal Study: The "ground truth" for in vivo performance (e.g., CSF leakage, infection) and histopathologic findings (e.g., adhesion formation, resorption, foreign body reactions) was established through direct observation, clinical assessment, and microscopic evaluation by qualified personnel (e.g., veterinarian, pathologist).
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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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: (508) 828-3262 Fax Number: (508) 828-3212
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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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§ 882.5900 Preformed craniosynostosis strip.
(a)
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.(b)
Classification. Class II (performance standards).