The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.

Device Description

The CODMAN® CRANIOSORB™ Absorbable Fixation System consists of The CODMAN® Clearn of craniofacial reconstruction. The Imm thick plates, mesit, and rivers to be esseesined in various shapes and sizes typical of other marketed fixation devices. The biocompatible implant material used to manufacture the plates and mesh is a blend of poly(D,L-Lactide), polycaprolactone, and polydioxanone. The rivets are constructed of poly L-lactic acid (PLLA).

AI/ML Overview

The provided text describes a medical device called the CODMAN® CRANIOSORB™ Absorbable Fixation System. It details its purpose, materials, and a summary of performance testing.

Here's an analysis of the acceptance criteria and study information provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Mechanical Performance
Retained Strength Over Time	Performance assessed	No specific quantitative acceptance criteria or results are provided. The text only states that retained strength over time was evaluated.
Dimensional Stability	Performance assessed	No specific quantitative acceptance criteria or results are provided. The text only states that dimensional stability was evaluated.
Simulated Bend Testing	Performance assessed	No specific quantitative acceptance criteria or results are provided. The text only states that simulated bend testing was conducted.
Pullout/Pushout Testing	Performance assessed	No specific quantitative acceptance criteria or results are provided. The text only states that pullout/pushout testing was conducted.
Biocompatibility
Cytotoxicity	Performance assessed	No specific acceptance criteria or quantitative results are provided. The text only states that cytotoxicity was performed.
Sensitization	Performance assessed	No specific acceptance criteria or quantitative results are provided. The text only states that sensitization was performed.
Implantation Studies of Tissue Reaction	Performance assessed	No specific acceptance criteria or quantitative results are provided. The text only states that implantation studies of tissue reaction were performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample sizes used for the specific performance tests (retained strength, dimensional stability, bend, pullout/pushout). It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based physical and chemical testing rather than clinical study data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The "tests" described are physical and biocompatibility tests of the device components themselves, not studies involving human interpretation or diagnosis where expert "ground truth" would be established.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the physical and biocompatibility characteristics of the device, not on diagnostic performance or human reader interaction with an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. The device is a physical fixation system, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through standard engineering principles and biocompatibility testing methodologies. For example, for mechanical tests, the ground truth would be the physical properties measured against pre-defined engineering specifications. For biocompatibility, the ground truth would be the standard biological reactions defined by regulatory guidelines. The document does not explicitly state these specifications but implies they exist for "device suitability."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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1 2000 AUG

510(k) Summary for the CODMAN® CRANIOSORB™ Absorbable Fixation System

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

Contact Person

James M. Flaherty, Ir., RAC Regulatory Affairs Specialist Telephone Number. (508) 880-8404 Fax Number: (508) 828-3212

Name of Device

Proprietary Name:	CODMAN® CRANIOSORB™ Absorbable Fixation System
Common Name:	Craniofacial absorbable fixation system
Classification Name:	Cranioplasty plates, plate fasteners, and burr hole covers

Device Classification

These devices have been placed in Class II for preformed alterable cranioplasty plates per 21 CFR § 882.5320 (84GWO), for cranioplasty plate fasteners per 21 CFR § 882.5360 (84HBW), and for burr hole covers per 21 CFR § 888.5250 (84GXR).

Statement of Substantial Equivalence

The CODMAN® CRANIOSORB™ Absorbable Fixation System is substantially equivalent to both the LactoSorb® Trauma Plating System (K971870) and the MacroPore Protective Sheet (K972913) based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.

Indications for Use

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Physical Description_

Device Testing

Five (5) different performance tests were conducted on the CODMAN® CRANIOSORBTM Absorbable Fixation System in order to assess device suitability for its intended use. These studies evaluated retained strength over time, dimensional stability, simulated bend testing and pullout/push out testing. In addition, biocompatibility testing was performed on the polymer blend used to manufacture the CRANIOSORB™ Plates and Mesh including cytotoxicity, manufacture the organization, and implant studies of tissue reaction

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2000 AUG

Mr. James M. Flaherty, Jr. Regulatory Affairs Specialist Codman & Shurtleff, Incorporated 325 Paramount Drive 02767-0350 Raynham, Massachusetts

K992905 Re : Codman Craniosorb Absorbable Fixation System Trade Name: II Requlatory Class: JEY Product Code: May 2, 2000 Dated: May 3, 2000 Received:

Dear Mr. Flaherty:

We have reviewed your Section 510(k) notification of intent to we have reviewed your Becord above and we have determined the market the device references as a substations for device in Babbeanonal psure) to legally marketed predicate use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enacement aco been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls concisions of the Act include requirements for annual provisions of the hos affectives, 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back addroid device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set the current Souality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodio go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents respense or ligation you might have under sections 531 noc arrect any obligation for devices under the Electronic enrough Siz or cho notrol provisions, or other Federal laws or regulations.

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Page 2 - Mr. Flaherty

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for guestions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) Device Name

CODMAN® CRANIOSORB™ Absorbable Fixation System

Indications For Use:

The CODMAN® CRANIOSORB™ Absorbable Fixation System is contraindicated for use in the mandible and as a primary source of fixation in weight bearing areas.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510 Number _______________________________________________________________________________________________________________________________________________________________________

Prescription Use V (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.