(14 days)
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
The provided text describes a Special 510(k) submission for the Stryker® Patient Specific Polymer Implant, focusing on sterilization and a change in manufacturing location. The study's purpose is to demonstrate equivalence to the predicate nonsterile devices.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Sterilization via ISO 11137-2 | Achieved |
| Pyrogenicity testing via LAL test according to ANSI/AAMI ST72:2002 | Achieved |
| Bioburden testing to ISO 11137-2 | Conducted |
| Packaging validated to maintain sterility throughout labeled shelf-life (6 months) | Achieved |
| Integration of newer versions of Materialise software with full validation | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the tests conducted (sterilization, pyrogenicity, bioburden, packaging validation). It also does not provide information on data provenance (country of origin, retrospective/prospective) beyond stating that "Testing has been performed."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies performed are primarily laboratory-based equivalency testing (sterilization, pyrogenicity, packaging), not studies that would typically involve expert-established ground truth in the context of device performance in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where expert review is needed to establish ground truth from ambiguous or complex cases. The tests described are objective laboratory analyses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications related to sterilization and manufacturing, not on the clinical effectiveness or performance of the implant compared to human readers or other devices in a diagnostic or clinical decision-making context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable to this device. The Stryker® Patient Specific Polymer Implant is a physical implant, not a software algorithm or AI system for diagnostic or clinical decision support. While the manufacturing process involves commercially available software (Materialise), the submission does not detail standalone performance of this software in a clinical context but rather its integration and validation within the manufacturing process.
7. The Type of Ground Truth Used
For the studies mentioned (sterilization, pyrogenicity, bioburden, packaging validation), the "ground truth" is established by adherence to recognized international and national standards (ISO 11137-2, ANSI/AAMI ST72:2002) and validated laboratory testing protocols. These are not clinical ground truths (e.g., pathology, outcomes data) but rather objective measures of manufacturing and product quality.
8. The Sample Size for the Training Set
This is not applicable and therefore not provided. The device is a physical implant, and the submission describes manufacturing and sterilization validation, not the development of an AI algorithm or model that would require a training set. The "Materialise software" is mentioned as a commercially available tool integrated into the manufacturing process, implying it's not a newly developed algorithm by Stryker for this specific submission that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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K103010 page 1/2
510(k) Summary of Safety and Effectiveness:
Stryker® Patient Specific Polymer Implant
OCT 2 6 2010
| Proprietary Name: | Stryker® Patient Specific Polymer Implant |
|---|---|
| Common Name: | Preformed Alterable Cranioplasty Plate , PMMA |
| Classification Name and Reference: | Polytetrafluoroethylene with carbon fibers composite implantmaterial, 21 CFR §878.3500Preformed alterable cranioplasty plate 21 CFR §882.5320 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | KKY, GWO |
| For Information contact: | Stephanie M. Fitts, PhDDirector, Regulatory Affairs and Regulatory ComplianceHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5405 Fax: (201) 831-4405 |
| Date Prepared: | October 8, 2010 |
2
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K103010 Page 2/2
Description:
This Special 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the Stryker® Patient Specific Polymer Implant components in a sterile fashion.
Intended Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Proposed Modification:
The product will now be supplied sterile via gamma radiation in packaging that has been validated to maintain sterility throughout the product's labeled shelf-life. The manufacturing location will change from the contract manufacturer to Stryker. Although the manufacturing process has not changed since originally described in K043250, newer versions of the commercially available software described in the original submission (Materialise software) have been integrated into the process with full validation.
Device Description:
The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.
Summary of Data:
Testing has been performed to demonstrate equivalence of the subject sterile devices to the predicate nonsterile devices. The testing includes sterilization via ISO 11137-2, and pyrogenicity testing via the LAL test according to ANSI/AAMI ST72:2002. Bioburden testing was conducted to ISO 11137-2. The packaging has been validated to ensure that sterility is maintained throughout the product's labeled shelf life of 6 months.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation. % Stephanie M. Fitts, PhD Director, Regulatory Affairs and Regulatory Compliance 325 Corporate Drive Mahwah, New Jersey 07430
oci 2 6 2010
Re: K103010
Trade/Device Name: Stryker® Patient Specific Polymer Implant Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY, GWO Dated: October 8, 2010 Received: October 12, 2010
Dear Dr. Fitts:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Stephanie M. Fitts, PhD
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Stryker® Patient Specific Polymer Implant
Special 510(k)
OCT 2 6 2010
KID3010
Indications for Use
510(k) Number (if known): K103010
Device Name: Stryker® Patient Specific Polymer Implant
Indications for Use:
The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daind Keane for MXM
(Division Sign-Off)
Page 1 of 1
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K103010
4 l
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.