(232 days)
Not Found
No
The description focuses on patient-specific fabrication using CT data and standard materials, with no mention of AI/ML for design, analysis, or other functions.
No.
The device is an implant designed to correct cranial defects, which falls under the category of a prosthetic device rather than a therapeutic one used for treatment or cure of a disease.
No
The device is described as an implantable prosthetic to correct cranial defects, not to diagnose them.
No
The device description explicitly states the device is an "implantable prosthetic cranioplasty plate" composed of polymethyl methacrylate, which is a physical material. It is fabricated using CT data, but the final product is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The OsteoSymbionics Patient-Specific Cranial Implants are implantable prosthetic devices designed to fill cranial defects. They are physically placed within the patient's body.
- Intended Use: The intended use is to correct cranial defects by providing a physical implant. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a medical device used for surgical reconstruction, not a diagnostic test.
N/A
Intended Use / Indications for Use
The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
Product codes
GXN
Device Description
The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging data
Anatomical Site
Cranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Safety and effectiveness of the sterilized OsteoSymbionics Patient -Specific Cranial Implant has been established through comparative Testing analysis of physical properties and biocompatibility through standardized testing. Physical properties are comparable to the legally marketed device, and biocompatibility is unaffected by the change in sterilization. The sterilization and packaging validations will confirm that a sterility level of 10-6 is achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OsteoSymbionics Patient-Specific Cranial Implants (K072601)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
| osteo | symbionics™ |
|---|---|
| 1433082 | |
| Effectiveness | MAY 20 2014 |
510(k) Summary of Safety and (as required by 21 CFR § 807.92)
- 510(k) Submitter OsteoSymbionics, LLC 1768 East 25" St STE 316 Cleveland, OH 44114
- Contact Person Nicholas Wilkins, QA/RA Manager Phone: (216) 881-8500 e-mail: nw@osteosymbionics.com
Date Prepared December 4, 2013
Proprietary Name: OsteoSymbionics Patient-Specific Cranial Implant Device Name Common Name: Patient-Specific Cranial Implant Classification Name: "Plate, cranioplasty, preformed, non-alterable," a class II device in accordance with 21 CFR § 882.5330
The OsteoSymbionics Patient Specific Cranial Implants are individually Device Description sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.
- Indication for Use The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
- Substantial The OsteoSymbionics Patient-Specific Cranial Implants are substantially equivalent in terms of safety and effectiveness to the following legally Equivalence marketed device:
OsteoSymbionics Patient-Specific Cranial Implants (K072601)
These devices are identical except for the modification that they will be packaged and supplied sterile, instead of being supplied non-sterile with instructions for sterilization.
Summary of Safety and effectiveness of the sterilized OsteoSymbionics Patient -Specific Cranial Implant has been established through comparative Testing analysis of physical properties and biocompatibility through standardized testing. Physical properties are comparable to the legally marketed device, and biocompatibility is unaffected by the change in sterilization. The sterilization and packaging validations will confirm that a sterility level of 10-6 is achieved.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human figures, which is the department's symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
OsteoSymbionics, LLC Mr. Nicholas Wilkins OA/RA Manager 1768 East 25th St., STE 316 Cleveland, OH 44114
Re: K133082
Trade/Device Name: OsteoSymbionics Patient-Specific Cranial Plate Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed non-alterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: March 31, 2014 Received: April 2, 2014
Dear Mr. Wilkins:
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. 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 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
2
Page 2 - Mr. Nicholas Wilkins
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Carlos L. Pena -S
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133082
Device Name
OsteoSymbionics Patient-Specific Cranial Implant
Indications for Use (Describe)
The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."