(199 days)
Not Found
No
The description focuses on computer-aided design (CAD) and laser sintering for creating patient-specific implants based on CT scans, with no mention of AI or ML.
No.
The device replaces bony voids and acts as a structural component, which is a restorative function rather than a therapeutic one (i.e., treating a disease or condition).
No
The device is described as an implant for replacing bony voids in the cranial skeleton, not for diagnosing conditions.
No
The device is a physical implant (OPSCD) manufactured through laser sintering of PEKK polymer. While it uses software for design based on CT scans, the device itself is a hardware component intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "replacement of bony voids in the cranial skeleton." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a physical implant built for each patient and attached to bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.
N/A
Intended Use / Indications for Use
The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.
Product codes
GXN
Device Description
An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
cranial skeleton
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
Test: End-to-End Simulation Report for OPSCD for Single Stage Surgery
Study Type: Performance Bench Testing
Sample Size: Not specified, "Worst-case, representative cranial cases were selected"
Key Results: All acceptance criteria were met, showing that OPSCDs used in single stage cranial surgeries can successfully fill a defect that did not exist prior to the surgical procedure, that is, OPSCDs may be designed to fit pre-planned virtual defects and function as intended. Based on these results, the OPSCD is considered as safe and as effective as the predicate device and performs as well as the marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2018
Oxford Performance Materials, Inc. M. Beth Pashko Quality Director 30 South Satellite Road South Windsor, Connecticut 06074
Re: K180064
Trade/Device Name: OsteoFab Patient Specific Cranial Device Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: June 29, 2018 Received: July 2, 2018
Dear Ms. Pashko:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Valerie A. Flournoy -S
Carlos L. Peña, PhD, MS For Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180064
Device Name OsteoFab Patient Specific Cranial Device
Indications for Use (Describe)
The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary [As required by 21 CFR 807.92]
| I. Submitter | |
|---|---|
| 510(k) Owner: | Oxford Performance Materials, Inc. |
| 30 South Satellite Road | |
| South Windsor, CT 06074 USA | |
| Phone: +1.860.698.9300 | |
| Fax: +1.860.698.9978 | |
| Submitter/Contact: | M. Beth Pashko |
| Quality Director | |
| Oxford Performance Materials, Inc. | |
| 30 South Satellite Road | |
| South Windsor, CT 06074 USA | |
| Phone: +1.860.698.9300 | |
| Date Prepared: | June 29, 2018 |
| II. Device |
| Proprietary Name: | OsteoFab® Patient Specific Cranial Device |
|---|---|
| Common or Usual Name: | Patient Specific Cranial Implant |
| Classification: | 21 CFR 882.5330; Preformed non-alterable cranioplasty plate |
| Regulatory Class: | Class II |
| Product Code: | GXN |
| Review Panel: | Neurology |
III. Predicate Device
Predicate Device:
Oxford Performance Materials, Inc. OsteoFab® Patient Specific Cranial Device (K121818)
IV. Device Description
An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.
4
Indications for Use
The OsteoFab® Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.
V. Comparison of Technological Characteristics with the Predicate Device
Principle of Operation
The basic operational principle of the OPSCD remains the same as the predicate: the operating principle of the OPSCD is to replace bony voids in the cranial skeleton.
Technological Characteristics
New performance data was required to ensure that OPSCDs can be used successfully in preplanned defects in addition to existing cranial bone defects. The technological characteristics remain the same and are summarized below.
- Same operating principle: to replace bony voids in the cranial skeleton |
- Same material: there is no change to the implant material ।
- Same manufacturing process: laser sintering of PEKK polymer ।
- Same sterilization method: there is no change in the implant sterilization method ।
- । Similar design process: there is no change to the implant design process. Surgeons may now provide single-stage design inputs for the scope of the implant reconstruction boundary
- Same mode of fixation: commercially available cranioplasty fixation systems --
VI. Performance Data
The modifications described in this submission include a clarification to the device Warnings based on the prescribed Indications for Use. There are no changes to the device specifications, manufacturing process, or operating principle of the OPSCD. The following performance data were provided in support of the substantial equivalence determination based on the risk analysis that was performed.
Performance Bench Testing
The following performance bench test was completed:
OPSCD 510(k) Summary Page 2 of 3
5
| Test | Test Method Summary | Results |
|---|---|---|
| End-to-End Simulation | ||
| Report for OPSCD for Single | ||
| Stage Surgery | Worst-case, representative | |
| cranial cases were selected | ||
| for end-to-end simulation | ||
| testing. | All acceptance criteria were | |
| met, showing that OPSCDs | ||
| used in single stage cranial | ||
| surgeries can successfully fill | ||
| a defect that did not exist | ||
| prior to the surgical | ||
| procedure, that is, OPSCDs | ||
| may be designed to fit pre- | ||
| planned virtual defects and | ||
| function as intended. | ||
| The purpose of this test was | ||
| to verify the process of using | ||
| OPSCDs for single stage | ||
| cranioplasty procedures, that | ||
| is, where the defect is not | ||
| present at the time of the CT | ||
| scan. | Implants were designed to | |
| the specifications cleared in | ||
| K121818, manufactured | ||
| using the same process, | ||
| inspected, shipped, and fit | ||
| tested on skull models. Fit | ||
| testing was conducted using | ||
| commercially available | ||
| marking guides, as is typical | ||
| in single stage cranioplasties. | Based on these results, the | |
| OPSCD is considered as safe | ||
| and as effective as the | ||
| predicate device and | ||
| performs as well as the | ||
| marketed predicate device. | ||
| Acceptance criteria included | ||
| meeting existing product | ||
| release criteria, successful | ||
| shipment without damage to | ||
| the devices, successful | ||
| fixation of the implants onto | ||
| the skull models, and | ||
| satisfactory fit. |
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
VII. Substantial Equivalence Conclusion
Enabling surgeon design inputs for single stage procedures does not impact the safety or effectiveness of the device per the results of the non-clinical data. The summarized performance testing supports that the OsteoFab® Patient Specific Cranial Device is as safe and as effective as the predicate device and that it performs as well as the marketed predicate device in the prescribed indications. The technological principles of the subject device are unchanged and are substantially equivalent to the predicate device, according to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein.