K Number

Device Name

OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

Manufacturer

OXFORD PERFORMANCE MATERIALS

Date Cleared

2014-07-28

(224 days)

Product Code

KKY

Regulation Number

878.3500

Intended Use

The OsteoFab™ Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Device Description

An OsteoFab® Patient Specific Facial Device (OPSFD) is built individually for each patient. The OPSFD is made of polyetherketone (PEKK) polymer and built by a LASER sintering machine. The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. OPSFDs come in a variety of configurations that depend on the geometry of the application. OPSFDs are oblong and (for an individual patient) have shapes and sizes that vary within the following specifications: (1) maximum diameter is 20 cm (2) minimum thickness is 1 mm, (3) maximum thickness is 10 mm, (4) maximum open density is 25%, (5) minimum as built hole diameter is 3 mm, (6) maximum as built hole diameter is 5 mm, and (6) minimum distance from the edge of an as built hole to the edge of a device is 15 mm. The OPSFD is attached to native bone with commercially available fixation systems and it is a permanent implant. The OPSFD is a non-load bearing single use device and it does not impart mechanical strength to the implant area. The OPSFD implant is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validation for gravity displacement steam sterilization was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K924935, K111323, K103010

Reference Devices

K924935, K111323, K103010

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties, manufacturing process (LASER sintering), and mechanical performance of the implant based on patient CT data and computer-aided design. There is no mention of AI or ML algorithms being used for design, analysis, or any other function of the device.

Therapeutic

Yes
The device is intended to correct trauma and/or defects in facial bone, which falls under the definition of a therapeutic device as it treats or alleviates a medical condition.

Diagnostic

The device is an implant designed for enhancement, correction of trauma, and/or defects in facial bone, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device is a physical implant made of PEKK polymer, built by a LASER sintering machine. While it uses CT imaging data and computer-aided design in its creation, the device itself is a tangible hardware component intended for surgical implantation.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is designed for "enhancement, to correct trauma, and/or to correct defects in facial bone" and "non-load bearing enhancement of mandibular bone." This describes a surgical implant used directly on the patient's body.
Device Description: The description details a physical implant made of PEKK polymer, built using CT imaging data and computer-aided design, and attached to native bone. It is a permanent, non-load bearing, single-use device.
Anatomical Site: The specified anatomical sites are "facial bone, mandibular bone, maxillofacial, craniofacial bone," all of which are parts of the human body.
Performance Studies: The performance studies described are bench tests evaluating the physical properties and performance of the implant itself (tensile strength, screw insertion, drop characterization, dimensional stability, axial pullout force). These are tests of the device's structural integrity and interaction with bone, not tests performed on biological samples to diagnose or monitor a condition.

In Vitro Diagnostic (IVD) devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description. It is a surgical implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Product codes (comma separated list FDA assigned to the subject device)

KKY

Device Description

The OPSFD is attached to native bone with commercially available fixation systems and it is a permanent implant. The OPSFD is a non-load bearing single use device and it does not impart mechanical strength to the implant area. The OPSFD implant is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validation for gravity displacement steam sterilization

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT imaging data

Anatomical Site

facial bone, mandibular bone

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)

Biocompatibility Testing:

Tests selected according to FDA guidance document: "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995).
Results from PEKK test specimens were within acceptance criteria described in ISO 10993-3, 5, 6, 10, 11, and 18 standards.
Cytotoxicity testing on OsteoFab® test specimens (L-929 mouse fibroblast cells or human neuroblastoma SK-N-MC cells) were within ISO 10993-5 acceptance criteria.
Bacterial endotoxin evaluation using Limulus Amebocyte Lysate method (Gel-Clot method according to USP 85) on OsteoFab® test specimens; results were below the medical device contacting cerebral spinal fluid acceptance criterion (10 through holes).
- Range of through holes: 2 mm to 5 mm.
- Minimum spacing of through holes: 2 mm.
- Average diameter for 5 mm through holes (n=10) was 4.74 mm (SDEV 0.03); for 2 mm through holes (n=10) was 1.92 mm (SDEV 0.05).
- Average spacing for 5 mm through holes (n=10) was 4.81 mm (SDEV 0.02); for 2 mm through holes (n=10) was 1.79 mm (SDEV 0.03).
SCREW INSERTION:
- Experiments on PEKK test blocks (3 mm thick, straight or 45° angled edge, 14 fingers) to evaluate manual self-drilling and self-tapping screws.
- Results for self-drilling screws (1.5 mm diameter x 4 mm):
  - Fractures for straight edge: 0/28
  - Fractures for 45° angle edge: 2/28
- Results for self-tapping screws:
  - Fractures for straight edge: 0/28
  - Fractures for 45° angle edge: 0/28
DROP CHARACTERIZATION:
- N=1 test specimen per experiment, cranial flap configuration.
- Dropped from four feet above floor, horizontally (dome up/down) and vertically.
- Sterilized at 134°C for 4 minutes, dried for 30 minutes.
- Material loss was equal to or less than 0.020%.
- Results: Slight indentation on point of impact for all. Horizontal, dome up: 0.020% loss; Horizontal, dome down: 0.002% loss; Vertical: 0.008% loss.
EDGE DISTANCE:
- Four experiments applying screws to PEKK test blocks (each with 14 fingers, 3 mm thick, 45° edge).
- Inspections with 10x magnification.
- Rev B evaluation: 45/45 fingers had no cracks after screw insertion with pre-drilling at 5 mm screw centerline to edge.
- Rev D evaluation: 45/45 fingers had no cracks after screw insertion without pre-drilling at 7 mm screw centerline to edge.
- Rev A: 4/45 cracked.
- Rev C: 1/6 cracked (study discontinued).
MODIFICATION:
- Three experiments evaluating modification of PEKK test specimens (cranial flap configuration, N=2 per experiment).
- Steam sterilized at 134°C for 4 minutes, dried for 30 minutes.
- Edge modification (power tool, diamond or deep flute burr, light/heavy pressure):
  - Diamond burr light pressure: No issues.
  - Diamond burr heavy pressure: Debris melted due to friction.
  - Deep flute light pressure: No problems.
  - Deep flute heavy pressure: Burr head unstable.
- Re-contouring (power tool, diamond or deep flute burr, light/heavy pressure):
  - Diamond burr light pressure: Burr cut surface very well.
  - Diamond burr heavy pressure: Debris melted due to friction.
  - Deep flute light pressure: No problems.
  - Deep flute heavy pressure: Burr head unstable.
- Cutting (power tool, sagittal or reciprocating saw):
  - Sagittal saw: Edge cutting easy, surface cutting not as easy.
  - Reciprocating saw: Edge and surface cutting easy.
DIMENSIONAL STABILITY:
- Ten cranial flap PEKK test specimens subjected to steam sterilization cycles.
- Scanned with Romer arm prior to sterilization and after each cycle. Inspected with 10x eye loop.
- Experiment 1 (3 cycles): Sterilized at 134°C for 4 minutes.
  - 99% or more of datum points within ±0.005 inches of pre-sterilization data.
  - No cracking, fracturing, swelling, or shrinkage observed.
- Experiment 2 (9 cycles): First three at 134°C for 4-8 minutes, second three at 134°C for 4 minutes, third three at 137°C for 18 minutes.
  - After ninth cycle, 99% or more of datum points within ±0.005 inches of pre-sterilization data.
  - No cracking, fracturing, swelling, or shrinkage observed.
AXIAL PULLOUT FORCE AND PREDICATE COMPARISONS:
- Four experiments (n=8, 10, or 20 specimens) to evaluate axial pullout force according to ASTM F543-07, Annex A3.
- Comparison includes PEKK (subject device material), PMMA, and PEEK.
- Sterilization methods varied: Gamma for PMMA, Steam for PEKK and PEEK (single and repeat cycles).
- Mean Peak Axial Pullout Force (Newtons):
  - PMMA: 43.5 (SD 16.2), Gamma x 1
  - PEKK: 244.0 (SD 32.1), Steam x 1 (134C, 4min)
  - PEKK: 227.1 (SD 28.0), Steam x 1 (137C, 18min)
  - PEKK: 233.1 (SD 11.0), Steam x 1 (134C, 4min)
  - PEKK: 233.1 (SD 23.6), Steam x 2 (134C, 4min)
  - PEKK: 207.5 (SD 27.9), Steam x 3 (134C, 4min)
  - PEKK: 196.2 (SD 68.1), Steam x 1 (137C, 18min)
  - PEKK: 222.0 (SD 55.2), Steam x 2 (137C, 18min)
  - PEKK: 226.4 (SD 73.8), Steam x 3 (137C, 18min)
  - PEEK: 193.6 (SD 27.5), Steam x 1 (134C, 4min)
- All test specimens had "the screw pulled out of material" as failure mode.
- PEKK test specimens were stronger than PMMA and PEEK test specimens.
TENSILE STRENGTH PEKK DATA VERSUS A PMMA STANDARD:
- Comparison of tensile strength between OPSFD (OsteoFab® PEKK) and PMMA (predicate device material, ASTM D4802).
- Tensile at Break:
  - OPSFD Acceptance Criteria: ≥ 9,000 psi (ASTM D638)
  - PMMA Nominal values: 9,000 psi (ASTM D638)
- Elongation at Break:
  - OPSFD Acceptance Criteria: ≥ 1.5 % (ASTM D638)
  - PMMA Nominal values: 2% (ASTM D638)
- Conclusion: PEKK and PMMA materials are substantially equivalent based on tensile strength, as both prepared and tested per ASTM D638, PMMA tensile at break is same as PEKK QC acceptance criterion, and PMMA elongation at break is within PEKK acceptance criterion.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K924935, K111323, K103010

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

5 - OPSFD 510(k) Summary Statement as Required by Title 21 CFR 807.92(c)

510(k) Submitter: Oxford Performance Materials, Inc. P.O. Box 585 30 South Satellite Road South Windsor, CT 06074 1-860-698-9300

Contact Person: Leigh Ayres, Director of Scientific and Regulatory Affairs Date of 510(k) summary statement preparation: July 21, 2014 Proprietary name: OsteoFab® Patient Specific Facial Device Common or Usual Name: Polytetrafluoroethylene (PTFE) with Carbon Fibers Classification: 878.3500 General/Plastic Surgery Review Panel: General/Plastic Surgery Medical Device Classification: Class II Product Code: KKY Predicate Devices: Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935), the Synthes SynPOR HD Porous Polyethylene (K111323), and the Stryker® Patient Specific Polymer Implant (K103010)

Description of the Device

Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 1 of 14

was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

Intended Use Statement

Biocompatibility

Biocompatibility tests were selected according to the FDA guidance document: "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995) and the test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards.

The results of cytotoxicity testing on OsteoFab® test specimens utilizing L-929 mouse fibroblast cells or human neuroblastoma SK-N-MC cells were within ISO 10993-5 acceptance criteria.

The Limulus Amebocyte Lysate method was performed on OsteoFab® test specimens to evaluate bacterial endotoxin utilizing the Gel-Clot method according to USP 85. The test results were below the medical device contacting cerebral spinal fluid acceptance criterion (