(85 days)
Not Found
No
The document describes a mechanical suture anchor and its intended use and testing, with no mention of AI or ML technology.
No.
A therapeutic device is one that treats or heals a disease or condition. This device provides fixation for reattachment of soft tissue to bone, which is a supportive function, not a therapeutic one.
No
The device is an implantable suture anchor intended for the mechanical fixation/reattachment of soft tissue to bone during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical suture anchor made from PEKK polymer, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The OsteoFab® Suture Anchors are described as devices for the fixation/reattachment of soft tissue to bone during surgical procedures. They are physical implants used within the body to mechanically secure tissue.
- Lack of Specimen Examination: The device does not involve the examination of any biological specimens outside of the body. Its function is purely mechanical and surgical.
Therefore, the OsteoFab® Suture Anchors fall under the category of surgical implants or devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair.
Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis.
Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair.
Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair.
Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.
Product codes
MBI
Device Description
The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, hand and wrist, elbow, and foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
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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)
For determination of substantial equivalence, insertion testing, pullout testing, and fatigue testing were performed. Mechanical testing showed that the mechanical strength and function of the subject device is substantially equivalent to the legally marketed predicate device and that it is sufficient for the intended use. A biological safety assessment was also performed that demonstrated that the subject device is biocompatible for long term implantation and substantially equivalent to the legally marketed predicate device.
Performance Bench Testing:
- Insertion testing
- Static pullout testing
- Fatigue testing
Animal Testing: not required as a basis for substantial equivalence.
Clinical Testing: not required as a basis for substantial equivalence.
Biocompatibility Testing: evaluated endpoints including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity. Endotoxin testing was also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
July 3, 2019
Oxford Performance Materials, Inc. Mr. Andrus Maandi Product Development Engineer 30 South Satellite Road South Windsor, Connecticut 06074
Re: K190915
Trade/Device Name: OsteoFab® Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 8, 2019 Received: April 9, 2019
Dear Mr. Maandi:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Laurence Coyne, Ph.D. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name OsteoFab® Suture Anchors
Indications for Use (Describe)
The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair.
Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis.
Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair.
Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair.
Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image shows a logo with the letters OPM. The "O" is represented by an orange circle inside a diamond shape. The "P" is represented by a black letter inside a circle and square. The "M" is represented by an orange letter inside a triangle and square.
005 – 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: (860)-698-9300 | |
| Fax: (860)-698-9978 | |
| Submitter/Contact: | Andrus Maandi |
| Product Development Engineer | |
| Oxford Performance Materials, Inc. | |
| 30 South Satellite Road | |
| South Windsor, CT 06074 USA | |
| Phone: (860)-656-9437 | |
| Date Prepared: | April 17, 2019 |
| II. Device | |
| Proprietary Name: | OsteoFab® Suture Anchors |
| Common or Usual Name: | Bone anchors, suture anchors |
| Classification: | 21 CFR 888.3040; Smooth or threaded metallic bone fixation fastener |
| Regulatory Class: | Class II |
| Product Code: | MBI |
| Review Panel: | Orthopedic |
III. Predicate Device
K122314 Cayenne Quattro Link Knotless Anchors Predicate Device:
IV. Device Description
The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile.
4
Intended Use Statement
The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair.
Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis.
Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair.
Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair.
Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.
V. Comparison of Technological Characteristics with the Predicate Device Principle of Operation
The basic operational principle of the OsteoFab® Suture Anchors is the same as the predicate: the operating principle of the OsteoFab® Suture Anchors is to fixate/reattach soft tissue to bone.
Technological Characteristics
The technological characteristics of the OsteoFab® Suture Anchor devices are similar to the predicate device in terms of operating principle and intended use. The OsteoFab® Suture Anchors are deployed into a pilot hole using a custom inserter and recommended suture in order to secure soft tissue to bone. Any differences in technological characteristics are summarized below:
- । Design: optimized design for additive manufacturing with same general characteristics to achieve a secure interference fit in bone.
- । Material: polyetherketone (PEKK) is used instead of polyetheretherketone (PEEK).
- Manufacturing method: OsteoFab® Suture Anchors are manufactured in an additive । process compared to conventional machining.
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VI. Performance Data
For determination of substantial equivalence, insertion testing, pullout testing, and fatigue testing were performed. Mechanical testing showed that the mechanical strength and function of the subject device is substantially equivalent to the legally marketed predicate device and that it is sufficient for the intended use. A biological safety assessment was also performed that demonstrated that the subject device is biocompatible for long term implantation and substantially equivalent to the legally marketed predicate device.
Performance Bench Testing
The following performance bench tests were completed:
- । Insertion testing
- । Static pullout testing
- Fatigue testing ।
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.
Biocompatibility Testing
A biological safety assessment was performed that evaluated endpoints including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity. Endotoxin testing was also performed.
Sterilization and Cleaning
Sterilization and cleaning instructions in the subject device labeling are provided per validated methods and parameters.
VII. Substantial Equivalence Conclusion
This submission supports the position that the subject implants are substantially equivalent to the previously cleared predicate devices. The subject and predicate devices are similar in terms of indications for use, operating principles, technological characteristics, and mechanical strength. There are no significant differences between the subject and predicate device that would affect the safety and effectiveness of the OsteoFab® Suture Anchors. Any differences were not considered significant based on the data provided in this submission.