(341 days)
No
The device description and performance studies focus on the mechanical and biological properties of a PEEK implant for soft tissue fixation, with no mention of AI or ML.
Yes
The device is described as an implant used for soft tissue to bone reattachment to facilitate healing, which directly contributes to the treatment or management of a medical condition.
No
Explanation: The device is an implant designed for the reattachment of soft tissue to bone, specifically for rotator cuff repairs. Its purpose is therapeutic (fixation of tissue), not diagnostic (identifying a condition or disease).
No
The device description clearly states it is a PEEK implant, which is a physical hardware component, not software. The performance studies also focus on the physical properties and testing of the implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue to bone reattachment in rotator cuff repairs." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "PEEK implant" designed to be surgically implanted to fix a ruptured tendon to bone. This is a physical implant used in a surgical setting.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the SINEFIX does not involve any such testing of specimens.
The SINEFIX is a surgical implant, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.
Product codes
MBI
Device Description
The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus of the shoulder
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
The SINEFIX has been subject to non-clinical testing, including:
- Insertion testing
- ASTM F543-17 Pullout testing
- ASTM F543-17 Pullout testing after cyclic loading
- Static tensile test
- Dynamic testing pullout strength after cyclic loading
- Pyrogenicity and endotoxins
- Packaging testing was performed in accordance with ISO 11607-1/2 and has proven a shelf life of 5 years;
- Biological evaluation was performed in accordance with ISO 10993-1 and the Guidance for Industry and FDA Staff - Use of International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", September 4, 2020;
- Sterilization validation was performed in accordance with ISO 11137-1/2 and has proven a SAL 10-6:
- Reprocessing validation was performed for the cleaning, disinfection, steam sterilization and drying of the reusable surgical instruments in accordance with the Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 17, 2015;
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K051726, K994202, K062466, K162429, K983843, K123579, K101823, K132783, K091870
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.
0
March 8, 2023
Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
BAAT Medical Products B.V. Jasper Springer, Ph.D. Regulatory Affairs Officer F. Hazemeijerstraat 800-Building A04 Hengelo, Overijssel 7555 RJ Netherlands
Re: K220966
Trade/Device Name: SINEFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 8, 2023 Received: February 8, 2023
Dear Dr. Springer:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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.
Sara S. Thompson -S
For
Laurence D. Coyne, Ph.D. Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220966
Device Name SINEFIX
Indications for Use (Describe)
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.
| 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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Traditional 510(k) Summary
| Submitter Name: | BAAT Medical Products B.V. |
|---|---|
| Submitter Address: | F. Hazemeijerstraat 800 - Building A04 |
| 7555 RJ Hengelo | |
| The Netherlands | |
| Phone Number: | +31-(0)88-5656600 |
| Contact person: | Jasper Springer |
| Date Prepared: | March 30, 2022 |
| Device | |
| 510(k) Number | K220966 |
| Device Trade name: | SINEFIX |
| Common Name: | Not Applicable |
| Classification: | Smooth or threaded metallic bone fixation fastener (21 CFR Sec. |
| 888.3040) | |
| Class: | II |
| Product Code: | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Review Panel: | Office of Health Technology 6: Orthopedic Devices |
| Predicate Device | |
| Primary Predicate: | Coronet Soft Tissue Fixation System (K200028) |
| Reference devices: | Arthrex Tenodesis Screw Family (K051726) |
| Acufex Spiked Washer System (K994202) | |
| Interference Screw (K062466) | |
| ZipE Knotless Tissue Repair and Attachment Devices (K162429) | |
| Bio-Button (K983843) | |
| FOOTPRINT Ultra PK Suture Anchor (K123579) | |
| SwiveLock Anchors (K101823) | |
| ExoShape Duo Soft Tissue Fastener (K132783) | |
| PITON Fixation Implant System (K091870) |
4
Description of the Device 4.
The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.
5. Intended Use/Indication for Use Statement
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.
6. Summary of Technological Characteristics of the Device Compared to Predicate devices
A comparison of technological characteristics is made between the SINEFIX and the predicate devices in Table 5.1.
| Subject Device | Primary Predicate | |
|---|---|---|
| 510(k) | K220966 | K200028 |
| Device name | SINEFIX | Coronet Soft Tissue Fixation System |
| Manufacturer | BAAT Medical Products BV | CoNextions Medical, Inc. |
| Product code | MBI | MBI |
| Regulation # | 888.3040 | 888.3040 |
| Class | II | II |
| Image | Image: Subject Device | Image: Primary Predicate |
| Indications for Use | The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm. | ... intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications: |
| Shoulder: Rotator Cuff Repair... | ||
| Material | PEEK | PEEK, Stainless Steel |
| Size | Baseplate: 10mm x 8mm (17.7mm) - Plate thickness 0.7mm | |
| Medial Anchor: Ø3mm (4.42mm) x | Button: Ø 8.7mm x 2.4mm - Plate thickness 0.5mm |
Table 5.1: Technical Comparison, Subject Device and Predicate.
5
| 16.24mm
Lateral Anchor: Ø4.02 (6.8mm) X
18.21mm | #2 suture (FiberWire® Suture, Arthrex):
0.5mm
Anchor: Ø 3.5mm x 12.3mm |
| ------------------------------------------------------- | ------------------------------------------------------------------------------ |
|---|
7. Summary of Performance Data and Design Controls
The SINEFIX has the same technological characteristics as the predicate devices including design, intended use and material composition.
The SINEFIX has been subject to non-clinical testing, including:
- Insertion testing
- ASTM F543-17 Pullout testing
- ASTM F543-17 Pullout testing after cyclic loading
- Static tensile test
- Dynamic testing pullout strength after cyclic loading
- . Pyrogenicity and endotoxins
In accordance with the guidance for Industry and FDA Staff: Bone Anchors - Premarket Notification (510(k)) Submissions, March 3, 2020.
- . Packaging testing was performed in accordance with ISO 11607-1/2 and has proven a shelf life of 5 years;
- Biological evaluation was performed in accordance with ISO 10993-1 and the Guidance for Industry and FDA Staff - Use of International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", September 4, 2020;
- . Sterilization validation was performed in accordance with ISO 11137-1/2 and has proven a SAL 10-6:
- . Reprocessing validation was performed for the cleaning, disinfection, steam sterilization and drying of the reusable surgical instruments in accordance with the Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 17, 2015;
Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices.
8. Conclusion of Substantial Equivalence
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the SINEFIX to interstate commerce. Substantially equivalence has been demonstrated to the cited predicate device.