(55 days)
No
The device description and performance studies focus on the mechanical and material properties of the screws, with no mention of AI or ML.
No
The device is an interference screw used for internal fixation of soft tissues to bone, which is a structural component of a repair rather than a therapeutic agent delivering a treatment.
No
Explanation: This device is described as an interference screw intended for fixation of soft tissue to bone during surgical procedures, not for diagnosis.
No
The device description clearly states it is an interference screw manufactured from physical materials (PEEK, PEEK/Hydroxyapatite composite) and is intended for surgical implantation, indicating it is a hardware device.
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 used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws intended for fixation of soft tissue to bone during surgical procedures (specifically cruciate ligament reconstruction and other related repairs). They are implanted directly into the body.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's condition. Its function is purely mechanical support and fixation within the body.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:
- · ACL repairs
- · PCL repairs
- · Extra-capsular repairs
- · Medial collateral ligament
- Lateral collateral ligament
- · Posterior oblique ligament
- · Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
- · Illiotibial band tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee (specifically for cruciate ligament reconstruction surgeries)
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)
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:
- . Insertion Torque Testing per ASTM F543
- Torque to Failure Testing per ASTM F543 .
- Pullout Testing per ASTM F543 .
- . Biocompatibility Evaluation per ISO 10993-1
- Pyrogenicity and Endotoxin Testing per AAMI ST72 ●
- . Packaging and Shelf-Life Testing per ASTM F1980
- Sterilization Validation per AAMI TIR 56, inclusive of EO and ECH Residual Testing . per ISO 10993-7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Signature Orthopaedics Pty Ltd Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia
Re: K230655
Trade/Device Name: PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 21, 2023 Received: March 9, 2023
Dear Mr. Brazil:
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 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,
| Yu-chieh | Digitally signed by
Yu-chieh Chiu -S |
|----------|-----------------------------------------|
| Chiu -S | Date: 2023.05.03
16:29:42 -04'00' |
Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230655
Device Name
PEEK RCI, Bio-Composite and SignaLoc Screw
Indications for Use (Describe)
The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:
- · ACL repairs
- · PCL repairs
- · Extra-capsular repairs
- · Medial collateral ligament
- Lateral collateral ligament
- · Posterior oblique ligament
- · Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
- · Illiotibial band tenodesis
| 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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| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Signature Orthopaedics Europe Ltd
Unit A, IDA Business & Technology Park Garrycastle
Athlone Westmeath N37 DY26
Ireland |
| 510(k) Number | K230655 |
| Device Trade Name: | PEEK RCI, Bio-Composite and SignaLoc Screws |
| Common Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | Tuesday, May 2, 2023 |
| Classification: | Screw, Fixation, Bone (HWC, 21 CFR 888.3040)
Fastener, Fixation, Nondegradable, Soft Tissue (MBI, 21 CFR
888.3040) |
| Predicate Devices: | Primary Predicate Device
• Smith & Nephew Biosure PK Interference Screw (K083635)
Predicate Devices
• Smith & Nephew BioRCI Screw (K032224)
• Valeris Medical Apollo Suture Anchor System and Titan Screws (K142230)
Reference Devices
• Innovasis, Inc Px HA PEEK IBF System (K151785) |
Device Description:
The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length
4
of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.
Indications for Use:
The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws are RCI screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:
- ACL repairs ●
- PCL repairs ●
- Extra-capsular repairs .
- Medial collateral ligament 。
- o Lateral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs ●
- Vastus Medialis obliquus repairs o
- . Illiotibial band tenodesis
Summary of Technological Characteristics:
The PEEK RCI, Bio-Composite and Signaloc Screws share the following technological characteristics as the predicate devices:
- . The PEEK RCI, Bio-Composite and Signaloc Screws have the same intended use as the primary and secondary predicate devices.
- . The PEEK RCI, Bio-Composite and Signaloc Screws have the same indications for use as the Smith & Nephew Biosure PK Interference Screw.
- . The PEEK RCI Screws are manufactured from the same material as the Smith & Nephew Biosure PK Interference Screw and the Valeris Medical Apollo Suture Anchor System and Titan Screws. The Bio-Compoiste and Signaloc Screws are manufactured from the same material as the Innovasis Px HA PEEK IBF System.
- . The PEEK RCI, Bio-Composite and SignaLoc Screws have the same internal cannulation for a guide wire as the primary and secondary predicate devices.
- . The PEEK RCI, Bio-Composite and SignaLoc Screws share the same drive feature as the Biosure PK Interference Screw.
- . The PEEK RCI, Bio-Composite and Signaloc and the Smith & Nephew Biosure PK Interference Screw and the Smith & Nephew BioRCI Screw have a hemispherical head and are tapered.
- . The PEEK RCI, Bio-Composite and Signaloc Screws are sterilised by the same method as the Smith & Nephew BioRCI Screw.
The following are the technological differences between the PEEK RCI, Bio-Composite and Signaloc Screws, and the predicate devices:
- The PEEK RCI, Bio-Composite and Signaloc Screws are sterilised by a different method to the Smith & Nephew Biosure PK Interference Screw.
- . The Bio-Composite and Signaloc Screws is manufactured from a PEEK and hydroxyapatite composite where the Smith & Nephew Biosure PK Interference Screw is manufactured from only PEEK.
- . The PEEK RCI, Bio-Composite and Signaloc Screws are indicated for ACL/PCL repair, where the Valeris Medical Titan Mini Inteference Screw is not, all other indications are shared by the devices.
5
- The Innovasis Px HA PEEK IBF System is a Posterior Lumbar Interbody Fusion . (PLIF) device not an Interference Screw, but is a permanent tissue/bone contacting device of a similar length range and identical material as the Bio-Composite and Signaloc Screws.
Performance Data:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:
- . Insertion Torque Testing per ASTM F543
- Torque to Failure Testing per ASTM F543 .
- Pullout Testing per ASTM F543 .
- . Biocompatibility Evaluation per ISO 10993-1
- Pyrogenicity and Endotoxin Testing per AAMI ST72 ●
- . Packaging and Shelf-Life Testing per ASTM F1980
- Sterilization Validation per AAMI TIR 56, inclusive of EO and ECH Residual Testing . per ISO 10993-7.
Conclusion:
The subject devices are substantially equivalent to the predicate devices since it has the same intended use, indications for use, materials, design features, and sterilization to either all or one of the predicate devices. Non-clinical testing results support the substantial equivalence claim. Therefore, the subject devices are expected to perform adequately during clinical use.