(93 days)
The restor3d Metallic Interference Screw is used to provide bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
The proposed restor3d Metallic Interference Screw is a sterile, single use implant available in either titanium alloy or cobalt chrome alloy. The device is cannulated to allow a guidewire to assist with placement of the screw into the bone tunnel. The screw is used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
This document describes the premarket notification for the restor3d Metallic Interference Screw. The information provided does not pertain to an AI/ML powered device, but rather a traditional medical device (an orthopedic implant). Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study, standalone performance) are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a physical orthopedic implant and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on physical and mechanical testing rather than diagnostic accuracy metrics.
| Acceptance Criteria / Test Performed | Reported Device Performance (Summary from text) |
|---|---|
| Pullout Strength | Passed (supports substantial equivalence) |
| Insertion Torque | Passed (supports substantial equivalence) |
| Biocompatibility [ISO 10993-1] | Passed (supports substantial equivalence) |
| Pyrogenicity [ANSI/AAMI ST72] | Passed (supports substantial equivalence) |
| Sterilization | Passed (supports substantial equivalence, according to ISO 11137-1, ISO 11137-2, and AAMI TIR33) |
| Substantial Equivalence to Predicates (Overall) | The device is considered substantially equivalent to the predicate devices (Conmed EZ-Start Interference Screw, K182955, and Smith&Nephew CANNU-FLEX SILK Interference Screw, K921481) in intended use and important physical and performance specifications. |
The document states that "No new questions of safety or effectiveness were identified during device testing" which indicates the device met the pre-defined acceptance criteria for these tests. The specific quantitative values for "passed" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. For mechanical and biocompatibility testing of physical devices, the "sample size" refers to the number of physical devices tested, which is typically determined by relevant standards and statistical considerations to ensure robust results.
- Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by restor3d or a contracted testing facility. This is not clinical data, but rather engineering and materiale testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device, and the "ground truth" for its performance is established through standardized laboratory mechanical and material tests, not through expert human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not a diagnostic device or a study involving human interpretation, adjudication methods like 2+1 or 3+1 are irrelevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study is not relevant or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device (an interference screw), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical and Mechanical Standards Compliance: For this device, the "ground truth" is adherence to established engineering principles, material specifications, and performance requirements as defined by recognized standards (e.g., ISO 10993-1 for biocompatibility, ANSI/AAMI ST72 for pyrogenicity, ISO 11137 series for sterilization) and comparative performance to legally marketed predicate devices. The "truth" is whether the device physically performs as expected and is safe/effective, as demonstrated through laboratory testing.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device that requires a training set or associated ground truth.
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March 19, 2020
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restor3D Nathan Evans VP of Technology and Strategy 311 W Corporation St Durham, North Carolina 27701
Re: K193491/S001
Trade/Device Name: restore3d Metallic Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 16, 2019 Received: December 17, 2019
Dear Nathan Evans:
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
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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.
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193491
Device Name restor3d Metallic Interference Screw
Indications for Use (Describe)
The restor3d Metallic Interference Screw is used to provide bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
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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restor3d, inc.
510(k) Summary
510(k) Number:
Date Prepared: 3/13/2020
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: restor3d, inc. 311 W Corporation St Durham, NC 27701 984-888-0593
- B. Company Contact: Nathan Evans, Ph.D. VP of Technology and Strategy 404-660-4418 nathan@restor3d.com
| C. | Device Information: | |
|---|---|---|
| Trade Name: | restor3d Metallic Interference Screw | |
| Common Name: | Interference Screw | |
| D. | Classification: | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
- E. Predicate Device(s): Conmed EZ-Start Interference Screw (K182955) Smith&Nephew CANNU-FLEX SILK Interference Screw (K921481)
- F. Physical Description: The proposed restor3d Metallic Interference Screw is a sterile, single use implant available in either titanium alloy or cobalt chrome alloy. The device is cannulated to allow a guidewire to assist with placement of the screw into the bone tunnel. The screw is used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
- G. Indications for Use:
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The restor3d Metallic Interference Screw is used to provide bone-tendonbone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Comparison of Characteristics / Performance Testing / Substantial H. Equivalence:
The restor3d Metallic Interference Screw is substantially equivalent to the predicate devices (Conmed EZ-Start Interference Screw, K182955, and Smith&Nephew CANNU-FLEX SILK Interference Screw, K921481) in intended use and important physical and performance specifications. The devices have similar design / physical characteristics (i.e., similar sizing and mechanism of fixation) and the same indications for use. In addition, the restor3d Metallic Interference Screw is available with a rounded head feature, and may be provided in packaging which differs from the predicate devices. The proposed restor3d device was subjected to the following performance tests to support the assertion of safety and substantial equivalence to the predicate devices:
- Pullout Strength
- Insertion Torque
- Biocompatibility [ISO 10993-1] ●
- Pyrogenicity [ANSI/AAMI ST72] ●
- Sterilization [ISO 11137-1, ISO 11137-2, and AAMI TIR33] ●
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Metallic Interference Screw is considered substantially equivalent to the predicate device.
Nattungvana 3/13/2020
Nathan Evans, Ph.D. VP of Technology and Strategy 404-660-4418 nathan@restor3d.com
N/A