(178 days)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.
This is a 510(k) summary for a medical device called the "Pre-Sutured Tendon." It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device submission.
As such, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a traditional medical device (a pre-sutured tendon for ligament reconstruction) and its regulatory clearance based on substantial equivalence to existing predicate devices, rather than an AI/ML-driven diagnostic or prognostic device requiring specific performance metrics related to diagnostic accuracy or reader studies. The "Performance Data" section briefly mentions bench testing and a human cadaver study to demonstrate feasibility and user needs, but these are not presented in the format of acceptance criteria for an AI/ML device study.
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June 23, 2023
RTI Surgical, Inc Ellen Rounds Director Regulatory Affairs 11621 Research Circle Alachua, Florida 32615
Re: K230036
Trade/Device Name: Pre-Sutured Tendon Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: May 24, 2023 Received: May 24, 2023
Dear Ellen Rounds:
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.
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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 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 -S
Jesse Muir, PhD Assistant 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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Indications for Use
510(k) Number (if known) K230036
Device Name Pre-Sutured Tendon
Indications for Use (Describe)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
| 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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Image /page/3/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue square with a rounded corner. To the right of the square, the word "surgical" is written in gray letters. The logo is simple and modern.
510(k) Summary K230036
| Date Prepared | June 22, 2023 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Submitter | RTI Surgical, Inc. 11621 Research CircleAlachua, FL 32615 USA | ||||||||||||
| ContactInformation | Ellen RoundsSr. Regulatory Affairs SpecialistEmail: erounds@rtix.com | ||||||||||||
| Name of Device | Pre-Sutured Tendon | ||||||||||||
| Common Name | Pre-Sutured Tendon | ||||||||||||
| ClassificationName | Suture, Nonabsorbable, Synthetic, Polyethylene | ||||||||||||
| RegulationNumber | 21 CFR 878.5000 | ||||||||||||
| RegulatoryClass | Class II | ||||||||||||
| Product Code | GAT | ||||||||||||
| Panel | General and Plastic Surgery | ||||||||||||
| Legally MarketedPredicateDevice(s) | K181633 MTF Pre-Sutured TendonK170957 Allosource ReConnex Pre-Sutured Tendon | ||||||||||||
| Device Description | The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured withsterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbablesutures. The tendon is processed via the BioCleanse® Tissue SterilizationProcess (The BioCleanse Process). The Pre-Sutured Tendon device is offeredas a single strand and as a quadruple (quad) strand. | ||||||||||||
| Dimensions Implant Length (mm) Folded Diameter (mm) Single Strand 180-220 8.5-12 Quadruple Strand 50-70 9.0-13 | |||||||||||||
| Indicationsfor Use | The Pre-Sutured Tendon is intended for use as a construct in anterior cruciateligament and posterior cruciate ligament reconstruction.The Pre-Sutured Tendon is for single patient use only. | ||||||||||||
| Comparison ofTechnologicalCharacteristicswith the PredicateDevice | The subject and predicate devices are based on the following sametechnological characteristics and both function as constructs for anteriorcruciate ligament and posterior cruciate ligament reconstruction.The subject device is composed of donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) |
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Image /page/4/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green dot above it.
| Sterilization Process (The BioCleanse Process). Donors meet eligibilityrequirements for all communicable diseases via a medical doctor review ofdonor medical and social history and all applicable infectious disease screeningtests. The donor blood samples taken at the time of recovery were tested by afacility that is CLIA certified and registered with the FDA. The blood samplesare screened for the following: HIV-1 / HIV-2 Antibody, Hepatitis C VirusAntibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody (Total),Treponema pallidum (Syphilis), Human T-Cell, Lymphotropic Virus I/IIAntibody, and HIV-1/HCV/ HBV* NAT-TMA. The donor tissue utilizedmeets the requirements of the American Association of Tissue Banks (AATB).All infectious disease test results passed acceptability for screening. The Pre-Sutured Tendon has been determined to be suitable for implantation.There are no technological differences between the subject and predicatedevice. However, there are minor dimensional differences between the subjectdevice and the predicate devices. These differences do not affect the intendeduse, performance, safety, design or function of the subject device for itsintended use in anterior cruciate ligament and posterior cruciate ligamentreconstruction. | |
|---|---|
| PerformanceData | Visual characteristics and bench testing such as Ultimate Load, CyclicDisplacement, and Suture Pull Out Testing of the Pre-Sutured Tendons wereevaluated and are found to meet requirements that are clinically relevant.Non-clinical testing data submitted to demonstrate substantial equivalenceincludes packaging validation, tissue sterilization and viral inactivation, shelf-life, and biocompatibility. Biocompatibility testing was conducted usingmethods described in ISO 10993. Bacterial endotoxin testing was alsoperformed and was substantially equivalent to the predicates.A human cadaver study was conducted to demonstrate the feasibility of usingthe Pre-Sutured Tendon for ACL/PCL reconstruction. The results of this enduser validation establish that the Pre-Sutured Tendon implants labeling,packaging, dimensions (form), configuration (single/quadruple strand), andfunctionality meet user needs and expectations. Additionally, the resultsestablish that the single and quadruple strand Pre-Sutured Tendon constructsmet the intended use and therefore are appropriate for ACL and PCLreconstruction. The study also concluded that the subject device, the Pre-Sutured Tendon, constructs can be implanted using traditional clinical methodsby an orthopedic surgeon. |
| SubstantialEquivalence | The subject device was demonstrated to be substantially equivalent to thepredicate devices cited above with respect to indications for use, asepticprocessing, design, size, materials, function, storage, and performance. |
| Conclusion | The Pre-Sutured Tendon is substantially equivalent to the predicate deviceswith respect to indications for use, tissue sterilization processes, asepticpackaging, design, function, materials, and performance. Product safety andperformance are adequately supported by the substantial equivalenceinformation and test results. |
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.