(268 days)
The MTF Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The MTF Pre-Sutured Tendon is for single patient use only.
The MTF Pre-Sutured Tendon is a construct consisting of a single tendon pre-sutured with UHWMPE non-absorbable surgical suture. The device may include a semitendinosus tendon. bilateral anterior and posterior tibialis tendon, or bilateral peroneus longus tendon., The Pre-Sutured Tendon passes USP<71> sterility testing and is provided for a single patient use.
The provided text does not contain detailed information about acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to prove that the device meets those criteria with statistical rigor in the way one might expect for an AI/diagnosis device.
Instead, the document is a 510(k) summary for the MTF Pre-Sutured Tendon, a device that is compared to predicate devices to establish substantial equivalence. The "performance testing" section describes a comparison study and a cadaveric knee study to demonstrate equivalence or superiority to the predicate devices, rather than meeting pre-defined quantitative acceptance thresholds for accuracy, sensitivity, or specificity.
Here's an analysis based on the information provided, addressing your specific questions where possible. Many questions cannot be fully answered from this document because it's not a study report for an AI or diagnostic device with explicit acceptance criteria and performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance in qualitative terms of "equivalence to or better than" predicate devices rather than specific numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Visual characteristics comparable to predicate | Evaluated and found comparable. |
| Tensile strength equivalent to or better than predicate (K041553) | Equivalent to or better than. |
| Suture does not pull out or fail during pull testing | Suture does not pull out or fail. |
| Suture knot pull strength equivalent to or better than USP non-absorbable Surgical Sutures average knot pull strength | Equivalent to or better than. |
| Biomechanical performance (cadaveric knee study) equivalent to or better than surgeon-sutured quadruple bundled construct | No statistical difference either acutely or post-cycling. |
| Endotoxin level < 20 EU/device | Endotoxin level < 20 EU/device. Passed validated LAL USP <85> Tests. |
| Sterility (USP <71>) | Passed USP <71> sterility testing. |
| Ultimate load strength equivalent to predicate (K170957 & K041553) | Equivalent in ultimate load strength. |
2. Sample Size Used for the Test Set and Data Provenance:
- Tensile Strength/Pull Testing: Not specified.
- Cadaveric Knee Study: Not specified. The study involved "a cadaveric knee study," implying multiple cadaveric knees but no specific number is given. The provenance is implied to be cadaveric donations for research, but country of origin is not specified. It is a prospective study in the sense of comparing the novel device to a control construct in a controlled experimental setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Cadaveric Knee Study: The study involved orthopedic surgeons for implanting the construct. It compares the device to a "quadruple bundled construct sutured by a surgeon at the time of surgery." It does not explicitly state experts establishing "ground truth," but rather performing the control intervention and assessing implantability ("traditional clinical methods by an orthopedic surgeon"). No specific number or qualifications are provided beyond "orthopedic surgeon."
4. Adjudication Method for the Test Set:
Not applicable or not specified. This type of device does not involve subjective interpretations requiring adjudication for ground truth. The assessments are biomechanical and objective (tensile strength, pull out strength).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This device is not an AI or diagnostic tool that involves human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device (pre-sutured tendon), not an algorithm or AI.
7. Type of Ground Truth Used:
- Biomechanical Performance: Measured physical properties (tensile strength, suture pull-out strength, knot pull strength, ultimate load strength), and biomechanical outcomes in a cadaveric model.
- Biological Safety: Endotoxin levels and sterility testing.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the Study that Proves the Device Meets the (Implied) Acceptance Criteria:
The substantial equivalence of the MTF Pre-Sutured Tendon was demonstrated through a series of performance tests and a cadaveric knee study.
- Comparison Study: Visual characteristics and tensile strength of the pre-sutured tendon were evaluated and compared to the Arthrex Suture Grafting Kit (K041553). The suture's ability to resist pull-out and failure, along with its knot pull strength, were assessed against USP standards. The results indicated that the MTF Pre-Sutured Tendon was "equivalent to or better than" the predicate and USP standards.
- Cadaveric Knee Study: This study assessed the clinically relevant biomechanical performance of the construct when implanted with its intended fixation methods. It compared the MTF Pre-Sutured Tendon to a quadruple-bundled construct sutured by an orthopedic surgeon in an operating room setting. The study found "no statistical difference either acutely or post-cycling" between the two constructs. It also confirmed that the device could be implanted using traditional clinical methods.
- Biological Testing: The device's endotoxin levels were measured (less than 20 EU/device) and it passed USP <85> and USP <71> for sterility.
- Ultimate Load Strength: Comparison testing confirmed that the MTF Pre-Sutured Tendon is "equivalent in ultimate load strength" to its predicates (Allosource ReConnex K170957 and Arthrex Suture Grafting Kit K041553).
The overall conclusion was that the MTF Pre-Sutured Tendon is substantially equivalent to the predicate devices based on its materials, indications, function, and performance, with any differences not raising new questions of safety or effectiveness.
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March 15, 2019
Musculoskeletal Transplant Foundation Katrina Carroll Regulatory Affairs Manager 125 May Street Edison, New Jersey 08837
Re: K181633
Trade/Device Name: MTF 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: February 13, 2019 Received: February 13, 2019
Dear Ms. Carroll:
We have reviewed vour 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/cdrl/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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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)
Device Name MTF Pre-Sutured Tendon
Indications for Use (Describe)
The MTF Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The MTF 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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1. 510(k) Summary
| Device Trade Name: | MTF Pre-Sutured Tendon |
|---|---|
| Manufacturer: | Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837 |
| Contact: | Ms. Katrina CarrollPhone: (732) 661-3154Fax: (732) 661-2189Katrina_Carroll@mtf.org |
| Prepared by: | Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com |
| Date Prepared: | March 13, 2019 |
| Common Name: | Pre-Sutured Tendon |
| Classification Name: | Nonabsorable poly(ethylene terephthalate) surgical suture |
| Classification: | 21 CFR § 878.5000 |
| Class: | II |
| Product Codes: | GAT |
| Predicate Device: | Allosource ReConnex™ Pre-Sutured Tendon (K170957) ArthexSuture Grafting Kit (K041553) |
| Reference Device: | Riverpoint Medical HS Fiber™ Polyblend Non-Absorbable(K100006)MTF Fascia™ (K120479) |
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Indications for Use:
The MTF Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The MTF Pre-Sutured Tendon is for single patient use only.
Device Description:
The MTF Pre-Sutured Tendon is a construct consisting of a single tendon pre-sutured with UHWMPE non-absorbable surgical suture. The device may include a semitendinosus tendon. bilateral anterior and posterior tibialis tendon, or bilateral peroneus longus tendon., The Pre-Sutured Tendon passes USP<71> sterility testing and is provided for a single patient use.
Performance Testing:
The performance of the MTF Pre-Sutured Tendon was characterized through a comparison study to show that the MTF Pre-Sutured Tendon was comparable to the Arthrex suture grafting kit as described in K041553. Visual characteristics and tensile strength of the pre-sutured tendon were evaluated and are equivalent to or better than the tensile strength data for the predicate device cleared under K041553. The suture does not pull out, or fail when subjected to pull testing. The suture knot pull strength is equivalent to or better than USP non-absorbable Surgical Sutures average knot pull strength.
A cadaveric knee study was conducted to assess clinically relevant performance of the graft in combination with its intended fixation methods. The results of the human cadaveric knee study demonstrate that the construct is equivalent to or better than a quadruple bundled construct sutured by a surgeon at the time of surgery. The biomechanical assessment comparing the sutured tendon bundle constructed in the operating room using an allograft tendon, and a pre-sutured tendon constructed by MTF shows no statistical difference either acutely or post-cyclin. It was also demonstrated that the pre-sutured tendon construct can be implanted using traditional clinical methods by an orthopedic surgeon.
The MTF Pre-Sutured Tendon has an endotoxin level of less than 20 EU/device. Every lot of the MTF Pre-Sutured Tendon must pass a validated limulus amebocyte lysate (LAL) USP <85> Tests. The Pre-Sutured Tendon passes USP<71> sterility testing.
Risk Assessment:
MTF has performed a risk assessment in order to compare the risk profile of its Pre-Sutured Tendon to another predicate device that is also a pre-sutured, quadruple-bundled tendon (Allosource's ReConnex, K170957) as well as to a predicate device (Arthrex's Suture Grafting Kit, K041553) which is used to suture a standard allograft tendon into a quadruple-bundled construct in the operating room at the time of surgery. The risk assessment completed provides a sufficient risk/benefit profile to support the equivalence to both Arthrex Suture Grafting Kit and Allosource ReConnex.
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Substantial Equivalence:
The MTF Pre-Sutured Tendon is substantially equivalent with respect to materials, indications, function and performance to the Allosource ReConnex™ Pre-Sutured Tendon (K170957) and Arthex Suture Grafting Kit (K041553).
Technological Features and Substantial Equivalence:
The MTF Pre-Sutured Tendon and Allosource ReConnex™ Pre-Sutured Tendon (K170957) have identical indications, they are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction. The Arthex Suture Grafting Kit (K041553) is intended for use in soft tissue approximation and or ligation including, but not limited to anterior cruciate ligament and posterior cruciate ligament reconstruction. Like the subject device, the predicate devices incorporate nonabsorbable UHMWPE sutures and are indicated for single patient use only. The MTF Pre-Sutured Tendon is described for the identical patient population, intended use, and indication as the predicates, Allosource ReConnex™ Pre-Sutured Tendon (K170957) and Arthex Suture Grafting Kit (K041553). Any differences do not raise new questions of safety or effectiveness. In addition, comparison testing demonstrates that the MTF Pre-Sutured Tendon is equivalent in ultimate load strength. Therefore, the MTF Pre-Sutured Tendon is substantially equivalent to the Allosource ReConnex™ Pre-Sutured Tendon (K170957) and Arthex Suture Grafting Kit (K041553).
Prior to donation, the donor's medical/social history was screened for medical conditions or disease processes that would contraindicate the donation of tissues in accordance with current policies and procedures approved by the MTF Medical Board of Trustees. Donor blood samples taken at the time of recovery were tested by a facility that is CLIA certified and registered with the FDA. The donor blood samples were tested for: Hepatitis B virus (HBV) surface antigen, HBV core antibody, Hepatitis C virus (HCV) antibody, HIV-1/12 antibody, Syphilis, HIV-1 NAT, HCT NAT, and HBV Nat.
All infectious disease test results passed acceptability for screening. This allograft tissue has been determined to be suitable for transplantation.
The infectious disease test results, consent, current donor medical history interview, physical assessment, available relevant medical records to include previous medical history, laboratory test results, autopsy and coroner reports, if performed, and information obtained from any source or records which may pertain to donor suitability, have been evaluated by an MTF physician and are sufficient to indicate that donor suitability criteria current at the time of procurement, have been met. This tissue is suitable for transplantation. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue Based Products, as applicable. All procedures for donor screening, including laboratory testing, meet or exceed current standards established by the American Association of Tissue Banks.
§ 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.