(268 days)
No
The device description and performance studies focus on the physical properties and biomechanical performance of a pre-sutured tendon construct, with no mention of AI or ML technologies.
Yes
The device is described as a 'construct of a single tendon pre-sutured with non-absorbable surgical suture' intended for use in 'anterior cruciate ligament and posterior cruciate ligament reconstruction,' which directly treats a damaged ligament.
No
The device description indicates it is a pre-sutured tendon for ligament reconstruction, which is a therapeutic device and not one used for diagnosis.
No
The device description clearly states it is a "construct consisting of a single tendon pre-sutured with UHWMPE non-absorbable surgical suture," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical reconstruction of the anterior and posterior cruciate ligaments. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a pre-sutured tendon construct, which is a biological tissue product used for implantation. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
The device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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 sterility testing and is provided for a single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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 Tests. The Pre-Sutured Tendon passes USP sterility testing.
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.
Allosource ReConnex™ Pre-Sutured Tendon (K170957), Arthex Suture Grafting Kit (K041553)
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.
Riverpoint Medical HS Fiber™ Polyblend Non-Absorbable (K100006), MTF Fascia™ (K120479)
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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1. 510(k) Summary
| Device Trade Name: | MTF Pre-Sutured Tendon |
|---|---|
| Manufacturer: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| Contact: | Ms. Katrina Carroll |
| Phone: (732) 661-3154 | |
| Fax: (732) 661-2189 | |
| Katrina_Carroll@mtf.org | |
| Prepared by: | Mr. Dave McGurl |
| Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5797 | |
| Fax: 202.552.5798 | |
| dmcgurl@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) Arthex |
| Suture 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 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 Tests. The Pre-Sutured Tendon passes USP 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.