(178 days)
Not Found
No
The device description and performance studies focus on the physical properties and surgical use of a pre-sutured tendon, with no mention of AI or ML technologies.
Yes
The device is used as a reconstructive implant for damaged ligaments, which is a therapeutic intervention.
No
The device is a pre-sutured tendon intended for use in ACL and PCL reconstruction, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures," which is a physical, hardware component.
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 therapeutic procedure performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a pre-sutured human tendon, which is an implantable material used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device is a physical construct used for repair.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cruciate ligament and posterior cruciate ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeon
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)
Visual characteristics and bench testing such as Ultimate Load, Cyclic Displacement, and Suture Pull Out Testing of the Pre-Sutured Tendons were evaluated and are found to meet requirements that are clinically relevant. Non-clinical testing data submitted to demonstrate substantial equivalence includes packaging validation, tissue sterilization and viral inactivation, shelf-life, and biocompatibility. Biocompatibility testing was conducted using methods described in ISO 10993. Bacterial endotoxin testing was also performed and was substantially equivalent to the predicates.
A human cadaver study was conducted to demonstrate the feasibility of using the Pre-Sutured Tendon for ACL/PCL reconstruction. The results of this end user validation establish that the Pre-Sutured Tendon implants labeling, packaging, dimensions (form), configuration (single/quadruple strand), and functionality meet user needs and expectations. Additionally, the results establish that the single and quadruple strand Pre-Sutured Tendon constructs met the intended use and therefore are appropriate for ACL and PCL reconstruction. The study also concluded that the subject device, the Pre-Sutured Tendon, constructs can be implanted using traditional clinical methods by an orthopedic surgeon.
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.
K181633 MTF Pre-Sutured Tendon, K170957 Allosource ReConnex Pre-Sutured Tendon
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.
Not Found
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.
0
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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.
1
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
2
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 Circle | ||||||||||||
| Alachua, FL 32615 USA | |||||||||||||
| Contact | |||||||||||||
| Information | Ellen Rounds | ||||||||||||
| Sr. Regulatory Affairs Specialist | |||||||||||||
| Email: erounds@rtix.com | |||||||||||||
| Name of Device | Pre-Sutured Tendon | ||||||||||||
| Common Name | Pre-Sutured Tendon | ||||||||||||
| Classification | |||||||||||||
| Name | Suture, Nonabsorbable, Synthetic, Polyethylene | ||||||||||||
| Regulation | |||||||||||||
| Number | 21 CFR 878.5000 | ||||||||||||
| Regulatory | |||||||||||||
| Class | Class II | ||||||||||||
| Product Code | GAT | ||||||||||||
| Panel | General and Plastic Surgery | ||||||||||||
| Legally Marketed | |||||||||||||
| Predicate | |||||||||||||
| Device(s) | K181633 MTF Pre-Sutured Tendon | ||||||||||||
| K170957 Allosource ReConnex Pre-Sutured Tendon | |||||||||||||
| Device Description | 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. | |||||||||||||
| Dimensions Implant Length (mm) Folded Diameter (mm) Single Strand 180-220 8.5-12 Quadruple Strand 50-70 9.0-13 | |||||||||||||
| Indications | |||||||||||||
| for Use | 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. | | | | | | | | | | | | |
| Comparison of
Technological
Characteristics
with the Predicate
Device | The subject and predicate devices are based on the following same
technological characteristics and both function as constructs for anterior
cruciate 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 eligibility
requirements for all communicable diseases via a medical doctor review of
donor medical and social history and all applicable infectious disease screening
tests. The donor blood samples taken at the time of recovery were tested by a
facility that is CLIA certified and registered with the FDA. The blood samples
are screened for the following: HIV-1 / HIV-2 Antibody, Hepatitis C Virus
Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody (Total),
Treponema pallidum (Syphilis), Human T-Cell, Lymphotropic Virus I/II
Antibody, and HIV-1/HCV/ HBV* NAT-TMA. The donor tissue utilized
meets 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 predicate
device. However, there are minor dimensional differences between the subject
device and the predicate devices. These differences do not affect the intended
use, performance, safety, design or function of the subject device for its
intended use in anterior cruciate ligament and posterior cruciate ligament
| reconstruction. | |
|---|---|
| Performance | |
| Data | Visual characteristics and bench testing such as Ultimate Load, Cyclic |
| Displacement, and Suture Pull Out Testing of the Pre-Sutured Tendons were | |
| evaluated and are found to meet requirements that are clinically relevant. | |
| Non-clinical testing data submitted to demonstrate substantial equivalence | |
| includes packaging validation, tissue sterilization and viral inactivation, shelf- | |
| life, and biocompatibility. Biocompatibility testing was conducted using | |
| methods described in ISO 10993. Bacterial endotoxin testing was also | |
| performed and was substantially equivalent to the predicates. |
A human cadaver study was conducted to demonstrate the feasibility of using
the Pre-Sutured Tendon for ACL/PCL reconstruction. The results of this end
user validation establish that the Pre-Sutured Tendon implants labeling,
packaging, dimensions (form), configuration (single/quadruple strand), and
functionality meet user needs and expectations. Additionally, the results
establish that the single and quadruple strand Pre-Sutured Tendon constructs
met the intended use and therefore are appropriate for ACL and PCL
reconstruction. The study also concluded that the subject device, the Pre-
Sutured Tendon, constructs can be implanted using traditional clinical methods
by an orthopedic surgeon. |
| Substantial
Equivalence | The subject device was demonstrated to be substantially equivalent to the
predicate devices cited above with respect to indications for use, aseptic
processing, design, size, materials, function, storage, and performance. |
| Conclusion | The Pre-Sutured Tendon is substantially equivalent to the predicate devices
with respect to indications for use, tissue sterilization processes, aseptic
packaging, design, function, materials, and performance. Product safety and
performance are adequately supported by the substantial equivalence
information and test results. |