(563 days)
No
The summary describes a mechanical suture and delivery system, with no mention of AI/ML in the device description, intended use, or performance studies.
No.
This device is an implantable suture retention device used to facilitate soft tissue repairs, not to provide therapy itself.
No
The device is an implantable suture retention device used for soft tissue repairs, not for diagnosing medical conditions.
No
The device description explicitly states it is an implantable suture and an implant delivery inserter, which are physical hardware components.
Based on the provided information, the Arthrex SoftStitch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "implantable suture" used for "percutaneous or endoscopic soft tissue repairs." This describes a surgical device used in vivo (within the body) for treatment.
- Device Description: The description confirms it's an "implantable suture retention device" consisting of a suture and an inserter. This aligns with a surgical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
- Performance Studies: The performance studies described (cyclic pull-out testing, canine functional meniscus implant study, biocompatibility testing) are typical for implantable surgical devices, not IVDs.
Therefore, the Arthrex SoftStitch is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex SoftStitch is an implantable suture which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears. The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a wax coated barbed suture manufactured from nylon monofilament.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, meniscal
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)
Cyclic pull-out testing and arthroscopic/histologic imaging from a canine functional meniscus implant study were performed to demonstrate that the Arthrex SoftStitch performs substantially equivalent to the predicate devices.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex SoftStitch in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex SoftStitch does not introduce additional risks or concerns regarding sterilization and shelf-life.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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.
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.
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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October 2, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Arthrex Inc. David Rogers Regional Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190707
Trade/Device Name: Arthrex SoftStitch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: August 24, 2020 Received: September 1, 2020
Dear Mr. Rogers:
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
1
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.
for
Laura Rose. Ph.D. 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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Indications for Use
510(k) Number (if known)
Device Name
Arthrex SoftStitch
Indications for Use (Describe)
The Arthrex SoftStitch is an implantable suture which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
| 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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510(k) Summary
| Date Prepared | October 2, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Regional Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex SoftStitch |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code | GAT - Nonabsorbable polyethylene surgical suture |
| Classification Name | 21 CFR 878.5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | II |
| Predicate Device | K132043: Arthrex SpeedCinch |
| K073149: Arthrex Meniscal Cinch | |
| Reference Device | K052900: Quill Nonabsorbable Nylon Barbed Suture |
| K181769: Arthrex FiberTak Suture Anchor | |
| K162396: SILK Surgical Suture | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex SoftStitch as a line extension to the Arthrex All Inside Meniscal Repair devices | |
| cleared under K132043 and K073149. | |
| Device Description | The Arthrex SoftStitch is an implantable suture retention device which facilitates |
| percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears. | |
| The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. | |
| The implant is a polyester sheath preloaded on a wax coated barbed suture | |
| manufactured from nylon monofilament. | |
| Indications for Use | The Arthrex SoftStitch is an implantable suture retention device which facilitates |
| percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears. | |
| Technological | The Arthrex SoftStitch is substantially equivalent to the predicate devices cleared |
| Comparison | under K132043 and K073149 in which the basic design features, intended use, |
| fundamental scientific technology, sterility, packaging and shelf-life are identical. | |
| Compared to the predicate, the SoftStitch delivers a polyester soft anchor with a | |
| barbed suture as opposed to a hard anchor (PEEK) delivery with a braided suture | |
| design. The soft anchor is delivered through a push rod mechanism instead of a | |
| trigger design. | |
| Performance Data | Cyclic pull-out testing and arthroscopic/histologic imaging from a canine functional |
| meniscus implant study were performed to demonstrate that the Arthrex SoftStitch | |
| performs substantially equivalent to the predicate devices. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, | |
| Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was | |
| conducted on the Arthrex SoftStitch in accordance with ISO 10993-1:2018. | |
| Assessment of physical product attributes including product design, size, and | |
| materials as well as the conditions of manufacture and packaging has determined | |
| that the Arthrex SoftStitch does not introduce additional risks or concerns regarding | |
| sterilization and shelf-life. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the | |
| device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex SoftStitch is substantially equivalent to the predicate device in which the |
| basic design features and intended use are the same. Any differences between the | |
| Arthrex proposed device and the predicate device are considered minor and do not | |
| raised questions concerning safety and effectiveness. Based on the indications for | |
| use, technological characteristics, and the summary of data submitted, Arthrex Inc. | |
| has determined that the proposed device is substantially equivalent to the currently | |
| marketed predicate device. |
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