(563 days)
The Arthrex SoftStitch is an implantable suture which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
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.
The provided text does not describe an AI/ML device, and therefore the complete information requested in the prompt cannot be extracted. The document is a 510(k) premarket notification for a medical device called "Arthrex SoftStitch," which is an implantable suture retention device. This type of device falls under traditional medical device regulations and does not involve AI or machine learning.
Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" are not applicable.
Here's the information that can be extracted related to acceptance criteria and performance studies, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing conducted to demonstrate substantial equivalence to predicate devices rather than specific quantitative acceptance criteria with reported numerical performance values in a direct comparison. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to predicate devices (K132043 & K073149) regarding: | - Demonstrates substantial equivalence to predicate devices. |
| - Basic design features | - Basic design features are described as identical or comparable. |
| - Intended use | - Identical intended use. |
| - Fundamental scientific technology | - Identical fundamental scientific technology. |
| - Sterility, packaging, shelf-life | - Assessment determined no additional risks/concerns. |
| Biocompatibility (ISO 10993-1:2018) | - Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing conducted. |
| Physical/Mechanical Performance (Cyclic Pull-out) | - Cyclic pull-out testing performed to demonstrate substantial equivalence. |
| In Vivo Performance | - Arthroscopic/histologic imaging from a canine functional meniscus implant study performed to demonstrate substantial equivalence. |
| Pyrogenicity (EP 2.6.14/USP <85>) | - Bacterial endotoxin testing conducted; device meets pyrogen limit specifications. |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each test. For the "canine functional meniscus implant study," the sample size (number of animals) is not provided.
- Data Provenance:
- Cyclic pull-out testing: Laboratory testing.
- Canine functional meniscus implant study: Animal model (canine). No country of origin is specified.
- Biocompatibility testing: Laboratory testing.
- Bacterial Endotoxin testing: Laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance, not an AI/ML diagnostic or prognostic device study that requires expert ground truth establishment for a test set. The "truth" is established through engineering and biocompatibility testing, and animal studies.
4. Adjudication method for the test set
Not applicable. This is a medical device clearance, not an AI/ML study involving human readers or interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through:
- Direct physical and mechanical testing: "Cyclic pull-out testing."
- Biocompatibility testing: According to ISO 10993-1:2018 standards.
- In vivo animal studies: "Arthroscopic/histologic imaging from a canine functional meniscus implant study."
- Materia characterization and manufacturing controls: Assessment of product attributes, manufacturing conditions, packaging, sterilization, and shelf-life.
- Pyrogenicity testing: Bacterial endotoxin testing.
8. The sample size for the training set
Not applicable. This is a medical device clearance, not an AI/ML device that uses training sets.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this type of device.
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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
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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 <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications. | |
| Conclusion | The Arthrex SoftStitch is substantially equivalent to the predicate device in which thebasic design features and intended use are the same. Any differences between theArthrex proposed device and the predicate device are considered minor and do notraised questions concerning safety and effectiveness. Based on the indications foruse, technological characteristics, and the summary of data submitted, Arthrex Inc.has determined that the proposed device is substantially equivalent to the currentlymarketed predicate device. |
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§ 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.