(62 days)
No
The summary describes a mechanical implant and delivery system with no mention of AI/ML capabilities or data processing.
No
The device is an implantable suture retention device used for soft tissue repairs. It does not provide therapeutic treatment itself but rather facilitates the repair process.
No
The device is an implantable suture retention device used for repairing soft tissues, not for diagnosing conditions. It facilitates surgical repairs rather than identifying diseases or conditions.
No
The device description explicitly states it consists of a suture implant and an implant delivery inserter, which are physical components, not software.
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 describes a device used for surgical repair of soft tissues within the body (implantable suture retention device). IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health.
- Device Description: The device is an implantable suture and delivery system, not a reagent, instrument, or kit used for testing biological samples.
- Anatomical Site: The device is used directly on anatomical sites within the body (soft tissues, meniscal tears, rotator cuff repairs).
- Performance Studies: The performance studies described are related to the mechanical strength and pyrogenicity of the implantable device, not the analytical or clinical performance of a diagnostic test.
Therefore, the Arthrex SoftStitch falls under the category of a surgical implant/device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
Product codes
GAT
Device Description
The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, meniscal tears, rotator cuff repairs
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)
Tensile testing was performed on the subject device and compared to the reference device to demonstrate that the modifications do not negatively impact mechanical strength. 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 14, 2022
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex, Inc Kelsey N. Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222078
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: July 13, 2022 Received: July 14, 2022
Dear Kelsey N. Roberts:
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 C. 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) K222078
Device Name
Arthrex SoftStitch
Indications for Use (Describe)
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
Type of Use (Select one or both, as applicable)
| X 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 | September 1, 2022 |
|---|---|
| 510(k) Number | K222078 |
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Kelsey N. Roberts |
| Sr. Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72257 | |
| Kelsey.Roberts@arthrex.com | |
| Name of Device | Arthrex SoftStitch |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | ll |
| Primary Predicate Device | K190707: Arthrex SoftStitch |
| Reference Device | K203117: TissueTak Device |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expand the |
| indications of the Arthrex SoftStitch to include Rotator Cuff Augmentation. | |
| Device Description | The Arthrex SoftStitch consists of a suture implant and an implant delivery |
| inserter. The implant is a polyester sheath preloaded on a barbed suture | |
| manufactured from #1 USP nylon monofilament. The polyester sheath is coated | |
| with beeswax. | |
| Comparison Summary of | |
| Technological | |
| Characteristics and | The proposed and predicate device (K190707) have the same basic design, |
| intended use, packaging, shelf life, biocompatibility profile, and sterilization. | |
| Modifications Proposed | The proposed Arthrex SoftStitch is substantially equivalent to the predicate |
| device in which the basic design features and intended uses are the same. Any | |
| differences between the proposed device and the predicate device are | |
| considered minor and do not raise new or different questions concerning safety | |
| or effectiveness. | |
| 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 and fixation of prosthetic or biologic material to soft tissues in minimally | |
| invasive and open surgical procedures such as rotator cuff repairs. | |
| Performance Data | Tensile testing was performed on the subject device and compared to the |
| reference device to demonstrate that the modifications do not negatively impact | |
| mechanical strength. | |
| 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 raise 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. |