(214 days)
No
The device description and performance studies focus on the material properties and mechanical strength of a suture, with no mention of AI or ML technologies.
No
The device is a suture, which is used for soft tissue approximation and ligation, and incorporates components into surgical constructs. Its function is primarily structural and supportive, rather than directly treating a disease or medical condition.
No
The device description indicates Arthrex SutureTape is a suture used for soft tissue approximation and/or ligation, which are therapeutic rather than diagnostic actions.
No
The device description clearly states it is a suture made of physical materials (UHMWPE, polyester, nylon) and is a physical product (braided flat, precut lengths, with or without needles). It is a hardware medical device.
Based on the provided information, the Arthrex SutureTape is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "in soft tissue approximation and or ligation." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from a patient's body to diagnose a condition.
- Device Description: The device is a suture, a physical material used to hold tissues together during surgery. This is a surgical tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information clearly indicates that the Arthrex SutureTape is a surgical suture used for mechanical support and repair of soft tissue.
N/A
Intended Use / Indications for Use
The Arthrex SutureTape is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
Product codes
GAT
Device Description
Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.
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
Mechanical testing demonstrated that the strength of the proposed Arthrex SutureTape (straight pull, knot pull and needle pull) met the criteria established by the predicate device. Biocompatibility testing was conducted on the proposed Arthrex SutureTape in accordance with ISO 10993-1:2018. Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications.
Key Metrics
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.
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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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2020
Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K193575
Trade/Device Name: Arthrex SutureTape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: June 25, 2020 Received: June 26, 2020
Dear Ivette Galmez:
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
1
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 (OS) 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,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K193575
Device Name
Arthrex SutureTape
Indications for Use (Describe)
The Arthrex SutureTape is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
| 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 1.
| Date Prepared | July 21, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| ivette.galmez@arthrex.com | |
| Name of Device | Arthrex SutureTape |
| Common Name | Soft Tissue Fixation Device |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000: Non-absorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | Class II |
| Predicate Device | K171296: SutureTape |
| Reference Device | K122374: Arthrex Suture |
| K041553: Arthrex Suture Grafting Kit | |
| K032245: Arthrex FiberTape Family | |
| Purpose of Submission | This 510(k) premarket notification is submitted to obtain clearance for Arthrex |
| SutureTape suture with new colorant additives per 21 CFR 73.1015 and 21 CFR | |
| 74.3054. | |
| Device Description | Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene |
| (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat | |
| with round ends, and is available in precut lengths in straight and loop configurations, | |
| and with or without needles. Arthrex SutureTape is packaged sterile for single use. | |
| New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR | |
| 74.3054. | |
| Indications for Use | Arthrex SutureTape is intended for use in soft tissue approximation and or ligation. |
| These sutures may be incorporated, as components, into surgeries where constructs | |
| including those with allograft or autograft tissues are used for repair. | |
| Performance Data | Mechanical testing demonstrated that the strength of the proposed Arthrex |
| SutureTape (straight pull, knot pull and needle pull) met the criteria established by | |
| the predicate device. | |
| Biocompatibility testing was conducted on the proposed Arthrex SutureTape in | |
| accordance with ISO 10993-1:2018. | |
| Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the | |
| proposed device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex SutureTape is substantially equivalent to the predicate device in which |
| the basic design features, materials, manufacturing and intended uses are the same. | |
| Any differences between the proposed device and the predicate device are | |
| considered minor and do not raise questions concerning safety or 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 devices. |