(122 days)
No
The document describes a physical suture device and its material properties and performance standards. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a non-absorbable suture intended for soft tissue approximation and/or ligation, and its function is to hold tissues together, not to provide therapy itself.
No
The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation, functioning as a suture for repair. It is a surgical tool, not a device used to diagnose medical conditions or diseases.
No
The device description clearly states it is comprised of physical materials (UHMWPE, polyester, nylon, cyanoacrylate) and is a physical suture, not software.
Based on the provided information, the Arthrex SutureTape is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples outside of the body to gain information about a person's health. The Arthrex SutureTape is a surgical tool used within the body.
N/A
Intended Use / Indications for Use
The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissues are used for repair.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Arthrex SutureTape is comprised of non-absorbable sutures made of a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester yarns but may also include nylon yarns.
The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a round braided suture tail that is smaller than the tape portion. The tape and tail portion of the suture are implantable while the suture tail is not intended to be knotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter.
The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in various loop configurations, and in some cases, with various swaged needles and with stiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, and fully or partially striped. Dyes may include D&C Blue No. 6 and Logwood Black. Suture strands that are dyed with Logwood black are made of nylon. Additional material for the Arthrex 0.9 mm SutureTape includes cyanoacrylate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter. The attached needle at the suture tail portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for needle pull tensile strength for size 2-0 non-absorbable surgical sutures. Bacterial Endotoxins Test (BET) was performed on the representative samples utilizing the Kinetic Chromogenic Method 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 (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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 9, 2022
Arthrex Inc. Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K221354
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 17, 2022 Received: June 21, 2022
Dear Lai Saeteurn:
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
1
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,
for Deborah Fellhauer 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) K221354
Device Name Arthrex SutureTape
Indications for Use (Describe)
The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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 9, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Lai Saeteurn |
| Regulatory Affairs Specialist II | |
| 1-239-598-4302 Ext. 71764 | |
| Lai.Saeteurn@Arthrex.com | |
| Name of Device | Arthrex SutureTape |
| Common Name | Suture |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | II |
| Predicate Device | K171296: Arthrex SutureTape |
| Reference Devices | K193575: Arthrex SutureTape |
| K122374: Arthrex Suture | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex 0.9 mm SutureTape sutures as a line extension to the Arthrex | |
| SutureTape. | |
| Device Description | The Arthrex SutureTape is comprised of non-absorbable sutures made of a |
| polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester | |
| yarns but may also include nylon yarns. |
The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a round
braided suture tail that is smaller than the tape portion. The tape and tail
portion of the suture are implantable while the suture tail is not intended to be
knotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets
or exceeds USP performance standards for knot pull tensile strength for size 2
non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm
SutureTape suture meet the performance standards for USP 2-0 non-absorbable
surgical suture, except for an oversize in diameter.
The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in various
loop configurations, and in some cases, with various swaged needles and with
stiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, and
fully or partially striped. Dyes may include D&C Blue No. 6 and Logwood Black.
Suture strands that are dyed with Logwood black are made of nylon. Additional
material for the Arthrex 0.9 mm SutureTape includes cyanoacrylate. |
| Indications for Use | The Arthrex SutureTape is intended for use in soft tissue approximation and/or
ligation. The suture may be provided individually or be incorporated as a
component, into surgeries where constructs including those with allograft or
autograft tissues are used for repair. |
| Performance Data | The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or
exceeds USP performance standards for knot pull tensile strength for size 2 non-
absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm
SutureTape suture meet the performance standards for USP 2-0 non-absorbable
surgical suture, except for an oversize in diameter. The attached needle at the
suture tail portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds
USP performance standards for needle pull tensile strength for size 2-0 non-
absorbable surgical sutures. |
| | Bacterial Endotoxins Test (BET) was performed on the representative samples
utilizing the Kinetic Chromogenic Method 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. |
| Technological
Comparison | The Arthrex 0.9 mm SutureTape suture is a line extension to the predicate device.
In comparison to the predicate device, the Arthrex 0.9 mm SutureTape suture
share the same basic design features (e.g., flat braided with round-braided suture
tails, non-USP size), fundamental scientific technology, intended use, materials
(e.g., yarns, dyes, additive), shelf life, surgical technique, manufacturing,
packaging, and sterilization processes as the predicate device. However, the
Arthrex 0.9 mm SutureTape suture has a tape width and suture tail diameter
range smaller than that of the predicate. |
| Conclusion | The Arthrex 0.9 mm SutureTape devices are substantially equivalent to the
predicate device in which the basic design features, materials, manufacturing,
and intended use are the same. Any differences between the proposed and
predicate devices are considered minor and do not raise questions concerning
safety or effectiveness.
Based on the indication or use, technological characteristics, and the tensile test
data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |
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