(216 days)
No
The summary describes a physical suture device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for soft tissue approximation and/or ligation, which are therapeutic actions to repair or support biological tissues.
No
Explanation: The device description states its purpose is for "soft tissue approximation and or ligation" and that it is a "braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating," which are characteristics of a surgical suture, not a diagnostic device. Diagnostic devices are used to identify or characterize diseases or conditions.
No
The device description clearly states it is a braided construct made of physical materials (UHMWPE, polyester, collagen coating) and is a physical suture, not software.
Based on the provided information, the Arthrex BioSuture 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 on the body, not a test performed outside the body on a sample.
- Device Description: The device is a suture, a physical material used to hold tissues together during surgery. This is a surgical implant/device, not a diagnostic tool.
- 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 substances in samples
- Providing information for diagnosis, monitoring, or screening
The Arthrex BioSuture is clearly a surgical device intended for use within the body during a procedure.
N/A
Intended Use / Indications for Use
The Arthrex BioSuture is intended for 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.
Product codes
GAT
Device Description
The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.
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 (straight pull, knot pull) was conducted to demonstrate that the strength of the proposed Arthrex BioSuture met the established acceptance criteria.
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.
Mechanical testing (straight pull, knot pull) demonstrated that the strength of the proposed Arthrex BioSuture is substantially equivalent to that of the predicate device for the desired indications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K193575, K122374, K041553, K032245, K021434
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
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.
10/27/2022
Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K220880
Trade/Device Name: Arthrex BioSuture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: September 2, 2022 Received: September 7, 2022
Dear Stacy Valdez:
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,
Deborah Fellhauer RN, BSN 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
2
Indications for Use
510(k) Number (if known)
Device Name Arthrex BioSuture
Indications for Use (Describe)
The Arthrex BioSuture is intended for 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) |
escription 303 (Part 21 CFR 301 Subpart B)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared | October 17, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Stacy Valdez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72010 | |
| stacy.valdez@arthrex.com | |
| Name of Device | Arthrex BioSuture |
| Common Name | Suture |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | II |
| Primary Predicate Device | K112899: Arthrex Bio-Suture |
| Additional Predicate Device | K140019: Arthrex BioSuture |
| Reference Devices | K193575: Arthrex SutureTape |
| K122374: Arthrex Suture | |
| K041553: Arthrex Suture Grafting Kit | |
| K032245: Arthrex FiberTape Family | |
| K021434: Arthrex FiberWire Family, USP Size Sutures | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex BioSuture. | |
| Device Description | The proposed Arthrex BioSuture is a braided construct made of Ultra High |
| Molecular Weight Polyethylene (UHMWPE) and polyester and coated | |
| with collagen coating. The proposed suture is braided flat with round | |
| ends and may be available in precut lengths in straight and loop | |
| configurations. The Arthrex BioSuture is packaged sterile for single use. | |
| The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture | |
| consisting of a new size. | |
| Indications for Use | The Arthrex BioSuture is intended for 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 (straight pull, knot pull) was conducted to |
| demonstrate that the strength of the proposed Arthrex BioSuture met | |
| the established acceptance criteria. | |
| Technological Comparison | 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. | |
| The Arthrex BioSuture is substantially equivalent to the predicate devices | |
| cleared under K112899 and K140019 in which the overall design and | |
| configuration of the suture, intended use/indications, surgical technique, | |
| fundamental scientific technology, sterility, materials, packaging and | |
| manufacturing process are identical. | |
| diameter than the predicate devices cleared under K112899. | |
| The Arthrex BioSuture is labeled with a 4-year shelf life; whereas the | |
| predicate devices cleared under K112899 are labeled with a 2-year shelf | |
| life. However, the additional predicate devices cleared under K140019 | |
| are labeled with a 4-year shelf life. | |
| The Arthrex BioSuture has been evaluated for MR Safe labeling; whereas | |
| the predicate devices cleared under K112899 were not evaluated for MR | |
| Safe labeling. The needles are not implantable and therefore have not | |
| been evaluated for MR Safety. | |
| The Arthrex BioSuture is a line extension to the predicate devices, which | |
| include minor dimensional modifications with no change to intended use | |
| or function. Any differences between the Arthrex BioSuture and the | |
| predicate devices are considered minor and do not raise different | |
| questions of safety or effectiveness. | |
| Conclusion | The Arthrex BioSuture is substantially equivalent to the predicate device |
| in which the overall design and configuration of the suture, the intended | |
| use/indications, surgical technique, fundamental scientific technology, | |
| sterility, materials, packaging, and manufacturing process remain | |
| identical to the primary predicate Arthrex Bio-Suture (K112899) and | |
| additional predicate Arthrex BioSuture (K140019). Any differences | |
| between the proposed device and the predicate device are considered | |
| minor and do not raise different questions concerning safety or | |
| effectiveness. | |
| Mechanical testing (straight pull, knot pull) demonstrated that the | |
| strength of the proposed Arthrex BioSuture is substantially equivalent to | |
| that of the predicate device for the desired indications. | |
| 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. |
4