(27 days)
None
No
The device description and performance studies focus on the material properties and mechanical performance of a suture, with no mention of AI or ML technologies.
No
The device is a suture, intended for soft tissue approximation and ligation, which are supportive functions in a medical procedure, rather than directly treating a disease or condition.
No
The device is described as a suture intended for soft tissue approximation and ligation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical suture construct made of various materials (polyester, UHMWPE, collagen, nylon) and supplied with or without needles. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for 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 suture, which is a physical material used to close wounds or tie off blood vessels during surgery. This is a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
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 Arthrex Bio-Suture is a dyed or non-dyed braided polyester suture construct coated with type 1 bovine collagen. The suture construct is made of UHMWPE and polyester braided over a UHMWPE core. The suture tape construct is a flat suture construct composed of UHMWPE and polyester yarns braided over a FiberWire suture core and UHMWPE yarns. Arthrex Bio-Suture strands that are dyed black are made of nylon. The suture ends are stiffened with cyanoacrylate. The Arthrex Bio-Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter.
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 real-time stability testing (Ultimate Load and Anchor Pullout) data demonstrates that the extended shelf life does not affect the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112899: Arthrex BioSuture
Reference Device(s)
Not Found
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
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| Canada Canada Canada Call Canada Call Cara Cara Caracterial Cara Caracterial Compressional Concessione of Canadian Compressional Compressional Compressional Compressional Com | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A for a final development of the first from the many of the first and | AND on Active Accomments of Active | ||
|---|---|---|---|---|---|
| Status of Canadian Children Children Carder States of Children Company of Children Company | |||||
| 510(K) SUMMA | |||||
| 1 Page of the Back of | |||||
| . | Control Concession of Children Company of Children |
The mail of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the coun |
., . . . . .
| Date Summary Prepared | December 31, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex BioSuture |
| Common Name | Suture |
| Product Code -Classification Name | GAT |
| CFR | Nonabsorbable poly(ethylene terephthalate) surgical |
| suture | |
| 21 CFR 878.5000 | |
| Predicate Device | K112899: Arthrex BioSuture |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| extend the shelf-life of the Arthrex BioSuture. | |
| Device Description | The Arthrex Bio-Suture is a dyed or non-dyed braided |
| polyester suture construct coated with type 1 bovine | |
| collagen. The suture construct is made of UHMWPE and | |
| polyester braided over a UHMWPE core. The suture tape | |
| construct is a flat suture construct composed of | |
| UHMWPE and polyester yarns braided over a FiberWire | |
| suture core and UHMWPE yarns. Arthrex Bio-Suture | |
| strands that are dyed black are made of nylon. The | |
| suture ends are stiffened with cyanoacrylate. The | |
| Arthrex Bio-Suture will be supplied in pre-cut lengths with | |
| or without various swaged needles. The Arthrex Bio- | |
| Suture constructs meet USP standards for suture, except | |
| for diameter. | |
| Intended 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. | |
| Substantial Equivalence Summary | The Arthrex BioSuture is identical to the predicate |
| devices, in which the basic design features, materials, and | |
| intended uses are the same. The extension of the shelf | |
| life is the only change presented in this submission. | |
| The real-time stability testing (Ultimate Load and Anchor | |
| Pullout) data demonstrates that the extended shelf life | |
| does not affect the performance of the device. | |
| Based on the indication for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the BioSuture is | |
| substantially equivalent to currently marketed predicate | |
| devices. |
. . . .
1
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Arthrex Incorporated Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K140019
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: December 31, 2013 Received: January 3, 2014
Dear Ms. Smith:
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. 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 (reporting of medical
3
Page 2 - Ms. Courtney Smith
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140019
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 componens, into surgeries where constructs, including those with allograft tissues, are used for repair.
Type of Use (Select one or both, as applicable)
D)
☐ Over-The-Counter Use (21 CFR 8
Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
David Krause -S
FORM FDA 3881 (1/14)