(186 days)
Not Found
No
The description focuses on the material composition and physical properties of a suture, with no mention of AI or ML capabilities.
No
The device is a suture, used for approximating and ligating soft tissue, which is a structural component of a surgical repair rather than a therapeutic agent or device that directly treats or cures a disease or condition.
No
The device is a suture intended for soft tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical suture construct made of various materials and supplied with or without needles, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue approximation and or ligation." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a surgical suture, a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, 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 is a surgical tool used for repair within the body.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Suture 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.
Product codes (comma separated list FDA assigned to the subject device)
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)
Not Found
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.
Not Found
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.
0
। ତା ।
Arthrex SPECIAL 510(K): Arthrex Bio-Suture
4 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | September 30, 2011 |
|---|---|
| Purpose of Submission | To obtain clearance to distribute new suture devices, Arthrex Bio-Suture |
| Manufacturer/Distributor | |
| /Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Sally Foust, RAC |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1251, and Fax: 239/598-5508 | |
| Email: sfoust@arthrex.com | |
| Trade Name | Arthrex Bio-Suture: Bio-FiberWire, Bio-TigerWire, Bio-FiberLoop, Bio-TigerLoop, Bio-FiberTape, and Bio-TigerTape |
| Common Name | Suture |
| Product Code - | |
| Classification Name | 878.5000 - GAT - Nonabsorbable poly(ethylene terephthalate) surgical |
| suture | |
| Predicate Devices | Arthrex Graft Suturing Kit (K041553) |
| Arthrex BioWire (K091018) | |
| Device Description and | |
| Intended Use | 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. | |
| The Arthrex Bio-Suture 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. | |
| Substantial Equivalence | |
| Summary | The Arthrex Bio-Suture is substantially equivalent to the predicate |
| devices in which the material, basic features and intended uses are | |
| identical. Any differences between the Arthrex Bio-Suture and the | |
| predicate devices are considered minor and do not raise questions | |
| concerning safety and effectiveness. Based on the biocompatibility and | |
| tensile testing performed, Arthrex, Inc. has determined that the Arthrex | |
| Bio-Suture is substantially equivalent to the currently marketed predicate | |
| devices. |
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 6 2012
Arthrex, Inc. . % Courtney Smith, RAC Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K112899
Trade/Device Name: Arthrex Bio-Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: March 22, 2012 Received: March 28, 2012
Dear Courtney 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
2
Page 2 - Courtney Smith, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunel Keith
-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KI12899
Arthrex SPECIAL 510(k): Arthrex Bio-Suture
3 Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
Arthrex Bio-Suture
Indications For Use:
The Arthrex Bio-Suture 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.
Prescription Use _X_AND/OR Over-The-Counter Use ___
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kime ber MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112899
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