(24 days)
No
The 510(k) summary describes a physical suture device and its mechanical properties, with no mention of software, algorithms, or AI/ML technologies.
No
The device is a suture used for soft tissue approximation and/or ligation, which is a structural component for repair rather than a device with a direct therapeutic effect.
No
The device, SutureTape, is described as a braided suture intended for soft tissue approximation and/or ligation. Its function is to hold tissues together, not to diagnose conditions.
No
The device description clearly states it is a braided suture made of physical materials (UHMWPE, polyester, nylon) and is provided as a physical product (suture, with or without needles). It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a suture, a material used to hold tissues together during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening.
The device described is a surgical suture, which is a medical device used in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
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 tissue are used for repair.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
SutureTape is a braided 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 has a width of 1.3 mm. SutureTape is available in precut lengths in straight and loop configurations, and with or without needles. SutureTape is packaged sterile for single use. SutureTape meets USP standards for size 2 suture, except for an oversize in diameter.
The SutureTape modifications as compared to the predicate device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a suture core and different braiding pattern of colored yarns. Additionally, SutureTape is braided flat similar to the cleared LabralTape (K122374) but has round suture tails similar to the cleared FiberTape (K032245).
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 submitted mechanical testing demonstrates that the strength of the proposed SutureTape (straight pull, knot pull and needle pull) exceeds that of the USP requirements for size 2 suture. This specification is based on the diameter of the suture ends, which span USP size 1 and 2 diameter ranges. Bacterial endotoxin testing per EP 2.6.14/USP was conducted to demonstrate that the subject device meets pyrogen limit specifications. SutureTape is similar to the predicate devices in which the basic design features and intended use 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. The suture materials and the manufacturing, packaging, and sterilization processes are the same as those used for the predicate and reference devices. The biocompatibility and shelf life for the proposed SutureTape were reviewed and determined to be acceptable due to its similarities with the predicate. Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that SutureTape is substantially equivalent to currently marketed predicate device.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
Arthrex, Inc. Ms. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K171296
Trade/Device Name: SutureTape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: April 28, 2017 Received: May 2, 2017
Dear Ms. 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. 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 of medical device
1
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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the word "Arthrex" in bold black font, with a logo to the right of the word. The logo is a stylized image of a surgical instrument. To the right of the word "Arthrex" is the phrase "SPECIAL 510(K): SUTURETAPE" in a smaller, non-bold font. The phrase is likely a product name or description.
INDICATIONS FOR USE 2.5
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 below.
510(k) Number (if known) K171296
Device Name
SutureTape
Indications for Use (Describe)
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 tissue are used for repair.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ 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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY
| Date Summary Prepared | May 25, 2017 |
|---|---|
| Manufacturer/Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: (239) 643-5553, ext. 71263 | |
| Fax: (239) 598-5508 | |
| Email: igalmez@arthrex.com | |
| Trade Name | SutureTape |
| Common Name | Soft Tissue Fixation Device |
| Product Code - | |
| Classification Name | |
| CFR | GAT |
| Nonabsorbable poly(ethylene terephthalate) surgical suture | |
| 21 CFR 878.5000 | |
| Predicate Device | K122374: Arthrex Suture |
| Reference Predicates | K041553: Arthrex Suture Grafting Kit |
| K032245: Arthrex FiberTape Family | |
| K151230: Arthrex FiberTak | |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain |
| clearance for SutureTape. The proposed SutureTape was cleared | |
| as a component of Arthrex FiberTak (K151230). | |
| Device Description | SutureTape is a braided 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 | |
| has a width of 1.3 mm. SutureTape is available in precut lengths | |
| in straight and loop configurations, and with or without needles. | |
| SutureTape is packaged sterile for single use. SutureTape meets | |
| USP standards for size 2 suture, except for an oversize in | |
| diameter. | |
| The SutureTape modifications as compared to the predicate | |
| device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a | |
| suture core and different braiding pattern of colored yarns. | |
| Additionally, SutureTape is braided flat similar to the cleared | |
| LabralTape (K122374) but has round suture tails similar to the | |
| cleared FiberTape (K032245). | |
| Intended Use | 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 | The submitted mechanical testing demonstrates that the |
| strength of the proposed SutureTape (straight pull, knot pull and | |
| needle pull) exceeds that of the USP requirements for size 2 | |
| suture. This specification is based on the diameter of the suture | |
| ends, which span USP size 1 and 2 diameter ranges. | |
| Bacterial endotoxin testing per EP 2.6.14/USP was | |
| conducted to demonstrate that the subject device meets | |
| pyrogen limit specifications. | |
| SutureTape is similar to the predicate devices in which the basic | |
| design features and intended use 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. | |
| The suture materials and the manufacturing, packaging, and | |
| sterilization processes are the same as those used for the | |
| predicate and reference devices. The biocompatibility and shelf | |
| life for the proposed SutureTape were reviewed and determined | |
| to be acceptable due to its similarities with the predicate. | |
| Based on the indications for use, technological characteristics, | |
| and the summary of data submitted, Arthrex, Inc. has | |
| determined that SutureTape is substantially equivalent to | |
| currently marketed predicate device. |
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