(24 days)
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.
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).
The provided text is a 510(k) summary for a medical device called "SutureTape." It describes the device, its intended use, and performance data from various tests. However, it does not contain information about a study involving AI or human readers, or any other details related to AI performance criteria.
Therefore, many of your requested points cannot be answered from the provided document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Strength (straight pull, knot pull, needle pull) exceeds USP requirements for size 2 suture | Exceeds USP requirements for size 2 suture (based on diameter of suture ends spanning USP size 1 and 2 diameter ranges) |
| Pyrogen limit specifications (Bacterial endotoxin testing per EP 2.6.14/USP <85>) | Meets pyrogen limit specifications |
| Biocompatibility | Acceptable (due to similarities with predicate) |
| Shelf-life | Acceptable (due to similarities with predicate) |
2. Sample size used for the test set and the data provenance: Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI-assisted diagnostic device. The "ground truth" here refers to established standards (USP requirements, EP/USP standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: For mechanical properties, the ground truth is United States Pharmacopeia (USP) requirements for surgical sutures. For pyrogen testing, the ground truth is EP 2.6.14/USP <85> standards. Biocompatibility and shelf-life are determined based on similarity to predicate devices.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
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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
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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)
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510(K) SUMMARY
| Date Summary Prepared | May 25, 2017 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Ivette GalmezSenior Regulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: (239) 643-5553, ext. 71263Fax: (239) 598-5508Email: igalmez@arthrex.com |
| Trade Name | SutureTape |
| Common Name | Soft Tissue Fixation Device |
| Product Code -Classification NameCFR | GATNonabsorbable poly(ethylene terephthalate) surgical suture21 CFR 878.5000 |
| Predicate Device | K122374: Arthrex Suture |
| Reference Predicates | K041553: Arthrex Suture Grafting KitK032245: Arthrex FiberTape FamilyK151230: Arthrex FiberTak |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtainclearance for SutureTape. The proposed SutureTape was clearedas a component of Arthrex FiberTak (K151230). |
| Device Description | SutureTape is a braided suture made of Ultra High MolecularWeight Polyethylene (UHMWPE) and polyester, and may includenylon. The proposed suture is braided flat with round ends andhas a width of 1.3 mm. SutureTape is available in precut lengthsin straight and loop configurations, and with or without needles.SutureTape is packaged sterile for single use. SutureTape meetsUSP standards for size 2 suture, except for an oversize indiameter.The SutureTape modifications as compared to the predicatedevice(s) include smaller tape width (1.3mm vs. 1.5mm), lack of asuture core and different braiding pattern of colored yarns.Additionally, SutureTape is braided flat similar to the clearedLabralTape (K122374) but has round suture tails similar to thecleared FiberTape (K032245). |
| Intended Use | SutureTape is intended for use in soft tissue approximation andor ligation. These sutures may be incorporated, as components,into surgeries where constructs including those with allograft orautograft tissues are used for repair. |
| Performance Data | The submitted mechanical testing demonstrates that thestrength of the proposed SutureTape (straight pull, knot pull andneedle pull) exceeds that of the USP requirements for size 2suture. This specification is based on the diameter of the sutureends, which span USP size 1 and 2 diameter ranges.Bacterial endotoxin testing per EP 2.6.14/USP <85> wasconducted to demonstrate that the subject device meetspyrogen limit specifications.SutureTape is similar to the predicate devices in which the basicdesign features and intended use are the same. Any differencesbetween the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety oreffectiveness.The suture materials and the manufacturing, packaging, andsterilization processes are the same as those used for thepredicate and reference devices. The biocompatibility and shelflife for the proposed SutureTape were reviewed and determinedto 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. hasdetermined that SutureTape is substantially equivalent tocurrently marketed predicate device. |
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§ 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.