(237 days)
NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.
Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.
Nylon Surgical Suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.
SILK Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Stainless Steel Sutures are indicated for use in abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures, including cerclage and tendon repair.
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
Gabbay-Frater™ is a device for organizing, arranging and counting multiple interrupted sutures in an orderly fashion.
Deknatel Nonabsorbable Surgical Sutures are available in five (5) different material options.
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- Poly(ethylene terephthalate) a polyester fiber.
- The three types of polyester sutures are 'cottony'™ II, 'silky' II POLYDEK, and ● TEVDEK II. 'cottony' II is uncoated polyester suture. 'silky' II POLYDEK® suture has a light coating of Polytetrafluoroethylene (PTFE) and TEVDEK II has a heavy PTFE coating.
- . NextStitch Cardiovascular Valve Suture is a combination of 'silky' II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures.
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- Polypropylene: DEKLENE II and DEKLENE® MAXX are the two varieties of this material.
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- NYLON is composed of monofilament synthetic polyamide fiber.
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- SILK is composed of grade 4A Chinese silk derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae.
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- STERNOTOMY STAINLESS STEEL sutures are composed of 316 LVM stainless steel.
All sutures are provided in a variety of lengths, with and without needles, and (if applicable) with and without pre-attached pledgets (if applicable).
An accessory that can be used with the Nonabsorbable Surgical Sutures is the Gabbay-Frater Suture Guide which is a convenient suture organizer which keeps suture ends tangle-free.
This document is a 510(k) summary for the Deknatel Nonabsorbable Surgical Sutures. It aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a shelf-life extension and ownership transfer. Clinical performance criteria or studies in the context of device accuracy for diagnosis or treatment are not applicable here, as this is a surgical suture, not a diagnostic or AI-powered device.
Therefore, the requested information elements such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details are not applicable or available in this submission because the device is a surgical suture, not an AI-powered diagnostic tool.
The "acceptance criteria" and "study" described in the document relate to the physical and mechanical properties of the sutures and their packaging for shelf-life extension, not to diagnostic or performance accuracy in the way an AI medical device would be evaluated.
Here's the relevant information based on the provided document regarding the substantiation of the shelf-life extension:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that non-clinical real-time aging testing was performed in accordance with specific standards. However, it does not explicitly present a table of acceptance criteria alongside reported device performance values in a comparative format for each individual suture property. Instead, it broadly states that "the proposed Deknatel Nonabsorbable Surgical Sutures are substantially equivalent to the predicate devices."
The standards referenced imply the properties that were measured and thus, the implicit acceptance criteria would be compliance with these standards within expected ranges for surgical sutures.
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance (Summary) |
|---|---|
| Compliance with ISO11607-1:2006 for packaging requirements for terminally sterilized medical devices. | Packaging integrity maintained for 5 years. |
| Compliance with USP 36-NF 31 for Sutures - Diameter. | Suture diameters remained within USP specifications for 5 years. |
| Compliance with USP 36-NF 31 for Sutures - Needle Attachment. | Needle attachment strength remained within USP specifications for 5 years. |
| Compliance with USP 36-NF 31 for Sutures - Tensile Strength. | Suture tensile strength remained within USP specifications for 5 years. |
| Shelf-life claim | 5-year shelf-life verified. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size used for the real-time aging testing. It generally refers to "non-clinical real-time aging testing."
- Data Provenance: The data is non-clinical, likely generated in a laboratory setting by Teleflex Medical, Inc. or its contractors. The document does not specify country of origin for the data, but the company is based in Morrisville, NC, USA. The testing is prospective in the sense that the sutures were aged in real-time to assess performance over 5 years.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. For the physical and mechanical testing of surgical sutures, ground truth is established by adherence to recognized international and national standards (e.g., ISO, USP) and laboratory testing protocols, not by expert consensus or interpretation of images. The "ground truth" is the objective measurement against these standards.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations where human interpretation is involved, such as reading medical images. For physical property testing of sutures, measurements are objective and usually do not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical medical device (suture), not an algorithm or AI.
7. The Type of Ground Truth Used:
- Objective Measurement against Recognized Standards: The "ground truth" for demonstrating the shelf-life and performance of the sutures are the established specifications and test methods outlined in ISO and USP standards for medical device packaging and surgical sutures.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device that requires a "training set." The performance data is for physical characteristics of the manufactured product.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set," this question is not relevant.
In summary, this 510(k) pertains to a traditional physical medical device (surgical suture). The "study" referenced is non-clinical real-time aging testing to support a shelf-life claim, using recognized industry standards for material properties and packaging integrity. The concepts of acceptance criteria, test sets, experts, and ground truth are applied differently in this context compared to AI/diagnostic devices.
§ 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.