(72 days)
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.
This document describes the Polyester Surgical Suture, a nonabsorbable, sterile suture composed of Poly (ethylene terephthalate), intended for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tri-Cron® Non-Absorbable Polyester Surgical Suture and Ethibond® Nonabsorbable Polyester Surgical Suture) through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the POLYESTER surgical suture are primarily based on conformance to United States Pharmacopeia (U.S.P.) standards and demonstrating substantial equivalence to the predicate devices. The document explicitly states that the device meets these requirements.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures (matching predicate). | POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
| Suture Material | Flexible fibers of high-molecular weight, long-chain, linear poly-(ethylene terephthalate) having recurrent aromatic rings as an integral component (matching predicate). | Flexible fibers of high-molecular weight, long-chain, linear poly-(ethylene terephthalate) having recurrent aromatic rings as an integral component. |
| Suture Characteristics | Not absorbed and no significant change in tensile strength retention known to occur in vivo (matching predicate). | Not absorbed and no significant change in tensile strength retention known to occur in vivo. |
| Sterilization Method | Gamma Irradiation (same as or equivalent to predicate). | Gamma Irradiation. |
| How Supplied | Multifilament thread; offered coated or uncoated, undyed or dyed with FDA listed color additive D&C Green No. 6 (21CFR74.3206); sterile and for single use only; available with or without surgical needles (same as or equivalent to predicate). | Multifilament thread, it will be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). Sterile and offered for Single Use Only. Available with or without surgical needles. |
| Physical Properties | Suture Diameter, Suture Length, Knot Pull Tensile Strength, and Needle Attachment Strength must meet U.S.P. Requirements. | Meet U.S.P. Requirements. |
| Packaging | Dry packaged in Aluminum Foil and Polyester tear open packaging (same as or equivalent to predicate). | Dry packaged in Aluminum Foil and Polyester tear open packaging. |
| Labeling | In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996 and FDA Guidance documents "Alternate Suture Labeling," reformatted on December 17th, 1997. | In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996. Package Inserts in accordance with the FDA Guidance documents "Alternate Suture Labeling" Resulting from the January 11th 1993 meeting with HIMA, reformatted on December 17th 1997. |
| Overall Equivalence | Demonstrate substantial equivalence to the predicate device. | T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device."
- Sample Size: The specific sample sizes for the non-clinical tests are not provided in this summary.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's non-clinical testing for a device intended for U.S. market (submitted to FDA), it's highly likely the testing was conducted in a controlled laboratory environment, potentially in the U.S. or by a compliant international facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through expert consensus on qualitative assessments.
4. Adjudication Method for the Test Set
This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through human adjudication of qualitative data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI model.
7. The Type of Ground Truth Used
The ground truth used for evaluating the POLYESTER surgical suture is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. This involves objective physical and functional property measurements (e.g., suture diameter, length, knot pull tensile strength, needle attachment strength).
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.
In summary, the Polyester Surgical Suture demonstrated conformance to U.S.P. standards and substantial equivalence to predicate devices through non-clinical laboratory testing of its physical and functional properties. No clinical studies, expert-based ground truth, or AI-related evaluations were performed or required for this 510(k) submission.
§ 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.