(533 days)
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.
This 510(k) summary describes a Polydioxanone Synthetic Absorbable Monofilament Suture by Demetech Corporation, seeking substantial equivalence to existing predicate devices.
The document does not report on a study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study with a defined acceptance criterion and specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture and Ethicon PDS II Synthetic Absorbable Monofilament Suture) by showing that the new device has the same technological characteristics and meets the same performance requirements as defined by the United States Pharmacopeia (U.S.P.) for absorbable surgical sutures.
Therefore, the requested information elements related to diagnostic performance studies, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of device submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from USP 31, compared to predicate devices) | Reported Device Performance (vs. Predicates) |
|---|---|
| Suture Material: synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) | Same |
| Suture material offered un-dyed and dyed with D&C Violet No. 2 | Same |
| Suture Material supplied un-coated | Same |
| Suture Material: sterile, flexible, monofilament thread, various lengths and diameters, with or without needles | Same |
| Absorption profile: retains ~85% original tensile strength at 120 days, ~25% at 180 days; absorption essentially complete at 220 days | Same to Similar |
| Intended Use: general soft tissue approximation, pediatric cardiovascular tissue (growth expected), ophthalmic surgery; not for adult cardiovascular, microsurgery, neural tissue; extended wound support (up to six weeks) desirable. | Same |
| Meets USP 31 performance requirements for "Absorbable Surgical Suture" monograph | Same |
| Meets USP 31 performance requirements for Diameter | Same |
| Meets USP 31 performance requirements for "Tensile Strength" | Same |
| Meets USP 31 performance requirements for "Needle Attachment" | Same |
| Meets USP 31 performance requirements for "Suture Length Requirement" (95% of stated label length) | Same |
| Packaged in same or equivalent manner with sterile single/double package, labeling conforms to 21 CFR and USP XXXI | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not detail a "test set" in the context of a clinical performance study. The performance evaluation is based on meeting established material and performance standards (USP) which are generally tested in laboratory settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant to this type of device (surgical suture). The ground truth here is the established, published standards of the United States Pharmacopeia.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are for reconciling discrepancies among expert reviewers in diagnostic studies, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a surgical suture, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating equivalence is adherence to the United States Pharmacopeia (USP) 31 standards for synthetic absorbable surgical sutures, as well as comparison to the characteristics of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This submission does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. This submission does not involve a "training set" in the context of machine learning.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.