(246 days)
The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate tissue, without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
The provided text describes Dongwon Medical Co., Ltd.'s DW-1C absorbable polydioxanone surgical suture and its substantial equivalence to the predicate device, MINT. The document primarily focuses on demonstrating the safety and performance of the DW-1C through various tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document provides two main tables for performance data: "Biocompatibility test" on page 5 and "Bench (performance) testing" on page 6.
Table: Biocompatibility Test Acceptance Criteria and Results
| Test Identification | Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity MEM Elution Method (Cytotoxicity) | No evidence of causing cell lysis or toxicity to fibroblast cells | Not Cytotoxic (PASS) |
| ISO Guinea Pig Maximization Sensitization Test | No delay in dermal contact sensitization | No evidence SC and CSO extracts causing delayed dermal contact sensitization (PASS) |
| ISO Acute Intracutaneous Reactivity Study | No irritation | Primary Irritation Index Characterization SC extract = 0.0 CSO extract = 0.0 (PASS) |
| ISO Systemic Toxicity Study in Mice | No reaction, No Mortality during this study or evidence of systemic toxicity | No Mortality or Evidence or Significant Systemic toxicity (PASS) |
| Bacterial Reverse Mutation study (Ames test) | Tester strain char must exhibit sensitivity to crystal violet, UV, no growth biotin plates and growth histatine-biotin plates; number of mutation revertants (including spontaneous reversions) statistically less than negative control results | The Saline and dimethyl sulfoxide test article extracts were considered to be non-mutagenic to Salmonella typhimurium and Escherichia coli tester strains. (PASS) |
| Genotoxicity: In Vitro Chromosomal Aberration | Whether the extract would cause genotoxicity in Chinese Hamster Ovary cells | Not considered genotoxic (Pass) |
| Mouse Bone Marrow Micronucleus | No cellular toxicity | Not considered to be genotoxic (Pass) |
| 4 Week Subchronic Toxicity | No signs of behavioral change or toxicity in rats | No significant evidence of systemic toxicity from the subcutaneous article into rats. (Pass) |
| ISO Muscle Implantation Study in Rabbits | No significant macroscopic and microscopic reactions nonirritant compared to USP Negative Control Implant Material | Macroscopic reaction for the test article device was not significant as compared to the USP negative control implant material (PASS) |
Table: Bench (Performance) Testing Acceptance Criteria and Results
| No. | Title | Criteria | Result Summary |
|---|---|---|---|
| 1 | USP 32:2009 Absorbable Surgical Suture | Implicit criteria based on similar absorbable sutures, no explicit numerical criteria provided | In vivo absorption of absorbable suture were observed at 10, 80, 120, 220 days after implantation. Absorption time of MONOSORB was 180-220 days. |
| 2 | Dimension Test USP 37-NF 32:2014 Sutures - Diameter | Acceptance Criteria for this testing ±5% | No failed results were performed in any DW-1C during the performing period. |
| 3 | Tensile Strength USP 37-NF 32: 2014 Tensile Strength | Acceptance Criteria for this testing Not less than 300gf. | No failed results were performed in any DW-1C during the performing period. |
| 4 | Holding forces | No explicit numerical criteria provided, but implied to be comparable to reference samples. | There was no significant difference between test samples and reference samples. |
| 5 | Weights | Implied criteria would be a expected decrease over time as degradation occurs. | The weights of test samples in 1st (G1, Week 2), 2nd (G2, Week 4), 3rd (G3, Week 6), 4th (G4, Week 8), 5th (G5, Week 10), 6th (G6, Week 12) and 7th (G7, Week 14) necropsy groups were statistically significantly lower than that of the test samples in before implantation (p |
§ 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.