(90 days)
REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
REXMONO: Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle (REXMONO) are produced and provided by SM ENG Co., Ltd. REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXMONO manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOFAST. SM Eng is receiving bulk MONOFAST from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXMONO suture. REXMONO is a sterilized medical device composed with absorbable monofilament suture, poly (glycolide-co-caprolactone), with needle, stainless steel SUS 304. REXMONO Suture is a synthetic absorbable, monofilament, suture composed of poly (qlycolide-co-caprolactone). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 68~78% of tensile strength remain after 1 week. Complete absorption in tissues takes around 90 to 110 days.
PDREX: Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle (PDREX) are produced and provided by SM ENG Co., Ltd. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue. Suture of PDREX manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOSORB. SM Eng is receiving bulk MONOSORB from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes PDREX suture. PDREX is a sterilized medical device composed with polydioxanone surgical suture, with needle, stainless steel SUS 304. PDREX Suture is a synthetic absorbable, monofilament, suture composed of a Poly (p-dioxanone). The suture is available dyed (D&C Violet No.2). Approximately 50~60% of tensile strength remain after 6 week. Complete absorption in tissues takes around 180 to 210 days.
This looks like a 510(k) premarket notification for surgical sutures (REXMONO and PDREX). The document indicates that the devices are substantially equivalent to predicate devices, and the "study" mostly consists of non-clinical bench tests and biocompatibility testing against established standards.
Here's an analysis of the acceptance criteria and the "study" information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a formal "acceptance criteria" table with specific quantitative thresholds for each parameter alongside the device's performance results in the way a clinical study report might. However, it states that the proposed devices comply with various USP and ISO standards.
Here's a table based on the implicit acceptance criteria (compliance with standards) and the reported performance (that the device met these standards):
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Suture Diameter | USP SUTURES - DIAMETER | Complies with USP (with specified oversizes) |
| Needle Attachment | USP SUTURES - NEEDLE ATTACHMENT | Complies with USP |
| Tensile Strength | USP TENSILE STRENGTH | Complies with USP |
| Absorption Rate | USP monograph of absorbable surgical suture requirements & FDA Class II Special Controls Guidance Document | Studies demonstrated in accordance with requirements |
| Sterility Packaging | ISO 11607-1, ISO 11607-2, ASTM F 88, ASTM F 1929 | Complies with these standards |
| Shelf Life (Sterility) | ASTM F 1980 for accelerated aging | Accelerated aging stability testing performed |
| Biocompatibility | ISO 10993-1, 10993-2, 10993-3, 10993-4, 10993-5, 10993-6, 10993-10, 10993-11, 10993-12 | Complies with specified ISO 10993 standards (for suture and needle) |
It's important to note that the document generally states "complies" or "demonstrated in accordance with requirements" rather than providing specific numerical results for each test. The listed "MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P." for REXMONO and PDREX, and the remaining tensile strength percentages (68-78% for REXMONO after 1 week, 50-60% for PDREX after 6 weeks), are the most quantitative pieces of performance information provided for the sutures themselves.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the non-clinical bench tests (e.g., how many sutures were tested for tensile strength or diameter). It refers to the tests performed to "verify that the proposed device...met all design specifications."
- Data Provenance: The tests are described as "Bench tests" conducted by the manufacturer/sponsor (SM ENG CO., LTD) or its design partner (Samyang Biopharmaceuticals Corporation). The origin (country) of the raw data for these tests is not explicitly stated beyond the companies being based in Korea. These are typically simulated or laboratory tests rather than trials with human subjects. The data is retrospective in the sense that the tests were completed before this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for surgical sutures in a 510(k) context is typically established by recognized standards (e.g., USP monographs, ISO standards) and regulatory guidance documents, not by expert consensus on individual cases. The FDA's review process itself involves subject matter experts (e.g., engineers, scientists) who evaluate the compliance of the submitted data with these standards.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" refers to physical product samples undergoing laboratory testing against predefined specifications, not clinical cases requiring expert adjudication.
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
This section is not applicable. This submission is for surgical sutures, which are physical medical devices, not AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) software intended for interpretation by human readers. Therefore, no MRMC study looking at human reader performance with or without AI assistance would be relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable for the same reason as point 5. The device is a surgical suture, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating these sutures is primarily based on established industry standards and regulatory requirements:
- USP (United States Pharmacopeia) Monographs and Test Chapters: These define the physical and performance characteristics (e.g., diameter, tensile strength, needle attachment) accepted for surgical sutures.
- ISO (International Organization for Standardization) Standards: Specifically ISO 10993 for biocompatibility and ISO 11607 for packaging.
- ASTM (American Society for Testing and Materials) Standards: For seal strength and accelerated aging.
- FDA Class II Special Controls Guidance Document: Surgical Sutures: This document outlines specific performance testing requirements, including residual strength and absorption rate studies.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence. This concept is relevant to machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.