(62 days)
PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES
PD Synth is a synthetic absorbable surgical suture, (Monofilament Polydioxanone). PD Synth is a sterile flexible monofilament thread, composed of the polymer, Polydioxanone. The sutures are inert, non collageneous and non antigenic. PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated
The document provided describes a 510(k) premarket notification for a new absorbable surgical suture, "PD SYNTH," by Sutures India Pvt. Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance (PD SYNTH) |
|---|---|
| Physical/Material Characteristics: | |
| Absorbable (Polydioxanone) suture is synthetic, absorbable, monofilament | Same (comprised of Polydioxanone polymer) |
| Sterile, flexible monofilament thread | Same |
| Inert, non-collagenous, non-antigenic | Same |
| Dyed with D&C Violet #2 and uncoated (being monofilament) | Same |
| Supplied for single use only | Same |
| Sterilized by E.O. gas method | Same |
| Packaged in same or equivalent manner, with equivalent labeling claims | Same |
| Meets official monograph of USP 29 for extractable color | Meets USP 29 specifications |
| Meets performance requirements defined in USP 29 for Tensile strength () | Meets USP 29 specifications |
| Meets performance requirements defined in USP 29 for Needle attachment () | Meets USP 29 specifications |
| Meets performance requirements defined in USP 29 for Length requirement (95% of length stated on label) | Meets USP 29 specifications |
| Meets performance requirements defined in USP 29 for Sterility | Meets USP 29 specifications |
| Biocompatibility: | |
| Biologically compatible when tested as per ISO-10993 | Biologically compatible (tested as per ISO-10993) |
| Non-toxic when tested as per ISO-10993 for toxicity | Non-toxic (tested as per ISO-10993) |
| Clinical/Indications: | |
| Indicated for use in soft tissue approximation | Same |
| Indicated for use in ophthalmic procedures | Same |
| Not for use in cardiovascular and neurological procedures | Same |
Note: The document explicitly states "Same" across numerous comparison parameters, indicating that "PD SYNTH" performance matches that of the predicate devices, which are assumed to meet the established acceptance criteria (e.g., USP standards).
One point mentions "Finished suture material does not meet the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter". However, this is listed as "Same" for all three devices in the comparison table, suggesting it's either an accepted deviation for this type of suture or a characteristic shared by the predicates that doesn't preclude substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based to conform to USP standards and ISO-10993.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of device (surgical suture) relies on objective physical, chemical, and biological testing against established standards (USP, ISO) rather than expert consensus on subjective interpretations. Ground truth is derived from these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. The testing involves objective measurements against predefined specifications from USP and ISO standards. There is no mention of an adjudication process by human experts for the test results.
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 submission is for an absorbable surgical suture, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As mentioned, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the "PD SYNTH" device is based on:
- Established Industry Standards: United States Pharmacopeia (USP) 29 specifications for various suture properties (tensile strength, diameter, length, needle attachment, sterility, extractable color).
- International Standards: ISO-10993 for biocompatibility and toxicity.
- Regulatory Compliance: Conformance to Title 21 CFR § 74.3602 for colorant concentration.
- Comparison to Predicate Devices: Demonstrating equivalence to existing legally marketed absorbable polydioxanone sutures (PDS II and Unicryl M) across numerous characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device where a 'training set' would be used. The manufacturing process of the suture does not involve such a concept.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
§ 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.