(170 days)
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
DemeDIOX Barbed Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.
The provided text describes the submission of a 510(k) premarket notification for a medical device: DemeDIOX Barbed Absorbable Surgical Suture. This type of submission relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through extensive clinical trials.
Therefore, the study design described is focused on non-clinical testing to demonstrate conformance to established standards and comparison to predicate devices, rather than a clinical study measuring human-in-the-loop performance or outcomes in a clinical setting.
Based on the provided information, here's an analysis of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely derived from established standards for absorbable surgical sutures, primarily the United States Pharmacopeia (USP) and ISO 10993. The reported device performance demonstrates adherence to these standards and equivalence to predicate devices.
| Acceptance Criteria (Derived from USP 42, ISO 10993, and predicate equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Material Composition | Composed of polyester, poly (p-dioxanone), same as predicate devices. |
| Sterility | Sterile. Achieved via Ethylene Oxide (EO) sterilization. |
| Biocompatibility | Conforms to ISO 10993-1. Material (polydioxanone) has |
| "known biocompatibility" and "established history of use" in surgical sutures. | |
| In-vitro Resorption | Testing conducted to further demonstrate substantial equivalence to predicate devices. (No specific numerical results provided, but stated to support equivalence). |
| USP 42 Requirements for "Absorbable Surgical Suture" | Suture Material meets or exceeds requirements, with the exception of diameter (due to barbs). This includes: |
| a. Suture Diameter | Meets USP 42 requirements except for diameter. This deviation is explicitly acknowledged and attributed to the presence of barbs on the suture. |
| b. Suture Length | Meets or exceeds the performance requirements defined in USP for "Suture Length Requirement" (95% of stated length). |
| c. Tensile Strength ( USP) | Meets or exceeds the performance requirements defined in USP 42 for "Tensile Strength." |
| d. Needle Attachment ( USP) | For sutures supplied with needles, meets or exceeds the performance requirements defined in USP 42 for "Needle Attachment." |
| Extractable Color | Assured conformance to methods outlined in USP 42. (The device is dyed with D&C Violet No.2). |
| Physical Properties & Functionality | Assured conformance to suture diameter and length. (Reiterates USP conformance with the noted diameter exception due to barbs). The barbing allows for tissue approximation without knots. |
| Labeling | Sterile, Single Use. Packaging and labeling conform to 21 CFR standards. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to the predicate devices (Ethicon PDS Barbed Suture K113004 and DemeTECH Polydioxanone Synthetic Monofilament K082097) in terms of intended use, technical characteristics, material, sterilization, and performance (with the acknowledged exception for diameter due to barbs). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of sutures tested) for each non-clinical test (tensile strength, diameter, length, etc.). It generally states that "Non-clinical testing was conducted... to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro resorption." and "Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 42." These tests typically involve a statistically relevant number of samples to ensure robust results, as outlined in the respective standards (USP, ISO).
- Data Provenance: The data is generated from non-clinical laboratory testing performed specifically for this 510(k) submission. No information on the country of origin of the data or whether it was retrospective or prospective is given, but non-clinical tests would inherently be prospective for the purpose of demonstrating conformance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of submission. Ground truth, in the context of diagnostic AI or image analysis, typically involves expert human annotation or clinical outcomes. For a medical device like a surgical suture, the "ground truth" and acceptance criteria are defined by established performance standards (USP, ISO) and comparison to predicate device characteristics as detailed in their respective 510(k) clearances. The performance is measured against these objective standards through physical and chemical testing, not through expert consensus on a test set.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human experts are making subjective assessments, often in diagnostic accuracy studies. For testing a physical device like a suture, the "adjudication" is inherent in the standardized testing process where results are objectively measured against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done.
- This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., AI-assisted radiology).
- The device in question, DemeDIOX Barbed Absorbable Surgical Suture, is a physical surgical suture, not a diagnostic or AI-powered device that assists human readers.
- The submission explicitly states: "No clinical trials were conducted."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of an algorithm or AI) was not done.
- This is not an AI/algorithm-based device.
- The performance assessment for this device is based on its physical properties, material characteristics, and biological compatibility as measured directly through laboratory tests and comparisons to predicate devices, not through an algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Established Industry Standards: Primarily the United States Pharmacopeia (USP 42) monographs for absorbable surgical sutures, which define physical and chemical performance requirements (tensile strength, diameter, length, etc.).
- International Standards: ISO 10993-1 for biocompatibility.
- Predicate Device Characteristics: Demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices (Ethicon PDS Barbed Suture and DemeTECH Polydioxanone Synthetic Monofilament Suture) in terms of intended use, technology, and safety/performance profile.
8. Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (surgical suture), not a machine learning model or an AI algorithm. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of the suture material and manufacturing process would involve internal R&D and quality control, but not a formally defined "training set" for an AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for an AI algorithm in this context. The "ground truth" for the development and testing of the suture is established by the well-defined and often long-standing scientific and engineering principles of material science, biomaterials, and surgical product design, all guided by regulatory standards like USP and ISO.
§ 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.