(16 days)
QuillTM PDO Knotless Tissue-Closure Device comprised of Polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument is designed with small uni- directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0, 2-0 and 3-0 in various lengths affixed to various needle types.
This 510(k) submission describes a Quill™ PDO Knotless-Tissue Closure Device, Variable Loop Design (Polydioxanone), which is an absorbable surgical suture. The device is a sterile, synthetic absorbable tissue-closure device comprised of polyester [poly (p-dioxanone)], with uni-directional barbs and a welded primary and secondary loop design at the distal end. It is available in diameter Size 0, 2-0, and 3-0 in various lengths affixed to various needle types.
The submission focuses on demonstrating substantial equivalence to a predicate device (K113744 Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size -0-) by confirming that the new device, which differs only in suture diameter, meets established performance standards for absorbable sutures.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from USP Monograph for Absorbable Sutures and FDA Guidance) | Reported Device Performance (from Non-clinical Laboratory Testing) |
|---|---|
| Conformance to USP monograph for absorbable sutures for tensile strength. | Device conforms to USP monograph for absorbable sutures for tensile strength. |
| Conformance to USP monograph for absorbable sutures for needle attachment. | Device conforms to USP monograph for absorbable sutures for needle attachment. |
| Performance demonstrated as substantially equivalent to the predicate device in in vitro post-hydrolysis tensile testing. | In vitro post-hydrolysis tensile testing demonstrated substantial equivalence to the predicate device. |
Note: The document explicitly states the new device has "the same design and materials as the Quill™ PDO Knotless Tissue-Closure Device predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter." This implies the acceptance criteria for these performance aspects are to meet or exceed the performance of the predicate device and the general USP standards.
2. Sample size used for the test set and the data provenance
The document specifies "Non-clinical laboratory performance testing was conducted." It also mentions "Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing."
- Sample Size: The document does not explicitly state the sample size used for the non-clinical laboratory performance testing or the in vitro post-hydrolysis tensile testing.
- Data Provenance: The tests are described as "non-clinical laboratory performance testing" and "in vitro," indicating they were conducted in a laboratory setting, likely by the manufacturer, Angiotech. There is no information regarding the country of origin of the data or whether the data was retrospective or prospective in the context of animal or human studies, as these were material and mechanical property tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for this medical device (surgical suture) is established by adherence to recognized standards for material properties (e.g., USP monograph) and performance measures like tensile strength and needle attachment, rather than expert interpretation of images or clinical outcomes that require expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of ambiguous cases (e.g., diagnostic imaging). For non-clinical, laboratory-based material property testing, the "ground truth" is determined by objective measurements and reference to established standards.
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 a surgical suture, not an AI-assisted diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a surgical suture, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on:
- Established Standards: Primarily the USP monograph for absorbable sutures.
- Mechanical and Material Properties: Objective measurements of tensile strength, needle attachment, and in vitro post-hydrolysis tensile strength.
- Predicate Device Performance: The new device's performance was compared to that of the legally marketed predicate device (K113744) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train machine learning models. This submission is for a surgical suture, not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device submission.
§ 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.