(268 days)
The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
The synthetic barbed Sutures are made of polydioxanone (PDO) with needles attached to each end of the suture. The needles are straight and pre-loaded onto each end of the suture filament. The pigment for the violet dye is D&C Violet No.2. The sutures are inserted into the tissue using the needles. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament. The suture is barbed into two sections and each section are in opposite direction. The device is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The Synthetic Absorbable suture with needle, 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 suture is available in 2-0, 0 and 1, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The needles are 50mm in length (each) and are reverse cutting type.
This document pertains to a 510(k) premarket notification for a medical device called "PDO Max Suture with Dual Needle." It assesses the substantial equivalence of the new device to a legally marketed predicate device.
Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.
The document describes a medical device (surgical sutures) and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It details the device's characteristics, indications for use, and various performance tests conducted (or leveraged from previous submissions) to demonstrate its safety and effectiveness.
Key points from the document:
- Device Name: PDO Max Suture with Dual Needle
- Regulation Number: 21 CFR 878.4840 (Absorbable Polydioxanone Surgical Suture)
- Regulatory Class: Class II
- Product Code: NEW
- Indications for Use: Soft tissue approximation on the skin for dermatological applications only. Not for interior body cavity applications or lifting/supporting tissues.
- Predicate Device: Angiotech Quill™ PDO Knotless Tissue-Closure Device (K120827)
- Reference Device: PDO MAX, Inc. PDS Barbed Suture, PDO MAXX Threads (K190245)
- Performance Testing: Includes biocompatibility, sterilization validation, shelf-life, USP suture and needle performance, and in vivo animal testing. A barb holding strength test was also conducted comparing the subject device to the predicate device in porcine tissue.
- Clinical Testing: Not required to support substantial equivalence.
Therefore, I cannot answer the specific questions about acceptance criteria and a study proving an AI/ML device meets them, as this document does not describe such a device or study.
§ 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.