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An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.

The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation.

The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.

The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material.

The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The provided text is a 510(k) summary for the UroGyn DND 202™ Manual Urological Digital Needle Driver, which describes the device, its intended use, and indicates that the FDA found it substantially equivalent to a predicate device.

Specifically, the document states:

• No acceptance criteria or device performance data are reported.
• No study methodology, sample sizes, ground truthing, or adjudication methods are described.
• The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

The "Conclusions" section in {2} states: "From UroGyn's experience we believe that the UroGyn design offers an equally effective alternative to the DND 101™ device and/or the Deschamps™ device for the treatment of female vaginal prolapse. Furthermore, as a minimally invasive procedure, we also believe that it presents equal safety to the patient and surgeon." This is a belief statement based on experience, not reported data from a formal study with acceptance criteria.

The 510(k) review process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trial data with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.

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