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The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparobomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct incontinence due to urethral hypermobility.

The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter and suture pulling loop. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.

The provided document K971791 is a 510(k) Pre-Market Notification for a medical device submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what the document does provide:

• Acceptance Criteria and Study Data: The 510(k) pathway for medical device regulation in 1997 (and largely today) focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate). This typically involves comparing device design, materials, intended use, and technological characteristics. It does not generally require de novo clinical trials with predefined acceptance criteria and performance metrics like sensitivity, specificity, or outcomes data, unless there's a significant difference in technology or intended use that raises new questions of safety and effectiveness.

Instead, the document provides the following relevant information for a 510(k) submission:

• Identification of the Predicate Devices:

  • Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076)
  • Laurus Medical Suturing System (K932553)
  • "several surgical techniques that have been performed for over forty years."

• Statement of Substantial Equivalence: The document states that the Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension is substantially equivalent to the aforementioned predicate devices. The basis for this claim is similarity in:

  • Intended use (bladder neck suspension for female stress incontinence due to urethral hypermobility).
  • Technological characteristics: Both the subject device and predicates include kit components for delivering bone anchors and/or sutures for bladder neck suspension, use a method or component for positioning sutures, and use a standard scissors or suture cutter for cutting sutures.

• FDA Determination: The FDA reviewed the 510(k) notification and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This determination allows the sponsor to market the device.

In summary, because this is a 510(k) pre-market notification from 1997, it relies on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria.

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