(21 days)
The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid..
The CaverMap Surgical Aid Monitor consists of a self contained IBM compatible computer system with an integrated liquid plasma video screen. The integrated video display unit will be connected to the CaverMap Surgical Aid Control unit by a standard RS-232 port. The CaverMap Surgical Aid Monitor reads data directly from the CaverMap Surgical Aid Control Unit through a RS232 port, which will be a modification to the current control unit design. The video monitor displays the data to the video screen in text and graphical format. Communication between the CaverMap Surgical Aid and the CaverMap Surgical aid Monitor is unidirectional.
This document does not include acceptance criteria for device performance, nor does it describe a study to demonstrate the device meets any such criteria.
The document is a 510(k) summary for the Blue Torch Medical Technologies CaverMap Surgical Aid with Video Monitor. It focuses on demonstrating substantial equivalence to an existing predicate device (Blue Torch Medical Technologies CaverMap Surgical Aid K970971), rather than establishing performance against defined acceptance criteria through a clinical or performance study.
Here's a breakdown of why the requested information cannot be provided from this document:
- No Acceptance Criteria or Performance Claims: The document states that "Quality System & Design Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness." This implies that the device's performance is deemed acceptable because it is similar to a previously cleared device, not because it met specific, quantifiable performance metrics defined for this new device.
- Focus on Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on design comparisons, adherence to recognized standards (like ISO 46001, EN 60601-1, and 21 CFR § 820), and sometimes non-clinical testing to confirm that changes do not raise new questions of safety or effectiveness. It generally does not involve a formal study with acceptance criteria for a device's clinical performance.
- Nature of the Device Modification: The submission describes the addition of a video monitor to an existing surgical aid. This is presented as a modification that primarily changes how data is displayed (text and graphical format, tumescence signals, stimulation current, etc.) and not necessarily the fundamental function or accuracy of the nerve stimulation itself. Therefore, a clinical outcome study or a study with stringent performance acceptance criteria might not have been deemed necessary for this type of modification.
In summary, the requested information (performance acceptance criteria, details of a study proving those criteria were met, sample sizes, expert involvement, etc.) is not present in this 510(k) summary because the submission pathway focuses on demonstrating substantial equivalence rather than establishing de novo performance against new acceptance criteria.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.