(88 days)
The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an addition to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males. The device aids the physician in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy, prostate brachytherapy placement, prostate cryotherapy, 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 physician's skill determines whether these nerves are spared regardless of any aid.
The CaverMap Surgical Aid Perineal Tip has been designed specifically for use during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy procedures, where a nerve sparing technique is employed.
The perineal probe tip is designed as a single electrode made from surgical stainless steel. The probe tip is encapsulated in dielectrical insulating tubing, with the exception of the tip which is exposed to deliver the stimulation to the nerves. The tip also includes graduated length markings below the insulating tubing. The surface area of the stimulating (exposed) trocar tip is the same as the current electrodes of the currently marketed probe tip, giving the electrode the same charge density profile as the currently marketed probe tips.
A new reusable control handle was also designed in order to allow for a proper connection to the new probe tip. The materials used to manufacture the new handle are exactly the same as the currently marketed product.
The perineal probe tip functions exactly the same as the existing probe tip. The new tip was designed for use during nerve sparing procedures where a perineal approach to stimulating the cavernosal nerves is indicated.
The provided document for K041732 does not contain information about acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) premarket notification for a new accessory tip (CaverMap Surgical Aid Perineal Tip) for an existing device (Blue Torch Medical Technologies CaverMap Surgical Aid K970971).
The document focuses on demonstrating substantial equivalence to a previously marketed predicate device rather than presenting a performance study with defined acceptance criteria. Key aspects of the substantial equivalency argument include:
- Identical Intended Use and Indications for Use: The new perineal tip accessory shares the same intended use and indications for use as the existing CaverMap Surgical Aid system.
- Similar Design and Function: The perineal tip is described as a single electrode made from surgical stainless steel, encapsulated similarly to the existing probes, with the same exposed surface area and charge density profile. A new control handle was designed, but its materials are the same as the currently marketed product, and the tip functions "exactly the same as the existing probe tip."
- Compliance with Standards: The summary mentions adherence to FDA Quality Systems Regulation 21 CFR § 820, ISO 46001: Quality System, EN 60601-1, and ISO 10993. These are general standards for quality management, electrical safety, and biocompatibility, not specific performance criteria for nerve stimulation effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study from the provided text. The submission type (510(k) for an accessory demonstrating substantial equivalence) typically relies on comparisons to the predicate device's established safety and effectiveness, rather than new, extensive clinical performance studies with 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.