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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.

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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.

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The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and 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 prostatectomy and 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 UroMed CaverMap Surgical Aid combines the technologies of two devices into one contained unit. The CaverMap Surgical Aid incorporates a nerve stimulator and a penile rigidity (tumescence) monitor into a single unit. The device is designed for identifying exposed nerves during open prostatectorny and colorectal surgical procedures. The device aid's the surgeon in locating the cavernosal and sacral nerves, which both effect tumescence.

The provided 510(k) summary for the UroMed CaverMap® Surgical Aid does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on establishing substantial equivalence to a predicate device (K970971 UroMed CaverMap Surgical Aid) based on its intended use, indications for use, and a general description of its technological features. It also lists the standards achieved (e.g., FDA Quality Systems Regulation, ISO standards), which are related to manufacturing and design controls, but not directly to performance acceptance criteria for the device's function.

Therefore, for each of your requested points, the answer is that the information is not provided in the given text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states a general "Summary of Standards Achieved" related to quality systems and biological evaluation, not specific performance metrics.
2. Sample size used for the test set and the data provenance: No performance study is described, hence no test set or information about its size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described, hence no ground truth establishment details.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No performance study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No such study is mentioned. The device is a "Nerve Stimulator/Locator" and does not appear to involve AI or "human readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No performance study of this nature is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No performance study is described.
8. The sample size for the training set: No training set is mentioned as part of a performance study.
9. How the ground truth for the training set was established: No training set is mentioned.

In summary, the provided 510(k) pertains to substantial equivalence based on established regulatory standards and a predicate device, rather than a detailed performance study with specific acceptance criteria and results.

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