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The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system.

The sterile TargetScan system. This kit (K041638) includes The Biopsy Needle and the needle guide (K041637) containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan® transrectal probe Model #TS-360-P (K041639) an anesthesia administration needle and a latex probe cover that were included in the original 510(k) are now optional components of the kit and are currently not included. These items are still recommended and can be readily obtained from other sources.

Here's an analysis of the provided text regarding the TargetScan® Biopsy Kit and Biopsy Needle, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary for a Special 510(k), which is used for modifications to a previously cleared device. This type of submission relies heavily on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the typical acceptance criteria and study details you might expect for a novel device or a de novo submission will not be present in this document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria are primarily related to maintaining substantial equivalence to the predicate device after minor modifications (alternate manufacturing/sterilization, extended shelf-life, and minor design change to the needle guide profile).

Study Details:

Given that this is a Special 510(k) for modifications to a predicate device, the "study" demonstrating the device meets acceptance criteria is primarily an analysis of the impact of the changes on the device's substantial equivalence. Clinical studies proving diagnostic accuracy or clinical outcomes were not part of this submission. The focus is on non-clinical performance data and regulatory compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated as a traditional "test set" for diagnostic performance. The validation likely involved testing of materials, packaging, sterility, and accelerated aging for shelf-life, which would involve samples of the device components and packaged products. The exact number of units tested for these specific aspects is not detailed in the summary.
• Data Provenance: Not specified, but generally, such testing would be conducted in controlled laboratory environments in the country of manufacture or a qualified testing facility. The manufacturing facility is implied to be within the US, as it's an FDA registered facility.
• Retrospective/Prospective: The testing described (e.g., shelf-life extension, packaging validation) would be prospective (conducted post-modification to assess the new configuration).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to this submission. Since it's a Special 510(k) for modifications to an existing device, there was no new clinical study to establish diagnostic ground truth. The device is a biopsy instrument, not a diagnostic imaging AI algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication in this context.

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:

• Not applicable. This device is a physical biopsy kit and needle guide, not an AI software or a device that assists human readers/interpreters. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. As stated, this submission focuses on substantial equivalence for modified physical components, not on establishing diagnostic accuracy or clinical outcomes for a novel diagnostic claim. The "ground truth" for the submission is that the modified device performs as safely and effectively as the predicate, which is evaluated through engineering, material, and sterility testing, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device is not an AI algorithm.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (prostate), Transrectal. This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland. This imaging can be used to guide other procedures such as biopsy of the prostate.

The TargetScan™ Transrectal Ultrasound system is intended for diagnostic prostate applications. The TargetScan™ Transrectal Ultrasound system allows the probe to remain stationary inside the patient while the user controls the position of the scan planes that are displayed on the monitor. The probe design allows the capture of transverse and longitudinal scan planes. The system is PC based allowing comprehensive imaging, planning, targeting and data storage/ retrieval.

The provided text is a 510(k) summary for a medical device called the TargetScan™ Transrectal Ultrasound System (K041639). It outlines the device's intended use, technological characteristics, and regulatory compliance. However, it does not contain information about acceptance criteria, device performance, or any clinical studies to demonstrate device effectiveness.

The document primarily focuses on:

• Administrative details: Applicant, contact, date, trade name, common name, establishment registration, classification, and predicate device.
• Device Description: Explains the system's function for diagnostic prostate applications, including its ability to remain stationary while the user controls scan planes and its PC-based imaging capabilities.
• Intended Use: Specifies the purpose (transrectal diagnostic imaging of the prostate, guidance for biopsy), intended patient population (adults), and environment of use (medical professionals in physician offices or hospitals).
• Technological Characteristics: Compares the subject device to its predicate, highlighting similarities in intended use, external design, imaging planes, and biopsy targeting. The key difference mentioned is the subject device's ability to scan the whole prostate without moving the probe in the patient, as the transducer itself moves internally.
• Testing: Lists the safety and electromagnetic compatibility standards the device will comply with (IEC60601-1, EN60601-1, UL2601-1, IEC 60601-2-37, IEC 60601-1-2).
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices, outlines regulatory requirements, and requests a post-clearance special report with acoustic output measurements.
• Indications for Use Forms: Detail the specific clinical applications and modes of operation for the system and probe, indicating "N" for new indications for "Small Organ (prostate)" and "Transrectal" applications in B-mode.

Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them, nor can I provide answers to most of your specific questions.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Not Available: The document lists standards for safety and electromagnetic compatibility (e.g., IEC60601-1), which are essential for device approval, but these are general compliance standards, not performance-based acceptance criteria for the imaging capabilities or specific clinical effectiveness. There are no reported performance metrics for diagnostic accuracy, image quality, or clinical outcomes.

2. Sample sized used for the test set and the data provenance:

• Not Available: No information about a test set size, data provenance, or any clinical data is provided. This document is a 510(k) summary, which often relies on substantial equivalence to a predicate device rather than extensive new clinical trials, especially for a diagnostic imaging system of this nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Available: Since no test set or ground truth establishment is mentioned, this information is not present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Available: No information about a test set or adjudication method is provided.

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:

• Not Available: This device is a diagnostic ultrasound system, not an AI-powered diagnostic tool. There is no mention of AI assistance or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Available: This device is a human-operated imaging system. No standalone algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Available: No information regarding ground truth is provided.

8. The sample size for the training set:

• Not Available: No machine learning or AI components are described, so there is no mention of a training set.

9. How the ground truth for the training set was established:

• Not Available: As above, no training set is discussed.

In summary, the K041639 document is a regulatory submission for a diagnostic ultrasound system. It demonstrates compliance with general safety and performance standards relevant to such devices but does not provide details of clinical performance studies, such as specific acceptance criteria or reported accuracy/effectiveness data typically found in clinical evaluation sections for novel diagnostic algorithms or AI-driven systems. This type of 510(k) relies on demonstrating substantial equivalence to a pre-existing device rather than extensive new clinical validation for its inherent diagnostic capabilities beyond what the predicate already demonstrated.

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This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound system.
This device is indicated for performing planned and targeted ultrasound guided transrectal many I his device is indicated for performing plantive and with the Envisioneering TargetScan model TS-360-P probe.

The sterile TargetScan™ biopsy kit is designed to be used with the Targetscan™ Transrectal Ultrasound system. This kit includes a needle guide containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. This needle guide is the subject of a separate submission. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan™ transrectal probe Model #TS-360-P, which is the subject of a separate submission.

An anesthesia administration needle which can negotiate the curved needle guide and a latex probe cover are included in the kit as well.

The provided text describes the 510(k) summary for the TargetScan™ Biopsy kit (K041638). However, it does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets stated acceptance criteria in the format requested.

The document primarily focuses on:

• Device Description: What the TargetScan™ Biopsy kit is, its components (needle guide, biopsy needle, anesthesia needle, probe cover), and how it's intended to be used with the TargetScan™ Transrectal Ultrasound system.
• Intended Use: For performing planned and targeted ultrasound-guided transrectal biopsies of the prostate in adult patients by medical professionals.
• Technological Characteristics Compared to Predicate Devices: It highlights that the subject device (biopsy needle) uses a nitinol stylet and polyolefin cannula to negotiate a curved biopsy guide, distinguishing it from the predicate's stainless steel stylet and cannula.
• Non-Clinical Performance Data (Bench Testing): It states that the biopsy needle advances 22mm, and can protrude up to 2cm, allowing for a total advance of 42mm. It also mentions a bench test using calves' liver where the subject needle achieved "comparable sample size lengths and weights" to the predicate needle.

Based on the provided text, here's what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing using calves' liver" but does not specify the sample size for this test set nor the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The bench test likely relied on objective measurements rather than expert reads for "sample size lengths and weights."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of a bench test comparing physical characteristics (sample length/weight), an adjudication method in the context of expert review would not be applicable.

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 MRMC comparative effectiveness study was mentioned. The device is a biopsy kit, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned, as the device is a physical biopsy kit and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench test, the "ground truth" was likely direct physical measurement of the sample size lengths and weights achieved from the calves' liver.

8. The sample size for the training set
This information is not applicable/provided, as this is a physical medical device and not an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated above.

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This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system. This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.

The sterile TargetScan™ Biopsy needle Guide is designed to be used with the Targetscan™ Transrectal Ultrasound system. This needle guide contains a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. It allows a flexible biopsy needle to be directed into the tissue at an angle to the probe shaft.

This needle quide is intended for use with the TargetScan™ transrectal probe Model #TS-360-P which is the subject of a separate submission.

The provided text describes a 510(k) summary for the TargetScan™ Biopsy Needle Guide. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The document states that the TargetScan™ Biopsy Needle Guide is intended for use with the Envisioneering TargetScan Ultrasound system (specifically the TS-360-P probe) for performing planned and targeted ultrasound-guided transrectal biopsies of the prostate. It also identifies the Civco Transrectal Needle Guide (K970514) as the predicate device.

The FDA's letter (K041637) confirms that the device has been found substantially equivalent to legally marketed predicate devices based on the indications for use. This means the FDA determined that the new device is as safe and effective as a legally marketed device and does not require premarket approval (PMA).

Because the provided text is a 510(k) summary and FDA clearance letter, it primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Therefore, I cannot provide the requested information in a table or structured response as it is not present in the input. If this information were available, it would typically be found in sections describing performance data, clinical studies, or non-clinical tests.

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