(17 days)
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).
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Technological Characteristics | "The Modified TargetScan® Biopsy Kit and Guide use the same basic design, same sterility assurance level (SAL 10-6) and method (Ethylene Oxide), the same scientific technology and has the same intended use as the originally cleared predicate devices." |
| "The materials and intended use remain unchanged from the original 510(k)." | |
| "Minor changes to the labeling layout and package dimensions were made." | |
| "The End of the Needle Guide has a slightly different profile than the predicate device to aid insertion into the rectum." | |
| Sterility & Manufacturing | "The components in the Biopsy kit are provided sterile, as are the predicate device." |
| "An alternate contract manufacturing and sterilization facility is being added... The new manufacturing facility is an FDA registered facility and the quality management system is certified to ISO 13485." | |
| "Applicable testing was performed in accordance with approved Validation protocols and the Risk Analysis to ensure the product is properly manufactured, packaged and sterilized." | |
| Shelf-Life | "The predicate device included a 1 year shelf life; this has been tested and extended to 3 years in the modified device." |
| Packaging | "The package and materials used meet the requirements of ISO 11607-1." |
| Safety & Effectiveness | "These modifications do not raise new questions regarding safety or effectiveness of the devices originally cleared..." |
| Intended Use | "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." (Identical to predicate device's intended use). |
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.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.