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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

TargetScan® Biopsy Kit and Biopsy Needle Special 510(k)

Envisioneering, L.L.C. November 26, 2007

Section 8 - 510(k) Summary

510(k) Summary

Applicant:	Envisioneering, LLC1982 Innerbelt Business Center DriveSt. Louis, MO 63114
Contact Person:	David Kennedy
Telephone:	314-429-7367
FAX:	314-429-7701
Date Prepared:	November 26, 2007
Trade Name:	TargetScan® Biopsy kitTargetScan® Biopsy Needle Guide
Common Name:	Biopsy kitBiopsy Needle Guide
Establishment Registration Number:	3005673110
Establishment Address:	Envisioneering, LLC1982 Innerbelt Business Center DriveSt. Louis, MO 63114
Classification of the Device:	The Biopsy Kit is classified as a Biopsy Instrument, asdefined in CFR 876.1075, Class II device. The Needle Guideis a Class II, CFR 892.1570
Product Code:	Biopsy Kit FCGNeedle Guide ITX

Identification of Predicate Device(s):

Envisioneering TargetScan® Biopsy Kit 510(k) # K041638, originally cleared September 2, 2004.

Envisioneering TargetScan® Biopsy Needle Guide 510(k) # K041637, originally cleared September 1, 2004.

Device Description:

. .

Devree Deserription The steries Targetsound 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.

{1}------------------------------------------------

Envisioneering, L.L.C. November 26, 2007

TargetScan® Biopsy Kit and Biopsy Needle Guide Special 510(k)

Intended Use

Purpose and Function of the Device

This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan® Ultrasound system.

Intended Patient Population

This system is intended to be used with adult patients.

Intended Environment of Use

This system is intended for use by medical professionals in a physician office or hospital environment.

Technological Characteristics compared to those of the Predicate Devices

The components in the Biopsy kit are provided sterile, as are the predicate device. Minor changes to the labeling layout and package dimensions were made. An alternate contract manufacturing and sterilization facility is being added to manufacture the kits for Envisioneering Medical. The materials and intended use remain unchanged from the original 510(k). The new manufacturing facility is an FDA registered facility and the quality management system is certified to ISO 13485.

The predicate device included a 1 year shelf life; this has been tested and extended to 3 years in the modified device.

The anesthesia needle and latex probe cover included in the original 510(k) are optional components that may not be included in the kits (Currently are not included). These items are readily available from other sources and are still recommended for use.

The End of the Needle Guide has a slightly different profile than the predicate device to aid insertion into the rectum.

The Modified TargetScan® Biopsy Kit and Guide use the same basic design, same sterility assurance level (SAL 10th) and method (Ethylene Oxide), the same scientific technology and has the same intended use as the originally cleared predicate devices.

Performance Data

Applicable testing was performed in accordance with approved Validation protocols and the Risk Analysis to ensure the product is properly manufactured, packaged and sterilized. The package and materials used meet the requirements of ISO 11607-1.

Conclusion:

The addition of an alternate manufacturing and sterilization facility does not change the fundamental scientific technology or the intended use of the device as compared to the predicate device. These modifications do not raise new questions regarding safety or effectiveness of the devices originally cleared on September 1, 2004 and September 2, 2004 under 510(k) K041637 and K041638 respectively.

The performance data and declaration of conformity with design controls support the determination of continuing substantial equivalence of the previously cleared and predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, with three wavy lines above it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Mr. David Kennedy

Director, Quality Assurance and Regulatory Affairs Envisioneering Medical Technologies 1982 Innerbelt Business Center Drive ST LOUIS MO 63114

Re: K073399

Trade/Device Name: TargetScan® Biopsy Needle Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG and ITX Dated: November 26, 2007 Received: December 4, 2007

Dear Mr. Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Envisioneering, L.L.C November 26, 2007

TargetScan® Biopsy Kit and Biopsy Needle Guide Special 510(k)

Attachment III

Indications for Use Statement

Biopsy Needle Kit

Originally cleared under K041638

510(k) Number	K073399
Device Name	TargetScan Biopsy Needle Kit
Indications for 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.

Prescription Use ✓
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K073399

Regulation Number and Section

§ 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.