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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Implied)	Reported Device Performance
Needle advance during actuation	22mm (both predicate and subject device)
Needle protrusion beyond biopsy guide prior to firing	Up to 2cm
Total needle advancement capacity beyond disposable guide exit	As much as 42mm
Sample size length and weight in bench testing (compared to predicate)	Comparable to the predicate needle (Manan Biopsy needle K980122) in calves' liver

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.

Summary

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K041638

a Biopsy

SEP - 2 2004

Section 3 510(k) Summary

1. Applicant:	Envisioneering, LLC1982 Innerbelt Business Center DriveSt. Louis, MO 63114
Contact Person:	Tom Kappel
Telephone:	314-429-7367
FAX:	314-429-7701
2. Date Prepared:	March 22, 2004
3. Trade Name:	TargetScan™ Biopsy kit
4. Common Name:	Biopsy kit
5. Establishment Registration Number:	pending
6. Establishment Address:	Envisioneering, LLC1982 Innerbelt Business Center DriveSt. Louis, MO 63114
7. Classification of the Device:	This device is classifiedInstrument, as defined in CFR 876.1075, a Class II device.
8. Identification of Predicate Device(s):

Manan Biopsy needle (Medical Device Technology K980122) .
EP Deflectable Catheter, (EP Medsystems K033963) .

Device Description: ഴ്.

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

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10. 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.

11. Technological Characteristics compared to those of the Predicate Devices

The components in the Biopsy kit are provided sterile, as are the various predicates.

The subject and predicate device (biopsy needle) are both intended to perform biopsies of the prostate gland. They are both intended to be used with the same reusable biopsy gun. The predicate device is manufactured of a stainless steel stylet and cannula. The subject device has a nitinol stylet and a polyolefin cannula. The use of this design and these materials allows the biopsy needle to negotiate the curved biopsy guide required to take the biopsy. The performance of these devices is equivalent in bench testing.

The predicate catheter is manufactured using the same polyolefin material as the cannula of the subject device.

12. Non-Clinical Performance Data

The Biopsy needle advances 22mm during actuation of both the predicate and subject device. The needle is designed to allow the tip to protrude up to 2cm from the biopsy quide prior to firing the biopsy gun. Therefore the needle can be advanced as much 42mm beyond the disposable guide needle exit hole.

The subject needle was tested against the predicate needle in a bench test using calves' liver. In that test, they achieved comparable sample size lengths and weights.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight. The symbol is composed of three curved lines that create a sense of movement and flow.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

Envisioneering, LLC % Ms. Chantel Carson Section Manager Underwriter Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062, USA

Re: K041638

Trade/Device Name: TargetScan Biopsy Kit Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 90 ITX and 78 FCG Dated: August 19, 2004 Received: August 23, 2004

Dear Ms. Carson:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.

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. 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 (21 CFR Part 807); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter.

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) you may obtain. Other general information on your responsibilities under the ACT may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Brogdon

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

Enclosure

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510(k) Number (if known): __K041638 Device Name: TargetScan Biopsy Kit

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.