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.

Device Description

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.

AI/ML Overview

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.

Summary

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K041639

2 71114

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™ Transrectal Ultrasound System
4.	Common Name:	Diagnostic Ultrasound System with Accessories
5.	Establishment Registration Number:	pending
6.	Establishment Address:	Envisioneering, LLC1982 Innerbelt Business Center DriveSt. Louis, MO 63114
7.	Classification Names:	This system is a Class II device.
		Ultrasound Pulsed Echo Imaging System, (21 CFR 892.1560; Procode: IYO)

Identification of Predicate Device(s): 8.

The predicate device for the ultrasound probe and system is:

Carolina Medical Proscan® and Proscan® Plus Urological Ultrasound Imaging . systems (Teknar K864807)

ಳು Device Description:

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10. Intended Use

Purpose and Function of the Device

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.

Intended Patient Population

This systern 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 Device

Both the subject and predicate devices:

are intended for transrectal diagnostic imaging of the prostate gland. .
are similar in external design .
can image the prostate in the longitudinal and transverse plane and can display . both views simultaneously on the display.
allow biopsy targeting by indicating the needle path on the displayed image .

The subject device allows the scanning of the whole prostate without moving the probe in the patient, as the transducer itself moves inside the probe.

12. Testing

This device will be tested against and will comply with the following standards.

IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety
EN60601-1, Medical Electrical Equipment -- Part 1: General Requirements for . Safety
UL2601-1, Standard for Medical Electrical Equipment Part 1: General . Requirements for Safety
IEC 60601-2-37 Medical Electrical Equipment Particular Requirements for the . Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 60601-1-2 Medical Electrical Equipment Part 1: General Requirements . for Safety, 2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

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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 an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the shape of the bird's body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

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

Re: K041639

Trade Name: TargetScan Transrectal Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX 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 w one re retroned your been been 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 rear 20, 1770, 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. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the TargetScan Transrectal Ultrasound System, as described in your premarket notification:

Transducer Model Number

TS-360-P

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.

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 /

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CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) or N Fart 007), god a names of applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact . the Office of Compliance at (301) 594-4591. 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 Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) . 594-1212.

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(s)

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K041639

Diagnostic Ultrasound Indications for Use Form TargetScan Ultrasound System - Model TS-360aSYS

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
(Track I Only)	(Tracks I and III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imagingand Other	Fetal
	Abdominal
	Intraoperative(specify)Intraoperative
	Neurological
	Pediatric
	Small Organ (prostate)	N
	Neonatal Cephalic
	Adult Cephalic
	Transesophageal
	Transrectal	N
	Transvaginal
	Transurethral
	Intravascular
	Laparoscopic
	Musculo-skeletal
	Musculo-skeletalSuperficial
	Other (specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal(Cardiac)
	Other (specify)
PeripheralVessel	Peripheral Vascular
	Other (specify)

examples may include: A-mode, amplitude Doppler, 3-D imaging, Harmonic imaging, Tissue motion Doppler, color velocity imaging

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER P Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Nancy C. Roaflon

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Diagnostic Ultrasound Indications for Use Form TargetScan rectal probe -- Model TS-360-P

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
(Track I Only)	(Tracks I and III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imagingand Other	Fetal
	Abdominal
		Intraoperative(specify)
	Intraoperative
	Neurological
	Pediatric
	Small Organ (prostate)	N
	Neonatal Cephalic
	Adult Cephalic
	Transesophageal
	Transrectal	N
	Transvaginal
	Transurethral
	Intravascular
	Laparoscopic
	Musculo-skeletal
	Musculo-skeletalSuperficial
	Other (specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
		Trans-esophageal(Cardiac)
		Other (specify)
PeripheralVessel	Peripheral Vascular
	Other (specify)

examples may include: A-mode, amplitude Doppler, 3-D imaging, Harmonic imaging, Tissue motion Doppler, color velocity imaging

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal.

and Radiological Devic 510(k) Number

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.