(77 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on traditional ultrasound technology and PC-based image handling.
No
The device is described as an "ultrasound imaging system" intended for "diagnostic ultrasound imaging" and "diagnostic prostate applications," and its purpose is to "guide other procedures such as biopsy of the prostate," all of which point to diagnostic rather than therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and "This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland." The "Device Description" also mentions "The TargetScan™ Transrectal Ultrasound system is intended for diagnostic prostate applications."
No
The device description explicitly mentions a "probe" and a "PC based system," indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The TargetScan™ Transrectal Ultrasound system is an imaging device. It uses ultrasound waves to create images of the prostate gland inside the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and "transrectal diagnostic imaging of the prostate gland." This describes an imaging procedure, not an in vitro test.
Therefore, the TargetScan™ Transrectal Ultrasound system falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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 Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Small Organ (prostate) - Mode of Operation B
Clinical Application: Transrectal - Mode of Operation B
Product codes (comma separated list FDA assigned to the subject device)
90 IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Prostate gland
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical professionals in a physician office or hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Teknar K864807
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
- 2 71114
510(k) Summary
| 1. | Applicant: | Envisioneering, LLC
1982 Innerbelt Business Center Drive
St. 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, LLC
1982 Innerbelt Business Center Drive
St. 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:
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.
PAGE 3 OF 17
1
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.
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 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 /
3
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)
4
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 | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| and 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-skeletal | ||||||||
| Superficial | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (Cardiac) | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
5
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 | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| and 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-skeletal | ||||||||
| Superficial | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal | ||||||||
| (Cardiac) | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | 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