TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

K041637 · Envisioneering, LLC · ITX · Sep 1, 2004 · Radiology

Device Facts

• Record ID: K041637
• Device Name: TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
• Applicant: Envisioneering, LLC
• Product Code: ITX · Radiology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 system is intended to be used with adult patients. This system is intended for use by medical professionals in a physician office or hospital environment.

Device Story

TargetScan Biopsy Needle Guide; sterile accessory for TargetScan Transrectal Ultrasound system. Device features curved needle path; attaches to shaft of TS-360-P probe via biopsy attachment. Enables physician to direct flexible biopsy needle into tissue at specific angle to probe shaft. Used in physician offices or hospitals by medical professionals. Facilitates targeted prostate biopsy procedures; ensures secure, aligned fit to transducer without compromising device integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile biopsy needle guide; curved needle path; mechanical attachment mechanism for TargetScan TS-360-P probe. Designed for secure, aligned fit to transducer. No electronic components or software.

Indications for Use

Indicated for performing planned and targeted ultrasound-guided transrectal prostate biopsies in adult patients using the TargetScan model TS-360-P probe.

Regulatory Classification

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.

Predicate Devices

• Civco Transrectal Needle Guide (K970514)

Submission Summary (Full Text)

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SEP - 1 2004

K041631

# Section 2

## 510(k) Summary

| 1. Applicant: | Envisioneering, LLC<br>1982 Innerbelt Business Center Drive<br>St. Louis, MO 63114 |
|---------------|------------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------------|

- March 22, 2004 2. Date Prepared:
- 3. Trade Name: TargetScan™ Biopsy needle Guide
- 4. Common Name: Biopsy Needle Guide
- 5. Establishment Registration Number: pending
- Establishment Address: Envisioneering, LLC ે. 1982 Innerbelt Business Center Drive St. Louis. MO 63114
- Classification Names: This system is a Class II device. 7.

Diagnostic Ultrasound Transducer (21 CFR 892.1570; Procode ITX)

#### Identification of Predicate Device(s): യ

The predicate device for the biopsy needle quide is:

- Civco Transrectal Needle Guide (K970514) .
#### 9. Device Description:

The sterile TargetScan™ Biopsy needle Guide is designed to be used with the Targetscan™ Transrectal Ultrasound system. This needle guide contains a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. It allows a flexible biopsy needle to be directed into the tissue at an angle to the probe shaft.

This needle quide is intended for use with the TargetScan™ transrectal probe Model #TS-360-P which is the subject of a separate submission.

#### 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.

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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

### Biopsy Guide

The subject and predicate devices are designed for secure and aligned fit to the transducer while not altering transducer design integrity or function.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 1 2004

Envisioneering, LLC % Ms. Chantel Carson Section Manager Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062, USA Re: K041637

Trade/Device Name: TargetScan Biopsy Needle Guide 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) 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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogin manies of substantial equivalence of your device to a legally premaired 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 It you desire spoolite advise at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on as please note the regulation entitled, "Misbranding Other of Ochiphanoo at (2005) 2241522ation" (21CFR Part 807.97) you may obtain. Other general of Felection on your responsibilities under the Act may be obtained from the Division of Small mioritiation on your respensional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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):_____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

This device is indicated for performing planned and targeted ultrasound guided transrectal TS 260 R I his device is indicated for performing planned and targetScan model TS-360-P probe.

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

| Prescription Use | <div style="text-align: left;">✓</div> |
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OR

Over the Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal

Radiological Devices
510(k) Number K041637