TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

K073399 · Envisioneering, LLC · FCG · Dec 21, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K073399
• Device Name: TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
• Applicant: Envisioneering, LLC
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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.

Device Story

TargetScan Biopsy Kit facilitates ultrasound-guided transrectal prostate biopsies; used with Envisioneering TargetScan Ultrasound system and Manan Pro-Mag Automatic Biopsy System. Kit includes biopsy needle and needle guide with curved path; guide attaches to probe shaft to direct needle. Used by medical professionals in physician offices or hospitals. Needle guide profile aids rectal insertion. Device provides mechanical guidance for needle placement during biopsy procedure; assists clinicians in obtaining tissue samples for diagnostic purposes. Benefits include targeted biopsy capability for prostate tissue.

Clinical Evidence

Bench testing only. Validation protocols and risk analysis performed to ensure manufacturing, packaging, and sterilization compliance. Packaging and materials meet ISO 11607-1 requirements.

Technological Characteristics

Sterile, single-use biopsy kit. Includes needle and curved needle guide. Ethylene Oxide sterilization. Quality management system certified to ISO 13485. Packaging meets ISO 11607-1. No electronic components; mechanical guidance system.

Indications for Use

Indicated for performing planned and targeted ultrasound-guided transrectal prostate biopsies in adult patients using the Envisioneering TargetScan Ultrasound system.

Regulatory Classification

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.

Predicate Devices

• Envisioneering TargetScan® Biopsy Kit (K041638)
• Envisioneering TargetScan® Biopsy Needle Guide (K041637)

Reference Devices

• Manan Pro-Mag Automatic Biopsy System (K980226)
• TargetScan® transrectal probe Model #TS-360-P (K041639)

Submission Summary (Full Text)

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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, LLC<br>1982 Innerbelt Business Center Drive<br>St. Louis, MO 63114 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Kennedy |
| Telephone: | 314-429-7367 |
| FAX: | 314-429-7701 |
| Date Prepared: | November 26, 2007 |
| Trade Name: | TargetScan® Biopsy kit<br>TargetScan® Biopsy Needle Guide |
| Common Name: | Biopsy kit<br>Biopsy Needle Guide |
| Establishment Registration Number: | 3005673110 |
| Establishment Address: | Envisioneering, LLC<br>1982 Innerbelt Business Center Drive<br>St. Louis, MO 63114 |
| Classification of the Device: | The Biopsy Kit is classified as a Biopsy Instrument, as<br>defined in CFR 876.1075, Class II device. The Needle Guide<br>is a Class II, CFR 892.1570 |
| Product Code: | Biopsy Kit FCG<br>Needle 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.

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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.

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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 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.

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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 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 [phone] or [phone] 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

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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