BRAINPRO, BRAINPRO ACCESS

K060808 · PAJUNK GmbH Medizintechnologie · HAW · Jul 25, 2006 · Neurology

Device Facts

• Record ID: K060808
• Device Name: BRAINPRO, BRAINPRO ACCESS
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: HAW · Neurology
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set. The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue. The Pajunk BrainPro Access is an optional single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes. It is used in brain biopsy procedures. The BrainPro Access is provided sterile.

Device Story

Single-use dual cannula biopsy needle; stainless steel or titanium construction; used for stereotactic/guided brain tumor biopsies. Operates via vacuum suction (syringe-applied) to draw tissue into needle; inner cannula rotation cuts tissue. BrainPro Access provides anchoring/guidance via cutting titanium thread for drill holes. Used in clinical/neurosurgical settings by physicians. Output is harvested tissue sample for histological examination. Benefits patient by enabling precise, guided tissue acquisition for diagnosis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Single-use, sterile, non-pyrogenic, latex-free. Materials: stainless steel or titanium. Dual cannula design with vacuum-assisted tissue aspiration and mechanical rotation cutting mechanism. Includes optional titanium anchoring/guidance accessory. Compatible with BrainLab VectorVision Cranial image-guided surgery system.

Indications for Use

Indicated for stereotactic and other guided biopsy of brain tissue, including brain tumors, in patients requiring neurosurgical biopsy procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Radionics Nashold Biopsy needle - Single use (K032054)
• Ad-Tech Medical Instrument Corporation (K924348)
• Field Lee Brain Biopsy needle (K801760)

Reference Devices

• BrainLab Image guided surgery system VectorVision Cranial (K020631)

Submission Summary (Full Text)

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K060808

MEDIZINTECHNOLOGIE

.IUL

BrainPro and BrainPro Access Premarket Notification Submission

# 510(k) Premarket Notification Submission:

## Summary of Safety and Effectiveness

## Date of Preparation: July 20th, 2006

Contract Sterilizer:

Dreieichstrasse. 7

64546 Moerfelden

Fax [phone]

Germany

SteriPro Lab & EO Facility

Tel [phone] or [phone]

### Submitter Information/ production site:

Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: [phone] Fax: [phone]

## Contact:

Christian Quass, Regulatory Affairs Fon: [phone] Fax: [phone] E-Mail: [e-mail]

Establishment Registration Number:

9611612

## Device Information:

Trade Names: BrainPro, Brain Pro Access Common Name: Cannula for brain biopsy, Brain biopsy needle and accessory Classification Name: Stereotaxic instrument Classification 21 CFR §882.4560, April 1, 2005 Reference: Poposed Regulatory Class II Classification: Proposed Product HAW Classification Code: Panel: Neurology Predicate Devices: 1. Radionics Nashold Biopsy needle - Single use K032054 2. Ad-Tech Medical Instrument Corporation K924348

- 3. Field Lee Brain Biopsy needle K801760
CQ

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# BrainPro and BrainPro Access

# Premarket Notification Submission

Image /page/1/Picture/2 description: The image contains the word "PAJUNK" in large, bold, white letters. Below that, in smaller letters, is the word "MEDIZINTECHNOLOGIE". The background of the image is a dark, textured pattern.

## Device Description:

The Paiunk BrainPro biopsy cannula is a single-use device intended for use in navigational guided biopsy of brain tumors.

The Pajunk BrainPro Biopsy Needle is a singel use dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue.

The Pajunk BrainPro Access is a single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes.

### Predicate Devices:

- Radionics Nashold Biopsy needle Single use K032054 .
- Ad-Tech Medical Instrument Corporation K924348 .
- Field Lee Brain Biopsy needle K801760 .

The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.

### Sterilization

The contract sterilizer and the sterilizing process other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) is the same as that used for all Pajunk devices already cleared for market, most of them similar in technology and material to the BrainPro Set.

### Technology Characteristics:

Pajunk's BrainPro cannula for brain biopsy with or without the BrainPro Access fixation device is a single use, sterile, non-pyrogenic and latex free medical device kit for brain biopsy.

The special cutting construction of the cannula enables sufficient biopsy material to be removed for a histological examination.

The BrainPro has proven equipment compatibility with the BrainLab Image guided surgery system VectorVision Cranial cleared by FDA under K020631 (see executive summary section 10.0 of this submission).

#### Conclusion:

The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.

CQ

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, with three curved lines representing its wings and body. The bird is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pajunk GmbH Medizintechnologie % Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany

JUL 25 2006

Re: K060808

Trade/Device Name: BrainPro cannula and BrainPro Access anchoring device for brain biopsy Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 19, 2006 Received: June 22, 2006

Dear Christian Quass:

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. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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

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### Page 2 - Christian Quass

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Herbert Lemnios

Mark N. Melkerson Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: The image shows the logo for PAJUNK. The word "PAJUNK" is in large, bold, white letters against a dark, textured background. Below the logo, in smaller letters, is the word "MEDIZINTECHNOLOGIE".

# Indications for use

510(k) Number:

Device Name:

BrainPro cannula and BrainPro Access anchoring device for brain biopsv

Indications for Use:

The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set.

The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.

The Pajunk BrainPro Access is an optional single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes. It is used in brain biopsy procedures. The BrainPro Access is provided sterile.

Prescription Use (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lerner

Division of General. Restorative and Neurological Devices

**510(k) Number** K060808

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