(123 days)
No
The description focuses on the mechanical function of the biopsy cannula and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The document describes a biopsy cannula and related instruments designed for tissue sampling in the brain, not for treating a disease or condition.
No
The device is a biopsy cannula and associated instruments, used to collect tissue samples for diagnosis, rather than performing the diagnosis itself.
No
The device description clearly outlines physical components made of stainless steel and titanium, including cannulas, needles, and an anchoring instrument, which are hardware.
Based on the provided text, the Pajunk BrainPro biopsy cannula is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body in vitro (outside the body) to provide information for diagnosis. This typically involves tests performed on blood, urine, tissue samples, etc., in a laboratory setting.
- The Pajunk BrainPro biopsy cannula is a surgical instrument used to obtain a tissue sample from the brain in vivo (within the body). Its function is to collect the tissue, not to perform diagnostic tests on it.
The description clearly states its intended use is for "stereotactic and other guided biopsy of brain tissue" and describes the mechanical process of obtaining the sample. While the tissue obtained will likely be used for subsequent in vitro diagnostic testing, the device itself is the tool for collection, not the diagnostic test itself.
N/A
Intended Use / 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.
Product codes
HAW
Device Description
The Pajunk 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
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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 +49 6105 24760
Germany
SteriPro Lab & EO Facility
Tel +49 6105 23091 or +49 (0) 6105 93470
Submitter Information/ production site:
Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605
Contact:
Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
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
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- Field Lee Brain Biopsy needle K801760
CQ
- Field Lee Brain Biopsy needle K801760
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5 -
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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
cq