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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the BrainPro and BrainPro Access devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found for novel technologies or PMA submissions.

Therefore, the document does not contain the detailed information required for direct answers to all your questions, specifically regarding specific acceptance criteria with numerical targets and the study data proving the device meets them in the format requested.

However, I can extract the information that is available and explain why some parts are not present based on the nature of the submission.

1. A table of acceptance criteria and the reported device performance

This information is not provided in the 510(k) submission. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, intended use, and safety/effectiveness profiles, rather than presenting a performance study against predefined numerical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission does not detail a specific clinical "test set" or clinical study with patient samples. The basis of the submission is substantial equivalence to legally marketed predicate devices, meaning the focus is on comparing the device's design, materials, and intended use to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As there's no clinical test set described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Again, without a described clinical test set, adjudication methods are not applicable here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The BrainPro and BrainPro Access are physical medical devices (cannulas for brain biopsy), not AI-powered diagnostic tools. Therefore, an MRMC study related to AI assistance is not relevant or included in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. The devices are physical instruments, not algorithms. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Since there's no clinical study described with a "test set" requiring ground truth for performance evaluation, this is not applicable. The devices are used to obtain tissue for pathology, which then serves as diagnostic ground truth in clinical practice, but this submission does not evaluate the device against such an outcome.

8. The sample size for the training set

This information is not provided. As the devices are not AI-driven, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not provided. Not applicable for physical medical devices.

Summary of Device and Evidence Presented:

The 510(k) submission for BrainPro and BrainPro Access relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The arguments revolve around:

Device Description: The BrainPro biopsy cannula is a single-use device for navigational guided biopsy of brain tumors, made of stainless steel or titanium, using vacuum suction and a rotating inner cannula to cut tissue. The BrainPro Access is an optional anchoring and guidance instrument.
Predicate Devices:
1. Radionics Nashold Biopsy needle - Single use K032054
2. Ad-Tech Medical Instrument Corporation K924348
3. Field Lee Brain Biopsy needle K801760
Sterilization: The sterilization process (Sterigenics) is the same as that used for other Pajunk devices already cleared for market, suggesting established safety and efficacy in this regard.
Technology Characteristics: Highlighted features include the special cutting construction for sufficient biopsy material and proven equipment compatibility with the BrainLab Image guided surgery system VectorVision Cranial (K020631).
Conclusion of Submission: "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."

In essence, the "study" proving the device meets "acceptance criteria" in a 510(k) context is the comparison to predicates, which implicitly means the device performs at least as safely and effectively as those already deemed acceptable by the FDA. The acceptance doesn't come from meeting specific numerical benchmarks in a clinical trial but from demonstrating similar characteristics and performance as devices already on the market.

Summary

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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 +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

1. Field Lee Brain Biopsy needle K801760
  CQ
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 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.

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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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Indications for use

510(k) Number:

Device Name:

BrainPro cannula and BrainPro Access anchoring device for brain biopsv

Indications for Use:

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

Regulation Number and Section

§ 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).