The Disposable Brain Biopsy Needle 2.0 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 Disposable Brain Biopsy Needle 2.0 is provided in a set.

Device Description

Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.

Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.

Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.

There are different versions of the Biopsy Needle for following use-cases:

Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide, Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.

Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Disposable Brain Biopsy Needle 2.0. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets acceptance criteria, especially not for an AI/ML powered device. This submission focuses on comparing the new device's design and performance characteristics to a previously cleared predicate device (K060808, BrainPro/BrainPro ACCESS).

Here's why the requested information cannot be fully provided based on the given text:

No new clinical study details: The 510(k) process for this type of device (a modified existing device with unchanged intended use) often relies on design verification and validation testing to show that the modifications do not negatively impact safety or effectiveness, and that the new device performs comparably to the predicate. It does not typically involve human subject clinical trials with AI/ML-specific acceptance criteria.
Focus on Substantial Equivalence: The document explicitly states, "Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing." This implies bench testing and non-clinical performance comparisons, not a clinical trial with human readers or AI algorithms.
No AI/ML Component: The device described is a physical biopsy needle, not an AI/ML software device. Therefore, acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, reader improvement, standalone performance) are not applicable.

However, I can extract information related to the device's comparison to its predicate, which serves a similar function to demonstrating "acceptance" within the 510(k) framework for this type of device.

Based on the provided document, here's an attempt to address your questions, highlighting where the requested information is not applicable or not present:

The information provided describes a 510(k) premarket notification for a physical medical device (a brain biopsy needle), not an AI/ML-powered software. Therefore, many of the questions related to AI/ML specific performance studies (e.g., MRMC studies, standalone algorithm performance, expert consensus for AI ground truth) are not applicable to this submission. The "acceptance criteria" here are framed within the context of demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) for a physical device where the intended use is identical and modifications are primarily design updates, "acceptance criteria" revolve around ensuring the new device performs as safely and effectively as the predicate. The document states:

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Functional Equivalence: The fundamental technical design and mechanism of action (e.g., dual cannula, vacuum suction, rotating cutting mechanism, navigation via marker, blunt tip) should remain consistent with the predicate device, ensuring equivalent functional performance for tissue acquisition.	"The fundamental technical design of the brain biopsy needle as well as of brain biopsy needles in general - sterile supply, Sedan type blunt tip, vacuum suction chamber, rotating cutting mechanism, navigation via marker, labelling - basically remains unaltered.""Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing.""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." (Identical to predicate description).
Material Equivalence/Compatibility: Materials (e.g., stainless steel) should be equivalent or have demonstrated compatibility, especially if MRI compatibility is added.	"The Disposable Brain Biopsy Needle 2.0 is a dual cannula device made from stainless steel." (Predicate could be stainless steel or titanium, but the new device explicitly states stainless steel)."The Disposable Brain Biopsy Needle 2.0 is labelled as MRI conditional." (This is an added performance characteristic, not a change to the fundamental mechanism, but part of the stated equivalence).
Safety and Sterility: The sterilization method and sterile supply to the end-user should be maintained, and the device should be free from identified safety concerns.	"Sterilization method: Ethylene Oxide, disposable device supplied sterile to the end user." (Consistent with industry practice for such devices). No safety concerns are mentioned in the positive determination letter.
Intended Use and Indications for Use Equivalence: The scope of use, target patient population, and user group should be identical to the predicate.	"Neither the intended use nor the indications for use are altered.""Intended use as well as Indications for use, sequence of use, target patient population and user target group remain unaltered.""The Intended Use of the Predicate device and of the subject device is identical. The indications for use of the Predicate device and of the subject device is identical. In order to provide state of the art information, MRI information has been added. The subject device is substantially equivalent to the predicate device."
Performance (Bench Test) Equivalence: Bench testing should demonstrate comparable or equivalent performance characteristics (e.g., cutting ability, tissue acquisition, navigation compatibility if applicable, and adherence to specifications). This is implied by the "Design verification process" and "validated through testing with the predicate device." Specific metrics are not provided in this summary but would be detailed in the full 510(k) submission.	"So substantial identity of the modifications is based on earlier submissions by the sponsor and verified through Design verification process.""Performance of the subject device is verified and validated with the predicate device.""Each of the devices subject to this modification of a cleared 510(k) has been validated and verified initially and is under constant batch monitoring and testing/inspection according to the specifications cleared."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided summary. Performance testing for this type of device (bench testing) would typically involve a sample size sufficient to demonstrate consistency and equivalence, but it's not a "test set" in the context of clinical AI/ML validation data.
Data Provenance: The testing is likely retrospective (on manufactured devices/materials) and conducted by the manufacturer (PAJUNK® GmbH Medizintechnologie) in Germany. It refers to "Design verification process" and "testing with the predicate device," implying lab-based, non-clinical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is a physical device, and the "ground truth" for its performance is established through engineering design verification and validation (bench testing, material testing, functional testing), not through expert clinical interpretation of data as it would be for an AI/ML algorithm.

4. Adjudication Method for the Test Set

Not Applicable. As above, this isn't a study involving human readers or AI requiring adjudication of results. "Adjudication" for this device would refer to internal design control processes and quality assurance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No. An MRMC study is a clinical study design used to evaluate the diagnostic accuracy of imaging interpretations, especially with AI assistance. This device is a biopsy needle, not an imaging interpretation tool.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on adherence to engineering specifications, functional performance requirements (e.g., ability to acquire tissue, cut precisely), material properties, and sterility assurance, as demonstrated through a rigorous design verification and validation process (bench testing, mechanical testing, material compatibility, sterilization validation). This is typically compared directly to the predicate device during testing.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The development process involves design and manufacturing, not model training.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above.

Summary

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August 17, 2022

PAJUNK GmbH Medizintechnologie Christian Quass Director Regulatory Affairs Karl-Hall-Str. 1 Geisingen, Baden-Wuerttemberg 78187 Germany

Re: K220897

Trade/Device Name: Disposable Brain Biopsy Needle 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: July 18, 2022 Received: July 18, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220897

Device Name

Disposable Brain Biopsy Needle 2.0

Indications for Use (Describe)

The Disposable Brain Biopsy Needle 2.0 is a dual cannula device made from stainless steel. 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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary as required by 21 CFR 807.92(c).

Date of Preparation: 2022-08-17

510 (k) Number: K220897

510(k) owner:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612

Submitter Information/ production site:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number:

9611612

Contact:

Christian G. H. Quass Director Requlatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com

USA Contact:

PAJUNK MEDICAL SYSTEMS 4575 Marconi Dr. Alpharetta, GA 30005

Establishment Registration Number: 3004076349

Contact

Marco Wohnig President PAJUNK® Medical Systems L.P. Phone: (770) 493-6832 Direct: (470) 448-4070 Cell: (770) 757-2449 (678) 514-3388 Fax: E-Mail: marco.wohnig@pajunk-usa.com

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Device Information:
Device Name:	Disposable Brain Biopsy Needle 2.0
Components:	Needle with Marker and depth StopVacuum syringeStopcockExtension tube
Sterilization method:	Ethylene Oxidedisposable device supplied sterile to the end user
Contract Sterilizer:	Sterigenics Germany GmbHKasteler straße 4565203 WiesbadenGermany, HessenEstablishment Registration Number:3002807090
Document Control Number	K220897
Device Name:	Disposable Brain Biopsy Needle 2.0
Classification Name:	neurological stereotaxic instrument
Classification Reference:	21 CFR 882.4560
Product Code:	HAW
Establishment Registration Number:	9611612
Regulatory Class:	II
Panel:	Neurology
Predicate Device:	K060808, Manufacturer: PAJUNK GmbH

PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for a modification of the Disposable Brain Biopsy Needle cleared under K060808, intended to be brand-named Brain Biopsy Needle 2.0.

It is considered a Class II medical device as defined in 21 CFR §882.4560 neurological stereotaxic instrument, product code HAW.

Each of the devices subject to this modification of a cleared 510(k) has been validated and verified initially and is under constant batch monitoring and testing/ inspection according to the specifications cleared.

Subject to the modification is modernization of the outer appearance of the brain biopsy needle reflecting customer requirements. Furthermore this design update is intended to re-verify the state of the art in sterile needle manufacturing and navigation.

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So substantial identity of the modifications is based on earlier submissions by the sponsor and verified through Design verification process.

Neither the intended use nor the indications for use are altered. Intended use as well as Indications for use, sequence of use, target patient population and user target group remain unaltered.

The fundamental technical design of the brain biopsy needle as well as of brain biopsy needles in general - sterile supply, Sedan type blunt tip, vacuum suction chamber, rotating cutting mechanism, navigation via marker, labelling - basically remains unaltered.

Performance of the subject device is verified and validated trough testing with the predicate device as well as by additional testing.

The indications for use shall be extended under a new device name.

The technique – over the needle – is rarely identified in submissions with identical indications for use. Usually it is not mentioned whether the technique of placing a catheter is "over the needle" or "through the needle". This detail in application method does not make any difference in evaluating safety, effectiveness and efficacy of the device itself from the technological point of view.

So substantial identity of the modifications is based on earlier submissions by the sponsor and verified through Design verification process.

Performance of the subject device is verified and validated with the predicate device.

So substantial equivalence of the modifications is based on earlier submissions by the sponsor and verified through Design verification process.

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Indications for use subject device:

Device Description:

Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.

Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.

Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.

There are different versions of the Biopsy Needle for following use-cases:

Predicate Device:

The predicate device for the Brain Biopsy Needle 2.0 is the BrainPro/ BrainPro ACCESS cleared for market under K060808 and manufactured by PAJUNK® GmbH Medizintechnologie.

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Determination methods and results of Substantial Equivalence Determination:

Intended Use

The intended use of brain biopsy needles is to perform Biopsy of intracranial lesions.

Indications for use Use Subject Device

The Disposable Brain Biopsy Needle 2.0 is labelled as MRI conditional.

Intended Use K060808 E-Cath STIM acc. Tsui (Predicate Device)

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.

Discussion

The Intended Use of the Predicate device and of the subject device is identical.

The indications for use of the Predicate device and of the subject device is identical. In order to provide state of the art information, MRI information has been added. The subject device is substantially equivalent to the predicate device.

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).