The Disposable Pre-calibrated Biopsy Needle 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 Pre-calibrated Biopsy Needle is provided in a set.

Device Description

The Disposable Pre-calibrated Biopsy Needle 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.
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 Disposable Brain Biopsy Needle 2.0 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

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Pajunk GmbH Medizintechnologie regarding their Disposable Pre-calibrated Brain Biopsy Needle 2.0. The core of the information provided for acceptance criteria and device performance relates to MRI conditional labeling.

Here's an analysis of the provided information, structured to address your questions. Please note that many of your points (e.g., sample size for training set, number of experts for ground truth, multi-reader multi-case studies) are not applicable to this specific submission because it pertains to a physical medical device (a biopsy needle) and not an AI/ML algorithm or software as a medical device (SaMD). The acceptance criteria here are for the device's physical safety and compatibility, specifically in an MRI environment.

Acceptance Criteria and Device Performance for Disposable Pre-calibrated Brain Biopsy Needle 2.0

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Test Method Summary	Reported Device Performance / Result
MRI Safety: Magnetically Induced Displacement	According to ASTM F2052-15 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment". The medical device is suspended by a string in an MR system near the bore entrance. The angular deflection of the string from the vertical is measured. Acceptance Criterion (implicit based on ASTM F2052-15): If the device deflects less than 45°, then the deflection force induced by the MR System's magnetic field is less than the force on the device due to gravity (its weight). This is generally considered acceptable for "MR Conditional" labeling.	No magnetically induced displacement was detectable for the test object "Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm" used within this test and in the described MR environment of a 3 Tesla Siemens Magnetom Vida MR scanner. This result meets the implicit acceptance criterion of ASTM F2052-15.
MRI Safety: Usage within 5 Gauss line marking	Testing was conducted to demonstrate the device is safe to be used in an MR environment if a 5 Gauss line (0.5 mTesla) is clearly marked on the floor around the MR scanner. This likely implies that the device does not pose a significant hazard when brought into proximity of an MR scanner, provided appropriate safety zones are respected.	The document states that testing was conducted to demonstrate safety under these conditions. The "Conclusion" section indirectly confirms this by stating the device is "as safe and effective as the legal predicate devices" due to this testing. No specific quantitative result is provided beyond the statement of safety.
Biocompatibility	(Implied) Evaluation against ISO 10993-1.	ISO 10993-1 compliant material & set components. Result: Identical to predicate device, indicating compliance.

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

Sample Size: The document does not specify a numerical sample size for the MRI testing. It refers to "the test object 'Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm'". This wording suggests that the testing was performed on at least one representative unit of the device. For physical device testing, particularly for magnetic properties, often a single, representative sample is sufficient if the manufacturing process ensures consistency.
Data Provenance: The testing was conducted in a laboratory setting, likely in Germany (where Pajunk GmbH Medizintechnologie is located), using a Siemens Magnetom Vida MR scanner. This is a controlled, prospective laboratory study to assess device properties. It is not patient or clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

N/A. This submission is for a physical medical device (biopsy needle), not an AI/ML or diagnostic software. Ground truth in this context refers to physical properties tested in a lab, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As above, this is laboratory testing of a physical device, not an interpretation task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not a study involving human readers or diagnostic interpretation. It is a study on the physical properties of a medical device (MRI compatibility).

6. Standalone (Algorithm Only) Performance

N/A. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the device's MRI compatibility testing was established by physical measurement against a recognized standard (ASTM F2052-15) using a 3 Tesla MR scanner. The "truth" is whether the device exhibits magnetic displacement, as defined by the standard's criteria (e.g., deflection less than 45 degrees).

8. Sample Size for the Training Set

N/A. There is no "training set" as this is a physical device, not an AI/ML model.

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

N/A. As above, there is no training set.

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a brain biopsy needle) to a predicate device, with a specific emphasis on the addition of "MR Conditional" labeling. The "study" in question is a performance test (specifically, magnetic displacement) conducted under lab conditions, adhering to an ASTM standard, to prove the device's safety in an MRI environment.

Summary

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February 22, 2023

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

Re: K230201

Trade/Device Name: Disposable Pre-calibrated Brain Biopsy Needle 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 24, 2023 Received: January 25, 2023

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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. Digitally signed by Adam D. Pierce -S Pierce -> 16:36:12 -05'00'

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K230201

Device Name

Disposable Pre-calibrated Brain Biopsy Needle 2.0

Indications for Use (Describe)

The Disposable Pre-calibrated Biopsy Needle 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.

The Disposable Pre-calibrated Biopsy Needle is labelled as MRI conditional.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K230201: 510(k) Summary as required by 21 CFR 807.92(c).

Date of Preparation: 2023-02-10

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

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K230201 Page 2 of 6

Device Information:
Device Name:	Disposable Pre-Calibrated Brain BiopsyNeedle 2.0
Components:	Needle with Marker and depth StopVacuum syringeStopcockExtension tube
Sterilization method:	Ethylene Oxidedisposable device supplied sterile to theend user
Contract Sterilizer:	Rteigenistraße Germany GmbH65203 WiesbadenGermany, HessenEstablishment Registration Number:3002807090
Document Control Number	K230201
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:	K220897, Manufacturer: PAJUNK GmbHDisposable Brain Biopsy Needle 2.0
Reference Device:	K201752, Disposable Pre-CalibratedSuction

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Indications for use

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.

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.

The Disposable Pre-Calibrated Biopsy Needle is labelled as MRI conditional.

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 Disposable Brain Biopsy Needle 2.0 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.

Substantial Equivalence Discussion

The Intended Use and Indications for Use of the predicate and subject devices are identical except for MRI-labelling. MR Conditional is added to the labeling for the subject device.

In order to substantiate the MR Conditional labelling change, testing was conducted on the Disposable Brain Biopsy Needle 2.0 to demonstrate that it is safe to be used in an MR environment outside of a 5 Gauss line. In addition, the Reference Device, Disposable Precalibrated Suction, cleared under K201752 has been chosen to demonstrate MR compatibility.

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Side-by-side comparison table

Characteristics	Subject DeviceK230201 Disposable Brain Biopsy Needle 2.0Pajunk® GmbH Medizintechnologie	Predicate DeviceK220897 Disposable Brain Biopsy Needle 2.0Pajunk® GmbH Medizintechnologie	Result of comparison, ifnecessary with rationale
Biocompatibility	ISO 10993-1 compliant material & set components	ISO 10993-1 compliant material & set components	Identical
Labeling	21 CFR and European Medical Devices Directive compliantMR Unsafe	21 CFR and European Medical Devices Directive compliantMR Conditional	Labeling is different because of the addition of the MR Conditional Labeling.MRI testing included in this submission.
Packaging	Packed in a hard blister package consisting out of GGG PET foil and Tyvek (heat sealed) or medical paper	Packed in a hard blister package consisting out of GGG PET foil and Tyvek (heat sealed) or medical paper	identical
Overall design: Set components	Needles:a) Hubs:- clear or coloured Polymer needle hub- Connectivity: Luer Lockb) Glueneedle is glued in hubc) Tubings:- Stainless steel- with graduation ringsDepth stop:- Coloured polymer	Needles:a) Hubs:- clear or coloured Polymer needle hub- Connectivity: Luer Lockb) Glueneedle is glued in hubc) Tubings:- Stainless steel- with graduation ringsDepth stop:- Coloured polymer	identical
Technology	Mechanical end stops for situations:Biopsy chamber open/closedAdditionally, visually shown by combination of markers in the handle	Mechanical end stops for situations:Biopsy chamber open/closedAdditionally, visually shown by combination of markers in the handle	identical
Characteristics	Subject DeviceK230201 Disposable Brain Biopsy Needle 2.0Pajunk® GmbH Medizintechnologie	Predicate DeviceK220897 Disposable Brain Biopsy Needle 2.0Pajunk® GmbH Medizintechnologie	Result of comparison, ifnecessary with rationale
principles of operation	Suction of tissue in the window through a vacuumcreated with the syringe. Turn cut by windows rotatedagainst one another.	Suction of tissue in the window through a vacuumcreated with the syringe. Turn cut by windows rotatedagainst one another.	identical
Materials	Body contacting parts: Stainless SteelIndirect contacting parts (handle): Polycarbonate	Body contacting parts: Stainless SteelIndirect contacting parts (handle): Polycarbonate	identical

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Performance Testing

Testing was conducted on the Disposable Brain Biopsy Needle 2.0 to demonstrate that no magnetically induced displacement is detectable under the given contitions for the device being labelled as "MR Conditional".

Test	Test Method Summary	Result
Measurement of magneticallyinduced displacement force on"DisposablePre-calibrated Biopsy Needle2.1 x 257 mm" in the magneticresonance environmentof a 3 Tesla MR scanner.	According to ASTM F2052-15"Standard Test Method forMeasurement of MagneticallyInduced Displacement Force onMedical Devices in the MagneticResonance Environment" Themedical device is suspended bya string in an MR system at alocation near the entrance to thebore and on the axis of the bore.In order to increase themeasurement sensitivity, thislocation shall be chosen so thatthe spatial gradient of the fieldstrength is within 20 percent ofthe maximum value of thespatial gradient on the axis ofthe bore. The angular deflectionof the string from the vertical ismeasured. If the device deflectsless than 45°, then the deflectionforce induced by the MRSystem's magnetic field is lessthan the force on the device dueto gravity (its weight).	No magnetically induceddisplacement was detectable forthe test object "Disposable Pre-calibrated Biopsy Needle 2.1 x257 mm" used within this testand in the described MRenvironment of a 3 TeslaSiemens Magnetom Vida MRscanner.

Testing was conducted on the Disposable Brain Biopsy Needle 2.0 to demonstrate that it is safe to be used in an MR environment if a 5 Gauss line (0.5 mTesla) is clearly marked on the floor around the MR scanner.

Conclusion:

The comparison between the predicate devices and the subject device of this submission demonstrates that the subject devices are the predicate device and substantially equivalent in technical description to those devices already cleared for market and therefore demonstrated to be as safe and effective as the legal predicate devices.

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).