(28 days)
No
The summary describes a mechanical biopsy needle and its use with existing navigation systems. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as a biopsy needle used for collecting brain tissue samples, which is a diagnostic procedure, not a therapeutic treatment.
No.
Explanation: The device is a biopsy needle used to collect tissue samples. While these samples are often used for diagnostic purposes, the needle itself performs a collection function, not a diagnostic interpretation or analysis.
No
The device description clearly indicates it is a physical, dual-cannula needle made of stainless steel, requiring vacuum suction and rotation to cut tissue. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, treatment, or prevention of disease. The key is that the testing and analysis happen outside of the body (in vitro).
- This Device's Function: This device is a biopsy needle used to collect a tissue sample from the brain inside the body (in vivo). It is a surgical instrument used for tissue acquisition, not for the analysis or testing of that tissue.
While the tissue collected by this needle will likely be used for in vitro diagnostic testing later (e.g., pathology examination), the needle itself is a surgical tool for obtaining the sample, not an IVD.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 conditions for the device being labelled as "MR Conditional".
Test method summary 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 at a location near the entrance to the bore and on the axis of the bore. In order to increase the measurement sensitivity, this location shall be chosen so that the spatial gradient of the field strength is within 20 percent of the maximum value of the spatial gradient on the axis of the bore. The angular deflection of the string from the vertical is measured. 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).
Result: No magnetically induced displacement was detectable for the test object "Disposable Precalibrated 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K201752, Disposable Pre-Calibrated Suction
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Disposable Pre-calibrated Brain Biopsy Needle 2.0
Indications for Use (Describe)
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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Biopsy |
| Needle 2.0 | |
| Components: | Needle with Marker and depth Stop |
| Vacuum syringe | |
| Stopcock | |
| Extension tube | |
| Sterilization method: | Ethylene Oxide |
| disposable device supplied sterile to the | |
| end user | |
| Contract Sterilizer: | Rteigenistraße Germany GmbH |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment 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 GmbH |
| Disposable Brain Biopsy Needle 2.0 | |
| Reference Device: | K201752, Disposable Pre-Calibrated |
| Suction |
5
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.
6
Side-by-side comparison table
| Characteristics | Subject Device
K230201 Disposable Brain Biopsy Needle 2.0
Pajunk® GmbH Medizintechnologie | Predicate Device
K220897 Disposable Brain Biopsy Needle 2.0
Pajunk® GmbH Medizintechnologie | Result of comparison, if
necessary 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 compliant
MR Unsafe | 21 CFR and European Medical Devices Directive compliant
MR 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 Lock
b) Glue
needle is glued in hub
c) Tubings: - Stainless steel
- with graduation rings
Depth stop: - Coloured polymer | Needles:
a) Hubs: - clear or coloured Polymer needle hub
- Connectivity: Luer Lock
b) Glue
needle is glued in hub
c) Tubings: - Stainless steel
- with graduation rings
Depth stop: - Coloured polymer | identical |
| Technology | Mechanical end stops for situations:
Biopsy chamber open/closed
Additionally, visually shown by combination of markers in the handle | Mechanical end stops for situations:
Biopsy chamber open/closed
Additionally, visually shown by combination of markers in the handle | identical |
| Characteristics | Subject Device
K230201 Disposable Brain Biopsy Needle 2.0
Pajunk® GmbH Medizintechnologie | Predicate Device
K220897 Disposable Brain Biopsy Needle 2.0
Pajunk® GmbH Medizintechnologie | Result of comparison, if
necessary with rationale |
| principles of operation | Suction of tissue in the window through a vacuum
created with the syringe. Turn cut by windows rotated
against one another. | Suction of tissue in the window through a vacuum
created with the syringe. Turn cut by windows rotated
against one another. | identical |
| Materials | Body contacting parts: Stainless Steel
Indirect contacting parts (handle): Polycarbonate | Body contacting parts: Stainless Steel
Indirect contacting parts (handle): Polycarbonate | identical |
7
8
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 magnetically | ||
| induced displacement force on | ||
| "Disposable | ||
| Pre-calibrated Biopsy Needle | ||
| 2.1 x 257 mm" in the magnetic | ||
| resonance environment | ||
| of a 3 Tesla MR scanner. | 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 at a | ||
| location near the entrance to the | ||
| bore and on the axis of the bore. | ||
| In order to increase the | ||
| measurement sensitivity, this | ||
| location shall be chosen so that | ||
| the spatial gradient of the field | ||
| strength is within 20 percent of | ||
| the maximum value of the | ||
| spatial gradient on the axis of | ||
| the bore. The angular deflection | ||
| of the string from the vertical is | ||
| measured. 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). | 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. |
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.