(142 days)
Not Found
No
The description focuses on the mechanical function of the biopsy needle and its compatibility with navigation systems, with no mention of AI or ML.
No
The device is described as a biopsy needle used for collecting brain tissue samples, which is a diagnostic procedure, not a therapeutic intervention.
No
Explanation: The device is a biopsy needle, used for obtaining tissue samples. While these samples are used for diagnosis, the device itself is an instrument for tissue collection, not for analyzing or interpreting data to provide a diagnosis.
No
The device is a physical biopsy needle made of stainless steel, designed for surgical procedures. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. They are used for diagnosis, monitoring, or screening.
- Device Function: The Disposable Brain Biopsy Needle 2.0 is a surgical instrument used to obtain a tissue sample from the brain within the body. It is a tool for the biopsy procedure itself, not for analyzing the tissue sample once it's been collected.
- Intended Use: The intended use clearly states it's for "stereotactic and other guided biopsy of brain tissue." This describes a surgical procedure, not an in vitro diagnostic test.
The tissue sample obtained by this needle would then likely be sent to a laboratory for in vitro analysis (histology, pathology, etc.), but the needle itself is not the IVD.
N/A
Intended Use / 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.
Product codes
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain tissue
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
Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing.
Key Metrics
Not Found
Predicate Device(s)
K060808, Manufacturer: PAJUNK GmbH
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
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
1
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 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.
| 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 Stop |
| Vacuum syringe | |
| Stopcock | |
| Extension tube | |
| Sterilization method: | Ethylene Oxide |
| disposable device supplied sterile to the end user | |
| Contract Sterilizer: | Sterigenics Germany GmbH |
| Kasteler straße 45 | |
| 65203 Wiesbaden | |
| Germany, Hessen | |
| Establishment 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:
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.
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.
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 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 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.