The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.

Device Description

Brain Biopsy Needles are used to remove a targeted sample of brain tissue for analysis. These Brain Biopsy Needles are side-cutting needles. Side-cutting needles can extract several tissue samples without requiring a new trajectory.

Biopsy needles are used to sample brain tissue or to extract brain tissue samples to determine tissue abnormality or any deviation from healthy brain tissue. These Brain Biopsy Needles substantially consist of two cannulae that fit inside one another. Both cannulas have a sampling window opening in the distal tip. The inner cannula window opening has a sharp edge. The Brain Biopsy Needle is placed into tissue to the desired depth. An aspiration syringe may be attached to the brain biopsy to support aspiration of a small amount of tissue into the sampling window. The inner cannula is rotated such that the sampling window removes a tissue sample. The inner cannula is removed. The tissue sample from the inner cannula is removed for analysis. The inner cannula may be passed back through the outer cannula and additional biopsies can be taken as directed by the surgeon.

AI/ML Overview

This document describes the Ad-Tech Medical Instruments Corporation's Brain Biopsy Needle and its 510(k) summary for MRI Conditional labeling.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission (K112094), the acceptance criteria and reported device performance are related to the MRI Compatibility of a specific variation of the Brain Biopsy Needle.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
MRI Compatibility (for Model MDBM-08-28)	Acceptable performance under expected MRI conditions	Demonstrated acceptable performance through MR modeling and MRI testing.

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

The document does not specify a "test set" in the traditional sense of a clinical or observational study with a certain number of patient cases or samples. Instead, the testing relates to the physical device's interaction with MRI environments.

Sample Size: The testing was performed on the Model MDBM-08-28 Brain Biopsy Needle variation. The document does not specify a number of individual units of this variation that were tested, but rather refers to "MRI modeling and MRI testing."
Data Provenance: The testing was conducted by or for Ad-Tech Medical Instruments Corporation. The document does not specify country of origin for the data or whether it was retrospective or prospective, as it pertains to engineering/device characterization rather than clinical data.

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

Not applicable. This submission concerns the physical characteristics and safety of a medical device in an MRI environment, not diagnostic accuracy requiring expert interpretation for ground truth. The "ground truth" here is established by engineering standards and validated MRI testing protocols.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication of findings.

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

Not applicable. This device is a biopsy needle, not an AI-powered diagnostic tool. The submission is for a 510(k) premarket notification for an MRI-conditional label, not an AI/CAD device.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating MRI compatibility was based on established engineering principles, MRI safety standards, and validated testing protocols (e.g., for magnetic field interactions, RF heating, and image artifact assessment). The document specifically mentions "MR modeling and MRI testing."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/Machine Learning algorithm that requires a training set.

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

Not applicable. There was no training set for this device.

Summary

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AD-TECH MEDICAL INSTRUMENT CORPORATION

APR 2 4 2012

K112094 510(k) Summary

This summary is provided to support the 510(k) notification for the Brain Biopsy Needles - MRI Conditional Product Family, manufactured by Ad-Tech Medical Instruments Corporation.

Company Name:	Ad-Tech Medical Instruments Corporation
Address:	1901 Williams StreetRacine, WI 53404
Phone:	(262) 634-1555
Date Summary Prepared:	April 16, 2012
Trade Name:	Brain Biopsy Needle
Common Name:	Biopsy Instrument
Classification Name:	21 CFR 876.1075 Biopsy Instrument21 CFR 882.4560 Stereotaxic Instrument
Predicate Devices:	510(k) Number: K924348Trade Name: Brain Biopsy NeedleManufacturer: Ad-Tech Medical Instrument Corporation510(k) Number: K990278Trade Name: NeuroCut NeuroBiopsy NeedleManufacturer: Daum Corporation510(k) Number: K060808Trade Name: BrainProManufacturer: Pajunk GmbH Medizintechnologie

5.1 Product Description

901 WILLIAM STREET, RACINE, WISCONSIN 53404 U.S.A 262-634-1555 Email: Bolech @ ad(echmBO). 282-634-5668 Website: www.adtechmedical.com Toll Free (us a.): 800-776-1555

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By this submission, the MDBM-08-28 Brain Biopsy Needle variation was confirmed meeting conditions to support labeling as "MRI Conditional". The Model MDBN-08-28 Brian Biopsy Needle has an 8 mm sample window and a 28 cm length.

5.2 Intended Use of the Device

The intended use of the Ad-Tech Brain Biopsy Needle is the same as predicate devices:

The Brain Biopsy Needles are used during guided procedures and methods deemed safe by the physician/surgeon to remove a targeted tissue sample for biopsy.

5.3 Summary of Technological Characteristics

The following table provides a side-by-side comparison the Ad-Tech Brain Biopsy Needle to the predicate devices being used to support this notification.

Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	Ad-Tech Brain BiopsyNeedle Including MRIConditional Variations(Under Review)	Ad-Tech Brain BiopsyNeedleK924348	K990278NeuroCut NeuroBiopsyNeedle	K060808BrainProCannula for Brain Biopsy
Indicationsfor Use	The Brain Biopsy Needlesare used during guidedprocedures and methodsdeemed safe by thephysician/surgeon to removea targeted tissue sample forbiopsy.	The Brain Biopsy Needlesare used during stereotacticguided procedures to removea targeted tissue sample forbiopsy	The Daum NeuroCutNeuroBiopsy Needle isdesigned for biopsy of thesoft tissue in the brain. Thepatented surface treatment ofthe needle optimizes its usein the MRI setting,producing a low-artifactvisualization of the needle.	The Pajunk BrainPro biopsycannula for brain biopsy is asingle-use device intendedfor use in stereotactic andother guided biopsy of braintissue, for example braintumors.
SinglePatientDisposable	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes
MRICompatible	Yes,Once variation:8 mm Sample Window,28 cm Length	No	Yes	Yes

5.4 Performance tests to demonstrate substantial equivalency:

To establish the MRI Compatibility of the Model MDBN-08-28 Brain Biopsy Needle variation, MR1 modeling and MRI testing were performed to confirm acceptable performance under expected MRI conditions.

ર્સ્ડ Conclusion

The MRI Compatibility of the Model MDBM-08-28 Brain Biopsy Needle variation demonstrated acceptable performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ad-Tech Medical Instruments Corp. c/o Mr. Gary Syring Principal Consultant 800 Levanger Lane Stoughton, WI 53589

Re: K112094

Trade/Device Name: Brain Biopsy Needle Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW, FCG Dated: April 16, 2012 Received: April 17, 2012

Dear Mr. Syring:

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, 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.

APR 2 4 2012

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Page 2 - Mr. Gary Syring

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erich Fromm

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112094

Indications for Use

510(k) Number (if known): K112094

Device Name: Brain Biopsy Needle

Indications for Use:

The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-Page 1 of

Joe Hutter

510(k) Number

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KIIZO94

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).