(277 days)
Not Found
No
The description focuses solely on the mechanical function of the biopsy needle and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is a diagnostic tool used to collect tissue samples for analysis, not to treat a disease or condition.
Yes
The device is used to remove tissue for analysis to "determine tissue abnormality or any deviation from healthy brain tissue," which is a diagnostic purpose.
No
The device description clearly details a physical medical device (brain biopsy needles) used for tissue removal, not a software-only application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Brain Biopsy Needle is a surgical instrument used inside the body to obtain a tissue sample. It is the tool for collecting the specimen, not for analyzing it.
- Intended Use: The intended use clearly states the needles are used "to remove a targeted tissue for biopsy" and "to remove a targeted sample of brain tissue for analysis." This describes the act of obtaining the sample, not the analysis itself.
- Analysis is Separate: The description mentions the tissue sample is "removed for analysis." This implies the analysis is a separate process performed on the collected sample, likely using IVD devices or laboratory procedures.
The Brain Biopsy Needle is a surgical device used to facilitate the collection of a sample that will be used in an IVD process, but the needle itself is not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW, FCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Brain/soft tissue in the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician/surgeon
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)
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. The MRI Compatibility of the Model MDBM-08-28 Brain Biopsy Needle variation demonstrated acceptable performance.
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.
Not Found
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
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 Street |
| Racine, 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 Instrument |
| 21 CFR 882.4560 Stereotaxic Instrument | |
| Predicate Devices: | 510(k) Number: K924348 |
| Trade Name: Brain Biopsy Needle | |
| Manufacturer: Ad-Tech Medical Instrument Corporation | |
| 510(k) Number: K990278 | |
| Trade Name: NeuroCut NeuroBiopsy Needle | |
| Manufacturer: Daum Corporation | |
| 510(k) Number: K060808 | |
| Trade Name: BrainPro | |
| Manufacturer: Pajunk GmbH Medizintechnologie |
5.1 Product 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.
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
1
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 Biopsy | |||
| Needle Including MRI | ||||
| Conditional Variations | ||||
| (Under Review) | Ad-Tech Brain Biopsy | |||
| Needle | ||||
| K924348 | K990278 | |||
| NeuroCut NeuroBiopsy | ||||
| Needle | K060808 | |||
| BrainPro | ||||
| Cannula for Brain Biopsy | ||||
| Indications | ||||
| for Use | 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. | The Brain Biopsy Needles | |||
| are used during stereotactic | ||||
| guided procedures to remove | ||||
| a targeted tissue sample for | ||||
| biopsy | The Daum NeuroCut | |||
| NeuroBiopsy Needle is | ||||
| designed for biopsy of the | ||||
| soft tissue in the brain. The | ||||
| patented surface treatment of | ||||
| the needle optimizes its use | ||||
| in the MRI setting, | ||||
| producing a low-artifact | ||||
| visualization of the needle. | 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. | ||||
| Single | ||||
| Patient | ||||
| Disposable | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| MRI | ||||
| Compatible | 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
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
3
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
4
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