(75 days)
Not Found
No
The description focuses on the mechanical function of the biopsy needle and its use with a stereotactic system, with no mention of AI or ML.
No
This device is a biopsy needle used for diagnosis (collecting tissue samples) rather than for treating a condition.
No
The device is a biopsy needle used to collect tissue samples. While these samples may subsequently be used for diagnostic purposes, the needle itself performs the act of cutting and collecting tissue, not diagnosing.
No
The device description clearly states it is a physical device made from stainless steel needles and requires a syringe for suction and rotation for cutting 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 tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Radionics Nashold Biopsy Needle is a surgical instrument used to obtain a tissue sample from the brain within the body (in vivo). It is a tool for collecting the sample, not for analyzing it.
The description clearly states its purpose is for "stereotactic biopsy of brain tumors," which is a procedure to remove a small piece of tissue for later analysis (which would likely involve IVD tests, but the needle itself is not the IVD).
N/A
Intended Use / Indications for Use
The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.
Product codes
HAW
Device Description
The NBN-D is a dual cannula device made from stainless steel hypodermic needles. The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue. The device is designed to be used with the Radionics CRW system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain tumors
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
SEP 1 5 2003
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
| SUBMITTER: | Radionics, a division of Tyco Healthcare LP
22 Terry Ave.
Burlington, MA 01803
Tel.: (781) 272-1233
Fax: (978) 663-8405 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Kevin J. O'Connell
Senior Regulatory Associate |
| PROPRIETARY NAME: | Radionics Nashold Biopsy Needle - Single Use (NBN-D) |
| COMMON OR USUAL
NAME: | Disposable biopsy needle |
| CLASSIFICATION CODE: | 21 C.F.R. § 882.4560 |
| PREDICATE DEVICES: | MRI Devices Corporation (DAUM CORP.) Daum Neurocut
Neurobiopsy Needle, K990278
Ad-Tech's Brain Biopsy Needle For Stereotaxic, K924348
Elekta Instrument's Leksell Sedan Biopsy Needle, 510(k) unk |
| INTENDED USE: | The Radionics Nashold Biopsy Needle is intended for single
patient use in stereotactic biopsy of brain tumors. |
| DESCRIPTION: | The NBN-D is a dual cannula device made from stainless
steel hypodermic needles. The device requires suction
provided by a syringe to draw the tissue into the needle. The
inner cannula is then rotated to cut the tissue. The device is
designed to be used with the Radionics CRW system. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2003
Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics A Division of Tyco Healthcare LP 22 Terry Avenue Burlington, Massachusetts 01803
Re: K032054
Trade/Device Name: Radionics Nashold Biopsy Needle - Single Use Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 1, 2003 Received: July 2, 2003
Dear Mr. O'Connell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Kevin J. O'Connell
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 ODE Indications Statement:
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Radionics Nashold Biopsy Needle – Single Use
, "
The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
PRESCRIPTION USE
OR
Over-The-Counter Use
(Per 21 CFR 801.109
Miriam C. Provost
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032054