(74 days)
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No
The summary describes a disposable biopsy needle and its intended use with an image-guided surgery system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical device and its compatibility with a specific system.
No
The device is a biopsy needle used for diagnostic purposes (collecting tissue samples), not for treating a disease or condition.
No
The device is a biopsy needle, which is used to collect tissue samples. While these samples may subsequently be used for diagnostic purposes, the needle itself is a sampling tool, not a device that performs diagnosis.
No
The device description clearly states it is a "DISPOSABLE BIOPSY NEEDLE," which is a physical, hardware component used for surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device's intended use: The SNT DISPOSABLE BIOPSY NEEDLE is used to obtain a sample of brain tissue. It is a surgical tool used in a procedure (stereotaxic biopsy). It does not perform any diagnostic testing on the tissue sample itself. The diagnostic testing would be performed separately in a laboratory after the sample is collected.
Therefore, while the tissue collected by this needle might be used for subsequent in vitro diagnostic testing, the needle itself is a surgical instrument for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder.
Product codes
84HAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JUN 16 1997
510(k) Summary of Safety and Effectiveness
SNT DISPOSABLE BIOPSY NEEDLE
Surgical Navigation Technologies, Inc. I. Company: 530 Compton Street Broomfield, CO 80020
- II. Product Name: SNT DISPOSABLE BIOPSY NEEDLE
- The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for III. stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder.
- The SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially IV. equivalent to the stereotatic biopsy needle manufactured by RADIONICS and used in their Nashold Biopsy Needle Kit. The only difference is that their device uses stereotactic coordinates that are dialed into a guide holder on a headframe to lead the needle while our device is tracked using an LED that is tracked by the STEALTHSTATION™ . In addition, the SNT DISPOSABLE BIOPSY NEEDLE was claimed to be substantially equivalent to several commercially available biopsy needles. A comparison of these needles was supplied in support of establishing equivalence.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 1997
Mr. David A. Mire Clinical and Regulatory Affairs Associate Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: *K971247 SNT Disposable Biopsy Needle Trade Name: Requlatory Class: II Product Code: 84HAW Dated: March 14, 1997 Received: April 3, 1997
Dear Mr. Mire:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. David A. Mire
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CONFIDENTIAL
Page __ 1 __ of __ 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: :在
The SNT DISPOSABLE BIOPSY NEEDLE is intended to be used for stereotaxic biopsy of brain tissue. This needle is only intended for use with the StealthStation™ Image Guided Surgery System and it's rigid needle guide holder. The biopsy needle is supplied sterile and is intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| STATUTE AND STATUTE AND PROPERTY CONSULTION OF CHARACT OF CHEARTH OF CHEARTH A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|---|
| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |||
Division Sign Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Image /page/3/Picture/14 description: The image shows the words "Prescription Use" in bold font. Below this text, the words "(Per 21 CFR 801 109)" are printed in a smaller font size. There is a large "X" that crosses out the words "Prescription Use".
OR
Over-The-Counter Use_
(Optional Format 1-2-96)