(37 days)
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No
The summary describes a mechanical biopsy needle and does not mention any AI or ML components or functions.
No
This device is for diagnostic sampling of tissue, not for treatment.
No
Explanation: The device is a biopsy needle used to collect tissue samples. While these samples may subsequently be used for diagnostic purposes, the needle itself is a tool for sample collection, not for diagnosis. Diagnostic devices are those that analyze data or samples to identify diseases or conditions.
No
The device description clearly states it is a "spring loaded, disposable biopsy needle," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "take high quality histological core samples from soft tissue". This describes a device used to collect a sample from the body, not a device used to examine a sample outside of the body to diagnose a condition.
- Device Description: The device is a "spring loaded, disposable biopsy needle". This is a tool for sample collection, not for in vitro analysis.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples in a laboratory setting (e.g., reagents, assays, analyzers, etc.).
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device's function is solely to obtain the sample itself.
N/A
Intended Use / Indications for Use
This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The device is a spring loaded, disposable biopsy needle.
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
soft tissue, including (but not limited to) liver, kidney, prostate.
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)
The following tests were performed to demonstrate the safety and efficacy of the device.
TEST Firing Test Pyrogen Test (LAL) Biocompatibility
RESULT Passed Passed All tests are performed by the raw material suppliers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows a logo for Gallini. The logo consists of the word "GALLINI" written in bold, sans-serif font. The word is placed inside a circle that is divided into four quadrants by a cross shape. The cross shape is formed by two lines that intersect at the center of the circle.
K9647777
Jan 3, 1997
Medical Products and Services
510(K) SUMMARY
OWNER:
Gallini s.r.I. 88/90 Via S. Faustino 41037-Mirandola (MO) Italy
CONTACT PERSON: Paul L. Hawthorne U.S. Representative
November 22, 1996 SUBMISSION DATE:
"TZ®" Biopsy Needle DEVICE NAME:
ProMedical Ltd. - PRO-B Biopsy Needle PREDICATE DEVICE: 240(K)# - K824598
DESCRIPTION OF DEVICE FUNCTION:
The device is a spring loaded, disposable biopsy needle.
This device is intended to be used to take high INTENDED USE: quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The "TZ®" Biopsy needle is identical to the predicate devices in terms of technological characteristics.
The following tests were performed to demonstrate the safety and efficacy of the device.
TEST Firing Test Pyrogen Test (LAL) Biocompatibility
RESULT Passed Passed All tests are performed by the raw material suppliers.