(78 days)
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No
The summary describes a mechanical biopsy instrument and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a biopsy instrument used for obtaining tissue samples for diagnostic purposes, not for therapy.
No
Explanation: The device is a biopsy instrument and needle designed to obtain tissue samples for histological analysis, which is a method of acquiring samples. It does not perform analysis or diagnosis itself.
No
The device description clearly states it is a "biopsy instrument" and "biopsy Needle," indicating a physical, hardware-based medical device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to obtain histological core samples from organs like the prostate, kidney, and liver. This is a procedure performed on the patient's body to collect tissue, not a test performed on a sample of the patient's body outside of the body.
- Device Description: The device is described as a biopsy instrument/needle used for taking tissue specimens. This aligns with a surgical or procedural device, not a diagnostic test kit or instrument that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue after collection and processing), reagents, or any other components typically associated with in vitro diagnostic tests.
In summary, this device is a tool for collecting tissue samples from the body, which is a procedural or surgical function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This device is an automatic disposable biopsy Needle developed for taking a range of tissue specimens, including those from the prostate, kidney and liver.
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
prostate, kidney and liver
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 was performed to show the safety, efficacy and performance of the product.
Gun Firing Test (TX/F/T) see attch. protocol - passed
Pyrogen Test (LAL) - passed
All biocompatibility tests on the components are performed by the supplier of the row material.
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
OCT 11 1996
Summary of Safety and Effectiveness
- Owner : Gallini s.r.l. 88. Via S. Faustino 41037-Mirandola -Italy
- Contact Person: Caterina E. Galluzzo President, Gallini Intl.
Submission Date: July 1996
- Device Name : TX® Biopsy Needle
Predicate Device : Promedical Ltd.. - PRO-B Biopsy Needle ( 510 (k) # K951598 )
This device is an automatic disposable biopsy Needle developed for Description of taking a range of tissue specimens, including those from the prostate, Device function : kidney and liver.
This device is an automated, disposable and adjustable biopsy instrument Intended Use : designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The TX® Biopsy Needle is equivalent to the predicate devices in term of technological characteristics
The following tests was performed to show the safety, efficacy and performance of the product.
| TEST | RESULT |
|---|---|
| Gun Firing Test (TX/F/T) see attch. protocol | passed |
| Pyrogen Test (LAL) | passed |
All biocompatibility tests on the components are performed by the supplier of the row material.