(149 days)
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No
The device description and performance studies indicate a manually operated mechanical device with no mention of AI/ML or related concepts.
No
The device is described as a biopsy needle intended for drawing osteomedullary substances or explanting bone marrow, which is a diagnostic or procedural function, not a therapeutic one.
No
The device is described as a biopsy needle intended for drawing osteomedullary substances or explanting bone marrow. This is a collection device, not one that analyzes or interprets data to diagnose a condition.
No
The device description explicitly states it is a "manually operated 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 for "drawing osteomedullary substances and/or the explantation of bone marrow." This is a procedure performed on the body to collect a sample, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The device is described as a "manually operated biopsy needle used for aspiration or explantation of bony substance." This is a surgical or procedural tool, not a diagnostic reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
The device is clearly a tool for obtaining a sample, which might then be used in an IVD test, but the needle itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
Product codes
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Device Description
A manually operated biopsy needle used for aspiration or explantation of bony substance.
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
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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
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Key Metrics
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Predicate Device(s)
Promedical - Jamshidi style biopsy needle
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
NOV 27 1996
Image /page/0/Picture/1 description: The image is a logo for Gallini. The logo is a circle with the word "GALLINI" written across the top half of the circle. There is a cross shape inside the circle, with the vertical line of the cross going through the middle of the word "GALLINI". The logo is black and white.
Medical Products and Services
SUMMARY OF SAFETY AND EFFECTIVENESS
OWNER: Gallini s.r.l. 88/90 Via S. Faustino Mirandola, Italy 41037
CONTACT: Paul L. Hawthorne U.S. Representative C/O Coeurage Enterprises 3106 Bretton Court Glen Allen, VA 23060
April, 1996 SUBMISSION DATE:
DEVICE NAME: BIOMID® - Bone Marrow Biopsy Needle
PREDICATE DEVICE: Promedical - Jamshidi style biopsy needle
INTENDED USE: The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
DESCRIPTION OF A manually operated biopsy needle used for FUNCTION: aspiration or explantation of bony substance.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The ACRI® needle is equivalent to the predicate device in terms of technological characteristics and function.
The following tests were performed to demonstrate the safety, performance and efficacy of the product;
| TEST | RESULT |
|---|---|
| Intracutaneous Reactivity | Passed |
| Acute Systemic Toxicity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |