(149 days)
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No
The device description and performance studies indicate a manually operated mechanical device with no mention of AI or ML.
No
The device is described as a biopsy needle used for drawing osteomedullary substances, which is a diagnostic procedure, not a therapeutic one. The performance studies focus on safety and efficacy for the device itself (e.g., biocompatibility testing), not on treating a patient's condition.
No
The device is described as a biopsy needle used for drawing osteomedullary substances. This is a collection of samples for later analysis, not a direct diagnostic process itself.
No
The device description clearly states it is a "manually operated biopsy needle," which is a physical hardware device, not software.
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 from the sternum or from the iliac crest." This describes a procedure performed on a living patient to obtain a sample, not a test performed in vitro (outside the body) on a sample 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 reagent, instrument, or system intended for use in the examination of specimens derived from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes.
- 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.)
- Providing diagnostic information
- Using reagents or analytical methods
- Measuring biomarkers or other indicators
The device is clearly intended for the collection of a sample from a patient, which is a pre-analytical step that might be followed by an IVD test, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
A manually operated biopsy needle used for PROPRIETARY NAME: ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle 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
sternum or from the iliac crest.
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, performance and efficacy of the product:
| TEST | RESULT |
|---|---|
| Intracutaneous Reactivity | Passed |
| Acute Systemic Toxicity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
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.
Promedical - Jamshidi style biopsy needle
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.
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Image /page/0/Picture/0 description: The image shows a logo with the word "GALLINI" written in capital letters inside a circle. The circle is incomplete, with breaks at the top and bottom. A vertical line runs through the center of the circle and the word, intersecting with a horizontal line that forms a cross shape. The logo has a simple, geometric design.
Medical Products and Services
SUMMARY OF SAFETY AND EFFECTIVENESS
OWNER:
CONTACT:
NOV 27 1996
Gallini s.r.l. 88/90 Via S. Faustino Mirandola, Italy 41037
Paul L. Hawthorne U.S. Representative C/O Coeurage Enterprises 3106 Bretton Court Glen Allen, VA 23060
SUBMISSION DATE: April, 1996
DEVICE NAME: ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle
The device is intended to be used for drawing osteomedullary substances from the sternum or
PREDICATE DEVICE: Promedical - Jamshidi style biopsy needle
from the iliac crest.
INTENDED USE:
DESCRIPTION OF A manually operated biopsy needle used for FUNCTION: aspiration or explantation of bony substance.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The ISAN® 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 |
Gallini S.r.1. - Via S. Faustino, 88 - 41037 MIRANDOLA (MO) ITALY - Tel. 0535/21983 - Fax 0535/24184 Cap. Soc. Lit. 198.000.000.