ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE by GALLINI INTL., INC.

This document describes a medical device, the ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle, and outlines its intended use, function, and a comparison to a predicate device. It also lists several tests performed to demonstrate safety, performance, and efficacy. However, it does not provide acceptance criteria or a study proving the device meets specific performance criteria related to its intended function (drawing osteomedullary substances).

The listed tests (Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, Cytotoxicity) are safety-related biological compatibility tests, not performance studies of the core biopsy function.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered based on the input:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated for performance of the biopsy function. For the listed tests, the implicit acceptance criterion is "Passed."
- Reported Device Performance:
  - Intracutaneous Reactivity: Passed
  - Acute Systemic Toxicity: Passed
  - Pyrogen Test: Passed
  - Cytotoxicity: Passed
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be determined from the provided text. The document refers to "tests," but does not detail the methodology, sample sizes of these tests, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be determined from the provided text. The listed tests are laboratory-based biological evaluations, not diagnostic performance studies that would typically involve expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be determined from the provided text. (See reasoning for point 3).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a manually operated biopsy needle, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the biological tests, the "ground truth" would be the standard laboratory protocols and negative/positive controls as per relevant ISO or ASTM standards for biocompatibility testing. The document does not specify these. For the core function of the biopsy needle, no performance study data is provided, so no ground truth type can be identified.
The sample size for the training set:
- Not applicable/Cannot be determined. This is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. (See reasoning for point 8).

In summary, the provided document focuses on the safety of the biopsy needle through biocompatibility testing, but lacks detailed information regarding performance efficacy related to its primary function (drawing osteomedullary substances) and the associated acceptance criteria and studies.

Summary

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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

K962570

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.

Regulation Number and Section

§ 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.