← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K962570

# ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE (K962570)

_Gallini Intl., Inc. · FCG · Nov 27, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962570

## Device Facts

- **Applicant:** Gallini Intl., Inc.
- **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Intended Use

The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest.

## Device Story

Manually operated biopsy needle; used for aspiration or explantation of bony substance from sternum or iliac crest. Operated by clinicians in clinical settings. Provides bone marrow samples for diagnostic evaluation. Benefits patient by enabling minimally invasive access to bone marrow for clinical decision-making.

## Clinical Evidence

Bench testing only. Biocompatibility testing performed: Intracutaneous Reactivity (passed), Acute Systemic Toxicity (passed), Pyrogen Test (passed), and Cytotoxicity (passed).

## Technological Characteristics

Manually operated biopsy needle; stainless steel construction (implied by device type); sterile; single-use; form factor designed for sternal/iliac crest access.

## Regulatory 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.

## Predicate Devices

- Promedical - Jamshidi style biopsy needle

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

NOV 27 1996
GALINI
Medical Products and Services
K962570

# 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

**SUBMISSION DATE:** April, 1996

**DEVICE NAME:** ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle

**PREDICATE DEVICE:** Promedical - Jamshidi style biopsy needle

**INTENDED USE:** The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest.

**DESCRIPTION OF FUNCTION:** A manually operated biopsy needle used for 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.l. - Via S. Faustino, 88 - 41037 MIRANDOLA (MO) ITALY - Tel. 0535/21983 - Fax 0535/24184
Cap. Soc. Lit. 198.000.000 i.v. - Reg. Soc. Trib. di Modena n. 31718 - C.C.I.A.A. di Modena N. 226177 - P. IVA: 01935440360 - Cod. Fisc.: 01281650174

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962570](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962570)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com