ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES

K962568 · Gallini Intl., Inc. · FCG · Nov 25, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962568
• Device Name: ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
• Applicant: Gallini Intl., Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Nov 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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

Device Story

Manually operated biopsy needle; used for aspiration or explantation of bony substance from iliac crest. Operated by clinician; provides physical access to bone marrow/tissue. Benefits patient by enabling diagnostic sampling of osteomedullary material.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, and Cytotoxicity; all tests passed.

Technological Characteristics

Manually operated biopsy needle for bone aspiration. Materials and specific dimensions not provided. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring aspiration or biopsy of osteomedullary substances from the iliac crest.

Regulatory Classification

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)

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GALINI

NOV 25 1996

Medical Products and Services

K 96 2568

# 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: ACRI®-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 iliac crest.

DESCRIPTION OF FUNCTION: A manually operated, biopsy needle used for 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 |

Gallini S.r.l. - Via S. Faustino, 88 - 41037 MIRANDOLA (MO) ITALY - Tel. [phone] - Fax [phone]

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