(147 days)
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No
The description details a manually operated biopsy needle with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device is used for drawing substances (biopsy), which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is described as a manually operated biopsy needle for drawing substances, which is an interventional procedure rather than a diagnostic one. Its intended use is for drawing osteomedullary substances, not for detecting, diagnosing, or monitoring diseases or conditions.
No
The device description clearly states it is a "manually operated biopsy needle," which is a physical hardware device. The performance studies also relate to the biocompatibility of a physical 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 from the iliac crest." This is a procedure performed on the patient's body to collect a sample.
- Device Description: The device is a "manually operated biopsy needle used for aspiration or explantation of bony substance." This describes a surgical or procedural tool used to obtain a sample from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or treatment. This device's function is to collect the specimen, not to analyze it.
The tests performed (Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, Cytotoxicity) are related to the biocompatibility and safety of the device for use in the body, which is consistent with a medical device used for a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended to be used for drawing osteomedullary substances 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 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
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 Intracutaneous Reactivity RESULT Passed
Acute Systemic Toxicity RESULT Passed
Pyrogen Test RESULT Passed
Cytotoxicity RESULT 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.
0
Image /page/0/Picture/0 description: The image is a black and white logo for Gallini. The logo consists of the word "GALLINI" written in capital letters inside of a circle. There is a cross shape that divides the circle into four quadrants.
Medical Products and Services
25 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
OWNER: Gallini s.r.I. 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 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 Intracutaneous Reactivity Acute Systemic Toxicity Pyrogen Test Cytotoxicity
RESULT Passed Passed Passed 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 iv. - Reg. Soc. Trib. di Modena N. 226177 - P. VA: 01935440360 - Cod. Fisc: 01281650174