(100 days)
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No
The description focuses on robotic automation for needle guidance based on stereotactic imaging, with no mention of AI or ML for image analysis, decision-making, or control beyond programmed movements.
No.
The device is used for accurate positioning and penetration of a biopsy needle to acquire tissue samples, which is a diagnostic procedure, not a therapeutic one.
No
The device description indicates that the ROBOGUIDE is an automatic needle guidance system used for accurate positioning of a biopsy needle to penetrate breast lesions after they have been "previously detected". Its function is to facilitate the biopsy procedure (FNA or core biopsy) by guiding the needle, not to detect or diagnose the lesion itself. It is a tool for intervention (biopsy) based on prior diagnostic information, rather than a diagnostic device that identifies or characterizes disease.
No
The device description explicitly states that the ROBOGUIDE comprises a robotic biopsy unit and a film read out and motor control evaluation unit, which are hardware components.
Based on the provided information, the ROBOGUIDE is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The ROBOGUIDE is a device that assists in the physical process of obtaining a biopsy sample from a breast lesion. It is a tool used during a medical procedure, not a device that analyzes a sample after it has been collected.
- The description focuses on the mechanical guidance of a needle. The core function is to accurately position a needle for biopsy, which is an invasive procedure performed on the patient's body.
- There is no mention of analyzing biological samples. The device description does not involve any processes related to testing blood, tissue, or other bodily fluids.
The ROBOGUIDE is a medical device used for image-guided biopsy procedures, specifically for breast lesions. It falls under the category of devices used in interventional radiology or surgery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The ROBOGUIDE is an automatic needle guidanc system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or tor core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.
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
breast
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Shai - Syg Motion & Innovations Itd., P.O. Box 2412, Ra'anana 43654, Israel Contact person: Jacob Gross
Tel: +972.9.913611 Fax: +972.9.910662
010662
AUG 21 1996 K961849
...
Name of the Device: ROBOGUIDE
Predicate Devices: The ROBOGUIDE is substantially equivalent to a combination of the Cytoguide manufactured by Phillips Medical and the Mammoquide manufactured by Elscint Ltd.
Description of the Device: The ROBOGUIDE is an automatic needle guidanc system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or tor core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.
Technological Characteristics: The systems share many Comparison of hardware and functional characteristics :
- The biopsy units of the ROBOGUIDE and the Mammoguide are identical.
- All three units employ stereotaxis to identify the location of a breast lesion and then drives a needle carrier along three coordinate axes to a point that allows accurate placement the biopsy needle point into the lesion. of
- and immobilizing the - All three units have means for compressing breast during the procedure.
- All three units employ safety mechanisms to assure no movement of the needle carrier during biopsy needle injection.
The differences between the systems raise no new issues of safety or effectiveness.
MAY, 1, 1986
Date
Mr. Jacob Gross, President