(165 days)
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Not Found
No
The summary describes a mechanical puncturing device with a deflecting cannula and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "puncturing device" used for aspiration biopsy, drainage, injection, or fluid collection, and its intended use focuses on guiding punctures while avoiding obstacles. It is an interventional tool, not a device that provides therapy itself.
No.
The device is a puncturing device used for aspiration, biopsy, drainage, injection, or fluid collection, guided by imaging, but it does not perform diagnosis itself.
No
The device description explicitly states it is a "puncturing device capable of extending an inner cannula which deflects in a curved shape," indicating a physical hardware component.
Based on the provided information, the SmartGuide is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- SmartGuide's Intended Use: The SmartGuide is described as a "puncturing device" used for procedures like aspiration biopsy, drainage, injection, or fluid collection within the body. It's used to access anatomical sites directly.
- Lack of Specimen Analysis: The description focuses on the physical act of puncturing and guiding, not on the analysis of any collected specimens.
Therefore, the SmartGuide is a medical device used for interventional procedures in vivo (within the living body), not an IVD device used for in vitro (outside the living body) analysis of specimens.
N/A
Intended Use / Indications for Use
The SmartGuide is intended for use in punctures of anatomical sites such as in organs, cysts, lymph nodes, and tissue spaces, for purposes of aspiration biopsy, drainage, injection, or fluid collection. SmartGuide can be used in punctures where non-penetrable anatomic obstacles (e.g. bone, spine) or vital structures (e.g. blood vessels, nerves) are to be avoided. The device is intended for use in environments such as CT and radiographic ultrasound.
Product codes
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Device Description
The SmartGuide is a puncturing device capable of extending an inner cannula which deflects in a curved shape.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT and radiographic ultrasound.
Anatomical Site
organs, cysts, lymph nodes, and tissue spaces
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Homer MammaLock Ultra Breast Localization Needle Repositionable (Medical Device Technologies, Inc.), Goose-(Microvena Corporation), Wittich Neck Snare Nitinol Stone Basket (Cook, Incorporated)
Reference Device(s)
Not Found
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 shows the logo for Ferguson Medical. The logo has a stylized letter 'F' on the left side, with the words 'FERGUSON' and 'MEDICAL' stacked on the right side. The font is bold and black, and the logo appears to be a scan of a printed document.
916-342-4136 FAX: 916-343-454
1963894
MAR 1 1 1997
27 February 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Needle, aspiration and Classification name: A. injection, disposable.
Aspiration needle, probe Common/usual name: needle, or injection needle.
SmartGuide Proprietary name:
- Homer MammaLock Ultra Substantial equivalence: B. Breast Localization Needle Repositionable (Medical Device Technologies, Inc.), Goose-(Microvena Corporation), Wittich Neck Snare Nitinol Stone Basket (Cook, Incorporated), and others.
- The SmartGuide is a description: C. Device puncturing device capable of extending an cannula which deflects in a inner curved shape.
- The SmartGuide is intended for use D. Intended use: punctures of anatomical sites such as in organs, cysts, lymph nodes, and tissue spaces, for purposes of aspiration biopsy, drainage,
3407 Bay Avenue · Chico, California 95973 · USA
1
injection, or fluid collection. SmartGuide can be used in punctures where non-penetrable anatomic obstacles (e.g. bone, spine) or vital structures (e.g. blood vessels, nerves) are to The device is intended for use in be avoided. environments such as CT and radiographic ultrasound.
- E. Technological characteristics: The SmartGuide is similar to predicate devices in its design, function, and intended use.
The proposed device utilizes a memory retentive nickel titanium alloy which allows one component to be extended, changing its shape.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Hawk Ellis
Frank Ferguson Official Correspondent