(165 days)
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.
The SmartGuide is a puncturing device capable of extending an inner cannula which deflects in a curved shape.
The provided text is a 510(k) summary for a medical device called "SmartGuide." This document describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based solely on the input text. The 510(k) summary focuses on regulatory submission requirements and substantiating claims of equivalence, not detailed performance studies or statistical analyses of device accuracy.
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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
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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
§ 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.