SMARTGUIDE

K963894 · Ferguson Medical · FCG · Mar 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963894
• Device Name: SMARTGUIDE
• Applicant: Ferguson Medical
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The SmartGuide is intended for use in punctures of anatomical sites such as 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 radiographic environments such as CT and ultrasound.

Device Story

Puncturing device; features extendable inner cannula; cannula deflects into curved shape upon extension. Utilizes memory-retentive nickel-titanium alloy. Used in radiographic environments (CT, ultrasound) by clinicians to navigate around obstacles (bone, spine) or vital structures (vessels, nerves). Facilitates precise access for biopsy, drainage, injection, or fluid collection. Benefits patient by enabling access to difficult-to-reach anatomical sites while minimizing trauma to surrounding vital structures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Puncturing device; memory-retentive nickel-titanium alloy construction; shape-changing inner cannula mechanism; manual operation; compatible with CT and ultrasound imaging environments.

Indications for Use

Indicated for patients requiring needle puncture of organs, cysts, lymph nodes, or tissue spaces for aspiration biopsy, drainage, injection, or fluid collection, particularly when navigation around anatomical obstacles or vital structures is required.

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

• Homer MammaLock Ultra Repositionable Breast Localization Needle (Medical Device Technologies, Inc.)
• Goose-Neck Snare (Microvena Corporation)
• Wittich Nitinol Stone Basket (Cook, Incorporated)

Submission Summary (Full Text)

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FERGUSON MEDICAL

916-342-4133

FAX: [phone]

k963894

MAR 11 1997

27 February 1997

# 510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Needle, aspiration and injection, disposable.

Common/usual name: Aspiration needle, probe needle, or injection needle.

Proprietary name: SmartGuide

B. Substantial equivalence: Homer MammaLock Ultra Repositionable Breast Localization Needle (Medical Device Technologies, Inc.), Goose-Neck Snare (Microvena Corporation), Wittich Nitinol Stone Basket (Cook, Incorporated), and others.

C. Device description: The SmartGuide is a puncturing device capable of extending an inner cannula which deflects in a curved shape.

D. Intended use: The SmartGuide is intended for use in punctures of anatomical sites such as 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 be avoided. The device is intended for use in radiographic environments such as CT and 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

Frank Ferguson
Official Correspondent