MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE

K962736 · Mill-Rose Laboratory · EOQ · Jul 29, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962736
• Device Name: MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
• Applicant: Mill-Rose Laboratory
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jul 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.

Device Story

Laryngoscopic injection needle; consists of outer catheter and inner catheter with mounted needle. Inner catheter slides within outer catheter; needle tip advances predetermined distance past outer catheter end; needle remains fully retracted within lumen when not in use. Used by clinicians during laryngoscopy for therapeutic laryngeal injections. Facilitates treatment of laryngeal disorders; enables precise delivery of therapeutic agents to larynx.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Catheter-based injection system; inner/outer catheter design; manual actuation; materials consistent with predicate devices.

Indications for Use

Indicated for patients with laryngeal disorders including paralysis, tissue deficiency, contact ulcers, and spasmodic dysphonia requiring therapeutic injection via laryngoscope.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Wang/Mill-Rose Transbronchial Aspiration Needle (K914181)
• Endoscopic Injection Needle (K820973)

Submission Summary (Full Text)

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ATTACHMENT A
K962736
JUL 29 1996

# 510(k) Summary:

1.) Submitter: Mill-Rose Laboratories, Inc.
7310 Corporate Blvd.
Mentor, OH 44060
[phone]

2). Contact Person: Alan C. Poje

3.) Summary Preparation Date: July 12, 1996

4.) Classification Name: Bronchoscope and Accessory

5.) Common Name: Laryngoscopic Injection Needle

6.) Proprietary Name: Mill-Rose Laryngoscopic Injection Needle

7.) Substantially Equivalent Devices:
K914181: Wang/Mill-Rose Transbronchial Aspiration Needle
K820973: Endoscopic Injection Needle

8.) Description of Subject Device:
The device consists of an outer catheter and an inner catheter to which a needle is mounted. The inner catheter slides within the outer catheter such that the needle tip may advance a pre-determined distance past the end of the outer catheter and remains totally within the lumen catheter when the needle is fully retracted.

9.) Intended Use:
The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.

10.) Technological Characteristics:
The subject device has the same technological characteristics as its predicate devices. It is composed of the same type of materials and is of a similar design.