(14 days)
Not Found
No
The summary describes a purely mechanical injection needle system and explicitly states that AI/ML is "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic injection" for "various laryngeal disorders."
No
The "Intended Use / Indications for Use" states the device is for "therapeutic injection" and does not mention diagnosis.
No
The device description clearly outlines physical components (outer catheter, inner catheter, needle) and their mechanical interaction, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for therapeutic injection directly into the larynx for treating various laryngeal disorders. This is a direct medical intervention on a patient's body.
- Device Description: The device is a needle and catheter system designed for delivering substances into tissue. This is consistent with a surgical or interventional device, not a device used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue biopsies, etc.) in vitro (outside the living body) to provide diagnostic information.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver a substance into the body for treatment.
N/A
# Intended Use / Indications for 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.
# Product codes
Not Found
# Device Description
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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
larynx
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s)
[K914181](https://510k.innolitics.com/search/K914181), [K820973](https://510k.innolitics.com/search/K820973)
# 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)
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
0
ATTACHMENT A
K962736
JUL 29 1996
510(k) Summary:
| 1.) Submitter: | Mill-Rose Laboratories, Inc.
7310 Corporate Blvd.
Mentor, OH 44060
(216)255-7995 |
| ---------------- | ------------------------------------------------------------------------------------------- |
|---|
- Alan C. Poje 2). Contact Person:
- 3.) Summary Preparation Date: July 12, 1996
- 4.) Classification Name: Bronchoscope and Accessory
- Laryngoscopic Injection Needle 5.) Common Name:
- Mill-Rose Laryngoscopic Injection Needle 6.) Proprietary Name:
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.