(80 days)
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Not Found
No
The summary describes a simple irrigation catheter and does not mention any AI or ML components or functions.
Yes
The device is intended to irrigate the middle ear and aerate it during the treatment, which are therapeutic actions.
No
The device is described as an irrigation tool for the middle ear, delivering fluids and aerating the middle ear. Its purpose is therapeutic (irrigation and aeration), not diagnostic.
No
The device description clearly outlines physical components made of polyurethane and silicone, 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:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RWuC Intended Use: The Round Window u Cath™ is intended for irrigating the middle ear or round window area. This is a therapeutic or procedural use, not a diagnostic one involving the analysis of bodily specimens.
- Device Description: The device is a catheter designed for fluid delivery and removal within the ear. This aligns with a procedural device, not an IVD.
The device is used in the body for a therapeutic purpose (irrigation), not on specimens taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Round Window u Cath™ (RWuC) is intended to be used by any board certified otolaryngologist or otologist to irrigate the entire middle ear or the round window area of the middle ear. During the course of the irrigation treatment, it is intended that the vent tube through which the RW (C's dual lumen passes, will aerate the middle ear. The treating physician will choose, based on what hels will be most beneficial for his/her patient, the following: { }) the exact fluids to be delivered through the RWAC; (2) the proper quantities; and (3) the duration and interval of treatment (up to 14 days). It is intended that the physician load the RWuC with the initial fluid to be delivered prior to placement. The RWAC is intended to remain in place for up to 14 days. Neuro-Biometrix, Inc. recommends the physician use only fluids indicated for this use. The physician should refer to the fluid labelling prior to use with the RWC.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The RWAC consists of a double lumen (two parallel and attached Tecoffex 80A (polyurethane) extruded tubes) opening into a common fenestrated reservoir tip on the distal end. The soft, flexible reservoir tip of the RWuC will be available in three sizes: 2mm, 3mm, and 4mm diameters. It is intended that the surgeon will choose an appropriate sized tip to fit the anatomy of the patient (for background information about the anatomy in the Round Window Niche See Appendix 7). The double lumen is bent at approximately a 60-75 degree angle slightly proximal to the reservoir tip. One lumen is intended to serve as an in-flow and the other an out-flow. The outflow lumen is intended to (1) relieve or avoid a build up of air and/or fluid pressure in the device; and (2) facilitate the removal of fluid from the device. A silicone, paparella-type vent tube will be placed around the RWAC during manufacturing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Middle ear, round window area
Indicated Patient Age Range
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Intended User / Care Setting
board certified otolaryngologist or otologist
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)
Performance Testing: A bench test protocol was developed to assess the performance of the RWAC in terms of pressure vs. flow, distal tip bond strength of the catheter body, and proximal hub bond strength. All tests will be conducted on final sterile product. Sufficient samples will be used for each test. Each sample will also be visually inspected for workmanship and dimensional compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Microtek Irrigation System, tympanostomy tube
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.
0
Neuro-Biometrix, Inc.
Image /page/0/Picture/1 description: The image shows a black and white abstract design. The design appears to be composed of interconnected loops or curves, creating a sense of movement and complexity. The thick black lines contrast sharply against the white background, emphasizing the shapes and forms within the design. The overall impression is modern and artistic.
,3151 South Albion Street; Denver, Colorado 80222 (303) 806-0543
Fax (303) 788-4234
18. 510(K) Summary.
Contact Person: | I. Kaufman Arenberg, MD |
---|---|
Date Summary Prepared: February 13, 1997 | |
Trade Name: | Round Window u Cath™ (RWuC) |
Common Name: | Middle Ear Catheter |
Classification Name: | Class II |
Equivalence: The RWyC is substantially equivalent to the combination of the middle ear catheter and the tympanostomy tube. Both the RWgC and the middle ear catheters with a fenestrated reservoir tip on the distal end; both are designed to be attached to a syringe at the proximal end; and both are intended to be used to irrigate the middle ear. Both the RWAC and the vent tube allow air to pass between the middle ear and ear canal. This air passage serves to aerate the middle ear, thereby reducing the risk of middle ear infection. The RW4C and the vent tube are also similar in that they are intended to be left in place for longer periods of time than the middle ear catheter (the vent tube for up to a year, and the for up to 14 days).
Description: The RWAC consists of a double lumen (two parallel and attached Tecoffex 80A (polyurethane) extruded tubes) opening into a common fenestrated reservoir tip on the distal end. The soft, flexible reservoir tip of the RWuC will be available in three sizes: 2mm, 3mm, and 4mm diameters. It is intended that the surgeon will choose an appropriate sized tip to fit the anatomy of the patient (for background information about the anatomy in the Round Window Niche See Appendix 7). The double lumen is bent at approximately a 60-75 degree angle slightly proximal to the reservoir tip. One lumen is intended to serve as an in-flow and the other an out-flow. The outflow lumen is intended to (1) relieve or avoid a build up of air and/or fluid pressure in the device; and (2) facilitate the removal of fluid from the device. A silicone, paparella-type vent tube will be placed around the RWAC during manufacturing.
Intended use: The Round Window u Cath™ (RWuC) is intended to be used by any board certified otolaryngologist or otologist to irrigate the entire middle ear or the round window area of the middle ear. During the course of the irrigation treatment, it is intended that the vent tube through which the RW (C's dual lumen passes, will aerate the middle ear. The treating physician will choose, based on what hels will be most beneficial for his/her patient, the following: { }) the exact fluids to be delivered through the RWAC; (2) the proper quantities; and (3) the duration and interval of treatment (up to 14 days). It is intended that the physician load the RWuC with the initial fluid to be delivered prior to placement. The RWAC is intended to remain in place for up to 14 days. Neuro-Biometrix, Inc. recommends the physician use only fluids indicated for this use. The physician should refer to the fluid labelling prior to use with the RWC.
Principles of Operation: The distal end of the RWLC is a soft, flexible, fenestrated-reservoir tip which is designed to allow the surgeon to irrigate various locations in the middle ear. For example, the surgeon can (1) irrigate the middle ear generally by placing the tip in the middle ear space and applying the fluid with a syringe, (2) irrigate the round window area specifically by placing the appropriately sized tip in the round window niche; or (3) place the tip anywhere else in the middle ear he/she feels is appropriate. The RWpC's double lumen runs from the reservoir tip back through a ventilation tube in the ear drum and into the external ear canal where the proximal end will be accessible to the treating physician.
D:\wp51\Mike\IEMDS\510(K)2 February 13, 1997 2:17pm
Inner Ear Innovations for the 21st Century
1
Technological Characteristics: The RWgC and the predicate devices, the Microtek Irrigation System and the tympanostomy tube are constructed of class VI biocompatible materials (even though the materials are different). Each has been subjected to biocompatibility testing.
Performance Testing: A bench test protocol was developed to assess the performance of the RWAC in terms of pressure vs. flow, distal tip bond strength of the catheter body, and proximal hub bond strength. All tests will be conducted on final sterile product. Sufficient samples will be used for each test. Each sample will also be visually inspected for workmanship and dimensional compliance.
D:\wp51\Mike\IEMDS\510(K)2 February 13, 1997 - 2:17pm