(50 days)
No
The 510(k) summary describes a simple silicone catheter for fluid delivery and does not mention any AI/ML terms or functionalities.
Yes
The device is used for "delivery of fluids in the treatment of patients with ear disorders," which is a therapeutic purpose.
No
This device is described as a catheter for delivery of fluids, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is formed of silicone elastomer tubing with an injection port and a flange or bevel, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The TM Micro-Catheter is a device used to deliver fluids directly into the ear. It is a therapeutic device, not a diagnostic one. It is used for treatment, not for analyzing a sample from the body.
- Lack of Diagnostic Information: The description focuses on the physical characteristics of the catheter and its function in delivering fluids. There is no mention of analyzing any biological sample or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the TM Micro-Catheter is a medical device used for therapeutic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.
Product codes
Not Found
Device Description
The TM Micro-Catheters are formed of silicone elastomer tubing. Connected to the tubing at the proximal end is an injection port. The TM Micro-Catheter w/ Flange (In-dwelling style) has a small distal flange end for retention in the eardrum. The TM Micro-Catheter w/o Flange has a distal end with a bevel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear / middle ear / eardrum
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)
Reference Device(s)
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
§ 874.3880 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
Revised April 28, 1997
1 6 1997
510(k) Summary
971124
Date Prepared 1.0 March 24, 1997
2.0 Submitter (Contact)
David Timlin, Manager of Regulatory Affairs Xomed Surgical Products Jacksonville, FL (904) 279-7532 FAX 904-281-1057
Device Name 3.0
TM Micro-Catheter Proprietary Name: Common Name: Catheter Percutaneous Catheter Classification Name:
Device Classification 5.0
Xomed believes TM Micro-Catheters to be unclassified and review by the ENT Devices branch is suitable for the intended use. The TM Micro-Catheter is similar to a Tympanostomy Tube; 21CFR 874.3880 which is intended to be implanted into the tympanic membrane.
Device Description 6.0
The TM Micro-Catheters are formed of silicone elastomer tubing. Connected to the tubing at the proximal end is an injection port. The TM Micro-Catheter w/ Flange (In-dwelling style) has a small distal flange end for retention in the eardrum. The TM Micro-Catheter w/o Flange has a distal end with a bevel.
p. 026
1
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7.0 Intended Use
The TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.
8.0 Substantial Equivalence
The TM Micro-Catheter with Flange and TM Micro-Catheter without Flange described in this notification have the same intended use as the predicate Microtek Irrigation system (K844061) for delivery of fluids into the middle ear . TM Micro-Catheters have the technological characteristics of the predicate tympanostomy tubes and butterfly catheters (K820453 or K810461) and so do not raise any new issues of safety or effectiveness.