(126 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended to treat "mild to moderate high frequency hearing loss," indicating a therapeutic purpose.
No
The device description indicates it is a "Transcutaneous System" with a "processor in the outer ear canal," and it is intended for use in patients with "Mild to Moderate high-frequency hearing loss." This description suggests a therapeutic or assistive device for hearing loss, not a device used to diagnose a condition.
No
The device description explicitly mentions a "processor in the outer ear canal" and placement via a "functional piercing," indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The RetroX Transcutaneous System is described as a system with a processor placed in the outer ear canal to address hearing loss. This is a device that interacts with the body directly for a therapeutic purpose (improving hearing), not a test performed on a sample outside the body.
- Intended Use: The intended use is for treating mild to moderate high-frequency hearing loss, which is a functional issue, not a diagnostic test.
Therefore, the RetroX Transcutaneous System falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-frequency hearing loss.
The Transcutaneous Titanium Tube System: has the start of a hearing system for adults with Mild to Moderate high-frequency hearing loss.
Mild to moderate high frequency hearing loss.
Product codes
77 NIX, NIX
Device Description
The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice regulations (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer ear canal
Indicated Patient Age Range
adults
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3950 Transcutaneous air conduction hearing aid system.
(a)
Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA.” See § 874.1 for the availability of this guidance document.
0
Food and Drug Administration Food and Drug Titanium Tube System April 2004
| AUG 2 0 2004 | 510(k) Summary |
|---|---|
| Submitter's Name | |
| Submitter's Address | Gyrus ENT LLC |
| 2925 Appling Road, | |
| Bartlett, TN 38133 | |
| Submitter's Phone Number | (901) 373-0200 |
| Contact Person | Alicia E. Farage |
| Date Revised: | April 14, 2004 |
| Proprietary Name: | |
| Common Name: | |
| Classification Name: | RetroX Titanium Tube System |
| Transcutaneous Titanium Tube System | |
| Transcutaneous Air Conduction Hearing Aid System | |
| (TACHAS) (§ 874.3950) | |
| Classification | Class II |
| Classification Panel | Ear, Nose, Throat |
| Device Product Code | 77 NIX |
Subject Device Description
The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.
Applicable 510(k)s – Predicate Devices
| Device | Manufacturer | FDA Clearance |
|---|---|---|
| RetroX TACHAS Titanium Tube System | Auric Hearing Systems | K013298 |
Subject Device Intended Use
Subject Device Intended Ose The Transcutaneous Titanium Tube System: has the start of a hearing system for adults with Mild to Moderate high-frequency hearing loss.
1
0(k) Submission Exhibit 9 REVISED
Comparison Char
Gyrus TACHAS Tube System vs. Auric TACHAS Tube System
| | RetroX Transcutaneous Titanium
Tube System | RetroX Transcutaneous Titanium
Tube System |
|---------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | (Gyrus ENT LLC) | (Auric Hearing Systems, Inc.) |
| Intended Use | Hearing system for adults with Mild to
Moderate high-frequency hearing loss. | Hearing system for adults with Mild to
Moderate high-frequency hearing loss. |
| Material | Medical Grade Titanium Alloy | Medical Grade Pure Titanium |
| Number of Pieces for Tube | 2 | 3 |
| Various Sizes Available | Yes | Yes |
| Lengths Available | 7, 10, 13, 16, 19, 21, 23, and 25 mm | 15, 17, 19, 21, 23, and 25 mm |
| Diameter of Tube | 2.5 mm | 4.4 mm |
| How Supplied | Sterile | Non-Sterile |
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of three curved lines resembling waves or streams. The lines are arranged diagonally, starting from the upper right and descending to the lower left. The logo is encircled by text, which is arranged in a circular fashion around the central design. The text is small and difficult to read, but it appears to be evenly spaced around the circle.
Food and ()ruq Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2004
Gyrus ENT c/o Alicia E. Farage Manager Clinical/Regulatory Affairs 2925 Appling Road Bartlett, TN 38133
K040996 Re:
K040996
Trade/Device Name: RetroX Titanium Tube System for RetroX Transcutaneous Air Conduction Hearing Aid Regulation Number: 21 CFR 874.3950 Regulation Name: Transcutaneous Air Conduction Hearing Aid System Regulatory Class: Class II Product Code: NIX Dated: August 12, 2004 Received: August 13, 2004
Dear Ms. Farage:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed previce. Device Amendments for use stated in the encrosure) to regally manced to of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the chacments with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation listing of You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements michanding and general controls provisions of the Act merade requirements of the manage of the standing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (See addre) into crains major regulations affecting your device
it may be subject to such additional controls. Existed to 800 to 808. In additi it may be subject to such additional controls. Existing nager of 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, 2017 to the Andrest can be Tound in the Code of Pederal Regulation in your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualie of a substitive only of the requirements of the Act
that FDA has made a determination that your device for For Earliers . You must that FDA has made a determination that your arres by other Federal agencies. You must or any Federal statutes and regulations administered or registration and listing (21 T
comply with all the Act's requirements, including, mostices necurements as sel comply with all the Act s requirements, mename wantice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if applicable, the electronic CFR Part 807); labenng (21 CTK Farl ovi ); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 11 CFR 1000-1 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Alicia E. Farage
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin maneming your avree of your device of your device to a legally premarket non ication. The 117A midning of sabstandar of a
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de rice on our car note the regulation entitled, contact the Office of Compliance an (80th man and 807.97). You may obtain "Misbranding by relective to premainter notifically in the Act from the Division of Small other general Information on your responses Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of the company by w (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Palgyi Korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: I)evice Name:
K040996 RettoX Titanium Tube System for the RetroX Transcutancous Air Conduction Hearing Aid System
Indications For Usc:
- Mild to moderate high frequency hearing loss .
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Karin H. Lix
: Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K040726