(183 days)
Not Found
Not Found
No
The document describes the device as delivering "selected sound tracks" via a standard digital audio player, with no mention of adaptive algorithms, learning, or any terms associated with AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "relief of their Tinnitus symptoms," indicating a therapeutic purpose.
No
The "Intended Use / Indications for Use" section states the device is for "relief of their Tinnitus symptoms" and "may be used to suppress the symptoms of tinnitus", indicating it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states it uses "selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers," indicating the use of hardware components (digital audio player, earpiece/headphones) in addition to the sound tracks (which could be considered software).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The TST Suppressor 1000 delivers sound to the ear and is used for symptom relief of tinnitus. It does not involve the analysis of biological samples.
- The intended use and device description clearly indicate a therapeutic or symptom management purpose, not a diagnostic one.
Therefore, the TST Suppressor 1000 falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a rne 191 Supplessor 19ayer and using an air-conduction earpiece or headphone type Standard digital addio player and action is indicated for adult (over 18 years of age) transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
The TST Suppressor 1000 is for home use.
Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus Eden 191 Suppresser Loigital audio player, using commercially available earphones or headphones.
Product codes
KLW
Device Description
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a rne 191 Supplessor 19ayer and using an air-conduction earpiece or headphone type Standard digital addio player and action is indicated for adult (over 18 years of age) transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
adult (over 18 years of age)
Intended User / Care Setting
Home use.
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): 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.
Not Found
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.
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
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Neurosim Limited c/o Mr. Ian Brown V.P. Marketing and Operations 13 Fuchsia Street Blackburn Victoria Australia 3130
Re: K013827
Trade/Device Name: TST Suppressor 1000 Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 23, 2002 Received: April 24, 2002
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Ian Brown
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
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
2
Koi3 827
Append 15
Indications for Use Statement
510(k) Number:
K 013 827
Device Name:
TST Suppressor 1000
Indications for Use:
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a rne 191 Supplessor 19ayer and using an air-conduction earpiece or headphone type Standard digital addio player and action is indicated for adult (over 18 years of age) transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
The TST Suppressor 1000 is for home use.
Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus Eden 191 Suppresser Loigital audio player, using commercially available earphones or headphones.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
James K. Kane, Ph.D.
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K013827