(56 days)
Not Found
No
The summary describes a simple, passive medical device (a tympanostomy tube) made of silicone rubber. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The device description and intended use are purely mechanical.
Yes
The device is intended to be implanted for ventilation or drainage of the middle ear, which directly addresses a medical condition (middle ear issues) for therapeutic purposes.
No
Explanation: The device is a tympanostomy tube, which is an implantable device used for ventilation or drainage of the middle ear. Its purpose is therapeutic (to treat a condition), not diagnostic (to identify or determine a condition).
No
The device description clearly states it is a "single flexible tube made of silicone rubber," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be implanted for ventilation or drainage of the middle ear." This describes a surgical or therapeutic intervention performed directly on a patient's body.
- Device Description: The device is a "single flexible tube made of silicone rubber" intended for implantation. This is a medical device, specifically an implantable one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on the analysis of samples.
- Using reagents or other materials to perform tests on samples.
IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Otomedics STT is a device that is intended to be implanted for ventilation or drainage of the middle ear.
Product codes
ETD
Device Description
The Otomedics STT is a single flexible tube made of silicone rubber. The internal shape of the shaft is conical with T-shaped external flanges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear
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)
K852387, K941407, K822375, K781257, K791680
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
§ 874.3880 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
Page 1
SECTION 5 - 510(K) SUMMARY
JUN 2 2 2007
OTOMEDICS SOFT TYMPANOSTOMY TUBE
510(k) Number K_______________________________________________________________________________________________________________________________________________________________
Applicant's Name:
| Company name: | Otomedics Advanced Medical Technologies Ltd |
|---|---|
| Address: | 8 Bialik St. |
| Jerusalem, Israel 96221 | |
| E-mail: | cohen@otomedics.com |
| yossi@otomedics.com | |
| Tel: | +972 50 8685888 |
Contact Person:
Fax:
| Contact Name: | Ahava Stein |
|---|---|
| Company: | A. Stein - Regulatory Affairs Consulting |
| Address: | 20 Hata'as St. (P.O.B. 124) |
| Kfar Saba 44425 | |
| ISRAEL | |
| Tel.: | +972 (9) 7670002 |
| Fax.: | +972 (9) 7668534 |
| E-mail: | asteinra@netvision.net.il |
+972 2 6510808
Date Prepared:
April 22, 2007 Date:
Name of the device:
Soft Tympanostomy Tube
Trade or proprietary name, if applicable:
Otomedics Soft Tympanostomy Tube
Common or usual name:
Tympanostomy Tube,
1
Establishment Registration No.: Otomedics will submit form FDA 2891 (Initial Registration of Medical Device Establishment) for its operations at the above address and will submit Form FDA 2892 (Device Listing) for the product.
Classification Name:
21 CFR classification code 874.3880 Tympanostomy tube (product code ETD).
Classification:
Tympanostomy tube is a CLASS II medical device. The classification panel is the Prosthetic Devices Panel
Predicate Device:
The Otomedics Soft Tympanostomy Tube (STT) is similar to Goode T-Tubes (K852387 Manufactured by Xomed. Inc.), the Touma II T-Tube (K941407 Xomed - Treace Inc), the Armstrong Grommet (K822375 Manufactured by Xomed-Treace, Inc), the Straight Shank (510(k) K781257) Xomed Inc) and the Umbrella Tube (K791680 Xomed Inc) in the intended use and in technological characteristics of the devices.
Device Description:
The Otomedics STT is a single flexible tube made of silicone rubber. The internal shape of the shaft is conical with T-shaped external flanges.
Intended Use / Indication for Use:
Otomedics STT is a device that is intended to be implanted for ventilation or drainage of the middle ear.
Substantial Equivalence:
The Otomedics STT has the same intended use as the predicate devices. The Otomedics STT has the same technological characteristics, (i.e., same materials, same basic design and principles of operation) as the predicate Goode T-Tube, Touma II T-Tube, Armstrong Grommet, Straight Shank and Umbrella Tube. The differences in the new device do not raise new issues of safety or effectiveness.
Therefore, we believe that the Otomedics STT is substantially equivalent to the predicate devices cited above and therefore may be cleared for marketing in the United States.
2
COMPARISON TABLE
| | Soft
Tympanostomy
Tube | Goode T-
Tubes® | Touma II T-
Tube | Armstrong
Grommet | Straight
Shank | Umbrella
Tube |
|------------------------|---------------------------------------------------------|---------------------------|------------------------|------------------------|---------------------------|------------------------|
| Manufacturer
name | Otomedics
Advanced
Medical
Technologies
Ltd | Xomed, Inc. | Xomed -
Treace Inc | Xomed -
Treace Inc | Xomed Inc | Xomed Inc |
| Classification
Code | ETD | ETD | ETD | ETD | ETD | ETD |
| Intended use | Short and
Long Term | Short and
Long Term | Short and
Long Term | Short and
Long Term | Short and
Long Term | Short and
Long Term |
| Material | Silicon | Activent Silicon | Silicon/Blue | Silicon/Blue | Fluoroplastic/
White | Silicon/Blue |
| Color | White | White | Blue | Blue | White | Blue |
| Single use | Yes | Yes | Yes | Yes | Yes | Yes |
| Flexible | Yes | Yes | Yes | Yes | Yes | Yes |
| Shape of flange | Arched, flat,
asymmetric | Cylindrical,
symmetric | Flat,
symmetric | Flat,
asymmetric | Cylindrical,
symmetric | Arched,
symmetric |
.
:
.
3
Public Health Service
Image /page/3/Picture/13 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Otomedics Advanced Medical Technologies, Ltd. c/o Ahava Stein Regulatory Affairs Consulting, Ltd. Beit Hapamon, Box 124 20 Hata'as (Room 213) Kfar Saba 44425 ISRAEL
JUN 2 2 2007
Re: K071178
Trade/Device Name: Otomedics Soft Tympanostomy Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: II Product Code: ETD Dated: April 22, 2007 Received: April 27, 2007
Dear Mr. Stein:
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.
4
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman Simud
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Otomedics Soft Tympanostomy Tube
Indications for use:
Otomedics Soft Tympanostomy Tube is a device that is intended to be implanted for ventilation or drainage of the middle ear.
Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR
Over-The-Counter Use (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amat
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number 6/21/07 dade