(231 days)
K-973226
Not Found
No
The device description and other sections do not mention AI, ML, or any related concepts. The device is a simple mechanical implant.
Yes
The device is a temporary implant for ventilation or drainage of the middle ear, directly impacting bodily function by facilitating airflow and fluid removal.
No
The device is described as an "implant for ventilation and drainage of middle ear," which suggests a therapeutic or interventional function rather than a diagnostic one. It facilitates a physiological process (ventilation/drainage) rather than identifying or characterizing a disease or condition.
No
The device description clearly describes a physical implant (umbrella-type implant) and associated hardware (trocar point, trocar handle). It is not solely 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. They are used outside of the body (in vitro).
- Device Function: The described device is a temporary implant designed to be placed inside the middle ear for ventilation and drainage. It is a surgical device used in vivo (within the body).
- Intended Use: The intended use clearly states "Temporary implant for ventilation and drainage of middle ear," which is a therapeutic and surgical purpose, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a surgical implant or medical device used for treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Temporary implant for ventilation and drainage of middle ear.
Product codes (comma separated list FDA assigned to the subject device)
77 ETD, ETD
Device Description
The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle.
The tubes are available with or without retention wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear / tympanic membrane
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)
Testing in a 7.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
The results of design validation raise no new issues of safety and effectiveness.
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.
K-973226
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
§ 874.3880 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
K07 1150.
Special 510(k): 77 ETD Trocar Ventilation Tube
DEC 12 2007.
2. 510(k) SUMMARY of Safety and Effectiveness
As required by Section 807.92(c)
| 2.1 | Submitter: [807.92 (a)(1)] |
|---|---|
| Heinz Kurz GmbH Medizintechnik | |
| Tübinger Str. 3 | |
| D-72144 Dusslingen | |
| Germany | |
| Tel. +49-7072-91 79 0 | |
| Fax +49-7072-91 79 79 | |
| eMail info@kurzmed.de |
| 2.2 | Contact Person: [807.92 (a)(1)] | ||
|---|---|---|---|
| Dagmar S. Mäser | |||
| Business Support International | |||
| Amstel 320-l | Tel. | +31-20-428 95 91 | |
| 1017 AP Amsterdam | Fax | +31-20-428 94 29 | |
| The Netherlands | bsi@xs4all.nl |
2.3 Date Summary Prepared: [807.92 (a)(1)] April 17, 2007
- Device Names: [807.92 (a)(2)] 2.4 Proprietary Trocar Ventilation Tube
| Common | Ventilation, Tympanostomy or Myringotomy
Tube |
|----------------|--------------------------------------------------|
| Classification | Tube, Tympanostomy |
| Product Code | 77 ETD |
| Regulation # | CFR 874.3880 |
2.5 Reason for Submission:
Change in design and inclusion of sterile, single-use trocar point
1
2.6 Intended Use: {807.92 (a)(5)] Temporary implant for ventilation and drainage of middle ear.
2.7 Modification of Existing Device: [807.92 (a)(3)]
K 973226 Models: Tuebingen, Tympanic (1 or 2 eyes), Beveled, Minimal Cleared 11/04/1997
2.8 Device Description: [807.92(a)(4)+(6)]
The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle.
The tubes are available with or without retention wires.
2.9 Reasons for Device Modification: [807.92 (d)]
- Elimination of need for prior paracentesis. Simultaenous 1. incision of tympanic membrane and implant insertion
-
- Considerably shorter procedure
-
- Secure placement due to precise cut
- Reduced incrustation susceptibility due to clean and 4. precise cut
-
- Minimal trauma as considerably less invasive than traditional VT placement
2.10 Industry Standards: [807.92 (d)]
KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.
2.11 MRI Environment: [807.92 (d)]
Testing in a 7.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
2.12 Information Bearing on the Safety and Effectiveness:
(807.92 (b)(3)]
The ventilation tube is provided in gilded silver or pure titanium. Both materials have a long history of safe and effective use. The trocar point and handle are manufactured of stainless surgical steel. The trocar point projects just enough to penetrate the membrane and to create the opening for positioning the ventilation tube. The precise cut and secure placement of the implant should reduce the risk of premature extrusion or
13
2
dislocation. The umbrella design of the ventilation tube comparable to many others on the market - introduces no new risks. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.
The results of design valldation raise no new issues of safety and effectiveness.
3
15
2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS
| Device | Trocar Ventilation Tube | Tübingen, Tympanic w/1 or 2 Eyelets,
Beveled |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Pending | K-973226 |
| Catalog # | 1015 074, 1015 075
1015 076, 1015 077 w/retention wire | Tübingen 1015 020 - 1015 033
T/Eyelets 1015 064 - 1015 065
Beveled 1015 051 - 1015 056 |
| Intended
Use | Drainage and ventilation of middle ear
subsequent to acute otitis media | Identical |
| Design | Umbrella or conic end on bobbin base
mounted on sterile, single-use trocar tip
which is withdrawn after implant
placement | Typical bobbin shape, with eyelets, beveled opening,
and others |
| Accessories | Trocar Handle (reusable)
Cat. # 8000 143 | None |
| # of Sizes | 1 | Tübingen 2
T/Eyelets 1 each
Beveled 3 |
| Diameters | ID: 1.25 mm
OD: 2.80 mm | Tübingen ID 1.25/1.50 OD 2.55/2.80
T/Eyelets ID 1.50 OD 2.80/3.80/4.80
Beveled ID 0.75/1.25/1.50 OD 1.60/2.55/2.80 |
| Implant
Placement | Simultaneous Incision and Insertion | Insertion after prior paracentesis |
| Material | Implant:
Titanium ASTM F67 & Gilded Silver
Trocar Tip & Handle:
1.4305/AISI 303 Surg.Stainless Steel | Implants
Gold-Platinum, Gilded Silver, Titanium |
| Single Use | VT & Trocar Tip Yes
Trocar Handle Reusable | Ventilation Tubes Yes |
| Sterile | VT & Trocar Tip Yes
Trocar Handle No | Ventilation Tubes Yes |
| Design
Comparison | The tip extending into the tympanic
cavity is conical; substantially
equivalent bobbin base | Typical bobbin design, with eyelets, various openings |
| Safety &
Effectiveness
of Design
Change
[807.92
(b)(1)] | The simultaneous incision of the
tympanic membrane/insertion of the
tube significantly shortens the
procedure while providing a controlled,
precise cut for secure implant
placement. This surgical technique
should minimize patient trauma and
reduce the risks of premature implant
extrusion or dislocation.
There are no additional characteristics
known that should adversely affect the
safety and effectiveness of these
implants.
The results of design validation raise
no new issues of safety and
effectiveness. | |
| Date 18/04/2007 12:10 | Date 04/19/07
Signature | Heinz Kurz GmbH
Medizintechnik
Tübinger Strasse 8
D-72144 Dusslingen Germany
Phone +49 (0) 70 72 91 79 - 0
Telefax +49 (0) 70 72 91 79 79
Uwe Steinhardt kurzmed.com |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEPARTMENT OF HEALTH & HUMAN SERVICES USA
DEC 1 2 2007
Heinz Kurz GmbH Medizintechnik c/o Dagmar Maeser Business Support International Amstel 320-1 Amsterdam, Netherlands D72144
Re: K071150
Trade/Device Name: Trocar Ventilation Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy tube Regulatory Class: Class II Product Codc: ETD Dated: April 19, 2007 Received: April 25, 2007
Dear Ms. Maeser:
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 dctermination 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.
5
Page 2 – Dagmar Maeser
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Eglebus, MD
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
6
t 11
Indications for Use
510(k) Number (if known):
| Device Name: | Trocar Ventilation Tube |
|---|---|
| Indications for Use: | Temporary implant for ventilation or drainage of the |
| middle ear. | |
| Special Feature: | Design eliminates need for prior paracentesis: |
| Simultaneous incision and implant placement. |
4/23/2007 5:17 PM
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kace A. Bohn
ohthalmic Ear. hroat Devises
umber K071150
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