TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE

K071150 · Heinz Kurz GmbH Medizintechnik · ETD · Dec 12, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K071150
• Device Name: TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
• Applicant: Heinz Kurz GmbH Medizintechnik
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary implant for ventilation and drainage of middle ear.

Device Story

Device is a tympanostomy tube mounted on a single-use trocar point; used for middle ear ventilation and drainage. Procedure involves physician using a reusable trocar handle to simultaneously incise the tympanic membrane and insert the tube; trocar is then withdrawn. Eliminates need for separate prior paracentesis; provides precise cut; reduces procedure time and patient trauma. Implant materials include titanium (ASTM F67) and gilded silver; trocar components are stainless steel. Used in clinical settings by ENT specialists. Benefits include secure placement, reduced risk of premature extrusion/dislocation, and minimized tissue trauma.

Clinical Evidence

Bench testing only. Design validation confirmed performance of the simultaneous incision and insertion technique. MRI safety testing in a 7.0 Tesla field showed no implant movement or adverse heating effects.

Technological Characteristics

Implant materials: Titanium (ASTM F67) and gilded silver. Trocar tip/handle: AISI 303 stainless steel (1.4305). Form factor: Umbrella/conic end on bobbin base. Connectivity: None. Sterilization: Sterile single-use trocar tip and tube; reusable handle.

Indications for Use

Indicated for patients requiring temporary ventilation or drainage of the middle ear, typically following acute otitis media. Requires professional placement via simultaneous incision and insertion.

Regulatory Classification

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.

Predicate Devices

• Tübingen, Tympanic (1 or 2 eyes), Beveled (K973226)

Submission Summary (Full Text)

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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. [phone] |
| | Fax [phone] |
| | eMail [e-mail] |

| 2.2 | Contact Person: [807.92 (a)(1)] | | |
|--------------------------------|---------------------------------|------------------|--|
| Dagmar S. Mäser | | | |
| Business Support International | | | |
| Amstel 320-l | Tel. | [phone] | |
| 1017 AP Amsterdam | Fax | [phone] | |
| The Netherlands | eMail | [e-mail] | |

### 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<br>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

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### 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
- 2. Considerably shorter procedure
- 3. Secure placement due to precise cut
- Reduced incrustation susceptibility due to clean and 4. precise cut
- 5. 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

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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.

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# 2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS

| Device | Trocar Ventilation Tube | Tübingen, Tympanic w/1 or 2 Eyelets,<br>Beveled |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Pending | K-973226 |
| Catalog # | 1015 074, 1015 075<br>1015 076, 1015 077 w/retention wire | Tübingen 1015 020 - 1015 033<br>T/Eyelets 1015 064 - 1015 065<br>Beveled 1015 051 - 1015 056 |
| Intended<br>Use | Drainage and ventilation of middle ear<br>subsequent to acute otitis media | Identical |
| Design | Umbrella or conic end on bobbin base<br>mounted on sterile, single-use trocar tip<br>which is withdrawn after implant<br>placement | Typical bobbin shape, with eyelets, beveled opening,<br>and others |
| Accessories | Trocar Handle (reusable)<br>Cat. # 8000 143 | None |
| # of Sizes | 1 | Tübingen 2<br>T/Eyelets 1 each<br>Beveled 3 |
| Diameters | ID: 1.25 mm<br>OD: 2.80 mm | Tübingen ID 1.25/1.50 OD 2.55/2.80<br>T/Eyelets ID 1.50 OD 2.80/3.80/4.80<br>Beveled ID 0.75/1.25/1.50 OD 1.60/2.55/2.80 |
| Implant<br>Placement | Simultaneous Incision and Insertion | Insertion after prior paracentesis |
| Material | Implant:<br>Titanium ASTM F67 & Gilded Silver<br>Trocar Tip & Handle:<br>1.4305/AISI 303 Surg.Stainless Steel | Implants<br>Gold-Platinum, Gilded Silver, Titanium |
| Single Use | VT & Trocar Tip Yes<br>Trocar Handle Reusable | Ventilation Tubes Yes |
| Sterile | VT & Trocar Tip Yes<br>Trocar Handle No | Ventilation Tubes Yes |
| Design<br>Comparison | The tip extending into the tympanic<br>cavity is conical; substantially<br>equivalent bobbin base | Typical bobbin design, with eyelets, various openings |
| Safety &<br>Effectiveness<br>of Design<br>Change<br>[807.92<br>(b)(1)] | The simultaneous incision of the<br>tympanic membrane/insertion of the<br>tube significantly shortens the<br>procedure while providing a controlled,<br>precise cut for secure implant<br>placement. This surgical technique<br>should minimize patient trauma and<br>reduce the risks of premature implant<br>extrusion or dislocation.<br>There are no additional characteristics<br>known that should adversely affect the<br>safety and effectiveness of these<br>implants.<br>The results of design validation raise<br>no new issues of safety and<br>effectiveness. | |
| Date 18/04/2007 12:10 | Date 04/19/07<br>Signature | Heinz Kurz GmbH<br>Medizintechnik<br>Tübinger Strasse 8<br>D-72144 Dusslingen Germany<br>Phone [phone] - 0<br>Telefax [phone]<br>Uwe Steinhardt kurzmed.com |

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known):

| Device Name: | Trocar Ventilation Tube |
|----------------------|------------------------------------------------------------------------------------------------|
| Indications for Use: | Temporary implant for ventilation or drainage of the<br>middle ear. |
| Special Feature: | Design eliminates need for prior paracentesis:<br>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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