FISCH TITANIUM MIDDLE EAR PROSTHESES

K043375 · Karl Storz Endoscopy · ETA · Jan 24, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K043375
• Device Name: FISCH TITANIUM MIDDLE EAR PROSTHESES
• Applicant: Karl Storz Endoscopy
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Jan 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

Device Story

FISCH Titanium Middle Ear Prostheses are surgical implants used to restore middle ear sound transmission. The device line includes stapes pistons, incus prostheses, neomalleus prostheses, and total prostheses. These are implanted by surgeons during middle ear reconstructive procedures to replace missing or malformed ossicles. The prostheses are constructed from anodized titanium, providing biocompatibility. They function as mechanical bridges within the middle ear to facilitate sound conduction. The devices are provided sterile and are intended for single use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Anodized titanium. Design: One-piece, various lengths and diameters for stapes, incus, neomalleus, and total reconstruction. Connectivity: N/A (mechanical implant). Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring ossicular chain reconstruction to restore middle ear function due to missing or malformed ossicles, or following tumor or trauma surgery.

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• Stryker/Leibinger FISCH Titanium Stapes Piston (K993583)
• Stryker/Leibinger FISCH Titanium Incus Prosthesis (K993583)
• Stryker/Leibinger FISCH Titanium Neomalleus Prosthesis (K993583)
• Stryker/Leibinger FISCH Titanium Total Prosthesis (K993583)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is stylized and modern.

Karl Storz Endoscopy-America, Inc. 12 1 1 1 1 1 1 11 11 800 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone [phone]

Toll Free 900 421 0837 Fax [phone]

K043375

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez<br>Sr. Regulatory Affairs Associate |

#### Device Identification:

| Common Name: | Total ossicular replacement prostheses<br>Partial ossicular replacement prostheses |
|--------------|------------------------------------------------------------------------------------|
| Trade Name: | FISCH Titanium Middle Ear Prostheses |
| | FISCH Titanium Total Prosthesis |

- FISCH Titanium Stapes Piston (7.0 mm, 8.5 mm. 10.0 mm)
- FISCH Titanium Incus Prosthesis (3.0 mm, 4.0 mm, 5.0 mm) .
- FISCH Titanium Neomalleus Prosthesis .

Indication: The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after turnor or trauma operations.

Device Description: The FISCH Titanium Middle Ear Prostheses are made of anodized titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

Substantial Equivalence: The FISCH Titanium Middle Ear Prostheses are substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor difference between the FISCH Titanium Middle Ear Prostheses and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device. See Tables 1-4 for a detailed comparison.

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# TABLE 1: Stryker/Leibinger FISCH Titanium Stapes Prosthesis Comparison to Karl Storz FISCH Titanium Stapes Prosthesis

| DEVICE | STRYKER/ LEIBINGER - FISCH<br>TITANIUM STAPES PISTON (K993583) | | | KARL STORZ - FISCH TITANIUM<br>STAPES PISTON | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------------------------------------------|--------|----------|
| 1. INTENDED USE | Flat band and piston prosthesis for<br>attachment to the malleus or incus,<br>inserted through the footplate of the<br>stapes. | | | Same | | |
| 2. DIMENSIONS BY<br>MODEL # | 13-18040 | 13-18042 | 13-18044 | 227510 | 227511 | 227512 |
| Overall<br>Length | 7.00 mm | 8.5 mm | 10.00 mm | 7.00 mm | 8.5 mm | 10.00 mm |
| Piston<br>Diameter | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm |
| 3. MATERIAL | Titanium | | | Same | | |
| 4. SINGLE USE | Yes | | | Same | | |
| 5. STERILE | Yes | | | Same | | |
| 6. DESIGN<br>COMPARISON | One-piece design, flat loop to enable a<br>stable connection with the incus or<br>malleus. | | | Same | | |

: 上一篇:

## TABLE 2: Stryker/Leibinger FISCH Titanium Incus Prosthesis Comparison to Karl Storz FISCH Titanium Incus Prosthesis

| DEVICE | STRYKER/ LEIBINGER - FISCH<br>TITANIUM INCUS PROSTHESIS<br>(K993583) | | | KARL STORZ - FISCH TITANIUM<br>INCUS PROSTHESIS | | |
|-----------------------------|----------------------------------------------------------------------------|----------|----------|-------------------------------------------------|--------|--------|
| 1. INTENDED USE | Incus replacement to connect malleus<br>and head of stapes. | | | Same | | |
| 2. DIMENSIONS BY<br>MODEL # | 13-18030 | 13-18031 | 13-18032 | 227515 | 227516 | 227517 |
| Length | 3.00 mm | 4.0 mm | 5.0 mm | 3.00 mm | 4.0 mm | 5.0 mm |
| OD | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm |
| OD - Tapered<br>End | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm |
| 3. MATERIAL | Titanium | | | Anodized Titanium | | |
| 4. SINGLE USE | Yes | | | Same | | |
| 5. STERILE | Yes | | | Same | | |
| 6. DESIGN<br>COMPARISON | Design allows intraoperative shaping; 4<br>holes to pick up and manipulate | | | Same | | |

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# TABLE 3: Stryker/Leibinger FISCH Titanium Neomalleus Prosthesis Comparison to Karl Storz FISCH Titanium Neomalleus Prosthesis

| DEVICE | STRYKER/LEIBINGER - FISCH<br>TITANIUM NEOMALLEUS<br>PROSTHESIS (K993583) | KARL STORZ- FISCH<br>TITANIUM NEOMALLEUS<br>PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 1. INTENDED USE | Malleus replacement in combination<br>with the stapes prosthesis. | Same |
| 2. DIMENSIONS BY MODEL<br># | 13-18020 | 227522 |
| Length | 5.0 mm | 5.0 mm |
| OD - Grooved End | 1.1 mm | 1.1 mm |
| OD - Smooth End | 0.5 mm | 0.5 mm |
| 3. MATERIAL | Titanium | Anodized Titanium |
| 4. SINGLE USE | Yes | Same |
| 5. STERILE | Yes | Same |
| 6. DESIGN COMPARISON | Smooth end for insertion with the<br>traga perichondrium; grooves for<br>attachment to stapes piston | Same |

# TABLE 4: Stryker/Leibinger FISCH Titanium Total Prosthesis Comparison to Karl Storz FISCH Titanium Total Prosthesis

| DEVICE | STRYKER/LEIBINGER - FISCH TITANIUM<br>TOTAL PROSTHESIS (K993583) | KARL STORZ- FISCH<br>TITANIUM TOTAL<br>PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 1. INTENDED USE | Plate prosthesis with shaft and shoe as<br>replacement between the tympanic<br>membrane and the footplate of the<br>stapes. | Same |
| 2. DIMENSIONS BY MODEL<br># | 13-18090 | 227520 |
| Length | 10.0 mm | Same |
| Shaft Diameter | 0.6 mm | Same |
| Head Plate<br>Diameter | 5 mm | Same |
| 3. MATERIAL | Titanium | Anodized Titanium |
| 4. SINGLE USE | Yes | Same |
| 5. STERILE | Yes | Same |
| 6. DESIGN COMPARISON | Direct connection between tympanic<br>membrane and footplate; may be trimmed<br>to size; spike on foot for stable attachment | Same |

Signed: Yvonne Fernandez / Sr. Regulatory Affairs Associate

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy- America, Inc. c/o Ms. Yvonne Fernandez Sr. Regulatory Affairs Associate 600 Corporate Pointe, 5th Floor Culver City, CA 902307

Re: K043375

K043375
Trade/Device Name: FISCH Titanium Middle Ear Prostheses
Trade/Device Name: FISCH Titanium Middle Ear Prostheses
Sublice Name: FISCH SED CER 2405 - 874 3450 I rade/Device Name: 115677 874.3495; 874.3450 Regulation Number: 21 CFR 874.3495; 874.5450
Regulation Name: Total ossicular replacement prostheses; Partial ossicular replacement prostheses Regulatory Class: Class II Product Code: ETA; ETB Dated: December 7, 2004 Received: December 8, 2004

Dear Ms. Fernandez:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 IQC) premises in their views on the indications
referenced above and have device is substantially equivalent (for the indications referenced above and have device is substantialey of one of one of the marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally markets device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug. commerce prior to May 28, 1976, the enacument with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Appl devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The
You may, therefore, market the device, subject to the general controls of listin You may, therefore, market the device, subject of the general connul registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements as the more of the superior misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
ed in the support the same to the Fixisting major regulations affecti If your device is classified (see above) nito entile) eass if epenlations affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional conrois: Listing major regal to 898 In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Federal Regulations, This DS, Andrewing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that FDA's issuance of a substance of the requirements of the Act
that FDA has made a determination that your device compliss with other requirements of You that FDA has made a delermination inal your areas by other Federal agencies. You music or any Federal statutes and regulations administed by rot limited to: registration and listing.
comply with all the Act's requirements, including and manufactures and comply with all the Act's requirements, including, out not horses and one organizements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requ (21 CFR Part 807); labeling (21 CFR Patt 801); good managf applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050. forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Ms. Yvonne Fernandez

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse finding of substantial equivalence of your device to a legally promatics notification on or cassification 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 [phone]. 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 other general michination and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly 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

Enclosure

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043375

### Indications for Use

510(k) Number (if known): Not yet assigned

#### FISCH Titanium Middle Ear Prostheses Device Name:

The FISCH Titanium Middle Ear Prostheses are intended for Indications for Use: Indications for USe: ossicle replacement to restore inicule early in partial or completed broken. The vanous prosince models are implanted or in secondary procedures
reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page __ of ___ (Posted November 13, 2003) 00004 Division of Of
Division of Th 510(k) Number