Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical implant made of titanium for ossicle replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Therapeutic

Yes
The device is described as "ossicle replacement to restore middle ear function," indicating its role in treating a medical condition rather than just diagnostic or assistive purposes.

Diagnostic

No

The device is a prosthesis intended for ossicle replacement to restore middle ear function, which is a therapeutic rather than diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states the prostheses are made of anodized titanium, indicating a physical hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Function: The FISCH Titanium Middle Ear Prostheses are implantable devices designed to physically replace or reconstruct ossicles within the middle ear to restore hearing. They are used inside the body.
Intended Use: The intended use clearly states "ossicle replacement to restore middle ear function" and describes implantation for "partial or complete reconstruction." This is a surgical intervention, not a diagnostic test performed on a sample.

The information provided about the device's material, anatomical site, and predicate devices further supports that it is a surgical implant, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

ETA; ETB

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.

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): 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.

K993583

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

Regulation Number and Section

§ 874.3495 Total ossicular replacement prosthesis.

(a)
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.(b)
Classification. Class II.

Summary

0

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 310 338 8100

Toll Free 900 421 0837 Fax 310 410 5527

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.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 |
|------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez
Sr. Regulatory Affairs Associate |

Device Identification:

| Common Name: | Total ossicular replacement prostheses
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.

1

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

| DEVICE | STRYKER/ LEIBINGER - FISCH
TITANIUM STAPES PISTON (K993583) | | | KARL STORZ - FISCH TITANIUM
STAPES PISTON | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------------------------------------------|--------|----------|
| 1. INTENDED USE | Flat band and piston prosthesis for
attachment to the malleus or incus,
inserted through the footplate of the
stapes. | | | Same | | |
| 2. DIMENSIONS BY
MODEL # | 13-18040 | 13-18042 | 13-18044 | 227510 | 227511 | 227512 |
| Overall
Length | 7.00 mm | 8.5 mm | 10.00 mm | 7.00 mm | 8.5 mm | 10.00 mm |
| Piston
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
COMPARISON | One-piece design, flat loop to enable a
stable connection with the incus or
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
TITANIUM INCUS PROSTHESIS
(K993583) | | | KARL STORZ - FISCH TITANIUM
INCUS PROSTHESIS | | |
|-----------------------------|----------------------------------------------------------------------------|----------|----------|-------------------------------------------------|--------|--------|
| 1. INTENDED USE | Incus replacement to connect malleus
and head of stapes. | | | Same | | |
| 2. DIMENSIONS BY
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
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
COMPARISON | Design allows intraoperative shaping; 4
holes to pick up and manipulate | | | Same | | |

2

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

| DEVICE | STRYKER/LEIBINGER - FISCH
TITANIUM NEOMALLEUS
PROSTHESIS (K993583) | KARL STORZ- FISCH
TITANIUM NEOMALLEUS
PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 1. INTENDED USE | Malleus replacement in combination
with the stapes prosthesis. | Same |
| 2. DIMENSIONS BY MODEL

| 13-18020 | 227522 |

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

| DEVICE | STRYKER/LEIBINGER - FISCH TITANIUM
TOTAL PROSTHESIS (K993583) | KARL STORZ- FISCH
TITANIUM TOTAL
PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 1. INTENDED USE | Plate prosthesis with shaft and shoe as
replacement between the tympanic
membrane and the footplate of the
stapes. | Same |
| 2. DIMENSIONS BY MODEL

| 13-18090 | 227520 |

Signed: Yvonne Fernandez / Sr. Regulatory Affairs Associate

3

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

4

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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

5

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