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 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.

AI/ML Overview

The provided document is a 510(k) Summary for medical devices (FISCH Titanium Middle Ear Prostheses). This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically does not contain information about the device's performance in terms of specific measurable criteria, nor does it typically include clinical study data in the way one might expect for a novel device requiring extensive clinical trials. Instead, the focus is on comparing the new device's intended use, technological characteristics, and safety/effectiveness profile to an already approved device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the nature of this submission, the "study" that proves the device meets acceptance criteria is primarily a comparison of the new device to a predicate device and a demonstration of substantial equivalence, rather than a standalone performance study with measurable outcomes against defined acceptance criteria.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here is implicitly that the Karl Storz FISCH Titanium Middle Ear Prostheses are substantially equivalent to the predicate Stryker/Leibinger FISCH Titanium Middle Ear Prostheses in terms of intended use, dimensions, material, single use, sterility, and design.
Reported Device Performance: No specific performance metrics (e.g., auditory gain, complication rates) are reported. The "performance" is considered equivalent to the predicate device due to the similarities highlighted in the tables.

Table of Substantial Equivalence (summarized from the document):

Feature	Predicate Device (Stryker/Leibinger)	Karl Storz Device	Comparison
Intended Use	Ossicle replacement to restore middle ear function.	Same	Equivalent
Dimensions	Specific lengths and diameters for Stapes Piston, Incus, Neomalleus, Total Prosthesis	(Slightly different model numbers, but same dimensions)	Equivalent
Material	Titanium	Anodized Titanium (for Incus, Neomalleus, Total) / Titanium (for Stapes)	Equivalent (Anodized Titanium is a form of Titanium)
Single Use	Yes	Same	Equivalent
Sterile	Yes	Same	Equivalent
Design	One-piece, flat loop (Stapes); allows shaping, 4 holes (Incus); smooth/grooved (Neomalleus); plate with shaft/shoe (Total)	Same	Equivalent

2. Sample size used for the test set and the data provenance:

Not applicable as this is not a clinical performance study with a test set. It's a regulatory submission demonstrating equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically established by experts for performance evaluation is not part of this 510(k) submission.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a passive implantable medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a passive implantable medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the safety and effectiveness profile of the predicate device, which has already been legally marketed and deemed safe and effective by the FDA. The new device is compared against this established benchmark.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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 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 DriveCulver City, CA 90230(310) 338-8100
Contact:	Yvonne FernandezSr. Regulatory Affairs Associate

Device Identification:

Common Name:	Total ossicular replacement prosthesesPartial 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 - FISCHTITANIUM STAPES PISTON (K993583)			KARL STORZ - FISCH TITANIUMSTAPES PISTON
1. INTENDED USE	Flat band and piston prosthesis forattachment to the malleus or incus,inserted through the footplate of thestapes.			Same
2. DIMENSIONS BYMODEL #	13-18040	13-18042	13-18044	227510	227511	227512
OverallLength	7.00 mm	8.5 mm	10.00 mm	7.00 mm	8.5 mm	10.00 mm
PistonDiameter	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. DESIGNCOMPARISON	One-piece design, flat loop to enable astable connection with the incus ormalleus.			Same

: 上一篇:

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

DEVICE	STRYKER/ LEIBINGER - FISCHTITANIUM INCUS PROSTHESIS(K993583)			KARL STORZ - FISCH TITANIUMINCUS PROSTHESIS
1. INTENDED USE	Incus replacement to connect malleusand head of stapes.			Same
2. DIMENSIONS BYMODEL #	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 - TaperedEnd	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. DESIGNCOMPARISON	Design allows intraoperative shaping; 4holes 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 - FISCHTITANIUM NEOMALLEUSPROSTHESIS (K993583)	KARL STORZ- FISCHTITANIUM NEOMALLEUSPROSTHESIS
1. INTENDED USE	Malleus replacement in combinationwith the stapes prosthesis.	Same
2. DIMENSIONS BY MODEL#	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 thetraga perichondrium; grooves forattachment to stapes piston	Same

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

DEVICE	STRYKER/LEIBINGER - FISCH TITANIUMTOTAL PROSTHESIS (K993583)	KARL STORZ- FISCHTITANIUM TOTALPROSTHESIS
1. INTENDED USE	Plate prosthesis with shaft and shoe asreplacement between the tympanicmembrane and the footplate of thestapes.	Same
2. DIMENSIONS BY MODEL#	13-18090	227520
Length	10.0 mm	Same
Shaft Diameter	0.6 mm	Same
Head PlateDiameter	5 mm	Same
3. MATERIAL	Titanium	Anodized Titanium
4. SINGLE USE	Yes	Same
5. STERILE	Yes	Same
6. DESIGN COMPARISON	Direct connection between tympanicmembrane and footplate; may be trimmedto 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 (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

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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

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.