BELL VARIO: Partial ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes.
AERIAL VARIO: Total ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes between tympanic membrane and stapes foot plate.
Both devices are only intended for use by qualified medical personnel trained in the bridging of partial or complete auditory ossicle defects.

Device Description

KURZ Tuebingen Titanium Prostheses (TTP) BELL + AERIAL VARIO are length-variable sterile middle ear prostheses. They are identical to the previously cleared devices with the following exceptions: Instead of eight (8) and fourteen (14) fixed-length sizes (Bell and Aerial respectively), the TTP VARIO models come in one size only. The head plate slides on the shaft and can be irreversibly attached at the exact length point required for the patient. The extra shaft length is cut off behind the head plate (s. Package Insert and Manufacturer's Instructions).

AI/ML Overview

The provided document describes a 510(k) premarket notification for a device change to existing middle ear prostheses (Tuebingen Titanium Prosthesis (TTP) BELL VARIO and AERIAL VARIO). The change involves making the prostheses length-variable rather than having fixed-length sizes.

Here's an analysis of the acceptance criteria and the study reported in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance and Evidence
Mechanical Stability/Strength of the Connection	Tensile strength tests at approximately seven times the middle ear forces acting on the implant have proven the stability of the connection. This demonstrates that the length-adjustable mechanism maintains structural integrity under stress.
Safety and Effectiveness (comparable to predicate devices)	The Reason for Design Modification states: "This modification does not affect the safety and effectiveness of the previously cleared devices". The Information Bearing on the Safety and Effectiveness section reiterates: "With the exception of the described design change, 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." The comparison table explicitly states that the implant is "as safe and effective as the previously cleared Tuebingen Bell Partial Prosthesis" and "as safe and effective as the previously cleared Tuebingen Aerial Total Prosthesis" based on the tensile strength tests.
Biocompatibility/Material Safety	The material remains ASTM F67 Titanium, which is the same as the predicate devices and is widely accepted as biocompatible.
Sterility	The device is reported as "Sterile: Yes", implying compliance with established sterilization standards. The document also mentions compliance with "device-related standards that apply to the manufacture, packaging, labeling, sterilization".
MRI Compatibility (lack of movement, adverse tissue effects, significant image impediment)	Testing in a 0.5 Tesla nuclear magnetic resonance tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating. It notes that "The image quality may be impeded or blurred in direct vicinity of the implant," but this is an accepted characteristic of metallic implants and not considered an adverse effect on safety. "To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer."
Intended Use (unchanged from predicate)	The document explicitly states: "The KURZ Tuebingen Titanium Prostheses (TTP) BELL and AERIAL VARIO have the same intended use as the previously cleared devices." This is also confirmed in the "Indications for Use" section and the comparison table.
Compliance with Industry Standards	KURZ certifies compliance with required ISO/EN/ASTM/AAMI/ANSI and other device-related standards.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "tensile strength tests" as evidence of performance, but the number of devices or iterations tested is not provided.
Data Provenance: The document does not specify the country of origin for the tensile strength tests. It is likely internal testing by the manufacturer, Heinz Kurz GmbH Medizintechnik, which is located in Germany. The study is retrospective, as it focuses on demonstrating that the design change does not compromise the established safety and effectiveness of the existing predicate devices. It is a design validation study rather than a clinical trial.

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

Number of Experts: Not applicable. The "ground truth" for the tensile strength tests would be physical measurements and engineering standards, not expert consensus in a clinical context.
Qualifications of Experts: Not applicable in the traditional sense. The tests would be performed by engineers or technicians skilled in mechanical testing and quality control.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among multiple experts or datasets, which is not relevant for a mechanical tensile strength test.

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:

MRMC Study: No. This is a medical device, specifically an implantable prosthesis, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

Standalone Performance: Not applicable. This device is not an algorithm. Performance is assessed through mechanical testing and comparison to predicate devices, and its use requires human surgical intervention.

7. The type of ground truth used:

Ground Truth: For the mechanical performance, the ground truth is based on engineering standards and physical measurements of tensile strength and stability. The criteria for "safe and effective as the previously cleared devices" serves as the comparative ground truth. For the MRI compatibility, the ground truth is observational data (no movement, no adverse tissue effects, acceptable image impediment) in an MRI environment.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the new devices is based on an existing, cleared design, with a modification to the length adjustment mechanism.

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

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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31/99 L990922

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen

Heinz Kurz GmbH Medizintechnik

Hausanschrift: Tübinger Straße 3 D-72144 Dußlingen

Telefon (0 70 72) 91 79-C Telefax (0 70 72) 91 79-7

510(k) SUMMARY of Safety and Effectiveness 2. Heinz Kurz GmbH Medizintechnik

As required by Section 807.92(c)

DEVICE CHANGE 510(K) - 77 ETA + ETB

2.1 Submitter: [807.92 (a)(1)] Heinz Kurz GmbH Medizintechnik Tel. Tuebinger Str. 3 D-72144 Dusslingen Fax Germany eMail

+49-7072-91 79 79 tkurz@kurzmed.de usteinhardt(a)kurzmed.de

+49-7072-91 79 0

2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Maeser Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands

Tel. +31-20-428 95 91 Fax +31-20-428 94 29 eMail bsi(axs4all.nl bsi2@compuserve.com

2.3 Date Summary Prepared: [807.92 (a)(1)] March 10, 1999

2.4 Device Names: [807.92 (a)(2)] Proprietary Partial
Total

Common

Classification Partial

Total

Tuebingen Titanium Prosthesis (TTP) BELL VARIO Tuebingen Titanium Prosthesis (TTP) AERIAL VARIO Length-Adjustable Partial (BELL) and Total (AERIAL) Ossicular Replacement Prostheses

Middle Ear, Prosthesis, Partial Ossicular Replacement Prostheses (ETB, CFR 874.3450) Middle Ear, Prosthesis, Ossicular Replacement, Total (ETA, CFR 874.3490)

2-1

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt .- Id. Nr. DE 81 157032

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Reason for Submission: 2.5

Design change of previously cleared devices (s. 2.6, 2.7, 2.8, 2.12 and Comparison Table 2.13).

Design Change to Existing Devices: [807.92 (a)(3)] 2.6 Bell Prosthesis (Partial), Tuebingen K 972492 Aerial Prosthesis (Total), Tuebingen K 972585

2.7 Device Description: [807.92(a)(4)+(6)]

KURZ Tuebingen Titanium Prostheses (TTP) BELL + AERIAL VARIO are length-variable sterile middle ear prostheses.

They are identical to the previously cleared devices with the following exceptions: Instead of eight (8) and fourteen (14) fixed-length sizes (Bell and Aerial respectively), the TTP VARIO models come in one size only. The head plate slides on the shaft and can be irreversibly attached at the exact length point required for the patient. The extra shaft length is cut off behind the head plate (s. Package Insert and Manufacturer's Instructions).

Reasons for Design Modification: [807.92 (d)] 2.8

This modification does not affect the safety and effectiveness of the previously cleared devices, but has distinct advantages:

Precise fittings for the patient at 0.25 mm or less 1. intervals:
1. The assurance that the right length prosthesis is on hand - for every patient - regardless of length required.
1. Health care cost reduction due to the need for smaller inventories.

2.9 Intended Use:

BELL VARIO

interrupted sound conducting chain and intact mobile stapes. Total ossicle replacement in case of AERIAL VARIO interrupted sound conducting chain and intact mobile stapes between tympanic membrane and stapes foot plate.

Partial ossicle replacement in case of

Both devices are only intended for use by qualified medical personnel trained in the bridging of partial or complete auditory ossicle defects.

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Industry Standards: [807.92 (d)] 2.10

KURZ certifies compliance with required ISO/EN/ASTM/ AAMI/ANSI and other device-related standards that apply to the manufacture, packaging, labeling, sterilization, and reprocessing (custom instruments) of subject devices including the validation of these processes.

MRI Environment: [807.92 (d)] 2.11

Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer.

Information Bearing on the Safety and Effectiveness: 2.12

[807.92 (b)(3)]

The KURZ Tuebingen Titanium Prostheses (TTP) BELL and AERIAL VARIO have the same intended use as the previously cleared devices. With the exception of the described design change, 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.

2.13 KURZ Tuebingen Titanium Prostheses (TTP) VARIO BELL + AERIAL

D E S I G N + SAFETY and EFFECTIVENESS C O M P A R I S O N

Device	Bell VARIO	Bell	AerialVARIO	Aerial
Catalog #	1002 010	10022xx	1004 010	10042xx
IntendedUse	Partial OssicleReplacementin case ofinterruptedsoundconductingchain andintact stapes	PartialOssicleReplacementin case ofinterruptedsoundconductingchain andintact stapes	Total OssicleReplacementin case ofinterruptedsoundconductingchain andintact stapes	Total OssicleReplacementin case ofinterruptedsoundconductingchain andintact stapes

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Model #	1 –1.75-4.5 mm	8 –1.75-3.5 mm @ 0.25 mm intervals	1 –3.0-7.0 mm	14 –3.0-7.00 mm @ 0.25 mm intervals
Dimensions
- Shaft Ø	0.2 mm	0.2 mm	0.2 mm	0.2 mm
- Head Plate	2.6 x 3.6 x0.22 mm	2.6 x 3.6 x0.22 mm	2.6 x 3.6 x0.22 mm	2.6 x 3.6 x0.22 mm
Material	ASTM F67Titanium	ASTM F 67Titanium	ASTM F67Titanium	ASTM F67Titanium
Single UseReusable	Single Use	Single Use	Single Use	Single Use
Sterile	Yes	Yes	Yes	Yes
DesignComparison	The identicalhead plateglides on theidentical Øshaft to theexact lengthrequired forthe patientand is thenirreversiblyconnected.The extrashaft length iscut off.	8 commonlengths at0.25 mmintervals. Thehead plate ispermanentlyattached toprosthesisshaft.	The identicalhead plateglides on theidentical Øshaft to theexact lengthrequired forthe patientand is thenirreversiblyconnected.The extrashaft length iscut off.	14 commonlengths at 0.25mm intervals.The headplate ispermanentlyattached tothe prosthesisshaft.
Safety &Effectivenessof DesignChange[807.92 (b)(1)]	Tensilestrength testsat approx.seven timesthe middle earforces actingon the implanthave proventhe stability oftheconnection.The implant isas safe andeffective asthe previouslyclearedTuebingenBell PartialProsthesis.Carefulattention is tobe paid toKURZinstructions.		Tensilestrength testsat approx.seven timesthe middle earforces actingon the implanthave proventhe stability oftheconnection.The implant isas safe andeffective asthe previouslyclearedTuebingenAerial TotalProsthesis.Carefulattention is tobe paid toKURZinstructions.
AdditionalRequiredAccessory	VARIOHolder		VARIOHolder

Signature

Dagmar S. Maeser
FDA Liaison for KURZ

Signature

Date March 11, 1999

2-4

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three parallel lines that curve and taper, resembling a bird in flight or a symbolic representation of human services.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Minn 3 1 133

Dagmar S. Maeser FDA Liasion for Heinz Kurz GmbH Medizintechnik Amstel 320-I 1017 AP Amsterdam Netherlands

Re: K990923 Trade Name: Partial/Total Length-Variable Titanuim Middle Ear Prostheses Regulatory Class: II Product Code: 77 ETB and 77 ETA Dated: February 3, 1999 Received: February 4, 1999

Dear Mr. Maeser:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 – Mr. Dagmar S. Maeser

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/2 description: The image shows the text '510(k) Number' on the left side. To the right of this text is the number 'K990923'. The number is handwritten in a cursive style. A line is drawn underneath the number.

Tuebingen Titanium Prosthesis (TTP) AERIAL VARIO Device Name

INDICATIONS FOR USE

Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes between the tympanic membrane and the stapes foot plate.

The Tuebingen Titanium Prosthesis (TIP) AERIAL VARIO is intended for bridging a complete auditory ossicle defect.

Description of Implant and Intended Situs

510(k) Number

The prosthesis consists of a cup, a shaft and a head plate. The correct length must be measured and the prosthesis adjusted accordingly (see manufacturer's instructions for measuring and adjusting the correct length!). Then the cup is placed centrally on the foot plate. After regular implantation the head plate is under the manubrium mallei, the tympanic membrane or another tympanic cover, and is covered laterally (between head plate and tympanic membrane) with a thin slice of cartilage or a cartilage-perichondrium transplant.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per CFR 801 109)

Over-The-Counter Use
----------------------	--

VI
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Devices

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Heinz Kurz GmbH Medizintechnik

SPECIAL 510(k) - 77 ETB

510/1,1BERTEREA
	Annone of the drum to the directive the charges of the charges of the charges of the charges of the charges of the charges of the charges of the charges of the charges of the

Tuebingen Titanium Prosthesis (TTP) BELL VARIO Device Name

INDICATIONS FOR USE

Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes.

The Tuebingen Titanium Prosthesis (TIP) BELL VARIO is intended for partial replacement of the auditory ossicles.

Description of Implant and Intended Situs

The prosthesis consists of a slit bell, a shaft and a head plate. The correct length must be measured and the prosthesis adjusted accordingly (see manufacturer's instructions for measuring and adjusting the correct length!). Then the bell is placed centrally on the stapes head or - if it no longer exists - on the still complete stapes arch. After regular implantation the head plate is under the manubrium mallei, the tympanic membrane, or another tympanic cover, and is covered laterally (between head plate and tympanic membrane) with a thin slice of cartilage or a cartilage-perichondrium transplant.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801 109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K990923

Karen Bohu (for HKS)

Regulation Number and Section

§ 874.3450 Partial ossicular replacement prosthesis.

(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.