(12 days)
K 972492, K 972585
Not Found
No
The description focuses on the mechanical design and function of the prostheses, with no mention of AI or ML.
Yes
The device is described as a "middle ear prosthesis" intended for "partial or total ossicle replacement" to address an "interrupted sound conducting chain." This indicates its purpose is to treat a medical condition and restore function, aligning with the definition of a therapeutic device.
No
The device description clearly states "partial ossicle replacement" and "total ossicle replacement," indicating its use as a prosthetic for treatment, not diagnosis. The intention is to bridge defects in the sound conducting chain.
No
The device description clearly states it is a "length-variable sterile middle ear prostheses," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The BELL VARIO and AERIAL VARIO are surgical implants designed to replace or bridge damaged ossicles in the middle ear. They are used in the body during a surgical procedure, not to test samples from the body.
- Intended Use: The intended use clearly describes a surgical intervention to restore hearing by replacing or bridging ossicles, not a diagnostic test.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
77 ETB, 77 ETA
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).
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
qualified medical personnel trained in the bridging of partial or complete auditory ossicle defects.
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)
Tensile strength tests at approx. seven times the middle ear forces acting on the implant have proven the stability of the connection. The implant is as safe and effective as the previously cleared Tuebingen Bell Partial Prosthesis. Careful attention is to be paid to KURZ instructions.
Tensile strength tests at approx. seven times the middle ear forces acting on the implant have proven the stability of the connection. The implant is as safe and effective as the previously cleared Tuebingen Aerial Total Prosthesis. Careful attention is to be paid to KURZ instructions.
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.
K 972492, K 972585
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
§ 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.
0
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
1
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:
-
- The assurance that the right length prosthesis is on hand - for every patient - regardless of length required.
-
- 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.
2
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 | Aerial
VARIO | Aerial |
|-----------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Catalog # | 1002 010 | 10022xx | 1004 010 | 10042xx |
| Intended
Use | Partial Ossicle
Replacement
in case of
interrupted
sound
conducting
chain and
intact stapes | Partial
Ossicle
Replacement
in case of
interrupted
sound
conducting
chain and
intact stapes | Total Ossicle
Replacement
in case of
interrupted
sound
conducting
chain and
intact stapes | Total Ossicle
Replacement
in case of
interrupted
sound
conducting
chain and
intact stapes |
3
| 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 x
0.22 mm | 2.6 x 3.6 x
0.22 mm | 2.6 x 3.6 x
0.22 mm | 2.6 x 3.6 x
0.22 mm |
| Material | ASTM F67
Titanium | ASTM F 67
Titanium | ASTM F67
Titanium | ASTM F67
Titanium |
| Single Use
Reusable | Single Use | Single Use | Single Use | Single Use |
| Sterile | Yes | Yes | Yes | Yes |
| Design
Comparison | The identical
head plate
glides on the
identical Ø
shaft to the
exact length
required for
the patient
and is then
irreversibly
connected.
The extra
shaft length is
cut off. | 8 common
lengths at
0.25 mm
intervals. The
head plate is
permanently
attached to
prosthesis
shaft. | The identical
head plate
glides on the
identical Ø
shaft to the
exact length
required for
the patient
and is then
irreversibly
connected.
The extra
shaft length is
cut off. | 14 common
lengths at 0.25
mm intervals.
The head
plate is
permanently
attached to
the prosthesis
shaft. |
| Safety &
Effectiveness
of Design
Change
[807.92 (b)(1)] | Tensile
strength tests
at approx.
seven times
the middle ear
forces acting
on the implant
have proven
the stability of
the
connection.
The implant is
as safe and
effective as
the previously
cleared
Tuebingen
Bell Partial
Prosthesis.
Careful
attention is to
be paid to
KURZ
instructions. | | Tensile
strength tests
at approx.
seven times
the middle ear
forces acting
on the implant
have proven
the stability of
the
connection.
The implant is
as safe and
effective as
the previously
cleared
Tuebingen
Aerial Total
Prosthesis.
Careful
attention is to
be paid to
KURZ
instructions. | |
| Additional
Required
Accessory | VARIO
Holder | | VARIO
Holder | |
Signature
Dagmar S. Maeser
FDA Liaison for KURZ
Signature
Date March 11, 1999
2-4
4
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 .
5
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
6
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) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
VI
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Devices
7
Heinz Kurz GmbH Medizintechnik
SPECIAL 510(k) - 77 ETB
| 510/1,
1
| BERTEREA | |
|---|---|
| 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)
OR
Over-The-Counter Use
V
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K990923
Karen Bohu (for HKS)