(11 days)
K 972492
None
No
The summary describes a mechanical ossicle replacement prosthesis made of titanium and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for ossicle replacement to restore sound conduction, which is a therapeutic intervention.
No
This device is an ossicle replacement prosthesis, which is a therapeutic device designed to restore the sound-conducting chain, not to diagnose a condition.
No
The device description clearly states it is a physical prosthesis made of titanium, consisting of a clip, shaft, and head plate. This indicates a hardware device, not software.
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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information describes a titanium prosthesis intended for surgical implantation in the middle ear to replace ossicles and restore sound conduction. This is a device that is surgically placed inside the body to perform a mechanical function.
The device's function is to physically replace damaged ossicles within the middle ear, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.
Product codes
ETB
Device Description
The all-titanium prosthesis consists of a clip with seven (7) resilient prongs, a shaft, and a head plate. Holding the device vertically to the stapes axis, the clip is gently pushed over the stapes head so that the titanium prongs with their built-in tension securely grasp the stapes head and upper part of the stapes and the two somewhat shorter rear prongs are positioned on either side of the stapedial tendon. The head plate is covered with a thinned cartilage slice and placed under the manubrium mallei or under the tympanic membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear / ossicle / stapes
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
MRI Environment: Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
Key Metrics
Not Found
Predicate Device(s)
K 972492
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 0 9 2001
2.1
1
K 013573
Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dusslingen
Heinz Kurz GmbH Medizintechnik
Tübinger Straße 3 D-72144 Dussling
Telefon (0 70 72) 9 Telefax (0 70 72) 9
Internet: http://www.kurzme
E-Mail: info@kurzn
2. 510(k) SUMMARY of Safety and Effectiveness
As required by Section 807.92(c)
| Submitter: [807.92 (a)(1)] | ||
|---|---|---|
| Heinz Kurz GmbH Medizintechnik | ||
| Tübinger Str. 3 | Tel. | +49-7072-91 79 0 |
| D-72144 Dusslingen | Fax | +49-7072-91 79 75 |
| Germany | info@kurzmed.de |
| 2.2 | Contact Person: [807.92 (a)(1)] | ||
|---|---|---|---|
| Dagmar S. Mäser | |||
| Business Support International | |||
| Amstel 320-I | Tel. | +31-20-428 95 91 | |
| 1017 AP Amsterdam | Fax | +31-20-428 94 29 | |
| The Netherlands | bsi@xs4all.nl |
- Date Summary Prepared: [807.92 (a)(1)] 2.3 October 10, 2001
- 2.4 Device Names: [807.92 (a)(2)] Proprietary Clip Partial Prosthesis - Titanium "Dresden"
- Common Partial Ossicular Replacement Prosthesis Classification Middle Ear Prosthesis, Partial Ossicular Replacement Product Code 77 ETB Regulation # CFR 874.3450
2.5 Reason for Submission:
Change in material and design when compared to previously cleared device
Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 8115701
Volksbank Steinlach-Wiesaz eG (BLZ 640 618 54) Konto-Nr. 70 150 001 SWIFT: GENODES1STW IBAN DE386406 18540070 150001
2-1
BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641 IBAN DF186417 0020 1701 1072 00
Amtsgericht Tübingen
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Image /page/1/Picture/0 description: The image shows a logo with the word "KURZ" inside of a circle. The letters are in a simple, sans-serif font and appear to be slightly distressed or textured. The circle is not fully closed at the top, leaving a small gap above the letter "K". The logo has a vintage or worn appearance, possibly due to the texture and style of the letters and circle.
Heinz Kurz GmbH Medizintechnik
Modification to Existing Device: [807.92 (a)(3)] 2.6
Bell Prosthesis (Partial) K 972492
Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dussfieleared 08/04/97
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Device Description: [807.92(a)(4)+(6)] 2.7
Tübinger Straße 3 The all-titanium prosthesis consists of a clip with seven (7-72144 Dussinge resilient prongs, a shaft, and a head plate. Telefon (0 70 72) 91
Reasons for Device Modification: [807.92 (d)] 2.8 Material:
Internet:
- http://www.kurzme Titanium provides excellent sound conduction even E-Mail: info@kurzm at higher frequencies
- Due to the lower specific weight of titanium, the 2. device is substantially lighter than the gold KURZ Bell "Dresden" prosthesis
Design:
By pushing the elastic clip over the stapes head and upper part of the stapes, a more secure connection is established that not only eliminates the need for device manipulation in situ but also the chance of implant dislocation with a high degree of certainty.
2.9 Intended Use: [807.92 (a)(5)]
Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes
Industry Standards: [807.92 (d)] 2.10
KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.
2.11 MRI Environment: [807.92 (d)]
Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
Information Bearing on the Safety and Effectiveness: 2.12
[807.92 (b)(3)]
The KURZ Clip Partial Prosthesis -- Titanium "Dresden" has the same intended use as the previously cleared device made of pure gold. With the exception of the described material and design changes, 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.
Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt .- Id. Nr. DE 8115.
2-2
BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641
Telefax (07072) 91 Internet:
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Image /page/2/Picture/0 description: The image is a black and white logo. The logo consists of the word "KURZ" in a stylized font, with the letters arranged in a slightly curved manner. The word is enclosed within a circle that is not fully complete, with gaps at the top and bottom. Below the circle, the letters "ESS" are visible.
2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS
| | Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-721 | | Gold
Heinz Kurz GmbH
Medizintechnik |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Clip Partial Prosthesis
"Dresden" | | Dresden Bell Prosthesis
Tübinger Straße
D-72144 Dusslingen |
| Catalog # | 1002 250 - 257 | | 1001 023 - 030 |
| Intended Use | Ossicle replacement in case of
interrupted sound conducting
chain in patients with intact,
mobile stapes | | Telefon (0 70 72)
Identical
Telefax (0 70 72) |
| # of Sizes | 8 | | Identical |
| Dimensions | | | |
| Length | 1.75 - 3.5 mm (0.25 mm intervals) | | Identical |
| Head Plate Ø | 2.6 mm | | |
| Shaft Ø | 0.2 mm | | |
| Material | ASTM F67 Titanium | | Pure Gold |
| Weight | 4-5 mg | | 10-12 mg |
| Single Use | Yes | | Identical |
| Sterile | Yes | | Identical |
| Design
Comparison | Clip with seven (7) resilient
prongs securely clips around
stapes head and upper part of
stapes. No manipulation and/or
adjustment in situ. | | The four (4) gold strips of Bell
prosthesis are gently pushed
against stapes with wire crimper
to achieve mechanically close fit. |
| Custom
Accessories | KURZ Sizer Cat.# 8000 121
KURZ Precise Cat # 8000 101 | | Identical |
| Safety &
Effectiveness of
Material and
Design
Changes
[807.92 (b)(1)] | Titanium is a clinically well-
established implant material with
excellent biocompatibility. The
much lighter weight appears to
be better suited for implantation
in the middle ear. Clinical
evidence suggests that titanium
has excellent sound conduction
properties resulting in improved
hearing gain.
The tensile clip mechanism
significantly reduces the risk of
implant implant dislocation while
the secure but vibrant connection
to the stapes head is expected to
improve long-term hearing gains
with appropriate physiological
conditions.
Careful attention must be paid to
KURZ operating guidelines | | |
Signature
A. Mihaes M
Uwe Steinhardt Technical Director
Date
October 22, 2001
Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 81157
A ﺳﻪ ۵۰ -- ۱۰: ۱۰ -- ۳ : ۱ : ۱ --
Volksbank Steinlach-Wiesaz eG
(BLZ 640618 54) Konto-Nr. 70 150001 SWIFT. CENIONES 1 STAI
BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300
รังกรรม ค.ศ. 1 201 402 300
ราคมีความคร ทรรรคร
2-3
3
Image /page/3/Picture/1 description: The image contains the text "Public Health Service" in a bold, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2001
Heinz Kurz GmbH Medizintechnik c/o Dagmar S. Mäser Business Support International Amstel 320-I 1017 AP Amsterdan The Netherlands
Re: K013573
Trade/Device Name: Clip Partial Prosthesis-Titanium Dresden, Model 1002 Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: October 24, 2001 Received: October 29, 2001
Dear Ms. Mäser:
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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotes with and my of the FDA finding of substantial equivalence of your device to a legally premailed notification of the sification 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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
Sincerely 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
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510(k) Number
Device Name
Clip Partial Prosthesis – Titanium "Dresden"
NOV 0 9 2001
INDICATION FOR USE
Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.
Kolz573
Description of Implant and Intended Situs
The prosthesis consists of a clip consisting of seven (7) resilient prongs, a shaft, and a head plate.
Holding the device vertically to the stapes axis, the clip is gently pushed over the stapes head so that the titanium prongs with their built-in tension securely grasp the stapes head and upper part of the stapes and the two somewhat shorter rear prongs are positioned on either side of the stapedial tendon. The head plate is covered with a thinned cartilage slice and placed under the manubrium mallei or under the tympanic membrane.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
( )[ર
Prescription Use
(Per CFR 801 109)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K0/3573
()ver-The-Counter Use
(Optiona) Format 1-2-96)
V