(278 days)
Not Found
No
The device description focuses on the mechanical properties and design of the prostheses, with no mention of AI or ML. The performance studies are based on bench testing and standard medical device validations, not AI/ML model performance.
Yes
The device is intended for the "treatment" of various conditions affecting the middle ear and aims to "restore" the mechanical transfer of sound, which are therapeutic actions.
No
Explanation: The device is a middle ear prosthesis intended for the surgical replacement of parts of the ossicular chain to restore sound transfer. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the devices are made of physical materials like titanium and Nitinol and are intended for surgical implantation, indicating they are hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "partial or total surgical replacement of the ossicular chain of the human middle ear." This is a surgical implant designed to restore mechanical function.
- Device Description: The description details the physical components and materials of the prostheses, which are surgically implanted devices.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro testing.
- Anatomical Site: The device is used within the human middle ear, which is an in vivo application, not an in vitro one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
Specifically, the devices are designed for the treatment of
-
- Chronic middle ear inflammation (also following removal of a tumor, e.g. cholesteatoma) with functional impairment of the ossicular chain
-
- Otosclerosis (stapedial fixation) / congenital stapedial fixation
-
- Traumatic injury to the ossicular chain
-
- Malformation of the middle ear
-
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
Product codes (comma separated list FDA assigned to the subject device)
77 ETB
Device Description
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
NiTiFLEX Stapes Prosthesis:
The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain.
It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67).
The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved.
Detroit Piston:
The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
Roberson Stapes Prosthesis
The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device).
Skarzynski Piston
The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear / ossicular chain
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)
Safety and effectiveness has been demonstration within the Bench testing and performance specifications are met.
The following tests were conducted:
- NiTiFLEX: Attachment Forces
All products: - MRI environment according ASTM F2119, F2052, F2182
- Biocompatibility according EN ISO 10993
- Shelf life testing according EN ISO 11607
- Sterilization validation according EN ISO 11137-1, 11137-2, Gamma Sterilization with a confirmed sterility assurance level of
§ 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
Date: 17-May-2013
Page 1 o' 8
1. Submitter
Heinz Kurz GmbH Medizintechnik Tübinger Str. 3 D-72144 Dusslingen Germany Tel. +49-7072-91 79 0 Fax +49-7072 -91 79 79
DEC 02 2013
Contact Person: Kristina Bitzer
Manager Regulatory Affairs, Heinz Kurz GmbH Medizintechnik Email: kbitzer@kurzmed.de
Date Summary Prepared: May 17, 2013
2. Device Name
| Trade | NiTiFLEX Stapes Prosthesis |
|---|---|
| Detroit Piston | |
| Skarzynski Piston | |
| Roberson Stapes Prosthesis | |
| Common | Stapes Prosthesis, Stapes Piston |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Product Code | 77 ETB |
| Regulation # | CFR 874.3450 |
3. Predicate Devices
| K002221 | K-Piston, Heinz Kurz GmbH Medizintechnik |
|---|---|
| K021479 | CliP® Piston àWengen, Heinz Kurz GmbH Medizintechnik |
| K112616 | NiTiBOND Stapes Prosthesis, Heinz Kurz GmbH Medizintechnik |
| unknown | Big Easy, Medtronic |
| K002897 | Roberson Stapes Prosthesis, Medtronic |
1
510(k) Summary
Date: 17-May-2013
ge 2 of 8
4. Device Description
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
NiTiFLEX Stapes Prosthesis:
Image /page/1/Picture/8 description: The image shows a drawing of a tool. The tool has a long handle with a bulbous end. The top of the tool has a curved shape with two hooks. The drawing is in black and white and has a vintage look.
The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain.
It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67).
The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the
superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved.
Detroit Piston:
Image /page/1/Picture/14 description: The image shows a tool with a cylindrical handle and a curved, hook-like head. The handle appears to be made of metal and has a smooth, polished surface. The head of the tool is also metal and has a series of openings or slots along its curved surface. The tool is likely used for gripping or manipulating objects, possibly in an agricultural or industrial setting.
The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
2
510(k) Summary
Date: 17-May-2013
Page 3 of 8
Roberson Stapes Prosthesis
The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device).
Skarzynski Piston
Image /page/2/Figure/8 description: The image shows a tool with a curved blade at the top and a long handle. The blade is shaped like a crescent moon, with the sharp edge facing inward. The handle is straight and cylindrical, providing a grip for the user. The tool appears to be made of metal, with a light gray color.
The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
3
510(k) Summary
Date: 17-May-2013
Page 4 of 8
5. Statement of Intended Use
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
Specifically, the devices are designed for the treatment of
- 1 . Chronic middle ear inflammation (also following removal of a tumour, e.g. cholesteatoma) with functional impairment of the ossicular chain
-
- Otosclerosis (stapedial fixation) / congenital stapedial fixation
- Traumatic injury to the ossicular chain 3.
- ব -Malformation of the middle ear
- ട്. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
The indications are identical to the predicate devices and therefore do not affect safety and effectiveness.
6. Comparison with Predicate Devices
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses, including the predicate devices, is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
4
| HEINZ KURZ GmbH MEDIZINTECHNIK
Tuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512
Stapes Prostheses | |
|---------------------------------------------------------------------------------|-------------------------------------------------|-------------|
| 510(k) Summary | Date: 17-May-2013 | Page 5 of 8 |
ార్యాల్యం
్ట్స్ బలిన్నారు. గ్రామం
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻮﺍﺻﻞ ﺍﻟﻤ
ATT
のお気になる。 この
2018
()
10
| Device | NITIFLEX
Stapes Prosthesis
Heinz Kurz GmbH | PREDICATE DEVICE
CliP® Piston
áWengen
Heinz Kurz GmbH
K021479 | PREDICATE DEVICE
NITIBOND
Heinz Kurz GmbH
K112616 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|
| Design Comparison | | | a |
| Intended Use | The prosthesis is
intended for ossicular
replacement to restore
functionality to the middle
ear in cases of
pathological changes of
the sound transmission
system. | Identical | Identical |
| Method of Attachment | Manually, without
crimping | Manually, without crimping | Heat activated |
| # of Sizes | 16 (8 for each shaft Ø) | 16 (8 for each shaft Ø) | 16 (8 for each shaft Ø) |
| Dimensions Length
[mm] | 3.5 - 5.5
(up to 5.0 in 0.25 mm
intervals
- 5.5 mm ) | 3.5 - 5.5
(up to 5.0 in 0.25 mm
intervals - 5.5 mm ) | 3.5 - 5.5
(up to 5.0 in 0.25 mm
intervals - 5.5 mm ) |
| Piston Ø
[mm] | 0.4 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 |
| Width of Loop Band
[mm] | 0.25 | 0.25 | 0.25 |
| Materials
Loop
Piston | Nitinol
Titanium (ASTM F67) | Titanium (ASTM F67) | Nitinol
Titanium (ASTM F67) |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| MRI | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional
1.5, 3 + 7 Tesla |
| Biocompatible | Yes | Yes | Yes |
5
| HEINZ KURZ GmbH MEDIZINTECHNIK
Tuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512
Stapes Prostheses | |
|---------------------------------------------------------------------------------|-------------------------------------------------|-------------|
| 510(k) Summary | Date: 17-May-2013 | Page 6 of 8 |
لم الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ا
ﺔ ﺍﻟﻤﺘﺤﺪﺓ
ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
a vegar
1 - 2 B
本社
For the specific the first and
्
| Device | Detroit Piston
Heinz Kurz GmbH | Skarzynski Piston
Heinz Kurz GmbH | PREDICATE DEVICE
K-Piston
Heinz Kurz GmbH
K002221 | PREDICATE DEVICE
Big Easy
Medtronic
510(k) number
unknown |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Design
Comparison | Image: Detroit Piston | Image: Skarzynski Piston | Image: K-Piston | Image: Big Easy |
| Intended Use | The prosthesis is
intended for partial
ossicular replacement
to restore functionality
to the middle ear in
cases of pathological
changes of the sound
transmission system. | Identical | Identical | Identical |
| Method of
Attachment | Manually, with
crimping | Manually, with
crimping | Manually, with
crimping | Manually, with
crimping |
| # of Sizes | 24
(8 for each shaft Ø) | 16
(8 for each shaft Ø) | 28
(14 for each shaft Ø) | 10 (4 straight, 3 each
left ear offset / right
ear offset) |
| Dimensions
Length
[mm] | 3.5 - 5.5
(up to 5.0 mm in 0.25
mm intervals + 5.5
mm) | 3.5 - 5.5
(up to 5.0 mm in 0.25
mm intervals + 5.5
mm) | 3.5 - 10.0
(up to 5.50 in 0.25
mm intervals; than
1.0 mm intervals) | 4.00 - 5.00
(0.25 mm intervals) |
| Piston Ø
[mm] | 0.4 / 0.5 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 | 0.5 |
| Width of Loop
Band
[mm] | 0.5 | 0.25 | 0.3 | 0.4 |
| Materials
Loop
Piston | Titanium (ASTM F67) | Titanium (ASTM F67) | Titanium (ASTM F67) | Platinum
Titanium |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| MRI | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional |
| Biocompatible | Yes | Yes | Yes | Yes |
- 手
6
HEINZ KURZ GmbH MEDIZINTECHNIK
Tuebinger Str. 3, D-72144 Dusslingen, Germany
Traditional 510(k) K130512 Stapes Prostheses
510(k) Summary
Date: 17-May-2013
| Device | Roberson Stapes Prosthesis
Heinz Kurz GmbH | PREDICATE DEVICE
Roberson Stapes Prosthesis
Medtronic
510(k) number unknown |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Design
Comparison | Image: Roberson Stapes Prosthesis | Image: PREDICATE DEVICE |
| Intended Use | The prosthesis is intended for ossicular
replacement to restore functionality to the
middle ear in cases of pathological
changes of the sound transmission system. | Identical |
| Method of
Attachment | Manually, without crimping | Manually, without crimping |
| # of Sizes | 6 (3 for each bucket Ø) | 6 (3 for each bucket Ø) |
| Dimensions
Length
[mm] | 4.0 - 4.5
(0.25 mm intervals) | 4.0 - 4.5
(0.25 mm intervals) |
| Piston Ø
[mm] | 0.6 | 0.6 |
| Bucket Ø
[mm] | 0.9 / 1.0 | 0.9 / 1.0 |
| Materials | Titanium (ASTM F67) | Titanium (ASTM F67) |
| Single Use | Yes | Yes |
| Sterile | Yes | Yes |
| MRI | MR Conditional
1.5, 3 + 7 Tesla | MR Conditional |
| Biocompatible | Yes | Yes |
7
7. Performance Testing
Safety and effectiveness has been demonstration within the Bench testing and performance specifications are met.
The following tests were conducted:
-
· NiTiFLEX: Attachment Forces
All products: -
· MRI environment according ASTM F2119, F2052, F2182
-
· Biocompatibility according EN ISO 10993
-
· Shelf life testing according EN ISO 11607
-
· Sterilization validation according EN ISO 11137-1, 11137-2, Gamma Sterilization with a confirmed sterility assurance level of