(16 days)
K 002221, K 021479
K 002221, K 021479
No
The device description and intended use describe a mechanical prosthesis for ossicular chain reconstruction, with no mention of AI or ML capabilities.
Yes
The device is described as a prosthesis used to bridge parts of the ossicular chain in cases of otosclerosis and defects, which directly addresses a medical condition to restore function.
No
Explanation: The device is described as an all-titanium prosthesis used for bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain. This is a therapeutic/implantable device, not a diagnostic one.
No
The device description clearly states it is an "all-titanium prosthesis" with physical components like a clip, shaft, and ball joint, indicating it is a hardware device.
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.
- Device Function: The description clearly states that this device is a prosthesis designed to be surgically implanted to bridge parts of the ossicular chain in the ear. It is a physical implant used for structural repair.
- Intended Use: The intended use is to surgically connect anatomical structures within the ear, not to analyze biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bridging the stapes and the incus in cases of otosclerosis, specifically for malleovestibulopexy.
Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)
Product codes
ETA
Device Description
The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip1 that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.2
Standard KURZ Piston connected to modified àWengen Clip w/ball joint articulation.
An open clip ( modified àWengen) is attached to a 0.2 mm rectangular shaft. A novel ball joint connection to the standard KURZ piston (0.4 + 0.6 mm) permits precise intra-operative 'bending' without implant manipulation to exactly accommodate patient's physiological requirements.
- The protuberance for grasping CliP has been moved to end
- Limb undulation has been changed to conform to more oval circumference of malleus handle
- CliP limb opening and length was slightly adjusted to assure precise fit around malleus handle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stapes, incus, malleus handle, ossicular chain, manubrium mallei, vestibulum (malleovestibulopexy)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 002221, K 021479
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Special 510(k): CLiP® Piston MVP
OCT 1 - 2004
510(k) SUMMARY of Safety 2. and Effectiveness
As required by Section 807.92(c)
2.1 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 79 |
| Germany | info@kurzmed.de |
2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International Tel. +31-20-428 95 91 Amstel 320-1 Fax +31-20-428 94 29 1017 AP Amsterdam eMail The Netherlands bsi@xs4all.nl
- 2.3 Date Summary Prepared: [807.92 (a)(1)] September 8, 2004
- 2.4 Device Names: [807.92 (a)(2)] CliP® Piston MVP Proprietary
- MVP Piston Common
- Classification Replacement, Ossicular Prosthesis, Total Product Code 77 ETA Regulation # CFR 874.3495
2.5 Reason for Submission:
Change in design and combination of design features of previously cleared devices
1
Intended Use: 1807.92 (a)(5)] 2.6 Bridging the stapes and the incus in cases of otosclerosis, specifically for malleovestibulopexy
Modification and Combination of Existing Device 2.7
Components: [807.92 (a)(3)]
| K 002221 | K-Piston Titanium Stapedial Prosthesis
(Partial and Total)
Cleared 08/09/2000 + |
|----------|---------------------------------------------------------------------------------------|
| K 021479 | CliP® àWengen Stapedial Piston
Cleared 05/21/2002 |
Device Description: [807.92(a)(4)+(6)] 2.8
The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip1 that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.2
Reasons for Device Modification: [807.92 (d)] 2.9
To facilitate and standardize intraoperative handling, reduce risks of patient trauma, and improve post-operative sound transmission in the affected ear.
Traditionally, common loop pistons had to be bent to an almost right angle to permit crimping to the malleus handle. With the piston articulation, no implant manipulation is required. The surgeon can bend the shaft to precisely match the patient's physiological condition.
By replacing the titanium band loop with a modified àWengen clip4 for fastening the prosthesis to the malleus handle, the clinically proven advantages of this method of attachment are added to the new device:
- (1) reduction of tissue necrosis by improving vascular circulation;
- (2) standardization and significant shortening of surgical procedure by means of 'click-on' mechanism for attachment to the malleus handle;
- (3) elimination of need for instruments and crimping to reduce the potential risks connected therewith;
- (4) improvement of audiological results as a result of gentle clip-on attachment to malleus handle.
l A modification of the CliP® àWengen
See magnified illustration and engineering drawing, pp. 4-8 to 4-9 ମ
3 K 002221
4 K 021479
2
2.10 Industry Standards: [807.92 (d)]
KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.
2.11 MRI Environment: 1807.92 (d)]
Testing in a 3.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
2.12 Information Bearing on the Safety and Effectiveness:
[807.92 (b)(3)]
Like some lengths of the K-Piston Titanium Stapedial Prosthesis, the CliP® Piston MVP is used for bridging the stapes and incus in cases of otosclerosis in malleovestibulopexy procedures. The ball joint eliminates implant bending. The click-on mechanism and the self-retaining clip design of the modified KURZ CliP® àWengen shorten the attachment procedure to the malleus handle, minimize the risks connected with instrument manipulation and, by improving vascular circulation, reduce the risk of tissue necrosis. The gentle attachment to the malleus handle along the axis of mechanical sound transmission is expected to result in equal if not better audiological postoperative hearing gain. 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.
3
| Device | CliP® Piston MVP | Titanium K-Piston
K 002221 | CliP àWengen
K 021479
(Only for Comparison of
CliP) |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 1006 711-13 0.4 mm
1006 761-63 0.6 mm | 1006 103 – 1006 170 | 1006 805 – 1006 861 |
| Intended Use | Bridging the stapes and incus in cases of
otosclerosis, specifically defects of the
ossicular chain between manubrium mallei
and vestibulum (malleovestibulopexy) | 1. Bridging the stapes in cases of
otosclerosis
2. Bridging the stapes and incus in
cases of otosclerosis, specifically
defects of the ossicular chain
between manubrium mallei and
vestibulum (malleovesti-bulopexy) | |
| Design | Standard KURZ Piston connected to
modified àWengen Clip w/ball joint
articulation
Image: [Piston MVP Design] | Standard KURZ Piston gradually
tapering towards band loop
Image: [Titanium K-Piston Design] | Standard KURZ Piston
with áWengen Clip
Image: [CliP aWengen Design] |
| # of Sizes | 6 (3 for each Ø) | 28 (14 for each Ø) | |
| Device
Lengths | 5.75 – 6.25 mm
(0.25 mm intervals) | 3.50 – 6.00 mm
(0.25 mm intervals)
6.00 – 10.00 mm
(1.00 mm intervals) | |
| Piston Ø | 0.4 + 0.6 mm | 0.4 + 0.6 mm | |
| Attachment to
Malleus Handle | Modified àWengen Clip | (Titanium band loop) | àWengen Clip |
| Implant
Manipulation | None: Articulation permits precise piston
bending to accommodate surgical site | Surgeon bends piston to almost 90°
for attachment to malleus handle | |
| Material | Titanium ASTM F67 | Titanium ASTM F67 | Titanium ASTM F67 |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Design
Comparison
- Implant | An open clip ( modified àWengen) is
attached to a 0.2 mm rectangular shaft. A
novel ball joint connection to the standard
KURZ piston (0.4 + 0.6 mm) permits
precise intra-operative 'bending' without
implant manipulation to exactly accom-
modate patient's physiological require-
ments. | A laterally displaced band loop is
attached to a 0.2 mm shaft that is
seamlessly laserwelded to the piston
(0.4 + 0.6 mm). Piston requires
almost 90° bending for attachment
to malleus handle. | An open clip (àWengen) is
attached to a 0.2 mm shaft
that is seamlessly
laserwelded to the piston
stem (0.4 + 0.6 mm) |
| Design
Comparision - CliP® | - The protuberance for grasping CliP has
been moved to end - Limb undulation has been changed to
conform to more oval circumference of
malleus handle - CliP limb opening and length was slightly
adjusted to assure precise fit around
malleus handle | | - The protuberance for
grasping CliP is located on
top of upper limb - Limb undulation has been
designed for exact fit
around long incudal
process |
| Custom
Accessories | KURZ Meter
Cat. # 8000 106 | Identical | |
| Safety &
Effectiveness
of Design
Changes
[807.92
(b)(1)] | The novel ball joint piston articulation
eliminates implant bending.
Attachment to the malleus handle with
the previously cleared tensile clip-on
mechanism5 shortens surgical
procedure, reduces risk of tissue
necrosis by improving vascular
circulation, reduces risk of implant
dislocation with high degree of
certainty, potentially improves long-
term hearing gain with appropriate
physiological conditions, and
significantly reduces risks of patient
trauma. Clinical test results confirm
the safety and effectiveness of this
design.
There are no known characteristics
that would introduce adverse effects. | | |
2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS
4
Heinz Kurz GmbH Medizintechnik
9/9/2004 11:37 AM
KURZ
Date 09/09/04 Signature
Heinz Kurz Gmar
Medizintechni.
Tübinger Stras
72144 Dusslingen, G
Phone +49 (0) 70 72790
Telefax +49 (0) 70 72/173
mip.twww.kulzmed.com
Uwe Steinhardt
Technical Director
CliP® Piston à Wengen K 021479 ર
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
OCT 1 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HEINZ KURZ GMBH MEDIZINTECHNIK c/o Business Support International Amstel 320-I Amsterdam, Netherlands 1017AP Attn: Dagmar Mäser
Re: K042503
Trade/Device Name: KURZ CLIP® Piston MVP Regulation Number: 21 CFR 874.3495 Regulation Name: Total Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETA Dated: September 14, 2004 Received: September 15, 2004
Dear Ms. Mäser:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 - Dagmar Mäser
This letter will allow you to begin marketing your device as described in your Section 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), 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 Mace facturers, 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 halyi 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
7
Indications for Use
Koyaso3 510(k) Number (if known):
Device Name: CLiP® Piston MVP
Indications for Use: Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)
9/9/2004 1:57 PM
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kasun L. Bake
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K042503
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