(16 days)
Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)
The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.
The provided document is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. It focuses on demonstrating substantial equivalence to predicate devices based on design and safety characteristics, rather than reporting on specific performance outcomes from a clinical study with predefined acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness simply does not exist within this 510(k) submission.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided in the 510(k) summary.
The 510(k) summary focuses on demonstrating substantial equivalence based on design similarities and a qualitative assessment of safety and effectiveness, rather than quantitative performance against pre-defined acceptance criteria from a specific study.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the 510(k) summary.
No specific "test set" and its sample size are mentioned, as this is a premarket notification based on design changes and comparison to predicate devices, not a clinical trial reporting on performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided in the 510(k) summary.
No "ground truth" establishment in a clinical context is described, as there is no reported performance study with a test set.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the 510(k) summary.
No adjudication method is described, as there is no reported performance study with a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done or reported in this 510(k) summary.
The submission focuses on design modifications and claims that the new device, by improving handling and reducing risks, is "expected to result in equal if not better audiological postoperative hearing gain." This is a qualitative statement of expectation, not a result from a comparative effectiveness study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable/Not provided in the 510(k) summary.
This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not relevant.
7. The Type of Ground Truth Used
Not applicable/Not provided in the 510(k) summary.
No ground truth is described in the context of a performance study. The "safety and effectiveness" claims are based on design comparisons to predicate devices and theoretical advantages of the new design features. The statement "Clinical test results confirm the safety and effectiveness of this design" is made, but no details of these "clinical test results" are provided, nor is the nature of the "ground truth" used.
8. The Sample Size for the Training Set
Not applicable/Not provided in the 510(k) summary.
No training set is mentioned, as this is not an AI/algorithm-based device and no such study is described.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the 510(k) summary.
No training set is mentioned, and therefore, no ground truth establishment for it.
Summary of what is present in the document relevant to safety and effectiveness:
- Rationale for Design Changes: The document clearly outlines the reasons for modifying the device, primarily focusing on facilitating intraoperative handling, reducing risks of patient trauma, and improving post-operative sound transmission.
- Safety Features: Mention of reduced tissue necrosis by improving vascular circulation, standardization and shortening of surgical procedures, elimination of instruments and crimping, and reduction of potential risks.
- Theoretical Performance Improvement: Expectation of "equal if not better audiological postoperative hearing gain" due to gentle clip-on attachment and alignment with sound transmission axis.
- MRI Compatibility: Testing in a 3.0 Tesla NMR tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
- Comparison to Predicate Devices: A detailed table compares the new device (CliP® Piston MVP) to its predicate devices (Titanium K-Piston and CliP® àWengen) in terms of design, intended use, materials, and specific features, highlighting the modifications and their perceived benefits.
- Conclusion on Safety and Effectiveness: The document concludes that the results of design validation raise no new issues of safety and effectiveness, and that "clinical test results confirm the safety and effectiveness of this design," though these results are not detailed.
Essentially, this 510(k) submission argues for substantial equivalence primarily through comparison of design features and theoretical benefits based on those design changes, rather than providing detailed data from a quantitative performance study with explicit acceptance criteria.
{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 PistonCleared 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-PistonK 002221 | CliP àWengenK 021479(Only for Comparison ofCliP) |
|---|---|---|---|
| Catalog # | 1006 711-13 0.4 mm1006 761-63 0.6 mm | 1006 103 – 1006 170 | 1006 805 – 1006 861 |
| Intended Use | Bridging the stapes and incus in cases ofotosclerosis, specifically defects of theossicular chain between manubrium malleiand vestibulum (malleovestibulopexy) | 1. Bridging the stapes in cases ofotosclerosis2. Bridging the stapes and incus incases of otosclerosis, specificallydefects of the ossicular chainbetween manubrium mallei andvestibulum (malleovesti-bulopexy) | |
| Design | Standard KURZ Piston connected tomodified àWengen Clip w/ball jointarticulationImage: [Piston MVP Design] | Standard KURZ Piston graduallytapering towards band loopImage: [Titanium K-Piston Design] | Standard KURZ Pistonwith áWengen ClipImage: [CliP aWengen Design] |
| # of Sizes | 6 (3 for each Ø) | 28 (14 for each Ø) | |
| DeviceLengths | 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 toMalleus Handle | Modified àWengen Clip | (Titanium band loop) | àWengen Clip |
| ImplantManipulation | None: Articulation permits precise pistonbending 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 |
| DesignComparison- Implant | An open clip ( modified àWengen) isattached to a 0.2 mm rectangular shaft. Anovel ball joint connection to the standardKURZ piston (0.4 + 0.6 mm) permitsprecise intra-operative 'bending' withoutimplant manipulation to exactly accom-modate patient's physiological require-ments. | A laterally displaced band loop isattached to a 0.2 mm shaft that isseamlessly laserwelded to the piston(0.4 + 0.6 mm). Piston requiresalmost 90° bending for attachmentto malleus handle. | An open clip (àWengen) isattached to a 0.2 mm shaftthat is seamlesslylaserwelded to the pistonstem (0.4 + 0.6 mm) |
| DesignComparision- CliP® | - The protuberance for grasping CliP hasbeen moved to end- Limb undulation has been changed toconform to more oval circumference ofmalleus handle- CliP limb opening and length was slightlyadjusted to assure precise fit aroundmalleus handle | - The protuberance forgrasping CliP is located ontop of upper limb- Limb undulation has beendesigned for exact fitaround long incudalprocess | |
| CustomAccessories | KURZ MeterCat. # 8000 106 | Identical | |
| Safety &Effectivenessof DesignChanges[807.92(b)(1)] | The novel ball joint piston articulationeliminates implant bending.Attachment to the malleus handle withthe previously cleared tensile clip-onmechanism5 shortens surgicalprocedure, reduces risk of tissuenecrosis by improving vascularcirculation, reduces risk of implantdislocation with high degree ofcertainty, potentially improves long-term hearing gain with appropriatephysiological conditions, andsignificantly reduces risks of patienttrauma. Clinical test results confirmthe safety and effectiveness of thisdesign.There are no known characteristicsthat 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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.