(519 days)
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.
The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.
Specifically, the devices are designed for the treatment of
- Otosclerosis (stapedial fixation) / congenital stapedial fixation 1.
-
- Traumatic injury to the ossicular chain
-
- Malformation of the middle ear
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation 4. of a prosthesis
The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67).
The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. The ContactFree Zones serve as heat blockers, limit heat dispersion on the mucosa and minimize the risk of incus stranqulation. The prosthesis comes with an accessory, the Thermo-Dummy®, to predetermine the lowest laser setting that will close the prosthesis loop outside the patient's ear before inserting the implant.
Here's an analysis of the provided 510(k) summary regarding the NiTiBOND Stapes Prosthesis, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly define acceptance criteria with quantifiable metrics for clinical performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The "performance specifications were met" statement refers to non-clinical tests rather than clinical outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance (NiTiBOND Stapes Prosthesis) |
|---|---|
| Clinical Performance: | |
| Equivalent hearing improvement | "post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices." |
| Safety | "as safe and effective as the predicate devices." |
| Effectiveness | "as safe and effective as the predicate devices." |
| No new safety/effectiveness issues | "The results of non-clinical and clinical design and performance validations raise no new issues of safety and effectiveness." |
| Non-Clinical Performance: | |
| Coupling Effectiveness | "The performance specifications were met." |
| Stability of Coupling during Sound Transmission | "The performance specifications were met." |
| MRI Environment Compatibility | "MR Conditional 1.5, 3 + 7 Tesla" (demonstrated compatibility with predicate devices) |
| Biocompatibility | "Yes" (demonstrated compatibility with predicate devices) |
| Shelf Life | "The performance specifications were met." |
| Sterilization Validation | "The performance specifications were met." |
| Packaging Validation | "The performance specifications were met." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "According to published literature, post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices." This implies that the clinical performance claim is based on literature review and comparison with published data for other legally marketed stapes prostheses (the predicate devices).
- Sample Size for Test Set: Not explicitly stated for this device's clinical performance assessment. The statement refers to "published literature" for predicate devices, so the sample sizes would be those of the studies included in that literature.
- Data Provenance: Not explicitly stated for this device's clinical performance, other than "published literature." For predicate devices, the original studies would have their own provenance (e.g., country, retrospective/prospective). This submission does not provide original clinical data for the NiTiBOND Stapes Prosthesis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no specific "test set" and no panel of experts convened to establish ground truth for this device's clinical performance in this 510(k) submission. The evaluation relies on comparability to existing devices whose performance is presumably established in published literature.
4. Adjudication Method for the Test Set
Not applicable. As there was no specific clinical test set for the NiTiBOND Stapes Prosthesis with original data collection, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a medical implant (stapes prosthesis), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI-related improvement effects are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical performance claim is the established clinical performance and safety profiles of legally marketed predicate devices, as documented in "published literature." This implicitly means that the predicate devices' performance was established through clinical outcomes data (e.g., audiometry results, patient reported outcomes, complication rates from clinical trials or retrospective studies).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model. There is no concept of a "training set" in this context. The non-clinical tests (e.g., MRI compatibility, biocompatibility) are conducted on samples of the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and standards (e.g., ASTM standards for material properties, ISO standards for biocompatibility).
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Page 1 of 4
FEB 8 2013
510(k) SUMMARY of Safety and Effectiveness
As required by CFR Section 807.92(c)
- Submitter [807.92 (a)(1)] Heinz Kurz GmbH Medizintechnik Tübinger Str. 3 D-72144 Dusslingen Germany +49-7072-91 79 0 Tel. Fax +49-7072-91 79 79 Email info@kurzmed.de
2. Submission Correspondent [807.92 (a)(1)] Dagmar Mäser Business Support International V.O.F. Amstel 320-l 1017 AP Amsterdam The Netherlands1 +31-20-428 95 91 Tel. + 1-828-622-7572 Tel. Fax +31-20-201-0175 Email bsi@xs4all.nl
-
- Date Summary Prepared [807.92 (a)(1)] February 4, 2012
-
- Reason for Submission [807.92(3)(i)] New Device
| 5. Device Names | [807.92 (a)(2)] |
|---|---|
| Proprietary | NiTiBOND Stapes Prosthesis |
| Common | Stapes Prosthesis, Stapes Piston |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Product Code | 77 ETB |
| Regulation # | CFR 874.3450 |
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Page 2 of 4
7. Device Description [807.92(a)(4)]
The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67).
The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. The ContactFree Zones serve as heat blockers, limit heat dispersion on the mucosa and minimize the risk of incus stranqulation. The prosthesis comes with an accessory, the Thermo-Dummy®, to predetermine the lowest laser setting that will close the prosthesis loop outside the patient's ear before inserting the implant.
8. Statement of Intended Use [807.92(a)(5)]
The prosthesis is intended for ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis acts as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.
The prosthesis consists of a nickel-titanium alloy (Nitinol) loop and a pure titanium piston (ASTM F67).
Specifically, the device is designed for the treatment of
- (1) Otosclerosis (stapedial fixation) / congenital stapedial fixation
- (2) Traumatic iniurv to the ossicular chain
- (3) Malformation of the middle ear
- (4) Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
9. Performance Data [807.92(b)]
(i) Non-Clinical Performance Tests [807.92(b)(1)]
The performance specifications were met. The following tests were conducted:
- Coupling Effectiveness .
- Stability of Coupling during Sound Transmission .
- MRI Environment .
- Biocompatibility .
- . Shelf Life Testing
- Sterilization Validation .
- Packaging Validation .
(ii) Clinical Evaluation [807.92(b)(2)]
According to published literature, post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices.
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Page 3 of 4
| NITIBONDStapes Prosthesis | SMart Piston | EclipseNitinol Piston | CliP® PistonáWengen | |
|---|---|---|---|---|
| Device | Heinz KURZ GmbH | GYRUS ACMI -Olympus | GRACE Medical Inc. | Heinz KURZGmbH |
| K112616 | K003214 | K063374 | K021479 | |
| DesignComparison | Image: NITIBOND Stapes Prosthesis | Image: SMart Piston | Image: Eclipse Nitinol Piston | Image: CliP® Piston áWengen |
| Intended Use | The prosthesis isintended for ossicularreplacement to restorefunctionality to themiddle ear in cases ofpathological changesof the soundtransmission system. | Identical | Identical | Identical |
| Method ofAttachment | Heat Application | Heat Application | Heat Application | Manual |
| # of Sizes | 16 (8 for each Ø) | 15 (5 for each Ø) | 12 (6 for each Ø) | 16 (8 for each Ø) |
| DimensionsLength[mm] | 3.5 - 5.5(0.25 mm intervals) | 3.75 - 4.75(0.25 mm intervals) | 3.75 - 5.0(0.25 mm intervals) | 3.5 - 5.5(0.25 mm intervals) |
| Piston Ø[mm] | 0.4 / 0.6 | 0.5 / 0.6 / 0.8 | 0.5 / 0.6 | 0.4 / 0.6 |
| Width ofLoop Band[mm] | 0.25 | Wire | Wire | 0.25 |
| MaterialsLoopPiston | NitinolTitanium (ASTM F67) | NitinolFluoroplastic | NitinolFluoroplastic | Titanium (ASTM F67)Titanium (ASTM F67) |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| MRI | MR Conditional1.5, 3 + 7 Tesla | MR Conditional3 Tesla or less | MR Conditional3 Tesla or less | MR Conditional1.5, 3 + 7 Tesla |
| Biocompatible | Yes | Yes | Yes | Yes |
| Accessory | Thermo-Dummy® todetermine lasersetting for closing theloop outside thepatient's ear prior toimplant insertion | No | No | Not Applicable |
10. Comparison with Predicate Devices [807.92(a)(6)]
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11. Information Bearing on Device Safety and Effectiveness [807.92 (b)(3)]
[807.92 (b)(3)]
The differences between the KURZ NiTiBOND Stapes Prosthesis and the predicate devices are designed to enhance the safety and effectiveness of stapedotomy procedures.
Nonclinical and clinical testing demonstrate that the KURZ NiTiBOND is as safe and effective as the predicate devices.
There are no known characteristics that would introduce adverse effects.
The results of non-clinical and clinical design and performance validations raise no new issues of safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Heinz Kurz GmbH Medizintechnik % Ms. Kristina Bitzer Manager Regulatory Affairs Maeser Support International, V.O.F. Amstel 320-1 Amsterdam Neitherlands
Re: K112616
Trade/Device Name: NitiBond Stapes Prosthesis Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: January 28, 2013 Received: February 6, 2013
Dear Ms. Bitzer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Kristina Bitzer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann for
Malvina B. Eydelman, M.D. Director Division of Opthalmic and Ear, Nose, and Throat Devices Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112616
Device Name:
KT12979
NiTiBOND Stapes Prosthesis
Indications for Use:
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.
The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.
Specifically, the devices are designed for the treatment of
- Otosclerosis (stapedial fixation) / congenital stapedial fixation 1.
-
- Traumatic injury to the ossicular chain
-
- Malformation of the middle ear
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation 4. of a prosthesis
Prescription Use X (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 OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic and Ear, Nose and Throat Devices | |
| 510(k) Number | K112616 |
| Page 1 of 1 | |
|---|---|
| ------------- | -- |
§ 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.