(74 days)
Not Found
Not Found
No
The document describes a physical medical device (a piston for ear surgery) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to bridge defects in the ossicular chain and stapes, which are medical procedures to treat conditions like otosclerosis, directly addressing a health problem.
No
The device descriptions and intended uses clearly state that these are implants for surgical procedures (bridging the stapes, ossicular chain defects), not for diagnosing conditions.
No
The device description clearly describes physical implants (pistons made of gold and titanium) intended for surgical implantation to bridge the stapes or ossicular chain. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these devices are implants (pistons) used for surgical procedures to bridge or replace parts of the ossicular chain in the ear. They are physically placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, these devices fall under the category of surgical implants rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
- (Fine Gold) a. K-Piston For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy).
- ANGULAR Piston (Gold with Titanium Bands) b. For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.
Product codes (comma separated list FDA assigned to the subject device)
77 ETB
Device Description
- K-Piston Like many of the SE devices, the K-Piston is shaped like a. a bishop's crosier. Its outstanding feature is the slightly laterally displaced, wide golden band. The bent end allows overclosure and, thus, extremely secure fastening, around long process of incus.
- ANGULAR Piston
An angled gold wire with two titanium bands, which are connected to the shorter leg. Specifically designed in cases of extreme arrosion of long incudal process.
Both devices are manufactured of fine gold (99.99%).
The implants are manufactured of one piece of pure gold; the two bands on the short leg of the ANGULAR Piston of pure titanium (99.99%).
Within the range necessary for implantation, any part of the prosthesis can be bent back and forth up to three times.
Placement of the K-Piston requires bending of the loop to attach it to the long incudal process. Placement of the ANGULAR Piston requires bending of the titanium clamps for attachment to the incudal process stump. In addition, the preset 90° angle will have to be adjusted in many cases.
Mentions image processing
The image quality may be impeded or blurred in direct vicinity of the implant.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
0.5 Tesla nuclear magnetic resonance tomograph
Anatomical Site
Stapes, ossicular chain (manubrium mallei, incudal process, vestibulum)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRIgenerated heating.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRIgenerated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K973356
Image /page/0/Picture/1 description: The image shows a logo with the word "KURZ" inside of a circle. The text and the circle appear to be made of small dots, giving it a textured or grainy appearance. The circle is not perfectly closed, with a gap at the top right. The overall impression is that of a stamp or an imprint.
Kurz GmbH technik
schrift: r Straße 3 4 Dußlingen
(0 70 72) 91 79 (0 70 72) 91 79
| Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen | Heinz K | ||
|---|---|---|---|
| 6. | 510(k) SUMMARY | ||
| As required by Section 807.92(c) | NOV 21 1997 | Medizin | |
| (1) | Submitter [807.92(a)(1)] | ||
| Dagmar S. Mäser | |||
| Business Support International | Hausan | ||
| Tübingen | |||
| D-7214 | |||
| Amstel 320-I | |||
| Amsterdam, 1017AP | |||
| The Netherlands | Tel. 011 - 31 - 20 - 428 9591 | ||
| Fax -428 9429 | |||
| e-mail bsi@xs4all.nl | Telefon | ||
| Telefax | |||
| (2) | Identification of Devices [807.92(a)(2)] | ||
| Proprietary Names | K-Piston; Angular Piston | ||
| Common Name | Middle Ear Pistons | ||
| Classification Name | Prosthesis, Partial Ossicular Replacement | ||
| Product Code | 77 ETB | ||
| Class | II | ||
| Regulatory Number | 874.3450 |
(3) Identification of Predicate Devices [807.92(a)(3)]
KURZ pistons are substantially equivalent in size and design to FDAapproved devices manufactured by Smith & Nephew Richards, Bartlett, TN, and XOMED, Jacksonville, FL, (which also markets TREACE devices). These devices have been found substantially equivalent through the 510(k) premarket notification process.
(4) Description of Device 1807.92(a)(4)]
Heinz
- K-Piston Like many of the SE devices, the K-Piston is shaped like a. a bishop's crosier. Its outstanding feature is the slightly laterally displaced, wide golden band. The bent end allows overclosure and, thus, extremely secure fastening, around long process of incus.
b. ANGULAR Piston
An angled gold wire with two titanium bands, which are connected to the shorter leg. Specifically designed in cases of extreme arrosion of long incudal process.
Both devices are manufactured of fine gold (99.99%).
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
1
Heinz Kurz GmbH Medizintechnik
510(k) Summary (Cont'd)
- Intended Use of Device | 807.92(a)(5)| (ર)
- (Fine Gold) a. K-Piston For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy).
- ANGULAR Piston (Gold with Titanium Bands) b. For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.
- Technological Characteristics and Adjustments (6) The implants are manufactured of one piece of pure gold; the two bands on the short leg of the ANGULAR Piston of pure titanium (99.99%).
Within the range necessary for implantation, any part of the prosthesis can be bent back and forth up to three times.
Placement of the K-Piston requires bending of the loop to attach it to the long incudal process. Placement of the ANGULAR Piston requires bending of the titanium clamps for attachment to the incudal process stump. In addition, the preset 90° angle will have to be adjusted in many cases.
(7) MRI Environment
1
. (
Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRIgenerated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer.
(8) Information Bearing on the Safety and Effectiveness
The KURZ K-Piston and ANGULAR Piston partial ossicular replacement prostheses have the same intended use as predicate devices. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.
Signature
Dagmar S. Maeser
10/20/97
Date
KRZ-PIST.SUM
6-2
Update 10/20/97
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH &" are written vertically along the left side of the logo. The words "HUMAN SERVICES" are written vertically along the right side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 | 1997
Ms. Dagmar S. Maeser Business Support International Amstel 320-I 1017 AP Amsterdam The Netherlands
Re: K973356
Heinz Kurz GmbH Medisintechnik Partial Ossicular Replacement Prosthesis Dated: October 20, 1997 Received: October 22, 1997 Regulatory Class: II 21 CFR 874.3450/Procode: 77 ETB
Dear Ms. Maeser:
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 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 misbranion.
If your device is classified (see above) into either class II (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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J.Liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure