(329 days)
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Not Found
No
The summary describes a physical prosthesis for the middle ear and contains no mention of AI, ML, or related concepts.
Yes
The device is used to treat defects, injuries, or congenital malformations in the middle ear, which aligns with the definition of a therapeutic device.
No
The device is a prosthesis used to correct defects in the ossicular chain, meaning it treats a condition rather than diagnosing it.
No
The device description clearly states "CAUSSE UNIVERSAL HA PROSTHESIS", indicating a physical prosthesis, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to address defects in the ossicular chain of the middle ear. This is a surgical implant used within the body to restore function.
- Device Description: It's described as a "HA PROSTHESIS," which is a type of implantable device.
- Anatomical Site: The middle ear is an internal anatomical site.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a physiological state, health, disease, or congenital abnormality based on sample analysis.
- Any laboratory or diagnostic testing context.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical implant used to physically replace or repair a structure within the body.
N/A
Intended Use / Indications for Use
This product may be used for any defect in the ossicular chain of injury or congenital malformation.
Product codes
77 ETA, 77 ETB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
middle ear
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
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§ 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Margaret Blackmore Regulatory Affairs Exmoor Plastics Ltd. Lisieux Way · · · ······ ··· Taunton, TA1 2LB, U.K.
Re: K963899
Causse Universal Ossicular Replacement Prosthesis Dated: July 29, 1997 ------. . . . Received: August 12, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETA 21 CFR 874.3495/Procode: 77 ETB
Dear Ms. Blackmore:
AUG 22 1997
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 Device Amendments, or to 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 misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (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 yitto 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.7liau 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
R
1
K963899 510(k) Number (if known)
CAUSSE UNIVERSAL HA PROSTHESIS Device Name: CAUSSE UNIVERSAL HAY ROOTHESTS
(formerly 'Causse Universal Ossicular Replacement Prosthesis)
Indications for Use:
This product may be used for any defect in the ossicular chain of
injury of This product may be used for any acreen in any delection of the middle ear, injury or congenital malformation.
9PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CORH, Office of Device Evaluation (ODE)
David A. Koyama
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiologica! Device; 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Optional Format 1-2-96)