(72 days)
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No
The summary describes a physical prosthesis for ossicular replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used to replace ossicles and restore hearing for individuals with conductive hearing loss, which is a therapeutic function.
No
Explanation: The device, an ossicular replacement prosthesis, is indicated for treatment of conductive hearing loss by restoring the function of the ossicular chain, not for diagnosing a condition.
No
The device description clearly states "Partial Ossicular Replacement Proshesis Total Ossicular Replacement Prostheses Porous Polyethylene Ossicular Replacement," which are physical implants, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an "Ossicular replacement prosthesis" and its intended use is to "function of the ossicular chain when a conductive hearing loss is present." This involves surgically implanting a device to restore mechanical function within the middle ear.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely mechanical and restorative.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include
- Chronic middle ear disease ●
- . Otosclerosis
- Congenital fixation of the stapes
- Secondary surgical intervention to correct for a significant and persistent conductive . hearing loss from prior otologic surgery
- Surgically correctible injury to the middle ear from trauma .
Product codes
77 ETB, 77 ETA
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
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 or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Anthony D. Prescott President Grace Medical, Inc. 7715 Highway 70 Suite 109 Bartlett, TN 38133
Re:
OCT - 8 1997 K972815 Partial Ossicular Replacement Proshesis Total Ossicular Replacement Prostheses Porous Polyethylene Ossicular Replacement Dated: July 11, 1997 Received: July 18, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETB 21 CFR 874.3495/Procode: 77 ETA
Dear Mr. Prescott:
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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 vours.
h.D.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
1
510(k) Number (if known):
Device Name Partial & Total Ossicular Replacement Prosthesis
Indications For Use
Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include
- Chronic middle ear disease ●
- . Otosclerosis
- Congenital fixation of the stapes
- Secondary surgical intervention to correct for a significant and persistent conductive . hearing loss from prior otologic surgery
- Surgically correctible injury to the middle ear from trauma .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Daniel L. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number