(45 days)
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Not Found
No
The summary describes a physical prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as restoring the hearing mechanism, which is a therapeutic action addressing loss, destruction, or damage to ear ossicles.
No
The device, a Partial Ossicular Replacement Prosthesis (PORP), is used to restore hearing by replacing or repairing damaged ear ossicles. This is a therapeutic or reconstructive function, not a diagnostic one. It treats a condition rather than identifying or characterizing one.
No
The device description explicitly states "Partial Ossicular Replacement Prosthesis (PORP)", which is a physical implantable device, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is a physical implant designed to replace damaged ear ossicles. Its purpose is to restore the mechanical function of hearing, not to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological specimens, chemical reactions, or diagnostic testing.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Product codes
77 ETB
Device Description
Partial Ossicular Replacement Prosthesis (PORP)
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
Ear
Indicated Patient Age Range
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Intended User / Care Setting
ear, nose and throat physicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 a logo for the Department of Health and Human Services. The logo consists of a stylized depiction of an abstract human figure with three wavy lines representing the hair or head. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo, curving to follow the shape of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Judy S. Chandler MedNet Locator, Inc. 7000 Shadow Oaks Memphis, TN 38125 Re: K972734 Partial Ossicular Replacement Prosthesis Dated: July 16, 1997 Received: July 22, 1997 Regulatory Class: II 21 CFR 874.3450/Procode: 77 ETB
SEP - 5 1997
Dear Ms. Chandler:
We have reviewed your Section 510(k) notification of intent to market the device 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 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, Tile 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 yours.
h.J.Liau Yin
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
Page 1 of of ------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_Partial Ossicular Replacement Prosthesis (PORP)
Indications For Use:
ﯽ ﺗ
The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Rume mctive, Redonneal, ENT, and Radiolomeai | |
| 510(k) Number | K972734 |
| Prescription Use_ | OR | Over-The-Counter Use_ |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)