(35 days)
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Not Found
No
The summary describes a physical prosthesis for middle ear reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Prosthesis" used for "total reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect" to treat "hearing loss." This directly indicates a therapeutic purpose.
No
The device description indicates it is a prosthesis for reconstruction of the ossicular chain, and the intended use describes conditions that lead to hearing loss, for which this device is a treatment, not a diagnostic tool.
No
The device description explicitly states it is a prosthesis made from Hydroxylapatite and HAPEX, which are physical materials, indicating it is a hardware device, not software.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a prosthesis used for the surgical reconstruction of the ossicular chain in the middle ear. It is an implantable device used in the body, not a device used to test samples from the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed These devices have the same indications for use, total reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.
Indications For Use:
- Otosclerosis .
- Congenital fixation of the stapes .
- When previous remedial surgery has been unsuccessful for the treatment of hearing loss . due to otosclerosis, and a significant conductive loss remains with good cochlear reserve.
- Chronic middle ear disease .
- Trauma .
Product codes (comma separated list FDA assigned to the subject device)
87 ETA
Device Description
The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed These devices have the same indications for use, total reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The head of the Bojrab Micro-TORP Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction, as are the heads of the two predicate devices. The Bojrab Micro-TORP Prosthesis and the predicate devices all have trimmable shafts. The Bojrab and Black implant shafts are made from HAPEX and the Schwaber implant shaft is manufactured from FLEX H/A.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Food and Drug Administration 510(k) Notification - Boirab Micro-TORP Prosthesis February 22, 1999
KG90601
510(k) Summary of Safety and Effectiveness
| Trade Name: | Bojrab Micro-TORP Prosthesis |
|---|---|
| Common Name: | Total Ossicular Replacement Prosthesis |
| Classification Name: | Total Ossicular Replacement Prosthesis (§ 874.3495) |
| Official Contact: | Alicia E. Farage |
| Senior Regulatory Affairs Specialist | |
| Smith & Nephew, Inc. | |
| ENT Division | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | February 22, 1999 |
The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed These devices have the same indications for use, total reconstruction of the by Xomed. ossicular chain that has lost its function due to disease, trauma, or congenital defect. The head of the Bojrab Micro-TORP Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction, as are the heads of the two predicate devices. The Bojrab Micro-TORP Prosthesis and the predicate devices all have trimmable shafts. The Bojrab and Black implant shafts are made from HAPEX and the Schwaber implant shaft is manufactured from FLEX H/A.
Differences between the Bojrab Micro-TORP Prosthesis and the predicate devices should not affect the safety or effectiveness.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Ms. Alicia E. Farage Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 2925 Appling Road Bartlett, TN 38133
Re: K990601 Trade Name: Bojrab Micro-TORP Prosthesis Regulatory Class: II Product Code: 87 ETA Dated: March 4, 1999 Received: March 5, 1999
Dear Ms. Farage:
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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
2
Page 2 - Ms. Alicia E. Farage, Sr. Regulatory Affairs Specialist
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,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Food and Drug Administration 510(k) Notification - Bojrab Micro-TORP Prosthesis February 22, 1999
510(k) Number: Device Name:
- 946601 Bojrab Micro-TORP®
Indications For Use:
- Otosclerosis .
- Congenital fixation of the stapes .
- When previous remedial surgery has been unsuccessful for the treatment of hearing loss . due to otosclerosis, and a significant conductive loss remains with good cochlear reserve.
- Chronic middle ear disease .
- Trauma .
(Division Sign-Off) Division of Ophthalmic Devices K99060 510(k) Number ـ
Karen Bohm (for HRS)
Prescription Use
(Per 21 CFR 801.109)