(55 days)
Allied Biomedical Nasal Implants, Allied Biomedical
Not Found
No
The 510(k) summary describes a passive silicone implant and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is used for augmentation and reconstruction of the nasal contour during rhinoplasty, which is primarily a cosmetic or reconstructive surgical procedure, not a treatment for disease or a therapeutic intervention.
No
The device is an implant used for augmentation and reconstruction of the nasal contour, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a silicone rubber implant, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "augmentation and reconstruction of the nasal contour during rhinoplasty." This is a surgical procedure performed on a patient's body.
- Device Description: The device is a "silicone rubber implant" designed for "implantation." This is a physical object inserted into the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly an implantable medical device used within the body for structural support and cosmetic purposes, not for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Seare Biomedical Nasal Implants are in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
Product codes
FZE
Device Description
Seare Biomedical Nasal Implants are"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal contour
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Clinical Tests: None
Key Metrics
Not Found
Predicate Device(s)
The Seare Biomedical Nasal Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Nasal Implants manufactured and marketed by Allied Biomedical.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.
0
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K982753 SEARE BIOMEDICAL CORPORATION
SEP 3 0 1998
510(k) Summary
| Contact Information: | Seare Biomedical Corporation
3190 Chula Vista Circle
Salt Lake City, Utah 84121
Telephone: 1(801) 355-5533
Facsimile: 1(801) 942-1999 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Seare Biomedical Nasal Implants |
| Common Name: | Silicone Elastomer Nasal Implants |
| Classification Name: | Prosthesis, Nose, Internal (per CFR section 878.3680) |
Substantial Equivalence: The Seare Biomedical Nasal Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Nasal Implants manufactured and marketed by Allied Biomedical
Device Description: Seare Biomedical Nasal Implants are"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.
Indications For Use: Seare Biomedical Nasal Implants are in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
Predicate Devices: The Seare Biomedical Nasal Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Nasal Implants manufactured and marketed by Allied Biomedical. The products have identical indications for use and are offered in the same exact size and options.
Clinical Tests: None
Adverse S&E Information: None
William A. Deane, Jr., M.D.
8/4/98
William J. Seare, Jr. M.D. President & C.E.O.
Date
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Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUM. SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
William J. Seare, M.D. President & C.E.O. Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121
Re: K982753 Trade Name: Seare Biomedical Nasal Implants Regulatory Class: II Product Code: FZE Dated: August 03, 1998 Received: August 06, 1998
Dear Dr. Seare:
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 requlatory 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 - Dr. William J. Seare
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Seare Biomedical Nasal Implants
Indications For Use:
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
(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 General Restorative Devices | |
| 510(k) Number | K9 82753 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)