(30 days)
Not Found
Not Found
No
The device description and intended use focus on the material properties and physical form of silicone sheeting for various surgical applications. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is used for various medical applications, including wound dressings, management of scarring, joint spacers, and repair of different anatomical structures such as the nasal septum, orbital floor, and tympanic membrane, all of which are therapeutic interventions.
No
The device description and indications for use clearly describe a material used for various surgical repairs, splinting, and wound dressings, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "flexible, translucent, medical grade silicone elastomer sheeting material" and is available in "polyester mesh reinforced and nonreinforced in a variety of thicknesses," indicating it is a physical material, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of this device clearly indicate it is a medical implant or surgical material designed for direct application within the body for various structural and reconstructive purposes. It is used for splinting, wound dressings, tissue repair, joint spacing, and other surgical interventions.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For short term application the indications for use are:
- nasal splinting; .
- wound dressings; .
- management of hypentrophic or kcloid scarring; .
- to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; .
- temporary joint spacers; .
- laboratory uses. .
For long-term application the indications for use are:
- nasal septal repair; .
- orbital floor reconstruction;
- tympanic membrane repair: .
- dialysis shunt anchoring:
- duramater repair:
- staged repair of omphaloccic;
- for lengthening extra ocular muscles in select cases of strabismus;
- as a protective sheathing to help facilitate neural regeneration and tendon anastomosis;
- as a protective sheathing to help facilitate osteogenesis;
- guided tissue regeneration between teeth and gingival margin, or external ear canal for example;
- other uses deemed appropriate by the using surgeon.
Warning: Not for permanent use in Temporo Mundibular Joint applications.
Product codes (comma separated list FDA assigned to the subject device)
MIB
Device Description
Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal, wound, soft tissue, joint, tympanic membrane, dialysis shunt, duramater, extra ocular muscles, neural, tendon, osteogenesis, teeth, gingival margin, external ear canal, subcutaneous tissue, facial, muscular, Temporo Mandibular Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Tests: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows a black circle on a white background. The circle is solid black, with some slight variations in the darkness of the black color. The circle is centered in the image and takes up most of the space. There are some minor imperfections around the edges of the circle.
SEARE BIOMEDICAL CORPORATION
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 Silicone Sheeting |
| Common Name: | Silicone Elastomer Sheeting |
| Classification Name: | Elastomer. Silicone Block |
Substantial Equivalence: The Seare Biometical Silicone Sheeting configurations are substantially equivalent in material, function, performance, and design to the Silicone Elastomer Sheeting manufactured and marketed by Dow Corning and Bentec Medical.
Device Description: Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.
Indications For Use: Seare Biomedical Silicone sheeting is intended for a variety of uses. For short term applications for use are: nasal splinting; wound dressings; management of hypentrophic or keloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus; temporary joint spacers; and laboratory uses.
For long-term application the indications for use are: nasal septal floor reconstruction; tympanic membrane repair; dialysis shunt anchoring: duramater repair of omphalocele; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or example; subcutaneous tissue augmentation; subcutaneous tissue suspentation; facial suspension; muscular and facial reinforcement; and other uses deemed appropriate by the using surgeon.
Warning: Not for permanent use in Temporo Mandibular Joint applications.
Predicate Devices: The Seare Biomedical Silicone Sheeting configurations are substantially equivalent in material, function, performance, and design to the Silicone Sheeting manufactured and marketed by Dow Corning and Bentec Medical. The products have virtually identical indications for use and are offered in the same basic sizes and options.
Clinical Tests: None
Adverse S&E Information: None
William J. Seare, Jr., M.D.
William J. Seare, V.M.D.
illiam J. Seare. Jr. M.D. President & C.E.O.
August 27, 1998
Date
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 image of an eagle or bird with its wings spread, with human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
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: K983041 Trade Name: Seare Biomedical Silicone Sheeting Regulatory Class: Unclassified Product Code: мів Dated: August 27, 1998 Received: August 31, 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 The general controls provisions of the Act 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Cella 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): | K983041 |
|---|---|
| --------------------------- | --------- |
Device Name: Seare Biomedical Silicone Sheeting
Indications For Use:
For short term application the indications for use are:
- nasal splinting; .
- wound dressings; .
- management of hypentrophic or kcloid scarring; .
- to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; .
- temporary joint spacers; .
- laboratory uses. .
For long-term application the indications for use are:
- nasal septal repair; .
- orbital floor reconstruction;
- tympanic membrane repair: .
- dialysis shunt anchoring:
- duramater repair:
- staged repair of omphaloccic;
- for lengthening extra ocular muscles in select cases of strabismus;
- as a protective sheathing to help facilitate neural regeneration and tendon anastomosis;
- as a protective sheathing to help facilitate osteogenesis;
- guided tissue regeneration between teeth and gingival margin, or external ear canal for example;
- other uses deemed appropriate by the using surgeon.
Warning: Not for permanent use in Temporo Mundibular Joint applications.
(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 | K983011 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)