(30 days)
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; and 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.
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.
The provided document, K983041, is a 510(k) summary for the Seare Biomedical Silicone Sheeting. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria.
Therefore, this document does not contain information on acceptance criteria for device performance or a study proving the device meets such criteria in the way a clinical trial would.
Instead, the submission focuses on establishing substantial equivalence based on material, function, performance, and design to already approved Silicone Elastomer Sheeting products.
Here's a breakdown of why the requested information is absent from this specific K983041 document:
- A table of acceptance criteria and the reported device performance: Not applicable. This document does not establish performance criteria for a novel device, but rather asserts equivalence to existing ones.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of a performance study described here. The submission refers to the material, function, performance, and design of the device's characteristics compared to predicates.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. While experts (engineers, material scientists) would have been involved in the design and manufacturing of the device, their role in establishing "ground truth" for a performance study for this type of 510(k) is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for a performance study is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a silicone sheeting material, not an AI-powered diagnostic or assistive technology.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their materials, intended use, and history of safe marketing.
- The sample size for the training set: Not applicable. There is no training set as this is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
Key takeaway from the document:
- Clinical Tests: The document explicitly states "Clinical Tests: None." This indicates that no new clinical studies were conducted to prove the safety and effectiveness of this specific device for its 510(k) clearance.
- Substantial Equivalence: The basis for clearance is "Substantial Equivalence" to predicate devices (Dow Corning and Bentec Medical Silicone Elastomer Sheeting) in terms of material, function, performance, and design. The FDA's letter concurs with this finding.
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SEARE BIOMEDICAL CORPORATION
510(k) Summary
| Contact Information: | Seare Biomedical Corporation3190 Chula Vista CircleSalt Lake City, Utah 84121Telephone: 1(801) 355-5533Facsimile: 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
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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.
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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
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| 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)
§ 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.