(30 days)
Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.
Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.
The provided text is a 510(k) premarket notification for a medical device called "Seare Biomedical Silicone Blocks." This document primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or AI-assisted improvements.
Therefore, many of the requested details about acceptance criteria, study methodology, and AI integration cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The primary criterion is "substantial equivalence in material, function, performance, and design" to predicate devices.
- Reported Device Performance:
- Material: Made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer.
- Function: For carving a finished device by the surgeon for custom use. Designed for carving flatter devices for bone onlay or curved blocks for malar and chin implants.
- Appearance: Clear to slightly opaque. Optionally, pigments (e.g., Iron Oxide) can be added for opacity to light and radiographic exam.
- Sterility: Will be provided sterile.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None. The document explicitly states "Clinical Tests: None." This suggests no formal test set or clinical study was conducted for this premarket notification.
3. 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. No clinical tests or ground truth establishment based on expert review were conducted or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process was described.
5. 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
- None. There is no mention of AI assistance or MRMC studies in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a silicone block for implantation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices, not clinical performance data from the device itself.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image is a circular graphic with a complex, abstract design. The design features a combination of dark and light areas that create a swirling, organic pattern. The dark areas appear to be interconnected, forming a network of shapes against the lighter background. The overall effect is visually dynamic and somewhat resembles a stylized representation of a cell or a planetary surface.
SEP 3 0 1998
K987047 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 Blocks |
| Common Name: | Silicone Elastomer Carving Blocks |
| Classification Name: | Elastomer, Silicone Block |
Substantial Equivalence: The Seare Biomedical Silicone Block configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Silicone Blocks manufactured and marketed by Allied Biomedical J and Hanson Medical Inc. ...............
Device Description: Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.
Indications For Use: Seare Biomedical Silicone Blocks are inthe cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.
Predicate Devices: The Scare Biomedical Silicone Block configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Silicone Blocks manufactured and markeed by Allied Biomedical and Hanson Medical Inc. The products have identical indications for use and are offered in the same basic sizes and options.
Clinical Tests: None
Adverse S&E Information: None
William J. Deane, Jr., M.D.
William J. Seare, Jr. M.D President & C.E.O.
August 27, 1998
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
William J. Seare, M.D. President & C.E.O. Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121
JAN 1 0 2017
Re: K983043
Trade/Device Name: Seare Biomedical Silicone Block Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: MIC Dated: August 27, 1998 Received: August 31, 1998
Dear Mr. Seare:
This letter corrects our substantially equivalent letter of September 30, 1998.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmission or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drio and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, l'usting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractig and warranties. We remind you, however, that device labeling must be truthful and not mislering.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements af the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reportions of
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Page 2 - William J. Seare, M.D.
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David-Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K983043
Device Name: Seare Biomedical Silicone Blocks
Indications For Use:
Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.
(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 K983045
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Formal 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.