(57 days)
Not Found
Not Found
No
The 510(k) summary describes a simple silicone rod used for surgical reconstruction and cosmetic correction. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The device is a passive implant shaped by the surgeon.
Yes
The device is used for cosmetic correction of soft tissue deformities and aid in reconstruction, which falls under therapeutic use.
No
Explanation: The device is a silicone rod intended for cosmetic correction and surgical repair, not for diagnosing medical conditions.
No
The device description clearly states it is a physical silicone rod made from silicone elastomers, intended for implantation and surgical shaping. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cosmetic correction of soft tissue deformities and surgical repair procedures. This involves direct interaction with the patient's body as an implant or temporary stent.
- Device Description: The device is a silicone rod intended to be shaped and implanted by a surgeon.
- Lack of In Vitro Testing: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed for testing biological samples in vitro (in a lab setting) to provide diagnostic or other health-related information. This device is an implantable medical device used in vivo (within the body).
N/A
Intended Use / Indications for Use
Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly incrt and flexible rod shaped material as deemed appropriate by the using surgeon.
Product codes (comma separated list FDA assigned to the subject device)
MIB
Device Description
Seare Biomedical Silicone Rods are made from specially formulated silicone elastomers designed for implantation. The intended use of the Seare Biomenical silicone rod is for forming a finished device by the surgeon for his or her own custom use. Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The Seare Biomedical Silicone Rods will be provided in 15cm or 30 cm lengtiss, 3FR - 28FR sizes, sterile and nonsterile. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is dear to slightly opaque. Surface characteristics will vary from smooth to varving degrees of texturing and porosity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
None
Description of the test set, sample size, data source, and annotation protocol
None
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
1983630
DEC 1 1 1998
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 Rods |
| Common Name: | Silicone Elastomer Rods |
| Classification Name: | Elastomer, Silicone Block |
Substantial Equivalence: The Seare Biometical Silicone Rod configurations are substantially equivalent in material, function, performance, and design to the Sil-Tec Rod manufactured and marketed by Technical Products, Inc., and the silicone rods manufactured and marketed by Bentec Medical, Inc.
Device Description: Seare Biomedical Silicone Rods are made from specially formulated silicone elastomers designed for implantation. The intended use of the Seare Biomenical silicone rod is for forming a finished device by the surgeon for his or her own custom use. Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The Seare Biomedical Silicone Rods will be provided in 15cm or 30 cm lengtiss, 3FR - 28FR sizes, sterile and nonsterile. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is dear to slightly opaque. Surface characteristics will vary from smooth to varving degrees of texturing and porosity.
Indications For Use: Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly incrt and flexible rod shaped material as deemed appropriate by the using surgeon.
Predicate Devices: The Seare Biomedical Silicone Rod configurations are substantially equivalent in material, function, performance, and design to the Sil-Tec Rod manufactured and marketed by Technical Products, Inc., and the silicone rods manufactured and marketed by Bentec Medical, Inc. The products have comparable indications for use and are offered in the same basic sizes and options.
Clinical Tests: None
Adverse S&E Information: None
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. William J. Seare, Jr., M.D. President and Chief Executive Officer Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121
Re: K983630 Trade Name: Seare Biomedical Silicone Rods Regulatory Class: Unclassified Product Code: MIB Dated: October 12, 1998 Received: October 15, 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 (OS) 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
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.D.
a 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): | K983630 |
|---|---|
| --------------------------- | --------- |
Device Name: Seare Biomedical Silicone Rods
Indications For Use:
Seare Biomedical Silicone Rods are intended for use in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create an implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly inert and flexible rod shaped material as deemed appropriate by the using surgeon.
(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 K983630
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)