SEARE BIOMEDICAL NASAL IMPLANTS by SEARE BIOMEDICAL CORP.

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.

Device Description

"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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Seare Biomedical Nasal Implants." It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically associated with performance evaluations of AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device based on material, function, performance, and design, as well as identical indications for use.

Here's an analysis based on your requested information categories:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criteria" for a 510(k) submission of this type is substantial equivalence to a predicate device.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported because the device is a passive implant, not a diagnostic or AI-powered system that generates numerical results. The performance is deemed equivalent to the predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set was used for this type of evaluation. The submission states "Clinical Tests: None." This indicates that no human subject data was collected or analyzed for this 510(k) clearance.
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 test set or ground truth establishment by experts was performed for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set required adjudication.
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
- No MRMC study was done. This device is a silicone nasal implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth measurements were described or required for this type of device clearance.
The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment was involved.

In summary, the provided document is a 510(k) submission for a traditional medical device (nasal implants) based on substantial equivalence, not a performance study for an AI/ML-powered device. Therefore, most of the requested information regarding acceptance criteria, test sets, experts, and AI-related studies is not present or applicable.

Summary

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K982753 SEARE BIOMEDICAL CORPORATION

SEP 3 0 1998

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 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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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.

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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.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

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Seare Biomedical Nasal Implants

Indications For Use:

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(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)

Regulation Number and Section

§ 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.