SILIMED NASAL RETAINER

K980221 · Silimed, LLC · LYA · Apr 2, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K980221
• Device Name: SILIMED NASAL RETAINER
• Applicant: Silimed, LLC
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients). Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

Silimed Nasal Retainer is a silicone elastomer device used for prophylaxis of stenosis and cicatricial structures following nasal surgery. It features two channels to maintain nasal patency and septum position while allowing immediate postoperative breathing. The device is soft, smooth, and adjustable in length. It is intended for single-patient use and is available in 13 sizes. It is inserted by a physician in a clinical setting to support tissue healing and prevent collapse or scarring post-rhinoplasty.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Silicone elastomer (HCRA 35M). Form factor: 13 sizes, two-channel design, adjustable length. Sterilization: Ethylene oxide. Connectivity: None. Software: None.

Indications for Use

Indicated for patients of all ages undergoing aesthetic and reconstructive rhinoplasty, rhinoseptoplasty, rhinoseptocheiloplasty, or primary/secondary rhinocheiloplasty (cleft-lip nose).

Regulatory Classification

Identification

An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

Predicate Devices

• Doyle Combo Nasal Airway Splint (K972151)
• Bivalve Nasal Splint (K972096)

Submission Summary (Full Text)

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K980221

Silimed. L.L.C.

#### 14014 Sullyfield Circle Suite C

Chantilly, Virginia 20151

#### SMDA SUMMARY

## APR - 2 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 .CFR 807.92.

Description: The Silimed Nasal Retainer was designed for prophylaxis of stenosis and cicatricial structures. It is recommended for all age groups, and for any type of nose. It has a functional format and can be sectioned by adjusting the length according to the requirement.

The Silimed Nasal Retainer is composed of chemically and mechanically resistance silicone elastomer (HCRA 35M). The elastomer is soft, smooth of surface and contains a defined volume of elastomer whose shape, density and overall consistency have been chosen to replace human tissue. It has a defined length, width and circumference for the two channels that form the opening for the right and left nostril.

The advantages of the Silimed Nasal Retainer are: 1) maintains the septum in a vertical position, 2) allows for nasal breathing immediately after the operation, without blocking air flow, 3) painless and non-traumatic, 4) easy to keep clean and 5) single patient use.

The Silimed Nasal Retainer is available in 13 sizes .

Silimed's Nasal Retainer is sterilized by ethylene oxide. The method of sterilization is shown on the package, which is a double peel pouch. An individual confirmation of each batch is carried out, as well as a quarterly confirmation by an independent laboratory.

Indications for Use: The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

# Predicate Device: Company

Boston Medical Products Boston Medical Products

Product Doyle Combo Nasal Airway Splint Bivalve Nasal Splint

510(k)Number K972151 K972096

Submitted by:

E.J.Smith, Consultant

Date:

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Silimed. LLC E.J. Smith Consultant c/o Smith Associates P.O. Box 4341 Crofton, MD 21114

Re:

K980221

Silimed Nasal Retainer Dated: January 22, 1998 Received: January 22, 1998 Regulatory class: Unclassified Procode: 77 LYA

APR - 2 1998

Dear Mr. Smith:

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 maior regulations affecting your device can be found in the Code of Feleral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/odrb/dsmaldsmamain.html".

Sincerely yours,

Kiliai Yi~

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K980221

Device Name: Silimed Nasal Retainer

Classification Panel: LYA

## Indications for Use:

The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhio onlined russure rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use_

Ehrid L. Begemann
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number