POREX NOSTRIL RETAINERS

K981374 · Porex Surgical, Inc. · LYA · Jul 2, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981374
• Device Name: POREX NOSTRIL RETAINERS
• Applicant: Porex Surgical, Inc.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Jul 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Porex Nostril Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty.

Device Story

Nasal retainer; U-shaped silicone device with tubular legs; inserted into nostrils post-rhinoplasty/rhinoseptoplasty/rhinocheiloplasty. Function: maintains nasal passage patency; reduces post-operative swelling. Used in clinical settings by healthcare providers. Device is identical to predicate in design and material; differences limited to sterilization method and labeling.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and material to the predicate device.

Technological Characteristics

Silicone material; U-shaped form factor with tubular legs for nostril insertion. Passive mechanical device. Sterilization method modified from predicate.

Indications for Use

Indicated for patients undergoing aesthetic and reconstructive rhinoplasty, rhinoseptoplasty, rhinoseptocheiloplasty, or primary/secondary rhinocheiloplasty to maintain nasal passage patency and reduce swelling.

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

• Nasal Retainer manufactured by Silimed Inc.

Submission Summary (Full Text)

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8 1374

Image /page/0/Picture/2 description: The image shows the logo for Porex Surgical Inc. The logo consists of a black and white checkered square with a white circle in the center, followed by the word "POREX" in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL INC." in smaller, black letters.

4715 Roosevelt Highway, College Park, Georgia 30349 USA [phone] · · [phone] · · Fax: [phone]

## 510(k) SUMMARY

Manufacturer and Submitter

Porex Surgical, Inc. 4715 Roosevelt Highway College Park, GA 30349

Tel: [phone] Fax: [phone]

Contact: Howard Mercer, Ph.D.

Date: May 30, 1997

Trade Name: Porex Nostril Retainer Classification Name: Nasal Conformer - Class II Device

Substantially equivalent to: A) Nasal Retainer manufactured by Silimed Inc.

Device description:

A nasal retainer is used after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty to assist in keeping the nasal passages open and reduce swelling. It is a silicone U shaped with the legs of the U being tubes that are inserted into the nostrils.

The device of this submission is the predicate device and is identical to the predicate device, in all aspects except for method of sterilization and labeling

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Rockville MD 20850

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.

Food and Drug Administration

9200 Corporate Boulevard

- 2 1998 JUL

Howard A. Mercer, Ph.D. Regulatory Affairs Porex Surgical Inc. 415 Roosevelt Highway College Park, GA 30349

Dear Dr. Mercer:

Re:

K981374 Porex Nostril Retainers Dated: April 15, 1998 Received: April 16, 1998 Regulatory class: Unclassified Procode: 77 LYA

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we lave 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 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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 clagnostic 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/cdrh/dsmaldsmam.html".

Sincerely yours,

William Yin

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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Image /page/2/Picture/0 description: The image shows the logo for Porex Surgical Inc. The logo consists of a black and white checkered square with a white circle in the center, followed by the words "POREX" in large, bold, black letters. Below "POREX" is the text "SURGICAL INC." in a smaller font.

Kag 1374 510(k) Number :_

Device Name: _Nostril Retainer

Indications for Use:

The Porex Nostril Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty.

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Prescription Use:
(Per 21CFR801.109

OR

Over the Counter Use: ________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K98/374

510(k) Number