(77 days)
The Porex Nostril Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty.
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
The provided text is a 510(k) summary for a medical device called the "Porex Nostril Retainer." This document outlines the device description, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence or statistical methods typically found in studies proving device efficacy.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these elements are not present in the provided text.
The document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool, and thus does not contain the kind of performance data usually associated with AI/ML-based medical devices.
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8 1374
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4715 Roosevelt Highway, College Park, Georgia 30349 USA (770) 969-8145 · · (800) 521-7321 · · Fax: (770) 969-8045
510(k) SUMMARY
Manufacturer and Submitter
Porex Surgical, Inc. 4715 Roosevelt Highway College Park, GA 30349
Tel: (770) 969-8145 Fax: (770) 969-8045
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
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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 (301) 594-4613. 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/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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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
§ 874.4780 Intranasal splint.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.