(70 days)
Not Found
No
The device description focuses on the physical properties and function of a silicone nasal retainer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for prophylaxis of stenosis and cicatricial structures after various rhinoplasty procedures, indicating a therapeutic role in preventing complications and aiding recovery.
No
The device description clearly states its purpose as a retainer for prophylaxis of stenosis and cicatricial structures, maintaining the septum, and allowing nasal breathing after surgery. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description explicitly states it is composed of silicone elastomer and has a defined physical shape and dimensions, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Silimed Nasal Retainer Function: The Silimed Nasal Retainer is a physical device designed to be inserted into the nasal passages within the body. Its purpose is to provide structural support and maintain the shape of the nose after surgery. It does not analyze or test any biological specimens.
The description clearly indicates it's a medical device used for post-surgical support and prophylaxis of complications, not for diagnostic testing.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
77 LYA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
all age groups
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
§ 874.4780 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.
0
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
Submitted by:
E.J.Smith, Consultant
Date:
1
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:
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 (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/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
2
Page 1 of 1
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