(70 days)
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).
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.
The provided text is a 510(k) summary for the Silimed Nasal Retainer, which is a regulatory submission to the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI or medical device might.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted or is not applicable to this document. The 510(k) process focuses on comparing a new device to an existing one, not on proving new clinical performance criteria in a traditional study.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance metrics from a formal study. It focuses on describing the device, its indications for use, and asserting substantial equivalence to predicate devices based on design and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: There is no "test set" and no sample size mentioned because this is not a performance study that tested a device against a dataset. The 510(k) submission is a regulatory declaration, not a clinical trial report of performance metrics.
3. 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/Not Provided: No experts were used in this context to establish ground truth for a test set, as no performance study with a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No adjudication method is mentioned as there is no performance study or test set.
5. 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
- Not Applicable/Not Provided: No MRMC study was done, as this device is a physical nasal retainer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This is not an algorithm or AI device, so no standalone performance study in that context would be conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: The concept of "ground truth" as it pertains to performance studies is not relevant to this 510(k) submission.
8. The sample size for the training set
- Not Applicable/Not Provided: No training set is mentioned as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: No training set is mentioned, so no ground truth establishment is discussed.
Summary of Relevant Information from the K980221 Submission:
- Device Name: Silimed Nasal Retainer
- Purpose of Submission: To demonstrate substantial equivalence to predicate devices for regulatory clearance (510(k)).
- Device Description: Made of chemically and mechanically resistant silicone elastomer (HCRA 35M), designed to be soft, smooth, and to maintain the septum in a vertical position after nasal surgery. Available in 13 sizes.
- Indications for Use: After aesthetic and reconstructive rhinoplasty, rhinoseptoplasty, rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).
- Predicate Devices:
- Sterilization: Ethylene oxide, confirmed for each batch and quarterly by an independent laboratory.
- Regulatory Decision: Determined substantially equivalent to legally marketed predicate devices.
This document describes a medical device and its regulatory clearance process based on its similarity to existing devices, not on specific performance metrics derived from a clinical study with acceptance criteria.
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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:
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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:
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
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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
§ 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.