(21 days)
Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.
Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large. The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular flanges come in varying diaments depending on the size of the button. The central post is elliptical in shape and can also be explained as an elongated circular section. The post dimensions vary with size and with the circular flange diameter based on the size of the nasal perforation and can be trimmed at the time of placement.
The provided text is a 510(k) pre-market notification for a medical device called the "Silmed Nasal Septal Button." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria and detailed performance results for the novel device.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether standalone performance (algorithm only) was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing "substantial equivalence" of the Silmed Nasal Septal Button to existing predicate devices (Nasal Septal Buttons from Boston Medical Products, Micromedics Inc., and Hood Laboratories Inc.) based on:
- Design concept
- Indications for use: "non-surgical closure of nasal septum perforations."
- Use of standard materials
- Feature comparisons
- Method of manufacture, cleaning, and device packaging
The FDA's decision to clear the device is based on this demonstration of substantial equivalence, not on independent performance testing against specific acceptance criteria for the new device outlined in the request.
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NOV 2 8 2001
Pre-market Notification 510(k) Summary of Safety and Effectiveness Information
MANUFACTURER
Silmed Incorporated 97 West 300 South Millville, UT 84326 Phone: (435) 753-7307 Fax: (435) 753-2207
MANUFACTURER CONTACT PERSON
Mr. Rama Gundlapalli Vice President and Chief Technology Office
PROPRIETARY NAME Silmed Nasal Septal Button
COMMON NAMES
Button, Nasal Septum Nasal Septal Button
CLASSIFICATION NAME Button, Nasal Septum
CLASSIFICATION REFERENCE Currently, no FDA classification exists for the Button, Nasal Septum
DEVICE PRODUCT CODE 77 LFB
CLASSIFICATION PANEL Ear, Nose and Throat Devices
PROPOSED REGULATORY CLASS
In accordance with FDA classification of Button, Nasal Septal as Class II medical devices, this device system is proposed for placement in Class II.
REASON FOR PREMARKET NOTIFICATION
The Silmed Nasal Septal Button is a new medical device proposed for placement in Class II.
SPECIAL CONTROLS
At this time, Food and Drug Administration generated Performance Standards applicable to Silmed Nasal Septal Button are not in force. However, Silmed, Inc. has looked at comparative configurations to demonstrate the substantial equivalence of the device. Additionally, Silmed, Inc. utilizes materials and vendor certifications, in-house standard operating procedures (SOP's) and ASTM standards, as appropriate.
INDICATIONS FOR USE
Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.
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SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES
SUBS LANTIALLY EQUIVALENT FREDICITE DE . Sees . Substantially equivalent of the Silmed Simed, Inc. befieves that sevelal commercially a famale do vices are used as predicate devices for comparison.
- Nasal Septal Button l. Boston Medical Products, Inc., West Borough, MA
- Micromedics Inc., Nasal Septal Button 2. Micromedics, Inc., Eagan, MN
- Hood Nasal Septal Button 3. Hood Laboratories Inc., Pembroke, MA
DEVICE DESCRIPTION
DEVICE DESCRIPTION
Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large.
The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular I he Similed Nasal Sepal Dutton reatures two on the size of the button. The central post is elliptical in tianges come in varying diaments depending on the other enay also be explained as an elongated circular section.
The post dimensions vary with size and with the circular flange diameter based on the size of the nasal I he post dimensions vary with size and with the oneana kenge and can be trimmed at the time of placement.
SUBSTATINTIAL EQUIVALENCE COMPARISION
SUBSTATINTIAL EQUIVALENCE COMI INSULES .
Based on the design concept, indications for use, use of standard materials, feature comparisons of selected Dased on the design concept, mateans is sufficient evidence exists to conclude that the Silmed Nasal production is substantially equivalent to existing legally marketed nasal sepal buttons.
To begin, the materials, method of manufacture, methods of cleaning and device packaging for all the I o ogin, the materials, mealou of mails are equivalent to those used for the predicate devices.
The Silmed Nasal Septal Buttons are indicated for use for non-surgical closure of nasal perforations. The The Similed Nasal Sepal Duttons are mansates increated for procedures involving septal perforations.
CONCLUSION
Based on the design concept, indications for use, use of standard materials and feature comparisons to the selected predicate devices, Silmed, Inc. believes that sufficient evidence exists to conclude that the Silmed Selected predicate devices, Similed, Includent to existing legally marketed nasal septal buttons.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Silmed, Inc. c/o Rama Gundlapalli Vice President and Chief Technology Officer 87 West 300 South Millville, UT 84326
Re: K013696
Trade/Device Name: Silmed Nasal Septal Button Regulatory Class: Unclassified Product Code: LFB Dated: October 31, 2001 Received: November 7, 2001
Dear: Mr. Gundlapalli:
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 above and we nave asseminent in interstate commerce prior to May 28, 1976, the stated in the onerounds) to wice Amendments, or to devices that have been reclassified in enacoment and of 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 therefore, maintons of the Act include requirements for annual registration, listing of devices, controls provisions or actice, 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 major regulations (1 remance ripproval), in the Code of Federal 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 (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 mspottonist are 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.
Keen baker / Gu. 2/14/21
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number __ KO136
Prescription Use _ 400 (Per 21 CFR 801.109)
N/A