NASAL SEPTAL BUTTON

K972060 · Boston Medical Products, Inc. · LFB · Jul 3, 1997 · EN

Device Facts

• Record ID: K972060
• Device Name: NASAL SEPTAL BUTTON
• Applicant: Boston Medical Products, Inc.
• Product Code: LFB · EN
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

To be used for non-surgical closure of nasal perforations.

Device Story

Nasal Septal Button is a medical device designed for non-surgical closure of nasal septal perforations. The device consists of two 3.2cm diameter silicone flanges connected by a 7mm diameter central post. It is intended to reduce symptoms associated with nasal perforations, specifically epistaxis and crusting. The device is placed by a clinician and can be trimmed to fit the patient's anatomy at the time of placement. It functions as a mechanical barrier to close the perforation.

Clinical Evidence

No clinical data provided. The submission relies on the established safety profile of the medical grade silicone material used in the device construction.

Technological Characteristics

Constructed from soft medical grade silicone. Features two 3.2cm diameter flanges connected by a 7mm diameter central post. Designed to be trimmable by the clinician during placement.

Indications for Use

Indicated for non-surgical closure of nasal perforations in patients requiring treatment for symptoms such as epistaxis and crusting.

Predicate Devices

• Product No. 20-10400 manufactured by Invotec International, Inc.

Submission Summary (Full Text)

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## JUL - 3 1997

SMDA Summary

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.

Product: Nasal Septal Button

Description: The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.

Indications For Use: To be used for non-surgical closure of nasal perforations.

Predicate Device: Product No. 20-10400 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.

Testing: Device is constructed using medical grade silicone, a well-established material for this application.

President

Stuart K. Montgomery, President

Date:

Submitted by:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stuart K. Montgomery President Boston Medical Products 117 Flanders Road Westborough, MA 01581 Re: K972060 Nasal Septal Button Dated: June 12, 1997 Received: June 16, 1997 Unclassified/Procode: 77 LFB

JUL - 3 1997

Dear Mr. Montgomery:

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 misbranion.

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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 [phone]. Additionally, for question 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/dsmamain.html".

Sincerely vours

ht. Jliau Yu
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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K97J060

Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 WeStborough, MANAGomery [phone] ext. 240

Page 1 of 1

510(k) Number (if known):

Device Name:

Nasal Septal Button

Indications For Use:

To be used for non-surgical closure of nasal perforations.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Vihil C. Segeam
(Division Sign-Off)

( - Cleron Of Reproductive, Abdominal, ENT,
Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

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