NASAL AIRWAY SPLINT

K972092 · Boston Medical Products, Inc. · LYA · Jul 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972092
• Device Name: NASAL AIRWAY SPLINT
• Applicant: Boston Medical Products, Inc.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Jul 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To maintain a nasal airway while providing septal support following surgery.

Device Story

Nasal Airway Splint provides septal support and maintains nasal airway post-operatively; features integral airway and preformed holes for suturing stabilization; supplied as sterile pair (left and right); constructed of medical-grade silicone; used by clinicians in surgical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Constructed of medical-grade silicone; includes integral airway and preformed holes for suturing; supplied sterile.

Indications for Use

Indicated for patients undergoing nasal surgery requiring septal support and maintenance of a nasal airway post-operatively.

Regulatory Classification

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.

Predicate Devices

• Invotec International, Inc. Product No. 20-10500

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Boston Medical Products. The logo consists of a stylized heart shape on the left, followed by the text "Boston Medical Products" stacked vertically. Below the text, there is a handwritten number "K972092".

## 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.

Description: The Nasal Airway Splint is designed provide septal support and allow nasal breathing post-operatively through the integral airway. The splints can be sutured through the preformed holes in the anterior tips for stabilization. The Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.

Indication For Use: To maintain a nasal airway while providing septal support following surgery.

Contraindications: None known.

Predicate Device: Product No. 20-10500 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.

Testing: Device is constructed using well-established medical grade silicone.

itted by:

Submitted by:

Stuart K. Montgomery, President

Date:

Boston Medical Products, Inc. 117 Flanders Road, Westborough, MA 01581 USA CUSTOMER SERVICE: 1-800-433-BMPI (2674) Tel: [phone] Fax: [phone]

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

川 - 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581

Re: K972092 Nasal Airway Splint Dated: June 3, 1997 Received: June 4, 1997 Regulatory class: Unclassified Procode: 77 LYA

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 interestated 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, 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 (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 notification submission does 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 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 questions on the promotion 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 yours

W.Lilian 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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Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 ATT: Stuart K. Montgomery [phone] ext. 240 1. 1. 1. 1.

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510(k) Number (if known):

K972092

Device Name:

ట్టుకుంటా

Nasal Airway Splint

Indications For Use:

To maintain a nasal airway while providing septal support following surgery.

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972092