CUSTOM NASAL SPLINT

K972082 · Boston Medical Products, Inc. · LYA · Jul 3, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972082
• Device Name: CUSTOM NASAL SPLINT
• Applicant: Boston Medical Products, Inc.
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

Device Story

Custom Nasal Splints are passive, implantable medical devices used in post-surgical nasal applications. Constructed from medical-grade fluoroplastic (Teflon) or silicone, these splints are designed to be trimmed by a surgeon to fit specific patient anatomy. The device is inserted into the nasal cavity by a physician to provide structural support to the septum and act as a physical barrier to prevent adhesions between the septum and the lateral nasal wall. The splints are supplied sterile and are intended for prescription use.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: medical-grade fluoroplastic (Teflon) or medical-grade silicone. Form factor: splints available in various thicknesses, trimmable by surgeon. Sterilization: supplied sterile.

Indications for Use

Indicated for patients undergoing nasal surgery requiring septal support and prevention of adhesions between the septum and lateral nasal wall.

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 Nos. 20-10670, 20-10675, 20-10685, 20-10680, and 20-10686

Submission Summary (Full Text)

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K972082

## 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.

Description: The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses.

The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.

Indication For Use: To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

Contraindications: None known.

Predicate Device: Product Nos. 20-10670, 20-10675, 20-10685, 20-10680, and 20-10686 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.

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

by:

Submitted by:

Stuart K. Montgomery, President

Date:

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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: K972082 Custom Nasal Splint Dated: June 12, 1997 Received: June 16, 1997 Unclassified/Procode: 77 LYA

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, 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 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 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 vitto 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 yours.

William 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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Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 WeStborough, MA 0100mery [phone]. ext. 240 ...... ....... ... ... ... ...

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972082

510(k) Number (if known):

Device Name:

Custom Nasal Splint

Indications For Use:

To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall 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)

ਾਸ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Segner
(Division Sign. Off.)

(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological D 510(k) Number