MONARCH NASAL IMPLANT

K041690 · Hanson Medical, Inc. · FZE · Feb 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041690
• Device Name: MONARCH NASAL IMPLANT
• Applicant: Hanson Medical, Inc.
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

Device Story

Monarch Nasal Implant is a nasal prosthesis used for cosmetic augmentation or contouring of the nasal dorsum and widening of narrow noses. Device consists of ePTFE material and Grade I Titanium alloy. Implant is available in 48mm and 44mm lengths, with varying thicknesses. Surgeon inserts implant via transcutaneous, intercartilaginous, or open technique. Device provides structural support to nasal tissues to achieve desired aesthetic outcome. Sold sterile in double peel pouch packaging.

Clinical Evidence

No clinical data provided; bench testing only. Physical and chemical properties evaluated per FDA files on ePTFE and Titanium. Sterilization validated to 10^-6 sterility assurance level. Packaging shelf-life established per ISO 10993.

Technological Characteristics

Materials: ePTFE and Grade I Titanium Alloy (ASTM F-67). Dimensions: 48mm and 44mm lengths, 1.5mm to 2mm edge tapering, 0.003 to 0.010 inch thickness. Sterilization: Validated to 10^-6 sterility assurance level. Form factor: Nasal implant for surgical insertion.

Indications for Use

Indicated for patients requiring augmentation or cosmetic alteration of nasal shape or contour, specifically for straightening the nasal dorsum or widening a narrow nose.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Predicate Devices

• The Monarch Nasal Implant of Trans Nasal Batten
• Gortex Guided Tissue Regeneration Device

Submission Summary (Full Text)

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# FEB 1 1 7005

#### February 4, 2005

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## REVISED 510(K) SUMMARY STATEMENT

The Monarch Nasal Implant by Hanson Medical, Inc., is substantially equivalent to the The Monarch Nasal Implant of Trans Nasal Batten, and the Gortex Guided Tissue Regeneration Device.

The Monarch Nasal Implant is a Class II Device.

The Intended use of the Monarch Nasal Implant is to augment or cosmetically change the I he intended use of the Monaton Nasal Infpical in the narrow nose and straighten the nasal dorsum.

Labeling and packaging will be similar to the predicate device with an outer carton and a Labeling and packaging will be simmal to the product will be sold sterlie.
double peel pouch inside with appropriate labels. The product will be sold steries double peel pouch miside will appropriate idio. As purance Level of 10 to the minus Stermization methods are vanuated to a Berestablish the 3-year expiration date of the packaging as per ISO 10993.

Physical and Chemical properties are reflected in the files at FDA on ePTFE and Medical Physical and Chemical properties are rerrest in Titanium ASTM F-67. The Titanium is
Grade Titanium Alloys. Certification is Grade I Titanium Ally Grade Thamum Anoys. Cortification is as a man Nickel Alloy (Nitinol) is only minimally shapeable.

The ePTFE component has a high temperature tolerance. It is a waxy white clock-like I he er I F C component has a mgh wirigh tear and tensile strength. The material with various degrees of porcery and inguinents have demonstrated a good percentage of elongation is 10w. Bour of these common of the ePTFE is 25 to 30 tregree of blocompanible in various thicknesses from .003 to .010 inches.

Sizes and configurations -- The Monarch Nasal Implant is available in 48mm and 44mm Sizes and contigurations - The Mondron Nation I (acar and 1cm wide at the ends. The icinguis in an omplied. Brering is 1.5mm to 2mm around the edges.

The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous I he Monarch Nasal Infplant may of Intercartilaginous Approach and The Open Technique.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2005

Mr. Gerald Hanson President Hanson Medical, Inc. P.O. Box 1160 Kingston, Washington 98346

Re: K041690

Trade/Device Name: Monarch Nasal Implant Regulation Number: 21 CFR 878.3680 Regulation Name: Nose prosthesis Regulatory Class: II Product Code: FZE Dated: January 19, 2005 Received: January 19, 2005

Dear Mr. Hanson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may) attras 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 (PMA). it n your devicet to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or uny I editare are are are requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or R Part 877) havenes (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quarty affections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot notification. The FDA finding of substantial equivalence of your device to a legally promated 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectorers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041690

Device Name: Monarch Nasal Implant Indications For Use:

For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K041690

Mark N Milkeson

Division of General, Restorative, and Neurological Devices

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