(234 days)
Trans Nasal Batten, Gortex Guided Tissue Regeneration Device
Not Found
No
The summary describes a physical implant made of ePTFE and titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The intended use explicitly states "augmentation or cosmetic alteration of the nasal shape or contour," which falls under cosmetic rather than therapeutic purposes.
No
The device description indicates its purpose is for "augmentation or cosmetic alteration of the nasal shape," which is a treatment or modification, not a diagnostic function. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description explicitly states it is comprised of ePTFE and Medical Grade Titanium Alloys, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "Augmentation or cosmetic alteration of the nasal shape or contour." This describes a surgical implant used directly on the patient's body for structural and aesthetic purposes.
- Device Description: The description details a physical implant made of ePTFE and titanium alloys, designed for surgical insertion into the nose.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the body) as a surgical implant.
N/A
Intended Use / 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.
Product codes
FZE
Device Description
The Monarch Nasal Implant is a Class II Device.
The Monarch Nasal Implant is available in 48mm and 44mm lengths, 1cm wide in the middle and 1cm wide at the ends. The implant is an elongated oval. Beveling is 1.5mm to 2mm around the edges.
The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
The Monarch Nasal Implant of Trans Nasal Batten, Gortex Guided Tissue Regeneration Device.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.
0
FEB 1 1 7005
February 4, 2005
TAB H
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)
Mark N Milkeson
Division of General, Restorative, and Neurological Devices
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