(463 days)
No
The 510(k) summary describes silicone implants for augmentation/reconstruction and does not mention any AI/ML terms, image processing, or performance studies related to algorithmic analysis. The predicate devices are also simple silicone implants.
No
The device is described as an implant for augmentation or reconstruction of facial contours, which is generally considered a cosmetic or aesthetic purpose rather than a therapeutic one aimed at treating a disease or condition.
No
The device, a silicone implant, is used for augmentation or reconstruction of contours, which is a therapeutic rather than a diagnostic purpose.
No
The device is described as silicone implants for augmentation or reconstruction, which are physical hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided information describes implants made of silicone intended for surgical augmentation or reconstruction of facial contours (nose, cheek, chin). These are devices that are surgically implanted into the body, not used to test samples from the body.
- Intended Use: The intended use clearly states augmentation or reconstruction of anatomical contours, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, this device falls under the category of a surgically implanted medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour
Silicone Malar Implant – For the augmentation or reconstruction of the malar contour
Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour
Product codes
FWP, ESR, LZK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, malar, and chin contours (facial)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized graphic of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hanson Medical, Inc. % Mr. Gerald Hanson P.O. Box 1160 Kingston, Washington 98346
Re: K090803
Trade/Device Name: Hanson Medical Facial Implants Regulation Number: 21 CFR 878.3550 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: FWP, ESR, LZK Dated: June 24, 2010 Received: June 28, 2010
JUN 3 0 2010
Dear Ms. 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 general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Gerald Hanson
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
TAB D
INTENDED USE FORM
510(k) Number K 973573 Silicone Nasal Implant K 973574 Silicone Malar Implant K 973575 Silicone Chin Implant
Device Name: Hanson Medical Facial Implants
Indications for use:
Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour
Silicone Malar Implant – For the augmentation or reconstruction of the malar contour
Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off Division of General and Restorative Devices 510(k) numbers K973573, K973574, K973575
Prescription Use
Optional Format 1-2-96
Division Sign-Off
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number