(35 days)
Not Found
No
The device description focuses on the material composition and physical form of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an implant used to augment or reconstruct contour, which falls under structural modification rather than treatment or therapy for a disease or condition.
No
The device description indicates that the Duralastic Malar implants are used to augment or reconstruct the malar cheek contour or maxillary Zygoma, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a silicone elastomer rubber implant, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that the Duralastic Malar implants are "silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation." They are physically implanted into the body to augment or reconstruct the malar cheek contour or maxillary Zygoma.
- Intended Use: The intended use is to "augment or reconstruct the malar cheek contour or the maxillary Zygoma," which is a surgical procedure performed on the body, not a diagnostic test performed on a specimen.
The information provided describes a surgically implanted medical device, not a diagnostic test.
N/A
Intended Use / Indications for Use
To augment or reconstruct the malar cheek contour or the maxillary Zygoma.
Product codes (comma separated list FDA assigned to the subject device)
LZK
Device Description
Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been mutagenicity, biocompatibility, tested for thoroughly carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
malar cheek contour or the maxillary Zygoma
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
0
OCT 24 1997
Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185 510(k) Submission Malar Implants
TAB H
510 (k) SUMMARY
PRODUCT DESCRIPTION
Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been mutagenicity, biocompatibility, tested for thoroughly carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.
SUBSTANTIAL EQUIVALENCE
Under it original 510(k) K952707, Duralastic Malar implants were found SE to the Applied Biomedical malar implants. In fact the very same molds and materials used to produce the Duralastic Malar implants in the sterile form, because these molds were sold to Allied and Allied has not changed raw material suppliers.
INTENDED USE
Duralastic Malr implants are intended for use in augmentation and reconstruction of the cheek. They are intended for insertion via an intraoral or cilliary incision.
PHYSICAL AND CHEMICAL PROPERTIES
Duralastic Malar implants are manufactured from Applied The Silicone's LSR-30 part # 40029 and Nusil Technologies' MED 4211 MAF 612 which are platinum cured dimethyl polysiloxane systems. All chemical characterizations are found in Applied Masterfile MAF-562 amd Nusil's MAF 612
The physical properties are: Durometer 30 Shore A, Elongation 650%, Tensile Strength 950 PSI, tear strength Tear Die C 150 PSI, Specific Gravity 1.12, Modulus 300 PSI at 200% Elongation, Surface Smooth and Textured.
1
TAB H Continued
STERILIZATION CYCLE
Duralastic Malar Implants are sterilized via gamma radiation cycles of 2.5 - 4.2 Megarads. The validation of this cycle was designed and performed by STI of Brea, California. Sterigenics Corporation is the contract gamma sterilizer. The validation used Method i Testing as defined in the ANSI/AAMI/ISO 1137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization. SAL 10 to the minus 6th.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Ms. Kathy Hanson Richardson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155
Re: K973574
Trade Name: Duralastic Anatomical Malar Implants Regulatory Class: II Product Code: LZK Dated: September 15, 1997 Received: September 19, 1997
Dear Ms. Richardson:
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, market the device, 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 requirements , 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Kathy Hanson Richardson
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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely, yours,
M. Witten. Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INTENDED USE FORM
Page 1 of 1
510(k) Number - ₩分 长973574
Device Name: Silicone Elastomer Malar Implant
:
To augment or reconstruct the malar cheek Indications For Use: contour or the maxillary Zygoma.
Concurrence of CDRH, Office of Device Evaluat (ODE)
poxto
Division of General Restorative Devices
510(k) Number K973574
Presecription Use √
(Per 21 CFR 801.109)
OR
Over The Counter Use (Optional Format 1-2-96)