(49 days)
Not Found
No
The device description focuses solely on the material and physical form of the chin implant, with no mention of software, algorithms, or any AI/ML related terms. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an implant used to augment or reconstruct the chin, which aligns with the definition of a therapeutic device as it is intended to treat or alleviate a medical condition or deformity.
No
Explanation: The device description clearly states its purpose is to "augment or reconstruct the chin or mandibular contour," indicating a therapeutic or reconstructive function rather than diagnosis. There is no mention of it detecting or analyzing any medical condition.
No
The device description clearly states it is a silicone elastomer implant, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "augment or reconstruct the chin or each and class and currentaun indicacionandibular contour." This is a surgical procedure performed directly on the patient's body for cosmetic or reconstructive purposes.
- Device Description: The device is a "crescent shaped concave convex Duralastic silicone elastomer rubber implant made from specially formulated silicone elastomers designed for implantation." This describes a physical implant intended to be placed inside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly an implantable medical device used inside the body (in vivo) for surgical purposes, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
Duralastic Chin implants are intended for use in augmentation and reconstruction of the chin. They are intended for insertion via an intraoral or submental incision.
To augment or reconstruct the chin or each and class and currentaun indicacionandibular contour.
Product codes (comma separated list FDA assigned to the subject device)
FWP
Device Description
Chin implants are crescent shaped concave convex Duralastic silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies' MAF 612. The Duralastic Chin Implants will be provided sterile and nonsterile.
Duralastic Chin implants are manufactured from Applied The Silicone's LSR-30 part # 40029 which is a platinum cured dimethyl polysiloxane system. All chemical characterizations are found in Applied Masterfile MAF-562 and in Nusil Technologies 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chin
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
KY15212
NOV - 7 1997
Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185 510 (k) Submission Chin Implant
TAB H
510 (k) SUMMARY
PRODUCT DESCRIPTION
Chin implants are crescent shaped concave convex Duralastic silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies' MAF 612. The Duralastic Chin Implants will be provided sterile and nonsterile.
SUBSTANTIAL EQUIVALENCE
Duralastic Chin implants are SE to the Allied Biomedical chin implants K971478. They are soft solid silicone implant grade cresent shaped implants in various sizes and styles.
INTENDED USE
Duralastic Chin implants are intended for use in augmentation and reconstruction of the chin. They are intended for insertion via an intraoral or submental incision.
PHYSICAL AND CHEMICAL PROPERTIES
Duralastic Chin implants are manufactured from Applied The Silicone's LSR-30 part # 40029 which is a platinum cured dimethyl polysiloxane system. All chemical characterizations are found in Applied Masterfile MAF-562 and in Nusil Technologies 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.
STERILIZATION CYCLE
Duralastic Chin Implants will be sterilized via gamma radiation cycles of 2.5 - 4.2 Megarads. The validation of this cycle was
1
TAB H 510 (k) Summary
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerald Hanson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155
NOV - 7 1997
Re: K973575
Trade Name: Duralastic Anatomical Chin Implant Regulatory Class: II Product Code: FWP Dated: September 18, 1997 Received: September 19, 1997
Dear Mr. Hanson:
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
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 vours.
Acoella
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1973575
Page 1 of 1
510(k) Number - N/A
Device Name: Silicone Elastomer Chin Implant
Indications For Use: To augment or reconstruct the chin or
each and class and currentaun indicacionandibular contour.
Concurrence of CDRH, Office of Device Evaluation (ODE) | |
---|---|
(Division Sign-Off) | |
Division of General Restorative Devices | |
510(k) Number | 14973575 |
Presecription Use ✓ OR Over The Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)