K Number
K971478
Device Name
DURALASTIC ANATOMICAL CHIN IMPLANTS
Date Cleared
1997-07-18

(86 days)

Product Code
Regulation Number
878.3550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duralastic Anatomical Chin Implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.
Device Description
Duralastic Chin implants are crescent shaped concave convex Bilicone 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. The Duralastic Chin Implants will be provided sterile and nonsterile.
More Information

Not Found

No
The summary describes a physical implant made of silicone elastomer and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

No.
The device is described as an implant used for augmentation or reconstruction, which falls under the category of a medical device, but its primary function is not to treat or cure a disease or medical condition.

No
Explanation: The device is an implant used for augmentation or reconstruction, not for diagnosing conditions.

No

The device description clearly states it is a physical implant made from silicone elastomer, which is a hardware component.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
  • Device Description: The Duralastic Anatomical Chin Implants are described as "Bilicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation." This clearly indicates a device that is surgically placed inside the body.
  • Intended Use: The intended use is "to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery." This is a surgical procedure, not a diagnostic test performed on a specimen.

Therefore, based on the provided information, the Duralastic Anatomical Chin Implants are an implantable medical device, not an In Vitro Diagnostic.

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.
The Duralastic Anatomical Chin Implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.

Product codes

FWP

Device Description

Duralastic Chin implants are crescent shaped concave convex Bilicone 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. 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.

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, mandible

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)

K952708

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K971478

Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, CA 93446

JUL 1 8 1997

TAB H

510 (k) SUMMARY

PRODUCT DESCRIPTION

Duralastic Chin implants are crescent shaped concave convex Bilicone 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. The Duralastic Chin Implants will be provided sterile and nonsterile.

SUBSTANTIAL EQUIVALENCE

Under it original 510(k) K952708, Duralastic Chin implants were found SE to the Applied Biomedical chin implants. In fact the very same molds and materials used to produce the Duralastic Chin implants in the sterile form, because these molds were sold to Allied and Allied has not changed raw material suppliers.

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.

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 are sterilized via gamma radiation cycles of 2.5 - 4.2 Meqarads. 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.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its 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 Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, California 93446

JUL | 8 1997

K971478 Re:

Trade Name: Duralastic Anatomical Chin Implants Product Code: FWP

K971479

Trade Name: Duralastic Anatomical Malar Implants Product Code: LZK

K971481

Trade Name: Duralastic Anatomical Nasal Implants Product Code: ESR

Regulatory Class: II Dated: April 15, 1997 Received: April 23, 1997

Dear Mr. Hanson:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the

2

Page 2 - Mr. Gerald Hanson

current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

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

3

Page of

:

510 (k) Number K971478

Device Name : Duralastic Anatomical Chin Implants

Indications For Use:

The Duralastic Anatomical Chin Implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription Use iPer 21 CFR 801 109)

(Optional Format 1-2-96)

Over-The Counter Use

OR