(90 days)
None
Not Found
No
The summary describes a passive, solid silicone implant with no mention of software, data processing, or any AI/ML related terms or concepts.
Yes
The device is intended to augment or reconstruct congenital or traumatic chin deficiencies, which is a therapeutic purpose.
No
The device is an implantable medical device used to augment or reconstruct chin deficiencies, not to diagnose a medical condition.
No
The device description explicitly states it is manufactured from "medical grade solid silicone elastomer," indicating it is a physical implant, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Spectrum Designs Anatomical Chin Implant is a solid silicone elastomer device that is implanted into the body. It is a surgical implant used for augmentation or reconstruction.
The intended use and device description clearly indicate that this is an implantable medical device, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Spectrum Designs Anatomical Chin Implant is a silicone facial implant, designed to augment or reconstruct congenital or traumatic chin deficiencies.
Product codes (comma separated list FDA assigned to the subject device)
79FWP
Device Description
The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular region of the facial skeleton; 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.
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
6 1998 MAY
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT Y 98 Off 2 510K SUMMARY
1. Submitter's Data
| Spectrum Designs Inc.
5921 C. Matthews Street
Goleta, CA 93117 | Contact Person: Jim Dishman
Telephone: (805) 681-4899
Date Prepared: December 30, 1997 |
| ---------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
|---|
2. Device Name, Classification
Name: Spectrum Designs Anatomical Chin Implant FDA Classification: Class II, Prosthesis, Chin, Internal, Classification Number 79FWP, 21 CFR 878.3550
3. Identification of Substantially Equivalent Devices
Spectrum Designs Meniscus Chin Implant McGhan Medical Corp. Curvilinear Chin Implant Implantech Associates Anatomical Chin Implant
4. Device Description
The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.
5. Indications for Use
The Spectrum Designs Anatomical Chin Implant is a silicone facial implant, designed to augment or reconstruct congenital or traumatic chin deficiencies.
6. Contraindications for Use
Contraindications for routine aesthetic surgery include the presence of infection anywhere in the body and in particular, in the region in which the device will be implanted.
7. Warnings, Precautions
Possible complications include:
- Displacement of the implant may occur, especially from dissection of too large a . pocket.
- Errors in positioning the implant may result in patient dissatisfaction ●
- Tissue necrosis may result in extrusion of the implant. This can occur as a result ● of such factors as the pocket created being too small, use of too large an implant, or when soft tissues are inadequate to maintain coverage over the prosthesis
- Resorption of the underlying bone may occur with use of the implant. ●
- Fibrous tissue encapsulation can occur around any implant, with subsequent ◆ increased firmness, possible displacement, and/or pains.
- Complications from this or any similar surgery may include infection, neural ● damage, hematoma, poor would healing, patient intolerance to foreign body implantation, and other similar complications.
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 representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1898 MAY
Mr. Jim Dishman ·Spectrum Designs, Incorporated 5921-C Matthews Street 93117 Goleta, California
Re: K980462 Spectrum Designs Anatomical Chin Implant Trade Name: Requlatory Class: ı İ Product Code: FWP Dated: December 30, 1997 Received: February 5, 1998
Dear Mr. Dishman:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 obliqation 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.
2
Page 2 - Mr. Dishman
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 victo diagnobere actions), productionally, 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
INDICATIONS FOR USE
Applicant: Spectrum Designs Inc.
980462 510(k) Number ( if known):
Device Name: Spectrum Designs Anatomical Chin Implant
Indications for Use:
The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
× Prescription use Per 21 CFR 801.109
or
| Over-the counter | |
|---|---|
| Station of client |
(Division Sign-Off)
Division of General Restorative Devices,
510(k) Number K980462