(27 days)
Not Found
Not Found
No
The device description and intended use describe a passive silicone implant with no mention of AI/ML capabilities or data processing.
No
The device is used for augmentation or reconstruction of the chin, which is a structural modification for aesthetic or reconstructive purposes, not for treating a disease or condition.
No
Explanation: This device is an implant for augmentation or reconstruction, not for diagnosing medical conditions.
No
The device description clearly states it is manufactured from solid silicone elastomer and is implanted, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Spectrum Designs Cleft Chin Implant is a physical implant made of solid silicone elastomer that is surgically placed in the body. It is a medical device used for augmentation or reconstruction, not for testing samples from the body.
- Intended Use: The intended use is to augment or reconstruct a part of the face, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Spectrum Designs Cleft Chin Implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectrum Designs Cleft Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.
Product codes
EWP
Device Description
The Spectrum Designs Cleft Chin Implant is manufactured from 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular or chin area of the face
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)
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 4 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT 510K SUMMARY
1. Submitter's Data
Spectrum Designs Inc. 5921 C Matthews Street Goleta, CA 93117
Contact Person: Jim Dishman 805 681 4899 Telephone: Date Prepared: January 17, 1998
2. Device Name, Classification
Name: Spectrum Designs Cleft Chin Implant FDA Classification: Class II, Prosthesis, Chin, Internal, Classification Number 79FWP, 21 CFR 879.3550
3. Identification of Substantially Equivalent Devices
Spectrum Designs Cleft Chin Implant
4. Device Description
The Spectrum Designs Cleft Chin Implant is manufactured from 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.
5. Indications for Use
The Spectrum Designs Cleft Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.
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 depiction of a bird or eagle in flight, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Dishman Spectrum Designs, Incorporated 5921-C Matthews Street Goleta, California 93117
MAR - 4 1998
Re: K980461 Trade Name: Spectrum Designs Cleft Chin Implant Regulatory Class: II Product Code: EWP Dated: January 17, 1999 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requirement, 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. 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. ···
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 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,
Celia M. Witten, Ph.D., M.
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
Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire 510(k) submission must support and agree with the "indications for use" statement.
*For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: Spectrum Designs, Inc.
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ *
Device Name: Spectrum Designs Cleft Chin Implant
Indications For Use
The Spectrum Designs Cleft Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980461 |
| Prescription Use Per 21 CFR 801.109 | X | or Over-the counter |
|---|---|---|
| ------------------------------------- | ----------------------------------------- | --------------------- |