(47 days)
Not Found
Not Found
No
The summary describes a solid silicone implant for facial augmentation and reconstruction. There is no mention of software, image processing, AI, or ML.
Yes.
The device is intended to augment or reconstruct the malar region of the face, which is a therapeutic purpose.
No
The device is a Spectrum Designs Projection Malar Implant, used to augment or reconstruct the malar region of the face. This is a therapeutic/reconstructive purpose, not a diagnostic one.
No
The device description explicitly states it is manufactured from "solid silicone elastomer" and is an "implant," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Spectrum Designs Projection Malar Implant is a physical implant intended to be surgically placed within the body to augment or reconstruct facial structure. It does not involve testing or analyzing biological samples.
- The device description focuses on the material and surgical placement. There is no mention of any components or processes related to analyzing blood, urine, tissue, or other bodily fluids or substances.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.
Product codes (comma separated list FDA assigned to the subject device)
79LZK
Device Description
Spectrum Designs Projection Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
malar region of the face, malar-zygomatic region of the facial skeleton
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.
Spectrum Designs Silhouette Malar Implant
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
SPECTRUM DESIGNS INC. PROJECTION MALAR IMPLANT 510k SUMMARY
MAR - 3 1998
498014
1. Submitter's Data
Spectrum Designs Inc. 5921 C Matthews Street Goleta, CA 93117
Contact Person: Telephone: Date Prepared:
Jim Dishman 805 681 4899 December 30, 1997
2. Device Name, Classification
Name: Spectrum Designs Projection Malar Implant FDA Classification: Class II, Implant, Malar, Classification 79LZK
3. Identification of Substantially Equivalent Devices
Spectrum Designs Silhouette Malar Implant
4. Device Description
Spectrum Designs Projection Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
5. Indications for Use
The Spectrum Designs Projection Malar Implant is a silicone facial implant, designed to augment or reconstruct the malar region 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Image /page/0/Picture/25 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. 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. Jim Dishman President Spectrum Designs, Incorporated 5921 C. Matthews Street Goleta, California 93117
MAR - 3 1998
K980139, K980140 & K980141 Re: Trade Name: Spectrum Designs Profile Malar Implant Spectrum Designs Medial Malar Implant and Spectrum Designs Projection Malar Implant Regulatory Class: II Product Code: LZK Dated: December 30, 1997 Received: January 15, 1998
Dear Mr. Dishman:
We have reviewed your Section 510(k) notifications 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 enclosures) 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 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 (OS) 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
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Page 2 - Mr. Dishman
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
Enclosures
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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.
K98014 * 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Spectrum Designs Projection Malar Implant
Indications For Use
.
The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region 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 | K980014 |
| Prescription Use | or | Over-the counter | |
|---|---|---|---|
| Per 21 CFR 801.109 |