(47 days)
The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.
Spectrum Designs Profile 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.
The provided text is a 510(k) summary for the "Spectrum Designs Profile Malar Implant". It describes the device, its indications for use, and identifies substantially equivalent devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot populate the table or answer the questions as the information is not present in the provided text. The document primarily focuses on the regulatory submission process and the characteristics of the device itself, not on performance studies or acceptance criteria.
Missing Information:
- Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are mentioned.
- Sample size and data provenance: No study details are provided, so sample size and data provenance are unknown.
- Number of experts and qualifications: No study details are provided, so expert information is unknown.
- Adjudication method: No study details are provided, so adjudication method is unknown.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone algorithm performance: This is a physical implant, not an algorithm, so this question is not applicable.
- Type of ground truth: No study details are provided, so ground truth type is unknown.
- Training set sample size: No study details are provided, so training set information is unknown.
- How ground truth for training set was established: No study details are provided, so training set ground truth establishment is unknown.
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SUMMARY OF SAFETY AND EFFECTIVENESS
SPECTRUM DESIGNS INC. PROFILE MALAR IMPLANT 510K SUMMARY
MAR - 3 1998
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 Profile 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 Profile 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 Profile 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 implantation, and other similar complications.
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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 the department's name encircling a stylized emblem. The emblem consists of three abstract human figures, possibly representing health, family, and community. The figures are interconnected, symbolizing the department's mission to protect the health of all Americans.
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 (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
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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.
K980139 * 510(k) Number (if known):
Device Name: Spectrum Designs Profile Malar Implant
Indications For Use
The Spectrum Designs Profile 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 Devices510(k) NumberK980139 | (Division Sign-Off) | Division of General Restorative Devices | 510(k) Number | K980139 | ||
| (Division Sign-Off) | ||||||
| Division of General Restorative Devices | ||||||
| 510(k) Number | K980139 | |||||
| Prescription UsePer 21 CFR 801.109 | or | Over-the counter __________ |
§ 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.