(90 days)
The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.
The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.
This document, K980463 for "Spectrum Designs Curvilinear Chin Implant," is a 510(k) summary from 1998 for a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device already on the market, rather than proving safety and effectiveness through clinical studies. Therefore, the information typically found in modern AI/ML device submissions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and adjudication methods will not be present in this document.
The document primarily focuses on:
- Identifying the submitter and device.
- Classifying the device.
- Identifying substantially equivalent predicate devices.
- Describing the device and its intended use and contraindications.
- Listing warnings and precautions.
No study is described in this document that establishes performance against acceptance criteria. The FDA's decision is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed performance study as would be required for a novel AI/ML device.
Therefore, most of the requested fields cannot be filled from the provided text.
Here is the information that can be extracted, along with explanations for the missing fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: This document does not establish specific performance acceptance criteria for the "Spectrum Designs Curvilinear Chin Implant" nor does it report device performance against such criteria. The 510(k) process for this type of device in 1998 primarily focused on demonstrating substantial equivalence to a predicate device, rather than novel performance claims from detailed clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
Sample Size: Not applicable. No test set or performance study is described.
Data Provenance: Not applicable. No test set or performance study is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Number of Experts: Not applicable. No test set or ground truth establishment is described.
Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Adjudication Method: Not applicable. No test set or adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
MRMC Study Done: No. This is a medical implant, not an AI/ML diagnostic or assistive device.
Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only)
Standalone Study Done: No. This is a medical implant, not an AI/ML algorithm.
7. Type of Ground Truth Used
Type of Ground Truth: Not applicable. No ground truth is established as no performance study is described. The relevant "truth" for this 510(k) is the existing safety and effectiveness profile of the predicate devices.
8. Sample Size for the Training Set
Sample Size: Not applicable. This document is for a physical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Method: Not applicable. This document is for a physical implant, not an AI/ML algorithm.
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SUMMARY OF SAFETY AND EFFECTIVENESS
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT MAY 6 1898
510K SUMMARY
-
- Submitter's Data
Spectrum Designs Inc. 5921 C. Matthews Street Goleta, CA 93117
- Submitter's Data
Contact Person: Jim Dishman (805) 681-4899 Telephone: Date Prepared: December 30, 1997
2. Device Name, Classification
Name: Spectrum Designs Curvilinear 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. Geniomandibular Groove Chin/Jowl Implant
4. Device Description
The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.
5. Indications for Use
The Spectrum Designs Curvilinear 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY _ 6 1998
Mr. Jim Dishman ·Spectrum Designs, Incorporated 5921-C Matthews Street Goleta, California 93117
K980463 Re: Spectrum Designs Curvilinear Chin Implant Trade Name: Requlatory Class: ı i Product Code: FWP Dated: January 12, 1998 February 5, 1998 Received:
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, Druq, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ति 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 In addition, FDA may publish further announcements action. 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.
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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,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Spectrum Designs, Inc.
510(k) Number (if known): _
Device Name: Spectrum Designs Curvilinear Chin Implant Indications for Use
The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed 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)
Prescription Use Per 21 CFR 801.109
OL
Over-the counter
P. Catella
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980463
§ 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.