(71 days)
Spectrum Designs Silicone Block Implant, Spectrum Designs Pectoral Implant Silimed Elastomer, Silicone Block, SILIMED Calf Implant
Not Found
No
The summary describes a physical silicone implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "pre-formed solid silicone block" for use as an implant to augment or reconstruct tissue, which fits the definition of a prosthetic or reconstructive device, not a therapeutic one. It does not actively treat a disease or condition.
No
This device is described as an implant used for augmentation or reconstruction, not for identifying or investigating a disease or condition.
No
The device description clearly states it is a "pre-formed solid silicone block" and "fabricated from solid silicone elastomer," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired." It's designed for "augmenting or reconstructing cartilaginous tissue, soft tissue and bone." This describes a surgical implant used directly in the body.
- Device Description: The description confirms it's a "solid silicone elastomer" implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Spectrum Designs Pre-Form Contour Silicone Carving Block is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.
Product codes
MBI
Device Description
The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Spectrum Designs Silicone Block Implant, Spectrum Designs Pectoral Implant Silimed Elastomer, Silicone Block, SILIMED Calf Implant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '982688'. The numbers are written in a cursive style, with some of the digits connected to each other. The image has a clear and legible quality, making the characters easily distinguishable.
OCT 13 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK IMPLANT
510K SUMMARY
1. Submitter's Data
Spectrum Designs Inc. 6387 B. Rose Lane Carpinteria, CA 93117 Contact Person: Jim Dishman (805) 684 -7678 Telephone: Date Prepared: July 22, 1998
2. Device Name, Classification
Name: Spectrum Designs Pre-Form Contour Silicone Carving Block FDA Classification: Class II FDA Code: MIB
3. Identification of Substantially Equivalent Devices
Spectrum Designs Silicone Block Implant Spectrum Designs Pectoral Implant Silimed Elastomer, Silicone Block , SILIMED Calf Implant
4. Device Description
The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.
5. Indications for Use
The Spectrum Designs Pre-Form Contour Carving Block is a pre-formed solid silicone block to be used where a shaped, cut-to-fit implant is desired.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Mr. Jim Dishman President Spectrum Designs, Inc. 6387 B Rose Lane Carpinteria, California 93013
Re: K982688 Trade Name: Spectrum Designs Pre-Form Contour Silicone Carving Block Regulatory Class: Unclassified Product Code: мів Dated: July 22, 1998 Received: August 03, 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 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. ਜੋ 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 requlation may result in requlatory 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.
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Page 2 - Mr. Jim 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 gener 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.qov/cdrh/dsmamain.html".
Sincerely yours,
C. 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
INDICATIONS FOR USE
Applicant: Spectrum Designs Inc.
510(k) Number : K982688
Device Name: Spectrum Designs Pre-Form Contour Silicone Carving Block
Indications for Use:
The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 12982688 |
| Prescription use | |
| Per 21 CFR 801.109 | or Over the counter |