(44 days)
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No
The summary describes a silicone block for carving, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
Yes.
It is designed to be used in aesthetic, corrective, or reconstructive surgery, which are medical applications for treating or remediating a condition.
No
Explanation: The device description states it is a "Silimed Silicone Carving Block" used to "carve a finished device." This indicates it is a raw material or a tool for creating a medical device, not a diagnostic device itself that identifies a disease or condition.
No
The device description clearly states "Silimed Silicone Carving Blocks," indicating a physical, hardware component.
Based on the provided information, the Silimed Silicone Carving Block is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aesthetic, corrective or reconstructive surgery" where the surgeon carves a finished device for custom use. This describes a surgical implant or material used in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: It's a "Silicone Carving Block," which is a material for creating surgical implants.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (reagents, analyzers, test results, etc.).
Therefore, the Silimed Silicone Carving Block falls under the category of a surgical material or implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Product codes
MIB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/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 a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1998 الا ال
Silimed, L.L.C. · Mr. E.J. Smith c/o Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K981851 Trade Name: Silicone Carving Block Regulatory Class: Unclassified Product Code: MIB Dated: May 26, 1998 Received: May 26, 1998
Dear Mr. Smith:
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. 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.
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.
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Page 2 - Mr. E.J. Smith
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,
M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K98 1851
Device Name: Silimed Silicone Carving Blocks
Classification Panel: MIB
Indications for Use:
The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
(D
Div
510(k) Number K981854