(459 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any data related to training or testing sets, which are typically associated with AI/ML devices. The intended use and device description (though not found) point towards a mechanical or structural device for bone re-attachment.
Yes
The device is indicated for the re-attachment of a bone flap, which implies a medical intervention to restore function or correct a condition, classifying it as therapeutic.
No
Explanation: The device is indicated for the re-attachment of the bone flap after a craniotomy, which is a therapeutic or surgical procedure, not a diagnostic one.
No
The provided 510(k) summary only describes the intended use of the device, which is a surgical procedure involving a bone flap. It lacks any description of the device itself, making it impossible to determine if it is software-only.
Based on the provided information, the SCC-100 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "re-attachment of the bone flap after a craniotomy." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or calibrators.
The SCC-100 appears to be a surgical device used for a physical procedure.
N/A
Intended Use / Indications for Use
The SCC-100 is indicated for the re-auachment of the bone flap after a craniotomy.
Product codes
GXN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone flap (after a craniotomy)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of flowing lines that suggest movement and transformation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 1998
Mr. Christophe Sevrain Chief Executive Officer Ikonos Corporation 320 SW 6th Ave., 2nd Floor Portland, Oregon 97204
Re : K971252 Trade Name: SCC-100 Requlatory Class: II Product Code: GXN Dated: April 6, 1998 Received: April 8, 1998
Dear Mr. Sevrain:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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
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Page 2 - Mr. Christophe Sevrain
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 at (301) 443-6597, or at its Internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
f
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
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K971252
Indication For Use
The SCC-100 is indicated for the re-auachment of the bone flap after a craniotomy.
Beeler
Sign-Off) 12971252
Prescription Use
(Per 21 CFR 801.109)