(391 days)
Not Found
Not Found
No
The summary describes a mechanical cranial clamp and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device is described as a clamp used to reattach bone flaps after a craniotomy, serving a structural or mechanical purpose rather than directly treating or mitigating a disease or condition.
No
Explanation: The device description states its purpose is to "cover the burr hole and reattach the bone flap after a craniotomy procedure," which is a surgical and restorative function, not diagnostic.
No
The device description explicitly states "Sevrain Cranial Clamp 200 Series (Polyethylene)", indicating a physical hardware device made of polyethylene. The intended use also describes a physical action ("cover the burr hole and reattach the bone flap"). There is no mention of software as the primary or sole component.
Based on the provided information, the SCC 200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to cover a burr hole and reattach a bone flap after a craniotomy procedure. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description indicates it's a physical clamp made of polyethylene, designed for mechanical use in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. The SCC 200 is a surgical implant/device used during a surgical procedure.
N/A
Intended Use / Indications for Use
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.
Product codes (comma separated list FDA assigned to the subject device)
GXN and GXR
Device Description
Sevrain Cranial Clamp 200 Series (Polyethylene)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial (burr hole, bone flap)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1998
Mr. Christophe J-P. Sevrain Chairman and CEO Ikonos Corporation 320 Southwest Sixth Avenue, Second Floor Portland, Oregon 97204-1749
K971408 Re : Sevrain Cranial Clamp 200 Series Trade Name: (Polyethylene) Regulatory Class: II Product Codes: GXN and GXR Dated: February 4, 1998 February 11, 1998 Received:
Dear Ms. 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 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 Requlations, Title 21, Parts 800 to 895. ದ 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 Adminietration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations. Bor __________________________________________________________________________________________________________________________________________________________________________
1
Page 2 - Mr. Christophe J-P. Sevrain
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sistem privalence of your device to a legally marketed predicate device results in a classification for your marketed production overmits 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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and clance 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
Division of General and Restorative Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
2
2971408 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sevrain Cranial Clamp 200 Series
Indications For Use:
ﻟﻴﺮﺍ
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.
(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 Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K971408
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)