(42 days)
K0001714
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices. The focus is on image-guided navigation and image enhancement, which can be achieved through traditional image processing techniques.
No
The device is described as a computer-aided, image-guided system for planning and navigation during procedures, which suggests it is a tool for surgery rather than a device that directly treats a condition.
No
The device is described as an "image-guided system intended for planning and intraoperative navigation." Its purpose is to assist in surgical procedures, not to diagnose medical conditions by identifying the nature or cause of diseases.
No
The summary describes a "computer-aided, image-guided system" and mentions an "Image Enhanced Fluoroscopy Module," which strongly suggests the inclusion of hardware components beyond just software for image acquisition and processing. The lack of a detailed device description prevents a definitive confirmation, but the terminology points away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures." This describes a system used during medical procedures on a patient, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: While "Not Found" for the full description, the intended use is the primary indicator of whether a device is an IVD.
- Input Imaging Modality: "Image Enhanced Fluoroscopy" is an imaging technique used on a living patient, not a method for analyzing biological samples.
- Anatomical Site: "cranial, spinal" refers to parts of the body, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on guiding procedures within the body using imaging.
N/A
Intended Use / Indications for Use
The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
Product codes
HAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, spinal
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)
K0001714
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2001
Ms. Krishna Sudhakaran Regulatory Compliance Manager Cbyon, Inc. 2275 E. Bayshore Road, Suite 101 Palo Alto, California 94303
Re: K012886
Trade/Device Name: Cbyon System with Image Enhanced Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 8, 2001 Received: September 10, 2001
Dear Ms. Sudhakaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Krishna Sudhakaran
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/1/Picture/5 description: The image shows a handwritten letter 'fa' in cursive. The letter is written in black ink on a white background. The letter is slightly tilted to the left.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT 2
Indications for Use Statement
510(k) # 0001714
Device Name: CBYON System with Image Enhanced Fluoroscopy Module
Indications for Use: The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
Signature Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
4 Number is for the predicate device, the CBYON System
A
510(k) Number K012886