(64 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also "Not Found," further limiting the ability to identify such technology.
No
The device is described as a "Passive Head Restraint System" intended for use in neurosurgical procedures, which suggests it is an accessory for positioning or securing a patient during surgery, rather than actively treating a condition.
No
Explanation: The "Intended Use" states that the device is a "Passive Head Restraint System intended for use in neurosurgical procedures." This describes a device used to immobilize the head during surgery, which is a supportive or assistive function, not one that diagnoses conditions.
No
The device is described as a "Passive Head Restraint System," which strongly implies a physical, hardware component used for restraining the head during neurosurgical procedures. The lack of information about software in the provided summary further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in neurosurgical procedures." This indicates a device used during a surgical procedure on a patient, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Mentioning reagents, assays, or laboratory settings.
The Navigus Passive Head Restraint System appears to be a surgical tool or accessory used to position and stabilize the head during neurosurgery.
N/A
Intended Use / Indications for Use
The Navigus Passive Head Restraint System is intended to immobilize the patient's head during neurosurgical procedures.
Product codes
HBL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical procedures
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 2003
Mr. David Lee Director of Regulatory Affairs Image-Guided Neurologics, Inc. 2290 West Eau Gallie Boulevard Melbourne. Florida 32935
Re: K031885
Trade/Device Name: Navigus Passive Head Restraint System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: June 13, 2003 Received: June 24, 2003
Dear Mr. Lee:
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 (OS) 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 - Mr. David Lee
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Mark N Milken
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
1 of Page
510(K) NUMBER (IF KNOWN): KO 31885
DEVICE NAME:
INDICATIONS FOR USE:
Intended Use: The Navigus Passive Head Restraint System is intended tinentied Use. The Nating ---------------------------------------------------------------------------------------------------------------------------------------------------neurosurgical procedures.
Mark A Milkeres
Division sign-Off eral. Restorative Di ision of Ge and Neurologi 1887
5 !0(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter - Use (Optional Format: 1-7