(185 days)
Not Found
No
The device description focuses on mechanical components and stereotactic guidance based on pre-operative imaging, with no mention of AI or ML algorithms for image analysis, planning, or execution.
No
The device aids in instrument placement for neurological procedures but does not directly treat or diagnose a disease or condition; it serves as a guidance and fixation system.
No
The device description clearly states its purpose is to "facilitate stereotactic targeting and positioning of various neurosurgical devices" and "provide stereotactic guidance, placement and fixation for the operation of instruments or devices." It aids in surgical procedures by guiding tools, which is an interventional function, not a diagnostic one.
No
The device description clearly outlines physical components like telescoping legs, a center ball joint, bone screws, and adapters, indicating it is a hardware device.
Based on the provided information, the Monteris Medical UFO™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures." This describes a surgical guidance and positioning tool used during a procedure on a patient.
- Device Description: The description details a mechanical device designed to be attached to the patient's skull to guide surgical tools. It does not mention any components or processes related to testing samples of human origin (like blood, tissue, or urine) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Monteris Medical UFO™ is a surgical tool used for physical guidance during a procedure.
N/A
Intended Use / Indications for Use
The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.
Product codes
HAW
Device Description
The Monteris Medical UFO™ (Universal Frameless platform for neur() surgical applications) is designed to facilitate stereotactic targeting and positioning of various neurosurgical devices through a burr hole in the patient's skull. These devices could include laser probes, biopsy needles, electrodes and catheters.
The UFO is comprised of three telescoping legs connected to a center ball joint. Each of the legs can be attached to the patient's skull with two MR1-compatible titanium bone screws. By adjusting the height of each leg, and the axis of the rotatable center ball, various trajectories can be obtained for the guide that runs through the center ball. UFO is MRI compatible
Multiple center ball adapters are available to interface with the center ball guide tube. These adapters reduce the guide tube diamcter down to an inner diameter that is compatible with the outer diameter of the tools that the user may want to place through the UFQ. The adapter for a specific tool ensures the tool remains lined up along the intended axis of the UFO.
Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.
All devices are single use only and ethylene oxide sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR or CT imaging
Anatomical Site
patient's skull (burr hole)
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
Biocompatibility analysis demonstrates that the UFO is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with the product specification, the expectations of the medical community and the product labeling.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the text "UFO™ System" on the first line and "Premarket Notification" on the second line. The text is written in a serif font. The image appears to be a document or a part of a document.
Section 5: 510(k) Summary
AUG 0 6 2009
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Monteris Medical, Inc. |
| 100 - 78 Innovation Drive | |
| Winnipeg, Manitoba | |
| CANADA R3T 6C2 | |
| Tel: 204-272-2220 | |
| Fax: 204-272-2219 | |
| www.monteris.com | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Frameless Stereotaxic Instrument Guide |
| Device Classification & | |
| Product Code: | Class II, |
| HAW | |
| Device Classification Name & | |
| Citation | Stereotaxic Instrument |
| 21 CFR 882.4560 | |
| Device Proprietary Name: | Monteris Medical UFO™ |
Predicate Device Information:
ERIS
| Predicate Devices: | Navigus Trajectory Guide |
|---|---|
| Predicate Device Manufacturers: | Image Guided Neurologics |
| K# | 992304 |
| Predicate Device Common Name: | Frameless Stereotaxic Instrument Guide t |
| Predicate Device Classification Name & | Stereotaxic Instrument |
| Citation: | 21 CFR 882.4560 |
| Predicate Device Classification & | Class II, |
| Product Code: | HAW |
| Predicate Devices: | Navigus II Trajectory Guide |
|---|---|
| Predicate Device Manufacturers: | Image Guided Neurologics |
| K# | 012366 |
| Predicate Device Common Name: | Frameless Stereotaxic Instrument Guide t |
| Predicate Device Classification Name & | Stereotaxic Instrument |
| Citation: | 21 CFR 882.4560 |
| Predicate Device Classification & | Class II, |
| Product Code: | HAW |
.
b. Date Summary Prepared
30 January 2009
1
c. Description of Device
The Monteris Medical UFO™ (Universal Frameless platform for neur() surgical applications) is designed to facilitate stereotactic targeting and positioning of various neurosurgical devices through a burr hole in the patient's skull. These devices could include laser probes, biopsy needles, electrodes and catheters.
The UFO is comprised of three telescoping legs connected to a center ball joint. Each of the legs can be attached to the patient's skull with two MR1-compatible titanium bone screws. By adjusting the height of each leg, and the axis of the rotatable center ball, various trajectories can be obtained for the guide that runs through the center ball. UFO is MRI compatible
Multiple center ball adapters are available to interface with the center ball guide tube. These adapters reduce the guide tube diamcter down to an inner diameter that is compatible with the outer diameter of the tools that the user may want to place through the UFQ. The adapter for a specific tool ensures the tool remains lined up along the intended axis of the UFO.
Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.
All devices are single use only and ethylene oxide sterilized.
d. Intended Use
The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.
e. Comparison to Predicate Device
The Monteris Medical UFO™ is substantially equivalent in intended use, technology, design, materials, and physician use to the Navigus Trajectory Guides (K992304 & K012366).
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
f. Summary of Supporting Data
Biocompatibility analysis demonstrates that the UFO is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with the product specification, the expectations of the medical community and the product labeling.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.
Public Health Service
AUG 0 62009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Monteris Medical, Inc. c/o Craig Coombs President Coombs Medical Device Consultant, Inc. 1193 Sherman St. Alameda, CA 94501
Re: K090240
Trade/Device Name: Monteris Medical UFO Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: July 6, 2009 Received: July 8, 2009
Dear Mr. Coombs:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ru. li. M., 46 for
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/16 description: The image shows a logo for Monteris Medical. The logo consists of a stylized graphic element on the left, resembling a signature or abstract design. To the right of the graphic is the word "MONTERIS" in capital letters, with the word "MEDICAL" in smaller capital letters underneath it.
Section 4: Indications for Use Statement
510(k) Number (if known): K09D240
Monteris Medical UFO™ Device Name:
Indications For Use:
The Monteris Medical UFO™ is intended to provide stereotactic quidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Prescription Use.
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number.