(189 days)
Not Found
No
The description focuses on computer-controlled mechanical positioning based on pre-operative plans and fiducial markers, without mentioning AI/ML algorithms for decision-making or image analysis beyond standard registration.
No
The device aids the surgeon in manually guiding instruments but does not directly treat or diagnose a disease.
No
The device is described as a surgical guidance system that positions instruments. It does not perform diagnosis; instead, it uses pre-operative imaging for guidance during surgery.
No
The device description explicitly mentions a "computer-controlled mechanical arm" and "CCD camera registration," indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a stereotaxic system used for spatial positioning and orientation of surgical instruments during neurosurgery. It guides the surgeon's hand based on pre-operative imaging.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical guidance based on imaging data.
Therefore, this device falls under the category of a surgical guidance system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
An image-guided computer-controlled mechanical arm intended to be used in a neurosurgical operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by surgeons to manually quide standard neurosuraical instruments, under a surgeon-developed carefully prepared stereotaxic plan. The mechanical arm does not contact the patient.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
A stereotaxic system with a computer-controlled mechanical arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
Mentions image processing
Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical operating room / neurosurgeons
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.
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
§ 882.4560 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
041477
DEC - 9 2004
Armstrong Healthcare Limited Knaves Beech Business Centre Loudwater, High Wycombe HP10 9QR United Kingdom
Telephone +44 (0) 1628 536900 +44 (0) 1628 536901 Fax enquire@armstrong.co.uk
510(k) SUMMARY
-
- TRADE NAME: PathFinder Image Guided Surgical Localiser
-
- COMMON NAME: Image Guided Surgical Localiser
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- CLASSIFICATION NAME: Instrument Stereotaxic per CFR 21, Section 882.4560
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- PREDICATE DEVICE: K991081 Frameless Neuromate (ISS Inc, Palo Alto, California)
-
- DESCRIPTION: A stereotaxic system with a computer-controlled mechanical arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
-
- INTENDED USE: An image-guided computer-controlled mechanical arm intended to be used in a neurosurgical operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by surgeons to manually quide standard neurosuraical instruments, under a surgeon-developed carefully prepared stereotaxic plan. The mechanical arm does not contact the patient.
-
- INDICATION FOR USE: Stereotaxic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon manually to guide standard neurosurgical instruments.
-
- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
- a. No substantive change in performance, function, method of operation, design principles or method of manufacture between this device and the predicate device. The system and its components have been used in the medical device industry for similar applications, with no record of any patient problems or adverse reactions.
1
- b. The device has been designed, built and independently tested for compliance with international safety and EMC standards.
- c. The function and use of the device are no different from that of the predicate device and other similar devices in the marketplace.
Name of contact for this summary: Dr Patrick A. Finlay, Managing Director, Armstrong Healthcare Limited. Contact details as shown above.
E - 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 symbol that resembles an abstract human figure or a series of interconnected shapes. The symbol is composed of three curved lines that appear to be connected, creating a sense of unity and collaboration.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Patrick A. Finlay Managing Director Armstrong Healthcare Limited Knaves Beech Business Centre Loudwater, High Wycombe HP 10 9QR United Kingdom
Re: K041477
Trade/Device Name: Pathfinder Image-Guided Surgical Localiser Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 22, 2004 Received: September 24, 2004
Dear Mr. Finlay:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becarell be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of togally to togener the Medical Device Amendments, or to conniner of Prial to Hilly 20, 2016 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmeter rece (110) that to device, subject to the general controls provisions of the Act. The Tourmal controls provisions of the Act include requirements for annual registration, listing of general controll provision gractice, 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 If your de roo 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 r toase be actived 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 or uny I edital bakates and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 677, aboning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Patrick A. Finlay
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in yourse of substantial equivalence of your device to a legally premated 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 11 you desire specific acreoliance at (240) 276-0115. 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 other general mionmarch on Jour ropsumer 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,
Muriam C. Provost
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
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Indications for Use
510(k) Number (if known): K041477
PathFinder Image Guided Surgical Localiser Device Name:
Indications For Use:
Stereotaxic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon manually to guide standard neurosurgical instruments.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041477