PATHFINDER

• K Number: K041477
• Device Name: PATHFINDER
• Manufacturer: ARMSTRONG HEALTHCARE LIMITED
• Date Cleared: 2004-12-09 ( 189 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K991081
• Predicate For: N/A

Intended 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.

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.

AI/ML Overview

The provided documents do not contain the details required to complete your request. Specifically, the 510(k) summary for the "PathFinder Image Guided Surgical Localiser" (K041477) focuses on its equivalence to a predicate device, its intended use, and compliance with safety and EMC standards. It does not include information about:

• Acceptance criteria and reported device performance: There is no table or description of specific performance metrics or thresholds the device must meet. The document states "no substantive change in performance" compared to the predicate, but doesn't quantify it.
• Study details:
  • Sample size for test set.
  • Data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study or its effect size.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training set.
  • How ground truth for the training set was established.

The document primarily asserts equivalence based on technological characteristics and safe use, rather than presenting a performance study with detailed acceptance criteria and results.

Summary

{0}------------------------------------------------

041477

DEC - 9 2004

Armstrong Healthcare Limited Knaves Beech Business Centre Loudwater, High Wycombe HP10 9QR United Kingdom

Telephone [phone] [phone] Fax [e-mail]

510(k) SUMMARY

• 1. TRADE NAME: PathFinder Image Guided Surgical Localiser
• 2. COMMON NAME: Image Guided Surgical Localiser
• 3. CLASSIFICATION NAME: Instrument Stereotaxic per CFR 21, Section 882.4560
• 4. PREDICATE DEVICE: K991081 Frameless Neuromate (ISS Inc, Palo Alto, California)
• 5. 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.
• 6. 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.
• 7. 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.
• 8. 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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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

Regulation Number and Section

§ 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).