(279 days)
Not Found
No
The summary describes a surgical navigation system with standard features like 3D marker search, registration, tracking, planning, and instrument learning. There is no mention of AI, ML, or related concepts in the device description, intended use, or the "Mentions AI, DNN, or ML" section. The listed features are typical of traditional image-guided surgery systems.
No
The device is described as a viewing and navigation tool for surgical procedures, aiding in localization and planning rather than directly treating a disease or condition.
No
Explanation: The device is described as a "viewing and navigation tool" and is intended for pre-operative planning and intraoperative localization and navigation during surgery. It does not perform any diagnostic functions like detecting disease or assessing medical conditions.
No
The device description explicitly lists several hardware components (Instrument Pointing, Instrument Learner, Instrument Switchbox, Tracker, Flexible camera pole, Pedicle Awl) as part of the EasyGuide Spine option, indicating it is not solely software.
Based on the provided information, the Philips EasyGuide with the Spine option is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a "viewing and navigation tool for all cranial surgical processes" and for "planning spine surgery and for localizing and navigating during spine surgery." This indicates the device is used during surgical procedures to guide the surgeon, not to perform tests on samples taken from the body to diagnose a condition.
- Device Description: The description focuses on hardware and software components used for tracking, registration, planning, and navigation within the surgical field. It mentions surgical instruments and components used in the sterile field. This aligns with a surgical navigation system, not an IVD device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Philips EasyGuide's function is to assist the surgeon in navigating and localizing within the patient's body during surgery.
N/A
Intended Use / Indications for Use
The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Spine option expands the intended use of the EasyGuide Standard Workstation to include spinal surgical procedures. The EasyGuide Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.
The Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as
- Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base . tumor, Metastasis
- Treatment of vascular malformations, aneurysms .
- Transnasal approaches .
The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.
EasyGuide Spine is specially designed for spinal application areas such as: - Stabilization techniques .
- . Tumor resection
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The EasyGuide Spine option, which is the subject of this premarket notification, is an option for the EasyGuide Standard Workstation. The Spine option extends the functionality and application areas of the EasyGuide Standard Workstation to include pre-operative planning and intraoperative localizing and navigation during spinal surgical procedures.
The Spine option has the following features:
Hardware:
- . Instrument Pointing
- Instrument Learner ●
- Instrument Switchbox ●
- . Tracker
- Flexible camera pole ●
- Pedicle Awl .
Software: - . 3D marker search
- Registration and tracking functions ●
- Planning and navigation functions .
- Instrument learning
All instruments can be used in the surgical environments used in the sterile field can be autoclaved at 134° C. All other parts are easy to clean.
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): 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.
ISG Viewing Wand (K970865), Picker ViewPoint (K970604), Zeiss Surgical Microscope Navigator (SMN) (K965139), Sofamor Danek StealthStation (K954276)
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
Image /page/0/Picture/1 description: The image shows the Philips logo. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield is a circle with two wavy lines and two four-pointed stars. The logo is black and white.
Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The text is black against a white background. The image appears to be a logo or brand name.
K981480
April 20, 1998
Philips Medical Systems
510(K) Summary
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device.
| CLASSIFICATION NAME: | Stereotaxic Instrument
(Class II; Tier 2; 84HAW, 21CFR 882.4560) |
|-------------------------|---------------------------------------------------------------------|
| COMMON/USUAL NAME: | Image Guided Surgery System |
| TRADE/PROPRIETARY NAME: | Philips EasyGuide |
| ESTABLISHMENT NO.: | 1217116 |
| CONTACT PERSON: | Peter Altman, Director of Regulatory Affairs |
PERFORMANCE STANDARDS:
This device complies with electrical safety standard UL-2601, electromagnetic compatibility standard IEC-601-1-2 and the ACR/NEMA DICOM Version 3 digital imaging communication standard.
SYSTEM DESCRIPTION:
The EasyGuide Spine option, which is the subject of this premarket notification, is an option for the EasyGuide Standard Workstation. The Spine option extends the functionality and application areas of the EasyGuide Standard Workstation to include pre-operative planning and intraoperative localizing and navigation during spinal surgical procedures.
The Spine option has the following features:
Hardware:
- . Instrument Pointing
- Instrument Learner ●
- Instrument Switchbox ●
- . Tracker
- Flexible camera pole ●
- Pedicle Awl .
Software:
- . 3D marker search
- Registration and tracking functions ●
- Planning and navigation functions .
- Instrument learning
All instruments can be used in the surgical environments used in the sterile field can be autoclaved at 134° C. All other parts are easy to clean.
Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: (203) 926-7674 Fax: (203) 929-6099
1
Image /page/1/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, uppercase letters above a shield-like emblem. The emblem features a globe-like design with wavy lines and star-like shapes within it. The logo is black and white.
INTENDED USE:
The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Spine option expands the intended use of the EasyGuide Standard Workstation to include spinal surgical procedures. The EasyGuide Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The Philips EasyGuide Standard Workstation with the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276).
SAFETY INFORMATION:
The Philips EasyGuide Standard Workstation with Spine option is designed to comply with applicable requirements of Underwriters Laboratories Standard for Safety of Medical Electrical Equipment (UL-2601) and be classified by Underwriters Laboratories. Additionally, the EasyGuide Standard Workstation with Spine option is in compliance with the ACR/NEMA Digital Imaging Communication (DICOM) standard. The position digitizer laser complies with Title 21 CFR Part 1040.10.
The results of a hazard analysis. combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
Additionally, the Philips EasyGuide Standard Workstation with Spine option is designed to comply with international standard IEC-601-1-2 for electromagnetic compatibility.
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.
2
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 stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. Frank Gianelli Senior Regulatory Affairs Specialist Philips Medical Systems 710 Bridgeport Avenue Post Office Box 860 Shelton, Connecticut 06484-0917
Re: K981480
Trade Name: Spine Option for the EasyGuide Standard Workstation Regulatory Class: II Product Code: HAW Dated: November 19, 1998 Received: November 20, 1998
Dear Mr.Gianelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Frank Gianelli
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name :
981480
Indications For Use :
The Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as
- Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base . tumor, Metastasis
- Treatment of vascular malformations, aneurysms .
- Transnasal approaches .
The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.
EasyGuide Spine is specially designed for spinal application areas such as:
- Stabilization techniques .
- . Tumor resection
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acolle
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981480
Prescription Use
( Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)