(279 days)
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
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.
The provided document (K981480 for the Philips EasyGuide Spine option) is a 510(k) summary for a medical device and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical or performance study with metrics like sensitivity, specificity, or accuracy.
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, and compliance with general safety and regulatory standards.
Therefore, for aspects of your request that pertain to performance metrics, sample sizes, expert adjudication, or MRMC studies, the information is not present in this document.
Below is a response based only on the information available in the provided text.
Acceptance Criteria and Device Performance (Based on provided document)
| Acceptance Criteria Category | Specific Criteria (as inferred from document) | Reported Device Performance (as inferred from document) |
|---|---|---|
| Safety Standards | Electrical safety standard UL-2601 | "This device complies with electrical safety standard UL-2601." "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." |
| Electromagnetic compatibility standard IEC-601-1-2 | "This device complies with ... electromagnetic compatibility standard IEC-601-1-2." "Additionally, the Philips EasyGuide Standard Workstation with Spine option is designed to comply with international standard IEC-601-1-2 for electromagnetic compatibility." | |
| Position digitizer laser compliance (21 CFR Part 1040.10) | "The position digitizer laser complies with Title 21 CFR Part 1040.10." | |
| Interoperability | ACR/NEMA DICOM Version 3 digital imaging communication standard | "This device complies with ... the ACR/NEMA DICOM Version 3 digital imaging communication standard." "Additionally, the EasyGuide Standard Workstation with Spine option is in compliance with the ACR/NEMA Digital Imaging Communication (DICOM) standard." |
| Hazard Analysis | Device identified as "minor level of concern" as per "Reviewer's Guidance..." | "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'." |
| Substantial Equivalence | Equivalence to predicate devices | "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)." |
1. Sample sized used for the test set and the data provenance:
- Not explicitly stated in the document. The document discusses compliance with safety and interoperability standards and substantial equivalence, but it does not describe a performance study with a test set of data or data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated. As no specific performance study utilizing a test set with ground truth is described, this information is not present.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not stated. No test set requiring adjudication is described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not described. The document focuses on the device itself for surgical guidance, not on diagnostic interpretation or human reader performance improvement with AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study with specific metrics was not described. The submission is for a surgical guidance system that is inherently human-in-the-loop. The "performance" assessment is based on compliance with standards and substantial equivalence, not quantitative standalone algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not stated. No specific performance study requiring ground truth is described. The "ground truth" implicitly referred to would be established regulatory standards and the functional capabilities of predicate devices for the substantial equivalence claim.
7. The sample size for the training set:
- Not applicable / Not stated. No machine learning or AI training set is mentioned or described in the context of this 510(k) submission.
8. How the ground truth for the training set was established:
- Not applicable / Not stated. As no training set is mentioned, this information is not available.
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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
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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.
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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.
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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
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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)
§ 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).