(84 days)
The OEC FluoroTrak 9800 Plus provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.
The OEC FluoroTrak 9800 Plus is the result of mechanically integrating the Instatrak 3000 System with FluoroTrak Module (marketed by Visualization Technology, Inc.) into the workstation of the OEC 9800 Mobile Imaging System. The 9800 Mobile Imaging System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the highvoltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-rav imaging components at various andles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices. The InstaTrak 3000 System is an image quidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. Using the InstaTrak 3000, the surgeon can readly identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 System allows the surgeon to view reconstructed twodimensional images of the patient's analomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's analomy based on pre-operative medical images.
Here's an analysis of the provided text regarding the OEC FluoroTrak 9800 Plus, focusing on acceptance criteria and study details.
Important Note: The provided 510(k) summary is very brief and primarily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria as might be found in a more comprehensive clinical trial report. As such, many of the requested fields below will indicate "Not provided" or "Not applicable" based on the limited information available in this summary.
Acceptance Criteria and Device Performance
The provided document (a 510(k) summary) does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) for the OEC FluoroTrak 9800 Plus in its primary function as a fluoroscopic imaging system or its surgical navigation feature. Instead, the acceptance criteria are implicitly tied to regulatory compliance with established product safety and performance standards, and demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| For Fluoroscopic Imaging System: | |
| Compliance with 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) | Device is designed in accordance with this standard. (Statement of compliance) |
| Compliance with IEC 60601 series for Medical Electrical Equipment (safety, EMC, radiation protection, programmable systems, HV/X-ray generators, X-ray tube assemblies, associated X-ray equipment) | Device is designed in accordance with these standards. (Statement of compliance) |
| Compliance with ANSI/NFPA 70 & 99 (National Electrical Code and Standard for Health Care Facilities) | Device is designed in accordance with these standards. (Statement of compliance) |
| Compliance with UL 2601 and CSA-C22.2 No. 601.1-M90 (Medical Electrical Equipment) | Device is designed in accordance with these standards. (Statement of compliance) |
| Compliance with 93/42/EEC - Annex 1 (Essential Requirements of the Medical Devices Directive) | Device is designed in accordance with this standard. (Statement of compliance) |
| For Surgical Navigation Feature: | |
| Substantial equivalence to predicate devices: OEC 9800 Mobile Digital Imaging System (K974355) and InstaTrak 3000 System with FluoroTrak Module (K994270) | The OEC FluoroTrak 9800 Plus is stated to be "substantially equivalent" to these predicates. (Regulatory finding) |
| Intended use remains the same as described in original 510(k)s for predicate devices. | The intended use of both the InstaTrak 3000 System with FluoroTrak Module and the OEC 9800 Mobile Imaging System remains the same. (Statement of fact) |
Rationale for Table Content:
The 510(k) summary is a regulatory document to establish "substantial equivalence" to a legally marketed predicate device. It demonstrates this primarily through compliance with recognized standards and a comparison of technological characteristics and intended use. Specific quantitative performance data and acceptance criteria for this particular device are not detailed in this summary. The "reported device performance" is thus a statement of the device's design adherence to these standards and the FDA's finding of substantial equivalence.
Study Details
Based on the provided 510(k) summary, a formal clinical study with detailed performance metrics, test sets, expert adjudication, or MRMC comparisons is not described. The submission relies on establishing substantial equivalence to previously cleared devices (OEC 9800 Mobile Digital Imaging System and InstaTrak 3000 System with FluoroTrak Module) and compliance with relevant safety and performance standards. The integration of two existing systems into one does not typically require a new, extensive clinical performance study if the fundamental component functions and intended uses remain unchanged and safety is addressed through component compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a specific test set or data provenance for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. No details on experts or ground truth establishment for a performance study are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No adjudication method is mentioned, as no specific test set is detailed.
5. 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
- Not applicable / Not provided. The device described is a fluoroscopic imaging system with a surgical navigation feature, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate reader improvement. The 510(k) summary does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. The device is a physical medical imaging and navigation system, not a standalone algorithm. Performance is integrated with human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. Details on ground truth for performance evaluation are not discussed in this summary. The "ground truth" for regulatory clearance is implicitly the established safety and effectiveness of the predicate devices and compliance with recognized standards.
8. The sample size for the training set
- Not applicable / Not provided. The document does not describe an algorithm requiring a training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As no training set is described for an algorithm, this information is not relevant to the provided summary.
{0}------------------------------------------------
SEP 1 7 2002
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Date: | June 21, 2002 |
|---|---|
| Name of Submitter: | GE OEC Medical Systems384 Wright Brothers DriveSalt Lake City, UT 84116801-874-778 |
| Corresponding Official: | BIII GislasonVice President, Quality Assurance, Requlatory andReliability |
| Device Proprietary Name: | OEC® FluoroTrak™ 9800 Plus |
| Classification Name: | Image Intensified Fluoroscopic X-ray System with imageProcessing System |
| Common/Usual Names: | Fluoroscopic Imaging System with Interactive ImageGuided Surgical System |
| Substantial Equivalence: | The OEC FluoroTrak 9800 Plus is substantially equivalentto the OEC 9800 Mobile Digital Imaging System(K974355) marketed by GE OEC Medical Systems, Inc.and the InstaTrak 3000 System with FluoroTrak Module(K994270) marketed by Visualization Technology, Inc. |
{1}------------------------------------------------
Indications for Use
The OEC FluoroTrak 9800 Plus provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.
General Description
The OEC FluoroTrak 9800 Plus is the result of mechanically integrating the Instatrak 3000 System with FluoroTrak Module (marketed by Visualization Technology, Inc.) into the workstation of the OEC 9800 Mobile Imaging System.
The 9800 Mobile Imaging System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the highvoltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-rav imaging components at various andles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
The InstaTrak 3000 System is an image quidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. Using the InstaTrak 3000, the surgeon can readly identify the immediate location and position of the surgical instrument during the indicated procedure.
The InstaTrak 3000 System allows the surgeon to view reconstructed twodimensional images of the patient's analomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's analomy based on pre-operative medical images.
The InstaTrak 3000 System with FluoroTrak Module (K994270) is being mechanically integrated into the workstation of the OEC 9800 Mobile Imaging System (K974355) to form the system configuration marketed as the OEC FluoroTrak 9800 Plus. The intended use of both the InstaTrak 3000 System with FluoroTrak Module and the OEC 9800 Mobile Imaging System remains the same as described in their respective original 510(k)s.
{2}------------------------------------------------
510(k) Summary
Product Standards
The OEC FluoroTrak 9800 Plus is designed in accordance with product safety and performance requirements established in the following standards:
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|---|---|
| ANSI/NFPA 70 & 99 | National Electrical Code and Standard for Health Care Facilities |
| UL 2601 | Medical Electrical Equipment |
| CSA-C22.2 No. 601.1-M90 | Medical Electrical Equipment |
| IEC 60601-1 | Medical Electrical Equipment, General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment, Electromagnetic Compatibility |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical Systems |
| IEC 60601-2-7 | Medical Electrical Equipment, HV/X-ray Generators |
| IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tube and Source Assemblies |
| IEC 60601-2-32 | Medical Electrical Equipment, Safety of Associated X-ray Equipment |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |
This concludes this 510(k) Summary.
GE OEC MEDICAL SYSTEMS, INC.
Bill Dickson
Bill Gislason Vice President, Quality Assurance, Regulatory, and Reliability
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the logo for the Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three horizontal lines curving upwards, representing health and human services. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bill Gislason Vice President. Quality Assurance. Regulatory and Reliability GE OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862
MAY 22 2012
Re: K022069
Trade/Device Name: OEC FluoroTrak 9800 Plus Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and OXO Dated: June 24, 2002 Received: June 25, 2002
Dear Mr. Gislason:
This letter corrects our substantially equivalent letter of November 14, 2011.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{4}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Simplified 510(k)
Indications For Use Statement
GE OEC Medical Systems, Inc. Applicant:
510(k) No. (if known):
OEC FluoroTrak 9800 Plus Device name:
- The OEC FluoroTrak 9800 Plus Mobile Imaging System provides Indications for use: the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The Fluorotrak surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or perculaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022069
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter __
(Optional Format 1-2-96)
GE OEC Medical Systems
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.