(38 days)
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images 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 be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is a fluoroscopic system with integrated surgical navigation capabilities.
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage 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-ray imaging components at various angles 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 integrated surgical navigation system allows the surgeon to view reconstructed two-dimensional images of the patient's anatomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy based on preoperative medical images.
The provided text is a 510(k) summary for the GE OEC Olympus Mobile Fluoroscopy System with Integrated Navigation. This document focuses on establishing substantial equivalence to previously marketed devices and compliance with safety standards rather than presenting a performance study with acceptance criteria in the typical sense for a new diagnostic device.
Therefore, many of the requested categories (acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth specifics for studies) are not present in this type of regulatory submission.
The document states that the device is "substantially equivalent to the OEC FluoroTrak 9800 Plus (K022069) and the OEC 9800 E/CV+ Digital Mobile System (K024012)." This statement implies that the device inherently meets the performance established by these predicate devices. The study proving this substantial equivalence would primarily involve demonstrating that its technical characteristics and indications for use are similar, and that it adheres to relevant safety and performance standards.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the 510(k) summary as a set of acceptance criteria for a new performance study. The core of this submission is demonstrating substantial equivalence to predicate devices rather than proving performance against novel performance metrics. The "performance" is implicitly considered equivalent to the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. There is no mention of a specific test set or data provenance in the context of a new 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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study was not mentioned or described. The device is a fluoroscopy system with integrated navigation, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not mentioned or described. The device is a system with human-in-the-loop (surgeon using navigation aid).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
Summary based on the 510(k) document:
The regulatory submission for the "OEC Olympus Mobile Fluoroscopy System with Integrated Navigation" focuses on demonstrating substantial equivalence to pre-existing devices (OEC FluoroTrak 9800 Plus (K022069) and OEC 9800 E/CV+ Digital Mobile System (K024012)) and adherence to various product safety and performance standards (e.g., 21 CFR 1020.30-32, ANSI/NFPA 70 & 99, UL 60601, IEC series). It does not present a de novo performance study with explicit acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic algorithm. The "study" proving the device meets criteria is implicitly the demonstration of its technical specifications aligning with predicate devices and compliance with established industry and regulatory safety standards.
{0}------------------------------------------------
K041931
Page 1 of 3
AUG 2 6 2004
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: | July 14, 2004 |
|---|---|
| Name of Submitter: | GE OEC Medical Systems, Inc.384 Wright Brothers DriveSalt Lake City, UT 84116801-536-4668 |
| Corresponding Official: | Jeff WagnerManager, Regulatory Affairs |
| Device Proprietary Name: | OEC Olympus Mobile Fluoroscopy System with IntegratedNavigation. |
| 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 Olympus Mobile Fluoroscopy System withIntegrated Navigation is substantially equivalent to the: |
| • OEC FluoroTrak 9800 Plus (K022069) marketed by GEOEC Medical Systems, Inc. | |
| • OEC 9800 E/CV+ Digital Mobile System (K024012)marketed by GE OEC Medical Systems, Inc. |
{1}------------------------------------------------
Kruger
Fruger
Indications for Use
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surqical 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 be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.
General Description
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is a fluoroscopic system with integrated surgical navigation capabilities.
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage 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-ray imaging components at various angles 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 integrated surgical navigation system allows the surgeon to view reconstructed two-dimensional images of the patient's anatomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy based on preoperative medical images.
{2}------------------------------------------------
Kotto3(
Page sof
Product Standards
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation 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 60601 | 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 DiagnosticX-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical MedicalSystems |
| 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-rayEquipment |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |
This concludes this 510(k) Summary.
GE OEC MEDICAL SYSTEMS, INC.
Jeff Wagner
Wagner
Jat Wagner Manager, Regulatory Affairs
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Mr. Jeff Wagner Manager. Regulatory Affairs GE OEC Medical Systems; Inc. General Electric Company 384 Wright Brothers Drive SLT LAKE CITY UT 84116-2862 Re: K041931
Trade/Device Name: OEC Olympus Mobile Fluoroscopy System with Integrated Navigation Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 JAA and IZL Dated: July 14, 2004 Received: July 19, 2004
Dear Mr. Wagner:
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 either class II (Special Controls) or class III (PMA), 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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and w you've ought.
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predicated 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 If you desire upositiv dompliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for queeronis (1301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compilarios as ( notification" (21CFR Part 807.97) you may obtain. Other general by Telect to premained nonitoation (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Mandidolarerors, International and address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boylen
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
{5}------------------------------------------------
Indications For Use Statement
| Applicant: | GE OEC Medical Systems, Inc. | ||
|---|---|---|---|
| 510(k) No. (if known): | K041931 | ||
| Device name: | OEC Olympus Mobile Fluoroscopy System with IntegratedNavigation. | ||
| Indications for use: | The OEC Olympus Mobile Fluoroscopy System with IntegratedNavigation provides the physician with fluoroscopic imagesduring diagnostic, surgical and interventional procedures. Thesurgical navigation feature is intended as an aid to the surgeonfor locating anatomical structures anywhere on the human bodyduring either open or percutaneous procedures. It is indicated foany medical condition that may be benefit from the use ofstereotactic surgery and which provides a reference to ridgedanatomical structures such as sinus, cranial, long bone orvertebra 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) | |
|---|---|
| ------------------------------------------------------- | -- |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter ______ |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ------------------------- |
| Nancy C Brogdon | (Optional Format 1-2-96) | ||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, and Radiological Devices |
| 510(k) Number | K041931 |
|---|---|
| --------------- | ---------------- |
| GE OEC Medical Systems | Company Confidential | Page 5 |
|---|---|---|
| ------------------------ | ---------------------- | -------- |
§ 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.