(148 days)
Not Found
No
The summary describes a navigation and visualization system that uses medical images and bone pins for stereotaxic surgery, but there is no mention of AI or ML in the device description, intended use, or performance study sections. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: The device is described as an aid for precisely locating anatomical structures during surgery, not for treating any medical condition or directly providing therapy. Its function is to guide the surgeon, which is distinct from therapeutic intervention.
No
Explanation: The device is described as a "Navigation and Visualization System" intended to aid surgeons in "precisely locating anatomical structures". It uses pre-existing medical images (CT, MR, x-ray) for guidance during surgical procedures, rather than diagnosing a medical condition itself.
No
The device description explicitly mentions the "GE Healthcare Navigation and Visualization System" and the "Axcess™ Bone Pin," which are hardware components. The system is described as being used "together with" the bone pin, indicating a physical interaction and reliance on hardware for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE Healthcare Navigation and Visualization System is a surgical navigation system. Its purpose is to aid surgeons in precisely locating anatomical structures during surgical procedures using medical images. It does not analyze samples from the body.
- Intended Use: The intended use clearly states it's an "aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures." This is a surgical guidance function, not an in vitro diagnostic function.
- Device Description: The description mentions a navigation and visualization system and a bone pin, which are surgical tools, not diagnostic tests.
- Input: The input is medical images (CT, MR, x-ray), not biological samples.
Therefore, this device falls under the category of surgical navigation systems, which are distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,
The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.
Product codes (comma separated list FDA assigned to the subject device)
HAW, LLZ, 90 JAA, IZL
Device Description
GE Healthcare InstaTrak® 3500Plus or FluoroTrak™ 9800 Plus System with Axcess™ Bone Pin
Mentions image processing
Image Processing System (21CFR 892.2050 Product Code LLZ) has been classified under section 513 of the Act as Class II by the Radiology Devices Panel.
Image-intensified Fluoroscopic x-ray System with Image Processing System (21CFR 892.1650 Product Code 90 JAA and 21CFR 892.1720 Product Code IZL) has been classified under section 533 of the Act as Class II by the Radiology Devices Panel.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR or x-ray
Anatomical Site
anywhere on the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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.
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/0 description: The image shows the GE Healthcare logo. The logo consists of a circular emblem with the letters 'GE' intertwined inside. Below the emblem, the words 'GE Healthcare' are printed in a bold, sans-serif font.
NOV 2 3 2005
KOSIT 34 510(K) STATEMENT / SUMMARY AS REQUIRED BY SECTION 807.92(c)
GE HEALTHCARE TECHNOLOGIES INSTATRAK® 3500 PLUS/FLUOROTRAK™ 9800 PLUS SYSTEM WITH AXCESS™ BONE PIN
1. SUBMITTED BY:
GE Healthcare Technologies 439 South Union Street, 3rd Floor Lawrence, MA 01843 Tel (978) 552-5200 Fax (978) 552-5183
2. DEVICE NAME:
GE Healthcare InstaTrak® 3500Plus or FluoroTrak™ 9800 Plus System with Axcess™ Bone Pin
| Systems | Instrument | |
|---|---|---|
| Proprietary Name | InstaTrak 3500 Plus System | |
| OEC FluoroTrak 9800 Plus System | Axcess Cranial Pin* | |
| Common/Usual Name | Interactive Image Guided Surgical System | |
| Fluoroscopic Imaging System with Interactive | ||
| Image Guided Surgical System | Stereotaxic Instrument | |
| Classification Name | Image Processing System | |
| Image-intensified Fluoroscopic x-ray System | ||
| with Image Processing System | Stereotaxic Instrument |
Table 1: System and Instrument Names
*Note that the Axcess™ Cranial Pin is one example of the Axcess™ Bone Pin.
3. DEVICE CLASSIFICATION:
Stereotaxic Instrument (21CFR 882.4560 Product Code HAW) has been classified under section 513 of the Act as Class II by the Neurology Devices Panel.
Image Processing System (21CFR 892.2050 Product Code LLZ) has been classified under section 513 of the Act as Class II by the Radiology Devices Panel.
Image-intensified Fluoroscopic x-ray System with Image Processing System (21CFR 892.1650 Product Code 90 JAA and 21CFR 892.1720 Product Code IZL) has been classified under section 533 of the Act as Class II by the Radiology Devices Panel.
GE Healthcare Technologies
1
Image /page/1/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram enclosed in a circle above the words "GE Healthcare". The monogram is a stylized version of the letters G and E. The text is in a simple, sans-serif font.
4. INTENDED USE / INDICATIONS FOR USE:
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,
The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.
5. SUBSTANIAL EQUIVALENCE:
The GE Healthcare InstaTrak 3500 Plus System with Axcess Bone Pin is substantially equivalent to the following:
- LandmarX™ Image Guided Surgical System (K992927) when used with Framelock™ . (K022370), the transmitter rigid fixation device - both manufactured by Medtronic Xomed, Inc.
- . VectorVision Cranial/ENT (K023651) system, which contains a proprietary transmitter rigid fixation device (Skull Reference Array)- manufactured by BrainLAB AG.
Each predicate device offers a minimally invasive means of direct and rigid fixation to bone. The GE Healthcare InstaTrak 3500 Plus System with Axcess Bone Pin has a similar intended use as the predicate devices. There are no new questions of safety and effectiveness when compared to the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The emblem is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Healthcare Technologies c/o Tamas Borsai Program Manager, Third Party Review Program TUV Rheinland of North America, Inc. 12 Commerce Road Newton. Connecticut 06470
Re: K051734
Trade/Device Name: GE Healthcare Technologies' InstaTrak® 3500 Plus System or OEAC FluoroTrak™ 9800 Plus with the new Axcess " Bone Pin Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 7, 2005 Received: November 14, 2005
Dear Mr. Borsai:
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.
3
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 Part 801), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buechner
Mark N. M elkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 1b
Page 1 of 1
510(k) Number (if known): K051734
Device Name: GE Healthcare Technologies' InstaTrak® 3500 Plus System or OEC FluoroTrak™ 9800 Plus with the new Axcess TM Bone Pin
Indications For Use:
The GE Healthcare Navigation and Visualization System [InstaTrak 3500 Plus System (K040050) or OEC FluoroTrak 9800 Plus (K022069)] together with the Axess Bone Pin, is intended as an aid to the surgeon for precisely 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray.
The Axess Bone Pin is intended to be used where rigid fixation of a tracking device to bone is required.
(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 Use
(Optional Format 1-2-96)
Barbara Buehns
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Numbe