(25 days)
No
The description focuses on magnetic tracking technology and calculations to overlay images, with no mention of AI or ML for image enhancement or prediction. The prediction of the future path appears to be based on the current position and orientation determined by the magnetic tracking, not learned patterns.
No
This device is an image enhancement system designed to improve the visualization of interventional needles during ultrasound-guided procedures; it is not directly involved in treating or diagnosing a disease or condition.
No
Explanation: The device enhances the visualization of an interventional needle during ultrasound-guided procedures and predicts its future path. It does not provide any diagnosis or interpret medical conditions; rather, it aids in performing a medical procedure.
No
The device description explicitly mentions the use of "magnetic transmitters and receivers, sold under the trade name 'PC Birds'," which are hardware components used to determine the location and orientation of the interventional needle. This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enhance the visualization and predict the path of an interventional needle during ultrasound-guided procedures. This is a tool used during a medical procedure on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device uses magnetic tracking and computer processing to overlay information onto an ultrasound image. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic claims, or the use of reagents or assays typically associated with IVDs.
The device is clearly intended to be a medical device used to assist in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future noth. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
Product codes
85 HHJ
Device Description
The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer.
The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
anatomical structures where ultrasound is currently used for visualizing such structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical applications
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
The USG 2000sa has undergone extensive bench tests for electrical safety and electromagnetic compatibility. The major components (the computer, ultrasound system, and PC Birds) are all commercial devices with published environmental and physical specifications.
Since this system uses the same technology as the predicate device, a clinical test is not necessary.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2225 Obstetric-gynecologic ultrasonic imager.
(a)
Identification. An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.(b)
Classification. Class II (performance standards).
0
OCT 2 2 2002
UltraGuide Ltd.
510(k) Summary
Special 510(k)
USG 2000sa
- I. Submitter Information
A. Name: UltraGuide Ltd.
B. Address: Yoqne'am, New Industrial Park, 7b Hayezira st., Israel UltraGuide P.O.B 570 Yokneam Illit 20692
C. Contact Person: Dr. George Myers, 201-727-1703, Fax 201-727-1708
August 15, 2002 D. Date of preparation:
II. Device Data
A. Trade Name: USG 2000sa
B. Common Name: Visualization Enhancement System of Interventional Needles under ultrasonic imaging.
C. Classification Name: Locator, Intracorporeal Device, Ultrasonic
III. Legally-marketed predicate devices.
A. UltraGuide 1000, K974432
IV. Description
The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer.
V. Intended Use
1
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such structures.
VI. Technological characteristics
The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
VII. Testing
A. Non-clinical tests
The USG 2000sa has undergone extensive bench tests for electrical safety and electromagnetic compatibility. The major components (the computer, ultrasound system, and PC Birds) are all commercial devices with published environmental and physical specifications.
B. Clinical Test
Since this system uses the same technology as the predicate device, a clinical test is not necessary.
VIII. Conclusion
The tests show that the UltraGuide USG 2000sa is equivalent to the predicate devices in safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person's head and torso. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2002
UltraGuide, Ltd. % Dr. George Myers Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07601 Re: K023227 Trade/Device Name: USG 2000sa Regulation Number: 21 CFR 884.2225 Regulation Name: Obstetric-gynecologic ultrasonic imager Regulatory Class: II
Product Code: 85 HHJ Dated: September 25, 2002 Received: September 27, 2002
Dear Dr. Myers:
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 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 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 one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
。10(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: USG 2000sa
Indications for Use:
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future noth. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________