(77 days)
Not Found
No
The description focuses on magnetic tracking and calculations for overlay, with no mention of AI/ML terms or concepts like learning, training, or prediction based on data patterns. The "predicting its future path" is likely based on the current trajectory and physics, not learned patterns.
No.
The device's purpose is to enhance ultrasonic images of needles and predict their path, not to treat a condition or disease.
No
The device enhances and predicts the path of an interventional needle during ultrasound-guided procedures, but it does not diagnose a disease or condition. Its purpose is to aid in the accurate placement of a medical device, not to identify or characterize medical conditions.
No
The device description explicitly mentions the use of "magnetic transmitters and receivers, sold under the trade name 'MiniBirds'," which are hardware components used to determine the location and orientation of the ultrasound scan head and the interventional needle. This indicates the device is not solely software.
Based on the provided information, the UltraGuide 1000 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The UltraGuide 1000 system is used to enhance the visualization and prediction of the path of an interventional needle within the patient's body during procedures guided by ultrasound.
- The intended use and device description clearly focus on guiding procedures in vivo (within a living organism). The system works by tracking the position of the needle and ultrasound probe relative to the patient's anatomy, not by analyzing biological samples.
The UltraGuide 1000 is a medical device used for image guidance during interventional procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike 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.
device is intended to be used in clinical The applications and for anatomical structures where ultrasound is currently used for visualizing such devices.
Product codes
90 IYO
Device Description
The UltraGuide 1000 provides visual enhancement of the the interventional needle by overlaying the image of insertion device and its predicted future path the on insertion action and of the internal organs, all displayed on the monitor of a personal computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging system
Anatomical Site
anatomical structures where ultrasound is currently used for visualizing such devices.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical
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
Non-clinical tests: The UltraGuide 1000 has undergone extensive bench tests for electrical safety and electromagnetic compatibility. The major components (the computer, ultrasound system, and MiniBirds) are all commercial devices with published environmental and physical specifications. Physical tests were comparable to that of the ColorMark, which uses a technology which is closer to that of the UltraGuide.
Clinical Test: A clinical test was compared on over 50 patients comparing the UltraGuide 1000 and EchoTip needles in an amniocentesis procedure. The UltraGuide 1000 permitted more rapid abd safer placement of the needles and a more rapid procedure. Neither procedure had any adverse events.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.
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UltraGuide Ltd.
510 (k) Summary
UltraGuide 1000
I. Submitter Information
A. Name: UltraGuide Ltd.
Tirat Hacarmel Industrial Park B. Address: POB 2070 Tirat Hacarmel 30200 Israel
C. Contact Person: Dr. George Myers, 201-727-1703, Fax 201-727-1708
September 25, 1997 D. Date of preparation:
II. Device Data
A. Trade Name: UltraGuide 1000
B. Common Name: Visualization Enhancement System of B. Common Name. Vedles under ultrasonic imaging.
C. Classification Name: Locator, Intracorporeal Device, Ultrasonic
III. Legally-marketed predicate devices.
A. ColorMark Visualization System, K 926351, EchoCath Inc.
B. EchoTip Needles, Cook Manufacturing Co.
C. Regulus Stereotactic system, K935456
D. Civco Needle Guide, K882383
IV. Description
The UltraGuide 1000 provides visual enhancement of the the interventional needle by overlaying the image of insertion device and its predicted future path the on insertion action and of the internal organs, all displayed on the monitor of a personal computer.
V. Intended Use
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UltraGuide Ltd.
The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike 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.
device is intended to be used in clinical The applications and for anatomical structures where ultrasound is currently used for visualizing such devices.
VI. Technological characteristics
device uses magnetic transmitters and receivers, The sold under the trade name "MiniBirds," to determine the location and orientation of the ultrasound scan head and the interventional needle. These devices have been used on medial devices cleared by the FDA. The positions and orientations of the interventional device, and the video of transmitted to a Personal ultrasound image, are the 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 UltraGuide 1000 has undergone extensive bench tests for electrical safety and electromagnetic compatibility. The major components (the computer, ultrasound system, and MiniBirds) are all commercial devices with published environmental and physical specifications. Physical tests were comparable to that of the ColorMark, which uses a technology which is closer to that of the UltraGuide.
B. Clinical Test
clinical test was compared on over 50 patients A comparing the UltraGuide 1000 and EchoTip needles in an amniocentesis procedure. The UltraGuide 1000 permitted more rapid abd safer placement of the needles and a more rapid procedure. Neither procedure had any adverse events.
VIII. Conclusion
The tests show that the UltraGuide 1000 is equivalent to the predicate devices in safety and efficacy.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle-like bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1998
UltraGuide Ltd. C/o George H. Myers, Sc.D. Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07601 Re:
K974432 UltraGuide 1000 Dated: November 19, 1997 Received: November 24, 1997 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Mr. Myers:
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 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 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 Radiation Control provisions, or other Federal laws or regulations.
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 marked predication 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) 594-4613. Additionally, for question 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.
h. Tiau Yu.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K974432 |
Device Name: UltraGuide 1000
Indications for Use:
is indicated for enhancing The UltraGuide 1000 system the ultrasonic image of an interventional needle or needlelike rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. 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.
intended be used in clinical The device is to 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (Per 21 CFR 810.109) (Optional Format 1-2-96)
(Division S Division of Reproductive, Abdominal, E and Radiological . 510(k) Number