(25 days)
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. 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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the UltraGuide USG 2000sa device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | The device underwent extensive bench tests for electrical safety and electromagnetic compatibility. The major components (computer, ultrasound system, PC Birds) are commercial devices with published environmental and physical specifications. The FDA determined the device is substantially equivalent to predicate devices in terms of safety. |
| Efficacy | The device uses the same technology as the predicate device (UltraGuide 1000, K974432). The FDA determined the device is substantially equivalent to predicate devices in terms of efficacy. |
Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, explicit quantifiable acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity) for device performance as we often see in modern submissions were not always explicitly stated or required in the same way for "substantial equivalence" claims. The focus here is on demonstrating equivalence to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or sample size for a clinical study is mentioned. The submission states, "Since this system uses the same technology as the predicate device, a clinical test is not necessary." This indicates that no new clinical data was generated for the USG 2000sa for its 510(k) clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new clinical test set was used for the submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "a clinical test is not necessary."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as enhancing the ultrasonic image and predicting the needle path for display on a computer monitor. This implies a human-in-the-loop interaction, where the user interprets the enhanced image. A standalone (algorithm-only) performance evaluation, separate from human interaction, is not indicated or discussed for this type of device. The clearance is based on the technology being equivalent to a predicate, not on a new standalone performance claim.
7. The Type of Ground Truth Used
No new ground truth from clinical data was established for the USG 2000sa's 510(k) clearance. The basis for safety and efficacy was the substantial equivalence to the predicate device, UltraGuide 1000. For the bench tests, the "ground truth" would have been established by engineering standards for electrical safety and electromagnetic compatibility rather than medical ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that typically requires a large training set in the modern sense. Its function relies on established physical principles of magnetic tracking and visual overlay, rather than learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a training set for an AI/ML model.
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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
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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.
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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.
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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
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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 ________________________________________________________________________________________________________________________________________________________________
§ 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).