USG 2000SA

K023227 · Ultraguide , Ltd. · HHJ · Oct 22, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023227
• Device Name: USG 2000SA
• Applicant: Ultraguide , Ltd.
• Product Code: HHJ · Obstetrics/Gynecology
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2225
• Device Class: Class 2

Intended 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 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.

Device Story

USG 2000sa provides visual guidance for interventional needles during ultrasound-guided procedures. System utilizes magnetic transmitters and receivers (PC Birds) to track needle location and orientation. Inputs include real-time needle position data and ultrasound B-scan video feed. Personal computer processes inputs to calculate needle trajectory and overlays predicted path onto ultrasound image. Output displayed on PC monitor for clinician. Assists in needle placement accuracy during biopsies or aspirations. Used in clinical settings where ultrasound guidance is standard. Benefits include improved visualization of needle path relative to anatomical structures.

Clinical Evidence

No clinical data. Bench testing only for electrical safety and electromagnetic compatibility.

Technological Characteristics

System uses magnetic transmitters and receivers (PC Birds) for spatial tracking. Components include a personal computer, ultrasound imaging system, and magnetic tracking hardware. Connectivity involves data transmission from tracking sensors and ultrasound video to a PC for image overlay processing. Operates as an add-on visualization enhancement system.

Indications for Use

Indicated for enhancing ultrasonic visualization and predicting the path of interventional needles (e.g., biopsy or aspiration needles) during clinical procedures where ultrasound imaging is utilized for anatomical visualization.

Regulatory Classification

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.

Predicate Devices

• UltraGuide 1000 (K974432)

Submission Summary (Full Text)

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OCT 2 2 2002

UltraGuide Ltd.

K023227

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 [phone]

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 ________________________________________________________________________________________________________________________________________________________________