U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000

K013902 · U-Systems, Inc. · IYN · Jun 5, 2002 · Radiology

Device Facts

• Record ID: K013902
• Device Name: U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
• Applicant: U-Systems, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs. The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.

Device Story

The USI-2000 Needle Guide is an accessory for diagnostic ultrasound systems. It overlays graphical representations of a rigid interventional instrument's position and projected path onto the live ultrasound image displayed on a computer monitor. Used in clinical settings by healthcare professionals, the device assists in guiding biopsy or aspiration needles during interventional procedures. By providing real-time visual feedback of the needle trajectory relative to target anatomy, the device aids clinicians in accurate needle placement, potentially improving procedural precision and patient outcomes during breast biopsies.

Clinical Evidence

Bench testing only. Performance of the needle guide accessory was validated according to the manufacturer's internal quality assurance procedures.

Technological Characteristics

The device is an accessory for diagnostic ultrasound systems (pulsed echo and pulsed Doppler). It functions by generating graphical overlays on a computer monitor. It is compatible with 7.5 MHz and 10 MHz transducers. The system is intended for small parts imaging, including breast biopsy.

Indications for Use

Indicated for clinical interventions and anatomical structures where ultrasound is used for visualization, specifically for small parts use for breast biopsy.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• UltraGuide 1000 System

Submission Summary (Full Text)

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K613902

JUN 0 5 2002

# 2.4 510(k) Summary

# 510(k) Summary

# U-Systems Ultrasound System U-Systems INC.

Prepared November 21, 2001

| Product Name: | USI-2000 Ultrasound System with Needle Guide |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | U-Systems Inc. |
| Generic Name | Diagnostic Ultrasound System accessory |
| Classification Name: | Ultrasound Imaging System and Transducers (Class II); Classification<br>codes:<br>IYO 892.1560 System, Imaging Pulsed Echo, Ultrasonic<br>IYN 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>ITX 892.1570 Transducer, Ultrasonic, Diagnostic |
| Contact Person: | Sheila W. Pickering Ph.D.<br>2081 Longden Circle<br>Los Altos, California 94024<br>Telephone/Fax [phone]<br>e-mail: [e-mail] |

### A. Legally Marketed Predicate Device

The modification to the USI-2000 is substantially equivalent to the UltraGuide 1000 System.

### B. Device Description

Indications For Use:

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.

### C. Intended Use

The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.

### D. Substantial Equivalence

The USI-2000 is substantially equivalent to the UltraGuide 1000 System, which is currently in commercial distribution.

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CONFIDENTIAL
U-Systems Inc.510(k) Notification
Device Modification

## E. Performance Data

The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features an abstract image of three human profiles facing right, stacked on top of each other. The profiles are black and have a stylized, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850

# JUN 0 5 2002

U-Systems, Inc. % Sheila W. Pickering, Ph.D. · 2081 Longden Circle LOS ALTOS CA 94024

Re: K013902

Trade Name: U-Systems USI-2000 Diagnostic Ultrasound System Addition of Needle Guide Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: · 90 IYN, IYO, and ITX Dated: May 1, 2002 Received: May 6, 2002

Dear Dr. Pickering:

We have reviewed your Section 510(k) premarket 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 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the U-Systems USI-2000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

7.5 MHz Transducer 10 MHz Transducer

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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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville. Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [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 at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 – Dr. Pickering

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

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(s)

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vstems Inc. 5100k) Notification

# 16013902

### FDA Submission Cover Sheet

# 510(k) Number (if known): K003479 Ko 13902

### Device Name: Modified U-Systems USI-2000 Diagnostic Ultrasound System

Indications For Use:

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.

The accessory is intended to be used in clinical interventions 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) | |
|------------------|--|----|--------------------------------------------------------|--|
| Prescription Use | | OR | Over-The-Counter Use | |
| (Per 21CFR 801) | | | | |

| (Division Sign-Off) | <i>Nancy C brogdon</i> |
|---------------------------------------------------------------|------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013902 |

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### Diagnostic Ultrasound Indications for Use

510(k) Number(s):

Device Name:

USI-2000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

Intended Use:

| | Mode of Operation | | | | | | | | | |
|------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note ! | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | N | N | | N | N | | Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal | | N | N | N | | N | N | | Note 1 | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy.

N = new indication P = previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number __________________________________________________________________________________________________

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### Diagnostic Ultrasound Indications for Use

510(k) Number:

Device Name:

7.5 MHz Transducer Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | | | N | N | Note 1 | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | N | N | N | | | N | N | Note 1 | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | | N | N | Note 1 | | |
| Musculo-skeletal<br>Conventional | N | N | N | | | N | N | Note 1 | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD

and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy.

N = new indication P = previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

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#### Diagnostic Ultrasound Indications for Use

510(k) Number:

Device Name:

10 MHz Transducer Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|------------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify)* | Other<br>(specify)* |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast, thyroid,<br>testes) | | N | N | N | | N | N | | Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laproscopic | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | |
| Musculo-skeletal | | N | N | N | | N | N | | Note 1 | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy.

- N = new indication
P = previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

ා ! O(k) Number

Nancy C Brogdon
Division Sign-Off)
usion of Reproductive, Abdominal,
Radiological Devices