SITE-RITE 3 ULTRASOUND SYSTEM

K993624 · Dymax Corp · IYO · Nov 10, 1999 · Radiology

Device Facts

• Record ID: K993624
• Device Name: SITE-RITE 3 ULTRASOUND SYSTEM
• Applicant: Dymax Corp
• Product Code: IYO · Radiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Site~Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The Site~Rite 3 is not intended for opthalmic applications.

Device Story

Site~Rite 3 is a portable, B-mode, pulsed echo ultrasound scanner; assists physicians with vascular access and needle/catheter placement. Inputs: proprietary ultrasound probes (3.5 MHz to 9.0 MHz). Processing: digital electronic signal processing. Outputs: real-time high-resolution images (up to 18 cm depth) displayed for clinician visualization. Used in bedside, ICU, ER, OR, angiography suites, and catheterization labs. Operates on battery or AC power. Benefits: facilitates accurate needle/catheter placement in vascular and non-vascular structures, reducing procedural risk.

Clinical Evidence

No new clinical data provided for Site~Rite 3. Clinical evidence relies on studies performed using the predicate Site~Rite 2, which utilizes identical transducers and image processing algorithms. These studies demonstrated utility for needle placement in vascular and non-vascular applications. Bench testing addressed electrical safety, electromagnetic emissions, and acoustic output.

Technological Characteristics

Digital electronic design; portable B-mode ultrasound scanner. Proprietary probes (3.5, 5.9, 7.5, 9.0 MHz). Imaging depth 0.5 cm to 18 cm. Battery or AC power. Digital signal processing. Complies with FDA guidance for diagnostic ultrasound systems.

Indications for Use

Indicated for ultrasound imaging of vascular structures, organs, and body structures, and for ultrasound-guided needle and catheter placement, either intraoperatively or percutaneously. Not for ophthalmic use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Site~Rite 2 Ultrasound Scanner (Dymax Plus 1 Scanner, K862127)
• Dymax Plus 1 (Dymax TM18, K850478)

Submission Summary (Full Text)

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K993624

# 510(k) Summary

## Site~Rite 3 Ultrasound Scanner

Common/Classification Name: Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560

> Dymax Corporation 271 Kappa Drive Pittsburgh, PA 15238

Contact: Charles Morreale: Prepared: October 18, 1999

### LEGALLY MARKETED PREDICATE DEVICES A.

The Site~Rite 3 Ultrasound Scanner is substantially equivalent to the Site~Rite 2 Ultrasound Scanner (cleared as the Dymax Plus 1 Scanner, K862127) and the Dymax Plus 1 (cleared as the Dymax TM18, K850478).

## DEVICE DESCRIPTION B.

The Site-Rite 3 pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist physicians in gaining vascular access to major veins and arteries. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical scenarios: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc.

The Site-Rite 3 ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe.

The disposable items, supplied in sterile packs, are currently marketed products.

#### C. INTENDED USE

The Site~Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of

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needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.

The Site~Rite 3 is not intended for opthalmic applications.

## D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Site~Rite 3 Ultrasound Scanner has similar, but not identical indications for use as the predicate devices. The Site~Rite 3 indications add specific vein access to the already cleared general vascular access indication. However, this difference clearly does not change the intended use.

The technological characteristics are somewhat different from the predicate devices since the electronics design of the Site~Rite 3 has included digital electronic technology, whereas the predicate devices were completely analog in nature. The transducers, however, are unchanged from the currently marketed products.

The differences in technological characteristics do not raise new types of questions of safety and effectiveness. There are standard methods for accessing safety and performance, primarily through the methods spelled out in the FDA quidance. Performance data are presented in the 510(k) and these data demonstrate equivalence.

## E. TECHNOLOGICAL CHARACTERISTICS

The primary difference in the Site~Rite 3 and the Site~Rite 2 is that the older Site~Rite 2 has a generator with an analog design, whereas the Site~Rite 3 is digital in design.

## ட் TESTING

Testing was carried out to address electrical safety, electromagnetic emissions, and acoustic output. - Data from this testing demonstrate equivalence with the predicate devices.

Clinical studies carried out using the Site~Rite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the Site~Rite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k).

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## G. CONCLUSIONS

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Public Health Service

NOV I 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dymax Corporation C/O Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

K993624 Re : Site-Rite 3 Ultrasound System Dated: October 22, 1999 Received: October 26, 1999

Dear Mr. Mosenkis:

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 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, Druq, 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 Site-Rite 3 Ultrasound System as described in your premarket notification:

Transducer Model Number

3.5 MHz, 5.9 MHz, 7.5 MHz, and 9.0 MHz

If your device is classified (see above) into either class II (Special Controls) or 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 Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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."

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If the special report is incomplete or contains unacceptable values (e.q., 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. Tt should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Druq 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 and additionally 809.10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at [phone].

Sincerely yours,

David h. de
CAPT Daniel Sc

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Site~Rite 3 Ultrasound Scanner Device Name:

Indications For Use:

The Site-Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.

The Site~Rite 3 is not intended for opthalmic applications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993624

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

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