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 Description

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study specifically designed to demonstrate that the Site-Rite 3 Ultrasound Scanner meets these criteria with reported performance metrics in a structured table or clinical trial format.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general safety and performance testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the Site-Rite 3 Ultrasound Scanner's performance (e.g., specific imaging resolution, penetration depth accuracy, or needle guidance success rates).
It does not report specific device performance data in a structured table format against predefined criteria.

The information related to performance is qualitative and comparative:

Claim: "Performance data are presented in the 510(k) and these data demonstrate equivalence." (Section D)
Claim: "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)." (Section F)

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Study Information Based on Provided Text:

Since a dedicated new clinical study for the Site-Rite 3 demonstrating performance against acceptance criteria is not described in detail, the following points address the mention of studies and the basis for equivalence.

2. Sample size used for the test set and the data provenance:

Not explicitly stated for a new study on Site-Rite 3. The document refers to "Clinical studies carried out using the Site~Rite 2 device" which are summarized elsewhere in the 510(k). The sample sizes and data provenance for these previous studies are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not described. The document mentions "usefulness for needle placement" but does not detail how ground truth was established or by whom in the context of the studies cited for the Site-Rite 2.

4. Adjudication method for the test set:

Not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, this type of study was not performed or described. The device is an ultrasound scanner, not an AI-based interpretation tool. The document refers to "human readers" (physicians using the device) for guidance, not interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable in the AI sense. The device is an imaging tool designed to assist human operators in real-time. It does not perform automated classification or diagnosis in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated for the cited Site-Rite 2 studies. The mention of "usefulness for needle placement" implies success rates or accuracy in reaching target structures, which would likely be determined by direct observation or confirmation (e.g., successful cannulation, fluid aspiration, or post-procedure imaging).

8. The sample size for the training set:

Not applicable. The device is a hardware imaging system, not a machine learning algorithm that requires a "training set" in the context of AI. Its design and validation rely on engineering principles, predicate device comparison, and clinical utility demonstrated by its predecessor.

9. How the ground truth for the training set was established:

Not applicable. (See point 8)

Summary of what the K993624 submission does rely on for substantial equivalence:

Predicate Device Comparison: The Site-Rite 3 is compared to the Site-Rite 2 (cleared as Dymax Plus 1 Scanner, K862127) and the Dymax Plus 1 (cleared as Dymax TM18, K850478).
Technological Characteristics: The primary difference is the shift from analog to digital electronics. Crucially, the transducers are unchanged from currently marketed products.
Non-Clinical Testing: Electrical safety, electromagnetic emissions, and acoustic output testing demonstrated equivalence.
Clinical Utility (leveraged from predicate): The submission relies on "Clinical studies carried out using the Site~Rite 2 device," which used the same transducers and image processing algorithms (implying the imaging performance relevant to "usefulness for needle placement" is conserved, despite the digital electronics). These studies are summarized and included in the full 510(k) submission, though details are not present in this excerpt.

In essence, the device's clearance is based on the argument that the core imaging performance affecting its intended use (vascular access guidance) is fundamentally unchanged due to the reuse of transducers and comparable image processing, backed by new electrical and acoustic characteristic testing for the revised digital platform.

Summary

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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 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing protection and vigilance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

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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Page - 2 - Robert Mosenkis

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 (301) 594-4591. 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 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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

anning

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 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

Regulation Number and Section

§ 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.