(15 days)
No
The document describes a standard ultrasound system and mentions "image processing algorithms" but does not include any terms or descriptions indicative of AI or ML technology.
No
The device provides ultrasound imaging and guidance for procedures (e.g., needle placement), but it does not directly treat or cure any medical condition. It's an imaging and guidance tool, not a therapeutic agent.
Yes
The "Intended Use" states that the device provides "ultrasound imaging of vascular structures, various organs, and structures of the body," which is a diagnostic function.
No
The device description explicitly details hardware components such as the ultrasound system, probes, and power options, indicating it is a physical device with associated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides ultrasound imaging of structures within the body and guidance for needle/catheter placement. This is an in vivo application, meaning it is used on a living organism.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such analysis on specimens.
- Device Description: The description focuses on the ultrasound technology and its use for imaging and guidance within the body.
Therefore, the Site-Rite 3 ultrasound system is a medical device used for imaging and procedural guidance within the body, not for testing samples outside the body.
N/A
Intended Use / 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.
Product codes
21 CFR 892.1560
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.
Mentions image processing
Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vascular structures, various organs, and structures of the body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a variety of clinical scenarios: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 SiteRite 3 Ultrasound Scanner is substantially equivalent to the SiteRite 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 SiteRite 3 Ultrasound Scanner has similar, but not identical indications for use as the predicate devices. The SiteRite 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 SiteRite 3 and the SiteRite 2 is that the older SiteRite 2 has a generator with an analog design, whereas the SiteRite 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 SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite 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
5
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
95