(17 days)
Not Found
No
The summary describes a standard ultrasound imaging system for vascular access and general imaging, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is used for guidance and imaging, not for directly treating a disease or condition.
Yes
The device is described as an "ultrasound guidance" system for placing needles and catheters in vascular structures and also for "ultrasound imaging of vascular structures, various organs and structures of the body". While its primary use is for guidance during procedures, the imaging function implies the ability to visualize and thus diagnose conditions or positions of structures.
No
The device description explicitly states it is an "Ultrasound System" with an associated "probe and accessories," indicating it includes hardware components for generating and receiving ultrasound waves.
Based on the provided information, the Site~Rite® 6 Ultrasound System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Site~Rite® 6 is an ultrasound system that images structures within the body (vascular structures, organs, etc.) in real-time. It does not analyze samples like blood, urine, or tissue.
- The intended use is for guidance during procedures and imaging of internal structures. This is a typical use case for medical imaging devices, not IVDs.
The description clearly indicates it's an imaging system used for visualization and guidance during medical procedures.
N/A
Intended Use / Indications for Use
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications: Abdominal, Intraoperative (specify), Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional.
Product codes
IYO, ITX
Device Description
The SiteRite® 6 Ultrasound System is a lightweight, low-output, real-time B-mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the Site~Rite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vascular structures, various organs and structures of the body, Abdominal, Intraoperative (epiaortic scanning), Small organ (breast, testes, thyroid, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional.
Indicated Patient Age Range
Adult, Neonatal
Intended User / Care Setting
physicians, intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories.
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)
Verification and validation tests have been performed in accordance with Design Controls per 21 CFR 820.30.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052517, Site~Rite® 5 Ultrasound System
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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Image /page/0/Picture/0 description: The image shows the logo for Bard Access Systems. The word "BARD" is written in large, bold, sans-serif font. Below the word "BARD" is the text "Bard Access Systems" in a smaller, regular font.
・
:
:
071204 Site~Rite® 6 Ultrasound System Special 510(k)
.
| | SiteRite® 6 Ultrasound SystemRite® 6 Ultrasound System | |
510(k) Summary | MAY 18 2007 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device trade name: | Site
| Device class and panel: | Class II, 21 CFR §892.1560, Ultrasonic Pulsed Echo Imaging System, 90IYO
Class II, 21 CFR §892.1570, Diagnostic Ultrasonic Transducer, 90ITX | |
| Applicant name: | Kimberly Geisler
Bard Access Systems, Inc. [wholly owned subsidiary of C.R. Bard, Inc.]
5425 West Amelia Earhart Drive
Salt Lake City, UT 84116
(801) 595-0700, x5421 (phone) | |
| Predicate device: | K052517, SiteRite® 5 Ultrasound System | |Rite® 6 Ultrasound System with associated probe and
| Performance Standards: | Performance standards have not been established by the FDA under
section 514 of the Federal Food, Drug and Cosmetic Act. | |
| Indications for Use: | The Site
accessories provide ultrasound guidance for placement of needles
and catheters in vascular structures. Ultrasound guidance may
occur intraoperatively or percutaneously. Ultrasound imaging of
vascular structures, various organs and structures of the body may
also be performed. | |
| Device description: | The SiteRite® 6 Ultrasound System is a lightweight, low-output,Rite® 6 Ultrasound System is portable
real-time B-mode ultrasonic pulsed echo imaging system designed
primarily to assist physicians in gaining vascular access to major
veins and arteries. The Site
and therefore easy to use at the bedside and in a variety of clinical
scenarios, including intensive care units, emergency rooms,
operating rooms, angiography suites, catheterization laboratories,
etc. In addition, the SiteRite® 6 Ultrasound System is designed withRite® 6
simple operating controls to facilitate easy operation. | |
| Technological
Characteristics: | Technological similarities between the subject Site
Ultrasound System and the predicate device remain identical. There
are no new questions raised regarding safety or efficacy of the
SiteRite® 6 Ultrasound System. | |Rite® 6 Ultrasound System
| Safety & Performance
Tests: | Verification and validation tests have been performed in accordance
with Design Controls per 21 CFR 820.30. | |
| Summary of Substantial
Equivalence: | Based on the indications for use, technological, and safety and
performance testing, the subject Site
meets the minimum requirements that are considered adequate for
its intended use and is substantially equivalent in design, material,
principles of operation and indications for use to the current
commercially available Site~Rite® 5 Ultrasound System. | |
®Site~Rite is a registered trademark of C.R. Bard, Inc.
000061
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2007
Ms. Kimberly Geisler Regulatory Affairs Specialist C.R. Bard, Inc. Bard Access Systems, Inc. 5425 West Amelia Earhart Drive LAKE CITY UT 84116
Re: K071204
Trade Name: Site~Rite® 6 Ultrasound 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: IYO and ITX Dated: April 30, 2007 Received: May 1, 2007
Dear Ms Geisler:
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 Site~Rite® 6 Ultrasound System, as described in your premarket notification:
Transducer Model Number
Site~Rite 6
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
2
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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Nancyc 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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1.2 Indications for Use Statement
510(k) Number (if known):
Device Name:
Site~Rite® 6 Ultrasound System
Kollade
Indications for Use:
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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, and Radiological Devices 510(k) Number
000008
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Site~Rite® 6 Ultrasound System Special 510(k)
Site~Rite® 6 Ultrasound System
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | P | |||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
Intraoperative (epiaortic scanning)
Small organ (breast, testes, thyroid, etc.) __________________________________________________________________________________________________________________________________
.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (Concurrence of CDRH, Office of Device Evaluation (ODE))
Prescription Use (Per 21 CFR §801.109)
Nancy C. Brogdon
(Division Sigr n of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Image /page/4/Picture/14 description: The image shows the number 000167 in a bold, sans-serif font. The numbers are closely spaced together and are all the same size. The image is black and white, and the numbers are black against a white background. The number appears to be a label or identifier.
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Image /page/5/Picture/0 description: The image shows the logo for Bard Access Systems. The logo consists of the word "BARD" in large, bold, sans-serif font. Below the word "BARD" is the text "Bard Access Systems" in a smaller, regular font. The logo is simple and professional, and it is likely used to identify the company and its products.
Site~Rite® 6 Ultrasound Transducer
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (specify) | P | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | P | |||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
. ·
Intraoperative (epiaortic scanning)
Small organ (breast, testes, thyroid, etc.)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) (Concurrence of CDRH, Office of Device Evaluation (ODE))
Prescription Use (Per 21 CFR §801.109)
Nancy C. Brogdon
on of Reproductive, Abdominal. Radiological Devices 510(k) Number
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