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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Site~~Rite® 6 Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Site~~Rite® 5 Ultrasound System) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, many of the requested categories in your prompt (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set size) cannot be extracted from the given document as they are not applicable to the type of regulatory submission described.

The document indicates that the Site~Rite® 6 Ultrasound System is a conventional ultrasound imaging system, not an AI-powered device. Its approval is based on "Technological Characteristics" being identical to the predicate device and "Safety & Performance Tests" being performed in accordance with Design Controls (21 CFR 820.30). There is no mention of an algorithm or AI.

However, I can provide the information that is present in the document which aligns with some of your points:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document states that the SiteRite® 6 Ultrasound System "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 SiteRite® 5 Ultrasound System." No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided, as this is a substantial equivalence claim for a non-AI device.
Reported Device Performance: No specific quantitative performance metrics (like accuracy, sensitivity, specificity) are reported. The performance is implied to be equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable/Not provided. The submission is based on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a test set of data for a new algorithm. Verification and validation tests were performed "in accordance with Design Controls per 21 CFR 820.30," but details on specific sample sizes for performance evaluation are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. This type of information is usually relevant for AI/CAD device submissions based on expert-adjudicated datasets.

4. Adjudication method for the test set:
* Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No. This is not an AI device, and therefore no MRMC study comparing human readers with and without AI assistance was conducted or described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is not an AI algorithm.

7. The type of ground truth used:
* Not applicable/Not provided in the context of performance for a novel algorithm. The system's "ground truth" for its intended use (ultrasound guidance for vascular access) is derived from its ability to visualize anatomical structures, which is implied to be equivalent to its predicate.

8. The sample size for the training set:
* Not applicable/Not provided. This is not an AI device that undergoes training.

9. How the ground truth for the training set was established:
* Not applicable/Not provided. This is not an AI device that requires a training set with established ground truth.

In summary: The provided document is a 510(k) summary for a conventional ultrasound system, not an AI-powered medical device. As such, the detailed information requested regarding acceptance criteria and study design for AI evaluation is not present because it does not apply to this type of device and submission. The basis for approval is substantial equivalence to a legally marketed predicate device.

Summary

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・

071204 Site~Rite® 6 Ultrasound System Special 510(k)

	Site~Rite® 6 Ultrasound System510(k) Summary	MAY 18 2007
Device trade name:	Site~Rite® 6 Ultrasound System
Device class and panel:	Class II, 21 CFR §892.1560, Ultrasonic Pulsed Echo Imaging System, 90IYOClass II, 21 CFR §892.1570, Diagnostic Ultrasonic Transducer, 90ITX
Applicant name:	Kimberly GeislerBard Access Systems, Inc. [wholly owned subsidiary of C.R. Bard, Inc.]5425 West Amelia Earhart DriveSalt Lake City, UT 84116(801) 595-0700, x5421 (phone)
Predicate device:	K052517, Site~Rite® 5 Ultrasound System
Performance Standards:	Performance standards have not been established by the FDA undersection 514 of the Federal Food, Drug and Cosmetic Act.
Indications for Use:	The Site~Rite® 6 Ultrasound System with associated probe andaccessories provide ultrasound guidance for placement of needlesand catheters in vascular structures. Ultrasound guidance mayoccur intraoperatively or percutaneously. Ultrasound imaging ofvascular structures, various organs and structures of the body mayalso be performed.
Device description:	The SiteRite® 6 Ultrasound System is a lightweight, low-output,real-time B-mode ultrasonic pulsed echo imaging system designedprimarily to assist physicians in gaining vascular access to majorveins and arteries. The SiteRite® 6 Ultrasound System is portableand therefore easy to use at the bedside and in a variety of clinicalscenarios, including intensive care units, emergency rooms,operating rooms, angiography suites, catheterization laboratories,etc. In addition, the Site~Rite® 6 Ultrasound System is designed withsimple operating controls to facilitate easy operation.
TechnologicalCharacteristics:	Technological similarities between the subject Site~~Rite® 6Ultrasound System and the predicate device remain identical. Thereare no new questions raised regarding safety or efficacy of theSite~~Rite® 6 Ultrasound System.
Safety & PerformanceTests:	Verification and validation tests have been performed in accordancewith Design Controls per 21 CFR 820.30.
Summary of SubstantialEquivalence:	Based on the indications for use, technological, and safety andperformance testing, the subject SiteRite® 6 Ultrasound Systemmeets the minimum requirements that are considered adequate forits intended use and is substantially equivalent in design, material,principles of operation and indications for use to the currentcommercially available SiteRite® 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

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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:

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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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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.