The Site-Rite® 5 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.

The Site-Rite® 5 Ultrasound System is intended to be used for diagnostic ultrasound imaging of fluid flow analysis of the human body in the following clinical applications.

Abdominal
Intraoperative (epiaortic scanning)
Small Organ (breast, testes, thyroid, etc.)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional

The Site-Rite® 5 Ultrasound System is not intended for opthalmic applications.

Device Description

The Site-Rite® 5 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. It offers high resolution imaging to a depth of 6.0 cm. The Site® 5 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, angiography suites, catheterization laboratories, etc. In addition, the Site® 5 Ultrasound System is designed with simple operating controls to facilitate easy operation.

Key features of the Site~Rite® 5 Ultrasound System are:

Compact, portable, real-time ultrasound scanner with:
Intuitive controls allowing for rapid and easy operation
Choice of battery or line voltage power
Operating parameters of scanner determined by image depth
Image freeze frame
Image printing and saving
Large screen

AI/ML Overview

This document describes the Site-Rite® 5 Ultrasound System, a Class II diagnostic imaging system intended to assist physicians in gaining vascular access and for general diagnostic ultrasound imaging. The provided text does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Site-Rite® IV Ultrasound System) and outlining regulatory compliance with various performance and safety standards.

Here's an analysis based on the provided text, highlighting the absence of the requested detailed study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market." However, no specific acceptance criteria or an associated table of reported device performance values are provided within this document. The performance is implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with general safety and performance standards.

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

Not explicitly stated in the document. The document mentions "Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market," but does not detail the nature of this testing, the sample sizes, or the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not stated. This document does not describe a clinical study involving experts establishing ground truth for a test set. The focus is on technical performance and safety standards.

4. Adjudication method for the test set

Not applicable/Not stated. As no detailed clinical test set and ground truth establishment are described, there is no mention of an adjudication method.

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

Not applicable. This device is an ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not applicable. This is a hardware device (ultrasound system), not a standalone algorithm.

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

Not applicable/Not stated. Given the nature of the device and the regulatory submission, the "ground truth" would likely refer to established physics and engineering principles for ultrasound performance, and the "truth" of safety protocols. However, specific types of ground truth (like pathology or outcomes data from a clinical trial) are not mentioned as being used for performance evaluation within this document. The equivalence claim relies on the predicate device's established performance and safety.

8. The sample size for the training set

Not applicable. This device is a traditional ultrasound system, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, this device does not utilize a training set in the AI/machine learning sense.

Summary of Device Acceptance Criteria and Study from the Provided Text:

The provided K052517 submission for the Site-Rite® 5 Ultrasound System focuses on demonstrating substantial equivalence to its predicate device, the Site-Rite® IV Ultrasound System. The "acceptance criteria" discussed are primarily related to compliance with recognized safety and performance standards for medical electrical equipment and diagnostic ultrasound.

The key statements regarding acceptance and performance are:

"Testing based on the following standards will be completed in order to evaluate the device's performance." A list of IEC, UL, and NEMA standards is provided (page 4 of the submission).
"Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market."
"Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market."
"Performance data must demonstrate that the Site~~Rite® 5 Ultrasound System is substantially equivalent to the Site~~Rite® IV Ultrasound System prior to placement of the Site~Rite® 5 Ultrasound System on the market."
A post-clearance special report is required, containing "complete information, including acoustic output measurements based on production line devices," to be submitted to the FDA (page 6).

In essence, the "study" referred to is the set of engineering and bench testing performed to ensure the device meets the specifications of the standards listed and demonstrates equivalent performance to the predicate device, particularly concerning safety (electrical, electromagnetic compatibility, acoustic output) and basic imaging capabilities. The document doesn't present a clinical study with statistical analysis of a test set, expert readers, or ground truth in the way one might find for an AI diagnostic device.

Summary

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KO52517

Site~Rite® 5 Ultrasound System Traditional 510(k)

SEP 2 9 2005

Section 5: 510(k) Summary of Safety and Effectiveness (21 CFR 807.92(a))

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5.2 Device Name

Device Name:	Site-Rite® 5 Ultrasound System
Trade Name:	Site-Rite® 5 Ultrasound System
Common/Usual Name:	Ultrasonic Pulsed Echo Imaging System and AccessoriesDiagnostic Ultrasonic Transducers
Classification Name:	90-IYO - Ultrasonic Pulsed Echo Imaging System21 CFR 892.1560 – Class IIDiagnostic Device90-ITX - Diagnostic Ultrasonic Transducer21 CFR 892.1570 - Class IIDiagnostic Device
Classification Panel:	Radiology Devices Panel

ડ 3 Address and Registration

The addresses and registration numbers of the manufacturer for the Site® 5 Ultrasound System are:

Manufacturer:

5.4

Submitter Name:	Bard Access Systems, Inc. (BAS)[Wholly owned Subsidiary of C. R. Bard, Inc.]
Address:	5425 West Amelia Earhart DriveSalt Lake City, Utah 84116
Telephone Number:	(801) 595-0700 ext. 5421
Fax Number:	(801) 595-5425
Contact Person:	Kimberly Geisler
Date of Preparation:	August 9, 2005
Registration Number:	1720496
Additional Registration Numbers:	C. R. Bard2212754
Manufacturing Site:
Name:	Dymax Corporation.[Wholly owned Subsidiary of C.R. Bard, Inc.]
Address:	271 Kappa DrivePittsburgh, Pennsylvania 15238
Registration Number:	2523003
Device Classification
Classification Name:	90-IYO - Ultrasonic Pulsed Echo Imaging System21 CFR 892.1560 -- Class IIDiagnostic Device90-ITX - Diagnostic Ultrasonic Transducer21 CFR 892.1570 - Class IIDiagnostic Device

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રે રે Predicate Device Information

The predicate devices are:

Device Name:	Site~Rite® IV Ultrasound System
Trade Name:	Site~Rite® IV Ultrasound System
Common/Usual Name:	Ultrasonic Pulsed Echo Imaging System and AccessoriesDiagnostic Ultrasonic Transducers
Classification Name:	90-IYO -- Ultrasonic Pulsed Echo Imaging System21 CFR 892.1560 - Class IIDiagnostic Device90-ITX - Diagnostic Ultrasonic Transducer21 CFR 892.1570 - Class IIDiagnostic Device
Classification Panel:	Radiology Devices Panel
Premarket Notification:	K032135, concurrence date July 21, 2003

5.6 Device Description

The Site-Rite® 5 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. It offers high resolution imaging to a depth of 6.0 cm. The Site® 5 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, cmergency rooms, angiography suites, catheterization laboratories, etc. In addition, the Site® 5 Ultrasound System is designed with simple operating controls to facilitate easy operation.

Key features of the Site~Rite® 5 Ultrasound System are:

. Compact, portable, real-time ultrasound scanner with:
- Intuitive controls allowing for rapid and easy operation ■
- . Choice of battery or line voltage power
- 발 Operating parameters of scanner determined by image depth
- . Image freeze frame
- 트 Image printing and saving
- r Large screen

5.7 Intended Use

The Site~Rite® 5 Ultrasound System with associated probes and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or perculaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

The Site~Rite® 5 Ultrasound System is intended to be used for diagnostic ultrasound imaging of fluid flow analysis of the human body in the following clinical applications.

י Abdominal
Intraoperative (epiaortic scanning)
" Small Organ (breast, testes, thyroid, etc.)
Neonatal Cephalic

{3}------------------------------------------------

포 Adult Cephalic
트 Cardiac
트 Peripheral Vascular
트 Musculo-skeletal Conventional

The Site~Rite® 5 Ultrasound System is not intended for opthalmic applications.

5.8 Substantial Equivalence Summary

New device is compared to marketed device?

Yes.

Does the new device have the same indication statement?

No. The indications for use are the same as the predicate Site~Rite® IV Ultrasound System, except that the indication for intraoperative neurological imaging has been removed. In addition, the Indications for Use statement has been reorganized to emphasize the indication for vascular access guidance:

The Site~Rite® 5 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.

Do the differences alter the intended therapeutic/diagnostic/etc. effect (in deciding, impact on safety and effectiveness may be considered)?

No. The differences do not alter the intended use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc?

Not in all regards. The Site® 5 Ultrasound System has an updated design compared to the predicate device. However, both the subject and predicate devices transmit and receive an ultrasound signal that is used to create an image to assist the radiologist or other clinician in placing a needle in the desired location.

Could the new characteristics affect safety or effectiveness?

Yes. The updated design could affect the safety or effectiveness of the technological characteristics are similar to the predicate devices except that the electronics design has been updated from the Site~~Rite® IV Ultrasound System. The Site~~Rite® 5 Ultrasound System has been designed for manufacturability and improved reliability. The Site-Rite® 5 Ultrasound System was designed to utilize a single linear array probe with a maximum imaging depth of 6.0cm in place of mechanical sector fluid filled probes of the predicate device.

Do the new characteristics raise new types of safety or effectiveness questions?

No. Safety and effectiveness questions are the same for the predicate and subject devices. Refer to the Risk Analysis Document in Attachment 7.

{4}------------------------------------------------

Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. Testing based on the following standards will be completed in order to evaluate the device's performance. Testing will be completed prior to placing the Site~Rite® 5 Ultrasound System on the market.

. IEC 60601-1:1988, Medical Electrical Equipment - Part 1: General Requirements for Safety
피 IEC 60601-1-1:2000, Medical Electrical Equipment -- Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General Requirements for 내 Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
. IEC 60601-2-37:2005, Medical Electrical Equipment - Part 2-37: Particular Reguirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
포 UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety
NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment
NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

Are performance data available to assess effects of new characteristics?

Performance testing will be completed prior to placing the Site® 5 Ultrasound System on the market. Performance data must meet predetermined acceptance criteria prior to placing the Site~Rite® 5 Ultrasound System on the market.

Performance data demonstrate equivalence?

Performance data must demonstrate that the Site~~Rite® 5 Ultrasound System is substantially equivalent to the Site~~Rite® IV Ultrasound System prior to placement of the Site~Rite® 5 Ultrasound System on the market.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight.

SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Access Systems, Inc. Division of C.R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K052517

Trade Name: Site~Rite 5° Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed ccho imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: September 13, 2005 Received: September 14, 2005

Dear Mr. Mosenkis:

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 for use surfal the May 28, 1976, the enactment date of the Medical Device Amendments, or to eoninero prof to the ridg " way" and " with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetions of the Act. The general controls provisions of the Act include requirements for annual provision, 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 5° Ultrasound System as described in your premarket notification:

Transducer Model Number

Site~Rite 5

{6}------------------------------------------------

Page 2 - Mr. Robert Mosenkis

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de fior is olabilional controls. Existing major regulations affecting your device can be may of babyer to early in the 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 I Tease of action that your device complies with other requirements of the Act or any I Dri has made a deceminations 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 laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Appondin of (encreove) version Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., 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. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug 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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

{7}------------------------------------------------

Page 3 – Mr. Robert Mosenkis

If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{8}------------------------------------------------

1.2 Statement of Indications for Use

510(k) Number (if known):

K052 SI7

Device Name:

Site~Rite® 5 Ultrasound System

Indications for Use:

The Site® 5 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)

Marney C brigdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517

.0005

. . . ...

{9}------------------------------------------------

Site~Rite® 5 Ultrasound System

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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 (Pcr 21 CFR 801.109)

Nancy C. Langdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517

000511

{10}------------------------------------------------

Site~Rite®) 5 Ultrasound Transducer

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

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))

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Jancyc brogdonPrescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052517

000512

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.