Site~~Rite Needle Guide Kits and Site~~Rite Probe Cover Kits are intended to be used with Site~Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.

Device Description

Site~Rite Needle Guide Kits - Single use sterile disposable needle guide kit available in 18 GA., 20 GA. and 21 GA. configurations. Each kit contains; 1 set of needle guides, conductive gel, elastic bands and a polyethylene sheath.

Site~Rite Probe Cover Kit – Single use sterile disposable sheath kit. Each kit contains; conductive gel, elastic bands and a polyethylene sheath.

AI/ML Overview

The provided text is a 510(k) summary for the "Site~~Rite® Needle Guide Kits and Site~~Rite® Probe Cover Kit," which primarily discusses substantial equivalence to predicate devices and provides details about the device's description and intended use. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document states:

"Testing was carried out to address the requirements associated with the required 510(k) information Based on March 12, 2000 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers."
"There are no changes made that affect the technological characteristics of the device."
"The characteristics of the components within the predicate device are the same as the predicate device."

This suggests that the testing focused on meeting regulatory requirements related to safety and functionality (like sterility, biocompatibility, or material integrity) as per the referenced guidance, rather than a performance study with specific metrics (e.g., accuracy, sensitivity, specificity) against defined acceptance criteria. The claim is for "substantial equivalence," meaning it's as safe and effective as a legally marketed device, not necessarily that it has met new, specific performance benchmarks for, say, needle guidance accuracy.

Therefore, most of the requested information cannot be extracted from this document as it's not present.

Here's a breakdown of what can be gathered, and what is absent:

Acceptance Criteria and Study Details

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document refers to testing "to address the requirements associated with the required 510(k) information" based on a guidance document, but it does not specify quantitative acceptance criteria or the results against them.
Sample size used for the test set and the data provenance: This information is not provided. The document mentions general "testing" but gives no details about sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As there's no described performance study involving clinical data and ground truth establishment, this detail is absent.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as no such study is described.
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: This is not applicable/provided. The device is an ultrasound needle guide and probe cover, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable/provided. The device is a physical accessory, not an algorithm. Its function inherently involves human interaction (guiding a needle).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided as no performance study requiring ground truth establishment is detailed.
The sample size for the training set: This is not applicable/provided. The device is a physical accessory, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established: This is not applicable/provided for the same reason as above.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on device description, intended use, and similar technological characteristics to predicate devices, along with general regulatory testing (e.g., for sterility, materials) rather than a detailed performance study with quantifiable acceptance criteria and clinical data analysis.

Summary

{0}------------------------------------------------

OCT 1 9 2004

K042445
Page 1 of 2

510(k) Summary SiteRite® Needle Guide Kits and SiteRite® Probe Cover Kit

Common/Classification Name: Diagnostic Ultrasound Transducer, 21 CFR 892.1570

Bard Access Systems 5425 West Amelia Earhart Drive, Salt Lake City, UT 84116 (801)595-5534 - (801)595-5425 (Fax)

Contact: Charles Morreale; Prepared: September 3, 2004

LEGALLY MARKETED PREDICATE DEVICES A.

The Site~~Rite Needle Guide Kits and Probe Cover Kit are substantially equivalent to the Site~~Rite Needle Guide (K931403) and the Protek Medical Products, Inc. Ultrasound Transducer Drape Kit. (K970889).

B. DEVICE DESCRIPTION

Site~Rite Probe Cover Kit – Single use sterile disposable sheath kit. Each kit contains; conductive gel, elastic bands and a polyethylene sheath.

C. INTENDED USE

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Site~~Rite Needle Guide Kits and Site~~Rite Probe Cover Kit have identical indications for use as the Site~Rite Needle Guide -K931403 and Ultrasound Transducer Drape Kits, Polyethylene. The characteristics of the components within the predicate device are the same as the predicate device. The primarv modifications are suppliers, manufacturing changes and to incorporate the product into Bard Access Systems design control and sterilization methods.

000023

{1}------------------------------------------------

K042445
Page 2 of 2

E. TECHNOLOGICAL CHARACTERISTICS

There are no changes made that affect the technological characteristics of the device.

ட் TESTING

Testing was carried out to address the requirements associated with the required 510(k) information Based on March 12, 2000 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers. (This guidance is referenced for ultrasound accessories on the FDA website, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm?pan el=RA#TopPage, retrieved June 25, 2004.)

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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Bard Access Systems, Inc. % Mr. Robert Mosenkis · President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K042445

Trade/Device Name: Site-Rite Needle Guide Kits and Probe Cover Kit Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: October 1, 2004 Received: October 4, 2004

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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 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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) r ms lotter wrification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on " a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you acon of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmaldsmamain.html

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

Enclosure

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

Indications for Use

510(k) Number (if known):	K042445
---------------------------	---------

Site~~Rite Needle Guide Kits and Site~~Rite Probe Cover Kit Device Name:

Indications for Use:

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

( of /

Division of Reproductive, Abdominal,
and Radiological Devices K042445
510(k) Number

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.