The Centurion® Pressure Injectable Extension set intended for the delivery and /or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

Device Description

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

Centurion® Pressure Injectable Extension Sets consist of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer. They are configured with female luer locks on the proximal and distal ends, respectively, and are available in straight, Y, and T configurations. A slide or snap clamp may be positioned over the tubing to obstruct the fluid flow when needed.

The Centurion® Pressure Injectable Extension Set is available in configurations with and without a needlefree valve. These valves are separately marketed devices and the applicable 510(k)'s are maintained by the respective manufacturers.

The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.

AI/ML Overview

The provided text describes a medical device, the Centurion® Pressure Injectable Extension Set, and its 510(k) submission to the FDA. It details the device's intended use, technological characteristics, and performance data from various tests. However, the document does not present acceptance criteria in a table format nor does it directly describe a study that proves the device meets specific acceptance criteria in terms of quantifiable performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

Biocompatibility testing: Ensuring the materials are safe for biological contact.
Sterilization validation: Confirming the device is sterile and non-pyrogenic.
Packaging validation: Ensuring the packaging maintains sterility and shelf life.
Functional testing: Implied by the statement "the functionality, integrity, and safety and effectiveness... are sufficient for its intended use." This likely includes pressure and flow rate capabilities as per the intended use, but specific quantifiable acceptance criteria and the results directly against those are not explicitly presented.

Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (an extension set) and not a diagnostic algorithm or image analysis system.

Here's an attempt to fill in the table and address the questions based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Summary)
Intended Use Compatibility	Max Pressure Setting: 325 psi	Device may be used in conjunction with power injectors having a maximum pressure setting of 325 psi.
	Max Flow Rate: 10 mL/second	Device may be used in conjunction with power injectors having a maximum flow rate of 10 mL/second.
Material Safety	Non-cytotoxic	Validated as non-cytotoxic.
	Non-sensitizing	Validated as non-sensitizing.
	Negligible irritant	Validated as a negligible irritant.
	Non-hemolytic	Validated as non-hemolytic.
	Low potential activator of complement system	Validated as a low potential activator of the complement system.
Sterility	Sterility Assurance Level (SAL): 1 x 10⁻⁶	SAL of 1 x 10⁻⁶ validated.
	Non-pyrogenic	Device is non-pyrogenic.
Packaging Integrity	Performance and Shelf Life Validated	Packaging validated for performance and shelf life.
Functional Integrity	Integrity for intended use	Functionality and integrity sufficient for intended use.
Safety and Effectiveness	Safety and effectiveness for intended use	Safety and effectiveness sufficient for intended use.

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

Sample Size for Test Set: Not specified for any of the tests (biocompatibility, sterilization, packaging, or functional). The data provenance is also not specified (e.g., country of origin, retrospective/prospective). These are typically found in detailed test reports, not summarized 510(k) documents.

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

Not Applicable. This device is a physical medical instrument (an extension set), not a diagnostic device or AI algorithm requiring expert-established ground truth for performance evaluation in the clinical sense. Biocompatibility, sterility, and functional tests are performed by laboratory technicians and engineers against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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 is not an AI or diagnostic imaging device.

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

Not Applicable. See point 5.

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

Standardized Test Methods and Industry Standards: The "ground truth" for this device's performance is established by adherence to recognized international and national standards and guidelines for medical devices:
- ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices) for biocompatibility.
- ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide) for sterilization.
- ISO 11607-1 (Packaging for terminally sterilized medical devices) for packaging.
- Functional requirements (e.g., pressure and flow rate capabilities) are likely tested against internal specifications derived from the intended use and predicate device characteristics.

8. The sample size for the training set

Not Applicable. This is not a device that involves machine learning or AI models with training sets.

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

Not Applicable. See point 8.

Summary

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

Image /page/0/Picture/0 description: The image shows the text "K103562 page 1 of 2" written in cursive. The text appears to be handwritten, with a slightly uneven stroke. The text indicates that the document is page 1 of a 2-page document and has the identifier K103562.

JUN 2 3 2011

510(k) Summary

Centurion Medical Products Corporation 100 Centurion Way Williamston, MI 48895

Mr. Matthew K. Price Director of Quality Assurance and Regulatory Affairs (517) 546-5400, x1135 Phone: Facsimile: (517) 546-3356

Date Summary Prepared:	November 29, 2010
Trade Name (Proprietary Name):	Centurion® Pressure Injectable Extension Set
Common Name of Device:	Intravascular Administration Set
Classification Name:	Set, Administration, Intravascular
Device Classification:	II
Regulation:	880.5440
Product Code:	FPA
Review Panel:	General Hospital
Reason for 510(k):	Marketing of Centurion® Pressure Injectable Extension Sets

Predicate SE Device(s):

Manufacturer:

Contact:

This product is similar in design, composition, function, and method of use to the following products:

Cardinal Health, Alaris ® Products, SmartSite® Needle Free Valve Administration Sets (K061285) .

for Physician and Hospital use.

Description:

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.

Centurion® Pressure Injectable Extension Sets 5-1 510(k) Summary, Rev. 0 510(k) Submission

100 CENTURION WAY | F.O. BOX 510 | WILLIAMSTON | MICHIGAN | 48895 phone 517.546 5400 | toll free 800 248 4059 | www.centurionmp.com

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

ION K.103562

Intended Use:

Centurion® Pressure Injectable Extension Sets are prescription devices intended to allow the aspiration, injection, or gravity/pump flow of fluids and may be used with power injectors having a maximum pressure setting of 325 psi. When used with a power injector, the Centurion® Pressure Injectable Extension Set must be secured to other devices, via a luer lock connection. These devices must also be rated for power injection applications.

Summary of Technological Characteristics between Subject and Predicate Device:

The differences in technological characteristics (e.g., design specifications) between the subject and predicate devices raise no new questions of safety or effectiveness. Slight differences in materials, dimensions, sterilization method, and warnings exist; however, these differences do not affect the safety and effectiveness of the subject device.

Performance Data:

The results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Centurion® Pressure Injectable Extension Set are sufficient for its intended use and support a determination of substantial equivalence.

Summary of Testing:

Biocompatibility testing was performed on Centurion® Pressure Injectable Extension Sets in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing and AAMI Standards and Recommended Practices, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices. Results of testing validate Centurion® Pressure Injectable Extension Sets are non-cytotoxic, non-sensitizing, a negligible irritant, non-hemolytic, and a low potential activator of the complement system.

Centurion® Pressure Injectable Extension Sets will be available only in sterile packaged form. The sterile product will be sterilized using ethylene oxide. The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. A sterility assurance level of 1 x 10 ° has been validated for this product.

Centurion's packaging has been validated for performance and shelf life in accordance with ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Centurion® Pressure Injectable Extension Sets 510(k) Submission

5-2

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and uses a black and white color scheme.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Matthew K. Price Director of Quality Assurance & Regulatory Affairs Centurion Medical Products Corporation 100 Centurion Way Williamston, Michigan 48895

JUN 2 3 2011

Re: K103562

Trade/Device Name: Centurion® Pressure Injectable Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 15, 2011 Received: June 16, 2011

Dear Mr. Price:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

Page 2- Mr. Price

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Runner

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K103542

Indications for Use Statement

510(k) Number (if known):

Device Name: Centurion® Pressure Injectable Extension Set

Indications For Use:

Contraindications:

Contraindicated for use with blunt cannulae systems.

Cautions:

For unattended medication delivery use only a luer-locking 1.V. set or syringe.
Refer to the Centurion pressure information sheet for applicable valve pressure rating and valve instructions.
When used with a power injector, the Centurion Pressure Injectable Extension Set must be secured to other devices via a luer lock connection. These devices must also be rated for power injection applications.
Centurion Pressure Injectable Extension Sets are intended for use with power injectors under the following conditions:

a. Before attempting power injection, ensure patency and that any unused access ports are securely capped.

b. All components (from injector to catheter) must be rated for use with a power injector at the selected pressure setting.
c. A 20-gauge or larger IV catheter should be used.
d. A minimum 60″ coiled connector tubing must be used between the injector syringe and Centurion set.
e. The injector pressure limit must be set to 325psi or below and the flow rate set to a maximum of 10ml/second.

Warning:

Do not use this product with pressure infusion systems at a pressure setting above 325 psi.

Prescription Use(Part 21 CFR 801 Subpart D)	x
-------------------------------------------------	---

AND/OR

Over-The-Counter Use(21 CFR 801 Subpart C)
------------------------------------------------	--

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103562

Centurion® Pressure Injectable Extension Sets 4-1 510(k) Submission

Indications for Use, Rev. 0

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.