Use with implanted infusion ports for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
Power injection of contrast media up to 325 PSI. .

The Power Injectable Infusion Set with male luer lock is indicated for:

Use with central venous catheters for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
. Power injection of contrast media up to 325 PSI.

Device Description

The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters.

The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.

AI/ML Overview

The MPS Acacia Power Injectable Infusion Set is a Class II device (product code FPA) intended for general infusion therapy and power injection of contrast media.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria with numerical targets or thresholds. Instead, it refers to general "necessary verification and validation testing" to assure "substantial equivalence" to predicate devices.

Acceptance Criteria (Not Explicitly Stated - Inferred)	Reported Device Performance
Ability to perform continuous/intermittent infusion therapy	"All necessary verification and validation testing has been performed"
Ability to withdraw IV fluids, blood, blood products, or drugs	"All necessary verification and validation testing has been performed"
Compatibility with implanted infusion ports	"All necessary verification and validation testing has been performed"
Compatibility with central venous catheters	"All necessary verification and validation testing has been performed"
Power injection of contrast media up to 325 PSI	Indicated for "Power injection of contrast media up to 325 PSI."
Maximum infusion rate for 19g/20g needles (5mL/sec)	Indicated for "maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles"
Maximum infusion rate for 22g needles (2mL/sec)	Indicated for "2mL/sec. for 22 gauge needles."
Material safety (non-DEHP PVC)	Consists of "non-DEHP PVC tubing"
Sterility, single use, non-pyrogenic	"will be provided as a sterile, single use, non-pyrogenic, disposable device"
Physical and technical characteristics similar to predicate devices	"The Power Injectable Infusion Set has similar physical and technical characteristics to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generically states that "All necessary verification and validation testing has been performed."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of device submission. The device is a medical accessory (infusion set) and its performance evaluation does not typically involve expert review or establishment of "ground truth" in the way a diagnostic AI algorithm would. Its performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. The Power Injectable Infusion Set is a physical medical device, not a diagnostic algorithm.

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

No, a standalone study (in the context of an algorithm) was not done. This device is a physical product and does not involve an algorithm.

7. The Type of Ground Truth Used:

This information is not applicable in the traditional sense of a diagnostic device. The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science standards, and performance testing against predetermined physical and functional parameters. For example, pressure ratings, flow rates, and material integrity are tested in a controlled environment. The document implies compliance with these via "all necessary verification and validation testing."

8. The Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this device.

Summary

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5. 510(k) Summary of safety and effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	MPS Acacia	APR 2 8 2009
TRADE NAME:	Power Injectable Infusion Set
COMMON NAME:	IV Extension Set
CLASSIFICATION NAME:	Intravascular Administration Set
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE	FPA
PREDICATE DEVICES:	MPS Acacia Safeguard Huber Device (K032934)SafeStep Max Power Injectable Infusion Set (K073050)Medegen Pressure Rated Extension Set (K083472)

Substantially Equivalent To:

The MPS Acacia Power Injectable Infusion Set is substantially equivalent in intended use, principal of operation and technological characteristics to the MPS Acacia Safeguard Huber Needle Device (K032934), the SHPI SafeStep Max Power Injectable Infusion Set (K073050), and the Medegen Pressure Rated Extension Set (K083472).

Description of the Device Subject to Premarket Notification:

The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.

Indications for Use:

The Power Injectable Infusion Set with Huber Needle is indicated for:

Use with implanted infusion ports for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
Power injection of contrast media up to 325 PSI. .

The Power Injectable Infusion Set with male luer lock is indicated for:

Use with central venous catheters for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
. Power injection of contrast media up to 325 PSI.

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SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Technical Characteristics:

The Power Injectable Infusion Set has similar physical and technical characteristics to the predicate devices.

Performance Data:

All necessary verification and validation testing has been performed for the Power Injectable Infusion Set to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Power Injectable Infusion Set is determined by MPS Acacia, to be substantially equivalent to the existing legally marketed devices.

(050809

247

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MPS Acacia C/o Mr. Mark Job Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

APR 2 8 2009

Re: K090809

Trade/Device Name: MPS Acacia Power Injectable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 16, 2009 Received: April 20, 2009

Dear Mr. Job:

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 (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.

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

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Page 2- Mr. Job

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

Sincerely yours.

Anthony D. Watson ber

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO90809

Device Name: MPS Acacia Power Injectable Infusion Set

Indications for Use:

The Power Injectable Infusion Set with Huber Needle is indicated for:

Use with implanted infusion ports for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs.
Use with ports that are indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5mL/sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
Power injection of contrast media up to 325 PSI.

The Power Injectable Infusion Set with male luer lock is indicated for:

Use with central venous catheters for continuous or intermittent infusion therapy. .
Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
Use with central venous catheters that are indicated for power injection of contrast media into the central venous system.
Power injection of contrast media up to 325 PSI.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

K090809 510(k) Number:

Page 1 of 1

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.