The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.

Acceptance Criteria (Standard & Section)	Reported Device Performance
Biocompatibility:
ISO 10993-4 Hemocompatibility	Acceptable
ISO 10993-5 Cytotoxicity	Acceptable
ISO 10993-10 Sensitization	Acceptable
ISO 10993-11 Intracutaneous Reactivity	Acceptable
Systemic Toxicity	Acceptable
Acute Toxicity	Acceptable
Subchronic Toxicity	Acceptable
Pyrogenicity	Acceptable
Mechanical/Functional Performance:
ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment):
4.1 Gauging	Acceptable
4.2 Liquid Leakage	Acceptable
4.3 Air Leakage	Acceptable
4.4 Separation Force	Acceptable
4.5 Stress Cracking	Acceptable
ISO 594-2 (Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings):
4.1 Gauging	Acceptable
4.2 Liquid Leakage	Acceptable
4.3 Separation Force	Acceptable
4.4 Unscrewing Torque	Acceptable
4.5 Ease of Assembly	Acceptable
4.6 Resistance to Overriding	Acceptable
4.7 Stress Cracking	Acceptable
ISO 8536-4 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed):
6.1 Particulate Contamination	Acceptable
6.2 Leakage	Acceptable
6.3 Tensile Strength	Acceptable
6.6 Tubing	Acceptable
6.7 Fluid Filter	Acceptable
6.9 Flow Regulator	Acceptable
6.10 Flow Rate	Acceptable
6.11 Injection Site	Acceptable
6.12 Male Conical Fitting	Acceptable
6.13 Protective Caps	Acceptable
Sterilization:
Sterility Assurance Level (ANSI/AAMI/ISO 11137-1 and 11737-1)	10^-6

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."

The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.

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

This information is not applicable and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.

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 MRMC comparative effectiveness study was done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.

8. The Sample Size for the Training Set

This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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

January 19, 2016

Hospira, Inc. Mr. Charles Neitzel Senior Regulatory Affairs Specialist 375 Field Drive Lake Forest, Illinois 60045

Re: K151969

Trade/Device Name: Hospira Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: FPA Dated: December 15, 2015 Received: December 17, 2015

Dear Mr. Charles Neitzel:

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.

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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 contact the Division of Industry and Consumer Education 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. 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.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K151969

Device Name Hospira Extension Sets

Indications for Use (Describe)

Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Hospira. The logo consists of the word "Hospira" in a gray, sans-serif font, with a stylized graphic above it. The graphic is composed of three curved lines that converge at the top, resembling a stylized leaf or abstract shape. The overall design is simple and modern.

510(k) Summary Section 5

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Hospira Extension Sets.

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60046
Phone number	(224) 212-6087
Fax number	(224) 212-5401
Establishment RegistrationNumber	3005579246 (Owner/Operator #9063339)
Name of contact person	Charles Neitzel, Senior Regulatory Affairs Specialist
Date prepared	January 13, 2016
Name of device
Trade or proprietary name	Hospira Extension Sets
Common or usual name	I.V Administration Sets
Classification name	Intravascular Administration Set, 21 CFR 880.5440, Class II
Product Code(s)	FPA
Legally marketed device(s) towhich equivalence is claimed	Extension Sets - K142974Hospira Extension Sets – K142433
Reason for 510(k) submission	The changes addressed in this submission include:1. Hospira is changing the tubing material formulation currently used in HospiraExtension Sets.2. Hospira is replacing the needleless valve Clave™ component on certain IVadministration Hospira Extension Sets with the MicroClave™ component.
Device description	The Hospira Extension Sets are intended for use as gravity sets. Hospira Extensionsets are comprised of various components including the following: male luer adapterwith cap, tubing, female luer adapter, flow control device, in-line adapter, injectionsite assembly, and Dial-A-Flo. Extension sets are configured to ensure the intendeduse of the device is met. Hospira Extension sets are intended for the delivery of fluidsfrom a container to a patient's vascular system. The sets are disposable devices forsingle patient use.
Intended Use of Device	Hospira Extension set is intended for the delivery of fluids from a container to apatient's vascular system.

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Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font. Above the name is an abstract graphic consisting of three curved lines that converge at a point, resembling stylized leaves or a modern arch. The logo is presented in grayscale.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Predicate	Proposed Device
Indications for Use	Hospira Extension Sets are indicated for the delivery of fluids from a container to a patient's vascular system.	Hospira Extension Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Design and Materials of Construction	The design and materials of construction are as cleared under the predicate 510(k)	The design and materials of construction remain the same as the predicate product with the following exceptions:1. Hospira is changing the tubing material formulation currently used in Extension Sets.2. Hospira is replacing the ClaveTM component on certain IV administration Extension Sets with the MicroClaveTM component.The MicroClave performs functionally the same as the Clave, for the same intended use, and is comprised of similar materials. The Microclave is a cleared component under ICU Medical 510(k) K970855 establishing substantial equivalence.
Summary of non-clinical tests for determination of substantial equivalence	All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993	New data has been generated demonstrating that all materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993.ISO Standard Biological Effect Tested ISO 10993-4 Hemocompatibility ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-11 Intracutaneous Reactivity Systemic Toxicity Suacute Toxicity Subchronic Toxicity Pyrogenicity

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font, with the letters in a light gray color. Above the name is an abstract graphic consisting of three curved lines that converge at a point, creating a sense of movement or flow. The lines are in varying shades of gray, with the central line being the darkest.

Summary of Performance Testing	Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.The product Sterility Assurance Level is 10-6.	New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, and ISO 8536-4. All testing is acceptable.
		ISO Standard Section Tested ISO 594-1 4.1 Gauging4.2 Liquid Leakage4.3 Air Leakage4.4 Separation Force4.5 Stress Cracking ISO 594-2 4.1 Gauging4.2 Liquid Leakage4.3 Separation Force4.4 Unscrewing Torque4.5 Ease of Assembly4.6 Resistance to Overriding4.7 Stress Cracking ISO 8536-4 6.1 Particulate Contamination6.2 Leakage6.3 Tensile Strength6.6 Tubing6.7 Fluid Filter6.9 Flow Regulator6.10 Flow Rate6.11 Injection Site6.12 Male Conical Fitting6.13 Protective Caps Sterilization validation has been conducted based on the ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11737-1 international standards for sterilization of medical devices. All testing is acceptable. The product Sterility Assurance Level is 10-6.

Conclusion

Hospira Extension Sets meet the functional claims and intended use as described in the product labeling. Hospira Extension Sets are substantially equivalent to the predicate device.

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.