The Hospira Extension Sets and the Hospira Primary 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, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.

AI/ML Overview

The provided document (K161036) is a 510(k) summary for medical devices (Hospira Extension Set and Hospira Primary Set), which are intravenous administration sets. It describes the device, its intended use, and the technological characteristics compared to predicate devices. The primary change addressed in this submission is the replacement of the current Dial-A-Flo flow control device with a new one from a different manufacturer.

The document does not contain information about acceptance criteria or performance from a study in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The acceptance criteria and performance data presented here are for a traditional medical device (IV administration sets) undergoing a change in a component.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device meeting them as if it were an AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the Hospira Extension Set and Hospira Primary Set as described in the document, which are related to non-clinical and performance testing of the physical medical device.

Acceptance Criteria and Reported Device Performance (as related to the physical medical device):

The acceptance criteria are generally implied by meeting applicable standards.

Acceptance Criteria Category	Specific Criteria / Standard Met	Reported Device Performance
Biocompatibility	All materials of construction meet applicable material test requirements for ISO 10993.	New data generated showing all materials of construction meet applicable material test requirements for ISO 10993. Tested ISO 10993-4 (Hemocompatibility), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-11 (Intracutaneous Irritation), Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Pyrogenicity.
Performance Testing	Device performs as intended in accordance with applicable standards, specifically ISO 8536-4. Compliance with ISO 594-1 and ISO 594-2 (covered by predicate). All testing is acceptable.	New performance data generated ensuring the device performs as intended in accordance with ISO 8536-4. Tested sections: 6.1 Particulate Contamination, 6.2 Leakage, 6.3 Tensile Strength, 6.6 Tubing, 6.7 Fluid Filter, 6.9 Flow Regulator, 6.10 Flow Rate, 6.11 Injection Site, 6.12 Male Conical Fitting, 6.13 Protective Caps. All testing reported as acceptable.
Sterility	Product Sterility Assurance Level (SAL) is 10-6.	The product Sterility Assurance Level is 10-6.
Functional Equivalence	Meet the functional claims and intended use as described in the product labeling. Substantially equivalent to predicate devices.	Hospira Extension Sets and Hospira Primary Sets meet the functional claims and intended use. Found substantially equivalent to K142974 and K143015.

Information Not Applicable to this Document (as it's not an AI/ML device study):

Sample sized used for the test set and the data provenance: Not applicable for this type of device submission. Performance testing is typically done on physical samples, and the number of samples is not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on objective measurements against engineering specifications and standards.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, ground truth is based on established ISO standards, engineering specifications, and validated test methods (e.g., flow rate measurement, leak detection, material compatibility assays).
The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
How the ground truth for the training set was established: Not applicable.

Summary

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

January 6, 2017

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

Re: K161036

Trade/Device Name: Hospira Extension Set and Hospira Primary Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA. ODA Dated: December 2, 2016 Received: December 5, 2016

Dear 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

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Tina Kiang, Ph.D. Acting 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) K161036

Device Name Hospira Extension Set Hospira Primary Set

Indications for Use (Describe)

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

Hospira Primary 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K161036

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Hospira Extension Sets and Hospira Primary Sets.

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60046
Phone number	(224) 212-6087
Mobile number	N/A
Fax number	(224) 212-5401
Establishment RegistrationNumber	3005579246 (Owner/Operator #9063339)
Name of contact person	Charles Neitzel, Senior Regulatory Affairs Specialist
Date prepared	12 April 2016
Name of device
Trade or proprietary name	Hospira Extension SetHospira Primary Set
Common or usual name	I.V. Administration Sets
Classification name	Intravascular Administration Set, 21 CFR 880.5440, Class II
Product Code(s)	FPAOJA
Legally marketed device(s) towhich equivalence is claimed	Hospira Extension Sets - K142974Hospira Primary Sets - K143015
Reason for 510(k) submission	The change addressed in this submission is:1. Hospira is replacing the current Dial-A-Flo flow control device with a new Dial-A-Flo flow control device.
Device description	The Hospira Extension Sets and the Hospira Primary 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, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
Intended Use of Device

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Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the word, there is an abstract graphic element composed of three curved lines that converge at the top, resembling an arch or a stylized representation of a medical device. The logo is presented in grayscale.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	PredicatesK142974 & K143015	Proposed Device
Indications for Use	Hospira Extension Sets and Hospira Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system.	Hospira Extension Sets and Hospira Primary 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 exception:• Hospira is changing the flow control device currently used in Extension Sets and Primary Sets.
Proposed Changes to Flow Control Device
Component	PredicateDial-A-Flo	ProposedDial-A-Flo
Manufacturer	ICU Medical, Utah	GVS, Italy
Assembly Materials	Acrylic receiving memberEthylene Propylene GasketAcrylic metering plateDelivery member	ABS PlasticSEBS thermoplastic elastomer
Regulatory Length	1.7 in	34.3 mm
Regulator Diameter	0.850 in	29.8 mm
Delivery Member Length	0.510 in	9 mm
Delivery Member Diameter	0.200 in	3.5 mm
Tubing Inner Diameter (I.D.) and Outer Diameter (O.D.)	0.100" I.D. x 0.138" O.D.	Same
Set Length	Available in 18", 79", and 89"	Same

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" capitalized. Above the word, there is an abstract graphic element composed of three curved lines that resemble stylized leaves or arcs. The lines are arranged in a fan-like shape, with the central line being the darkest and the outer lines gradually fading to a lighter shade of gray.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	PredicatesK142974 & K143015	Proposed Device
Summary of non-clinical tests fordetermination of substantialequivalence	All materials of construction forHospira I.V. Administration sets meetthe applicable material testrequirements for ISO 10993	New data has been generated demonstratingthat all materials of construction for HospiraI.V. Administration Sets meet the applicablematerial test requirements for ISO 10993.ISO Standard Biological EffectTested ISO 10993-4 Hemocompatibility ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-11 IntracutaneousIrritation Systemic Toxicity Subacute Toxicity Subchronic Toxicity Pyrogenicity
Summary of Performance Testing	Performance testing was conducted toensure the device performs as intendedin accordance with applicablestandards. All testing is acceptable.The product Sterility Assurance Levelis 10-6.	New performance data has been generatedto ensure the device performs as intended inaccordance with ISO 8536-4. All testing isacceptable. ISO 594-1 and ISO 594-2compliance is covered with the predicate510(k)s K142974 and K143015.ISO Standard Section Tested ISO 8536-4 6.1 ParticulateContamination 6.2 Leakage 6.3 Tensile Strength 6.6 Tubing 6.7 Fluid Filter 6.9 Flow Regulator 6.10 Flow Rate 6.11 Injection Site 6.12 Male ConicalFitting 6.13 Protective Caps The product Sterility Assurance Levelis 10-6.

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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that resemble an arch or a stylized representation of movement.

Conclusion

Hospira Extension Sets and Hospira Primary Sets meet the functional claims and intended use as described in the product labeling. The Hospira Extension Sets and Hospira Primary Sets are substantially equivalent to the Hospira Extension Sets and Hospira Primary Sets cleared under K142974 and K143015, respectively.

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.