The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically Hospira Primary Sets. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Hospira Primary Sets - K142367).

Based on the information provided, it's clear this document is for a physical medical device (intravascular administration sets) and not an AI/ML-driven diagnostic or image analysis software. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

The "acceptance criteria" for a physical device like this typically revolve around compliance with relevant engineering standards, material biocompatibility, and functional performance tests rather than diagnostic accuracy metrics.

Here's a breakdown of the applicable information:

Acceptance Criteria and Device Performance for Hospira Primary Sets (K143015)

The device in question, Hospira Primary Sets, is an intravascular administration set. The criteria for its acceptance are based on its functional performance, material safety, and compliance with established international standards for such medical devices, demonstrating substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (as reported)
Indications for Use	"Hospira Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system." (Matches predicate)
Design and Materials of Construction	"The design and materials of construction remain the same as the predicate product." (Meets predicate design/materials)
Material Biocompatibility	"All materials of construction for Hospira Primary Sets meet the applicable material test requirements for ISO 10993." (Meets ISO 10993)
Functional Performance	"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." (Meets specified ISO standards and performs as intended)
Sterility Assurance Level (SAL)	"The product Sterility Assurance Level is 10-6." (Meets acceptable SAL)

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

This information is not explicitly detailed in the provided document. For physical device performance testing, sample sizes are typically determined by statistical methods to achieve a certain confidence level for the specific tests performed (e.g., tensile strength, leak tests). The data provenance is generally from internal lab testing by the manufacturer.

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

This is not applicable as the device is a physical product, not an AI/ML diagnostic. Ground truth for its performance is established through engineering and laboratory testing against defined standards.

4. Adjudication Method for the Test Set

This is not applicable for a physical device. Performance is objectively measured against engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

This is not applicable. MRMC studies are relevant for diagnostic devices involving human interpretation, especially with AI assistance. This device is an intravenous fluid delivery set.

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

This is not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

Compliance with international standards such as ISO 10993 (biocompatibility), ISO 594-1 (luer fittings), ISO 594-2 (luer fittings), and ISO 8536-4 (infusion sets).
Demonstrated functional performance through engineering tests that confirm safe and effective fluid delivery.
Material properties meeting specified requirements.
Achieving a sterility assurance level of 10-6.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve AI/ML training.

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

This is not applicable for the same reason mentioned above.

Summary

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

February 25, 2015

Hospira, Inc. Ms. Anju Kurian Associate, Regulatory Affairs D- 0393 Bldg. H3 375 N. Field Drive Lake Forest, Illinois 60045

Re: K143015

Trade/Device Name: Hospira Primary Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: FPA Dated: January 23, 2015 Received: January 26, 2015

Dear Ms. Kurian:

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 yours,

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 Statement

K143015 510(k) Number:

Device Name: Hospira Primary Set

Indications for Use: Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5: 510(k) Summary

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

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60045
Phone number	(224) 212-6141
Fax number	(224) 212-5401
EstablishmentRegistration Number	3005579246 (Owner/Operator #9063339)
Name of contactperson	Anju Kurian, Associate, Global Regulatory Affairs
Date prepared	10/17/2014
Name of device
Trade or proprietaryname	Hospira Primary Sets
Common or usualname	I.V Administration Sets
Classification name	Intravascular Administration Set, 21 CFR 880.5440, Class II
Product Code(s)	FPA
Legally marketeddevice(s) to whichequivalence is claimed	Hospira Primary Sets - K142367
Reason for 510(k)submission	The changes addressed in this submission include:• Modification to Secure Lock Male Luer
Device description	The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.
Intended Use of Device	A Hospira Primary set is intended for the delivery of fluids from a container to a patient's vascular system.

CONFIDENTIAL

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Summary of the technological characteristics of the device compared to the predicatedevice
Characteristic	Predicate 510 (k) : K142367	Proposed Device
Indications for Use	Hospira Primary Sets are indicatedfor the delivery of fluids from acontainer to a patient's vascularsystem.	Hospira Primary Sets are indicated for thedelivery of fluids from a container to apatient's vascular system.
Design and Materials ofConstruction	The materials of construction for theproposed device are exactly the sameas the materials for the predicateproduct	The design and materials of constructionremain the same as the predicate product.
Summary of non-clinicaltests for determination ofsubstantial equivalence	All materials of construction forHospira Primary Sets meet theapplicable material test requirementsfor ISO 10993.	All materials of construction for HospiraPrimary Sets meet the applicable materialtest requirements for ISO 10993.
Summary of PerformanceTesting	Performance testing was conductedto ensure the device performs asintended in accordance withapplicable standards. All testing isacceptable.The product Sterility AssuranceLevel is 10-6.	New performance data has been generatedto ensure the device performs as intendedin accordance with ISO 594-1, ISO 594-2and ISO 8536-4. All testing is acceptable.The product Sterility Assurance Levelis 10-6.

Conclusion

Hospira Primary Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to Hospira Primary Sets cleared under K142367.

CONFIDENTIAL

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.