This document is a 510(k) premarket notification for a medical device called "Hospira Primary Sets." It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device is an Intravascular Administration Set, which is a hardware device, not an AI/ML device.

Therefore, I cannot provide information regarding acceptance criteria and studies related to AI/ML device performance, as the requested information is not applicable to this submission. The document discusses performance testing in a general sense to ensure the device performs as intended in accordance with applicable standards, but does not provide specific acceptance criteria or study details that would be relevant to an AI/ML device.

Here's an analysis based on the document if we were to interpret it for a standard medical device, but with the caveat that it doesn't involve AI/ML:

1. A table of acceptance criteria and the reported device performance:

The document broadly states: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable."

However, it does not provide a table of specific acceptance criteria (e.g., flow rate, burst pressure, leak rate maximums) or their corresponding reported device performance values. It only states that the product Sterility Assurance Level is 10-6, which is a performance characteristic, but not part of a comparative table.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for performance testing, nor does it mention the data provenance (country of origin, retrospective/prospective). It only refers to "performance testing" generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the device is a hardware product (intravascular administration set) and does not involve the interpretation of data by experts to establish ground truth in the way an AI/ML device would.

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

This information is not applicable for the same reason as point 3. It's a hardware device, not an AI/ML diagnostic tool.

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:

This information is not applicable as the device is a hardware product and does not involve human readers or AI assistance.

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

This information is not applicable as the device is a hardware product and does not have an algorithm.

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

For a hardware device like this, "ground truth" would typically refer to established engineering and material standards, or physical measurements that confirm the device meets its specifications (e.g., fluid flow rate, material strength, sterility). The document states: "All materials of construction for Hospira Primary Sets meet the applicable material test requirements for ISO 10993." and "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards." This implies that industry standards and physical measurements are used as the "ground truth" for evaluating the device's performance.

8. The sample size for the training set:

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

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

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

Summary

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

November 25,2014

Hospira, Incorporated Dr. Catherine Kang Senior Associate. Global Regulatory Affairs 375 North Field Drive, D-393, Bldg. H3 Lake Forest, IL 60046

Re: K142367

Trade/Device Name: Hospira Primary Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 26, 2014 Received: August 27, 2014

Dear Dr. Kang:

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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Page 2 - Dr. Kang

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

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

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Indications for Use

510(k) Number (if known) K142367

Device Name

Hospira Primary Set

Indications for Use (Describe)

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 sans-serif font, with a stylized graphic above it. The graphic features three curved lines that converge at the top, resembling a stylized representation of a plant or a network. The logo is presented in grayscale.

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. 60046
Phone number	(224) 212-4421
Fax number	(224) 212-5401
Establishment Registration Number	3005579246 (Owner/Operator #9063339)
Name of contact person	Catherine Kang, PhD, Senior Associate, Global Regulatory Affairs
Date prepared	August 22, 2014
Name of device
Trade or proprietary name	Hospira Primary 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	Hospira Primary sets:LifeShield Vision Infusion Sets - K113683Hospira Infusion Blood Sets – K101677
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.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 apatient's vascular system

CONFIDENTIAL

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Image /page/4/Picture/1 description: The image shows the logo for Hospira. The logo consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic appears to be three curved lines that converge at the top, resembling a stylized representation of a plant or a medical symbol. The logo is in grayscale.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Predicate	Proposed Device
Indications for Use	Infusion sets are intended for thedelivery of fluids including but notlimited to blood and blood productsfrom a container into a patient'svascular system.	Hospira Primary Set is intended for thedelivery of fluids from a container to apatient's vascular system.
Materials of Contruction	The materials of construction for the proposed device are the same as the materials forthe predicate product.
Summary of non-clinical tests fordetermination of substantialequivalence	All materials of construction forHospira Primary Sets meet theapplicable material test requirementsfor ISO 10993.	Same
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.	Same

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 the LifeShield Vision Infusion Sets cleared under K113683 and Hospira Infusion Blood Sets cleared under K101677.

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.