Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira Sapphire 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 document describes a 510(k) premarket notification for Hospira Sapphire Sets, an accessory for infusion pumps. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text. Many of the requested details about acceptance criteria and study specifics are not explicitly stated in this type of regulatory document, which focuses on demonstrating equivalence rather than a full clinical trial.

1. Table of acceptance criteria and the reported device performance:

The document outlines a series of tests performed to establish substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to the predicate device. Specific numerical acceptance criteria are generally not provided in this summary. Instead, it states that "All testing is acceptable."

Acceptance Criteria Category	Reported Device Performance (Hospira Sapphire Sets)
Biocompatibility (ISO 10993)	Meets applicable material test requirements for ISO 10993 (Hemocompatibility, Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Subacute Toxicity, Pyrogenicity).
Particulate Contamination (ISO 8536-4, 6.1)	Meets the requirements.
Leakage (ISO 8536-4, 6.2)	Meets the requirements.
Tensile Strength (ISO 8536-4, 6.3)	Meets the requirements.
Tensile Strength (ISO 1135-4, 5.3)	Meets the requirements.
Flow Rate Accuracy	Testing conducted using the proposed Hospira Sapphire Sets and the Sapphire Infusion System was acceptable.
Sterility Assurance Level (SAL)	10^-6

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes used for any of the tests (biocompatibility, particulate contamination, leakage, tensile strength, or flow rate accuracy).
Data Provenance: The tests were conducted to demonstrate substantial equivalence of the "Hospira Sapphire Sets," which are described as a "combination of Hospira IV set components with the Sapphire Cassette." The testing was performed for the new device as part of the 510(k) submission. It relates to the safety and performance of the device itself and its interaction with the Sapphire Infusion System. This would be considered prospective testing conducted by the manufacturer for regulatory submission. Country of origin of the data is not specified, but the applicant is Hospira, Inc. in Lake Forest, Illinois, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device submission. The "ground truth" for infusion pump accessories, in this context, is established through adherence to recognized international standards (e.g., ISO) and engineering performance specifications. There is no concept of expert "ground truth" establishment in the way it might apply to diagnostic AI or imaging devices.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs independent review to establish a consensus ground truth. For an infusion set, performance is measured against objective physical and chemical standards.

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 is not applicable. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, where human "readers" (e.g., clinicians interpreting images) are part of the diagnostic process and their performance might be augmented by AI. The Hospira Sapphire Sets are infusion pump accessories, not diagnostic imaging devices or AI-powered tools for interpretation.

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

This is not applicable. The device is an infusion set, not an algorithm or an AI-powered system. The tests described are for the physical and functional performance of the medical device itself.

7. The type of ground truth used:

The "ground truth" for the performance claims of the Hospira Sapphire Sets is based on adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 1135-4) and the engineering specifications and performance characteristics demonstrated to be "acceptable" through the conducted tests. It's essentially "compliance with established safety and performance benchmarks."

8. The sample size for the training set:

This is not applicable. The device is a physical medical device (infusion set), not a machine learning model that requires a training set.

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

This 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

December 6, 2016

Hospira, Inc. David Blonski Director Regulatory Affairs 375 North Field Drive Lake Forest, Illinois 60045

Re: K160492

Trade/Device Name: Hospira Sapphire Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: December 1, 2016 Received: December 2, 2016

Dear David Blonski:

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 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) K160492

Device Name Hospira Sapphire Set

Indications for Use (Describe)

Hospira Sapphire 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 Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized representation of a plant or a medical symbol. The logo is presented in grayscale.

Section 5 510(k) Summary: K160492

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

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60046
Phone number	24-212-5010
Mobile number	224-515-6807
Fax number	(224) 212-5401
Establishment RegistrationNumber	3005579246 (Owner/Operator #9063339)
Name of contact person	David Blonski, Director Regulatory Affairs
Date prepared	2/19/2016
Name of device
Trade or proprietary name	Hospira Sapphire Sets
Common or usual name	Infusion pump accessory
Classification name	Infusion Pump, 21 CFR 880.5725, Class II
Product Code(s)	MRZ
Legally marketed device(s) to whichequivalence is claimed	Q Core Medical Sapphire Sets - K123049 (Predicate 510(k))Hospira Plum Sets - K141789 (reference 510(k) for technological characteristics)Life Care PCA Infusion System - K043256 (reference 510(k) for technological characteristics)
Reason for 510(k) submission	New IV administration sets to be used with Q Core Medical Ltd.'s Sapphire Infusion System.
Device description	Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. HospiraSapphire sets are comprised of various components including the following: male luer adapterwith cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow controldevice, in-line adapter, injection site assembly, check valve, and burette chamber. HospiraSapphire sets are configured to ensure the intended use of the device is met. The sets aredisposable devices for single patient use.
Intended Use of Device	Hospira Sapphire sets are intended for use with the Sapphire Infusion System to deliver fluidsfrom a container to a patient's vascular system. Hospira Sapphire Sets are indicated for thedelivery of fluids from a container to a patient's vascular system.
Indication for use	Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient'svascular 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 sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines converging at the top, resembling a stylized plant or a modern architectural element. 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	The Q Core Sapphire infusion pump isintended for the controlled delivery throughintravascular,subcutaneous, intra-arterial and epiduralroutes. The pump is designed to deliversaline, Total ParenteralNutrition, lipids, IV medication, epiduralmedication, blood and blood products.The Sapphire pump includes the followinginfusion modes for all intended uses:Continuous, Intermittent,TPN, PCA, Multi-step, and Epidural.The pump is intended to be used by bothlicensed health care professionals in aclinical environment, andhome users in an ambulatory environment.The Sapphire pump is designed to follow thepatient throughthe various care areas, and in pre-hospitalmedical ground transportation.The dedicated Q Core administration sets forthe Sapphire pump are intended for single-patient use andsingle-use only.	Hospira Sapphire Sets are indicated for thedelivery of fluids from a container to apatient's vascular system.
Discussion of change inindication for use	The differences between the predicate and proposed indications for use stated above are notcritical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the proposeddevice. The predicate indication for use stated above is primarily related to use of theSapphire Infusion pump with an inclusionary statement that the Q Core administration setsfor the Sapphire pump are intended for single-patient use and single-use only. The HospiraSapphire sets are intended for use with the Sapphire pump and as such are a component ofthe predicate device system. The proposed sets are also intended for single patient use andsingle-use only. The proposed Hospira Sapphire sets have the same intended use, and asindicated below are tested to the same performance standards as the predicate sets andtherefore do not affect the safety and effectiveness predicate device system.
Design and Materials ofConstruction	The design and materials of construction ofall components for the set, with theexception of the Sapphire Cassette, are ascleared under the 510(k)s K141789 andK043256 which are reference 510(k)s fortechnological characteristics.The design and materials of construction ofthe Sapphire Cassette are as cleared underthe predicate Q Core Medical Ltd. 510(k)K123049.	The design and materials of construction forall components of the sets remain the sameas the predicate product.
Summary of non-clinical testsfor determination of substantialequivalence	All materials of construction for HospiraSapphire Sets meet the applicable materialtest requirements for ISO 10993 asdemonstrated in the predicate 510(k)s.	All materials of construction for HospiraSapphire Sets remain the same as thepredicate product. Additional data has beengenerated demonstrating that HospiraSapphire sets, which are comprised of acombination of Hospira IV set componentswith the Sapphire Cassette, meet theapplicable material test requirements forISO 10993 as follows:
		ISO Standard Biological Effect10993-4 Hemocompatibility10993-5 Cytotoxicity10993-10 Sensitization10993-11 Intracutaneous IrritationSystemic ToxicitySubacute ToxicityPyrogenicity
	Performance testing for all Hospira Sapphireset components, with the exception of theSapphire Cassette, was conducted asindicated in the predicate 510(k)s to ensurethe device performs as intended inaccordance with applicable standards. Alltesting is acceptable.Performance testing for the Q Core MedicalLtd. Sapphire Cassette , was conducted asindicated in the predicate 510(k) to ensurethe cassette performs with the SapphirePump as intended in accordance withapplicable standards.All testing is acceptable.	New performance data has been generatedto ensure the Hospira Sapphire Sets, acombination of Hospira IV set componentswith the Sapphire Cassette, perform asintended in accordance with:ISO 8536-4, 6.1 Particulate ContaminationISO 8536-4, 6.2 LeakageISO 8536-4, 6.3 Tensile StrengthISO 1135-4, 5.3 Tensile StrengthAdditionally, flow rate accuracy testingusing the proposed Hospira Sapphire Setsand the Sapphire Infusion System has beenconducted.All testing is acceptable.The product Sterility Assurance Level
	The product Sterility Assurance Level is 10-6	is 10-6

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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 sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the bottom and spread out at the top, resembling stylized blades of grass or a stylized flower. The logo is presented in grayscale.

Conclusion

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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).