Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

Device Description

The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette 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 document is a 510(k) summary for the Hospira Burette Sets, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of AI performance.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device meets those criteria, particularly those related to AI effectiveness, human readers, sample sizes for training sets, and expert adjudication, are not applicable to this document. This document describes a medical device, Burette Sets, not an AI or imaging diagnostic device.

However, I can extract and infer some information based on the document's content regarding the device's performance and the testing conducted.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might expect for an AI diagnostic study. Instead, it refers to compliance with international standards and internal testing.

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility (Material safety)	"All materials of construction for Hospira Burette Sets meet the applicable material test requirements for ISO 10993."
Performance (Functional intent)	"New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, ISO 8536-4. All testing is acceptable."
Sterility Assurance Level	"The product Sterility Assurance Level is 10-6."

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

Sample Size: The document does not specify the exact sample size used for performance or material testing. It states that "new performance data has been generated" and "all testing is acceptable."
Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by Hospira, Incorporated as part of their 510(k) submission. This would be prospective testing for regulatory submission.

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

Not Applicable. This is a physical medical device (intravascular administration set), not a diagnostic device requiring expert interpretation or ground truth establishment in the context of medical imaging or AI. Testing would involve engineering and laboratory personnel following established protocols and standards.

4. Adjudication method for the test set

Not Applicable. As above, this type of testing for a physical device does not typically involve adjudication methods like those used for expert consensus in diagnostic studies. Compliance with standards (e.g., ISO) is the primary method of evaluation.

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

Not Applicable. This study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's for a physical medical device.

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

Not Applicable. This is not an AI algorithm. It's a medical device. Performance testing for the device would be analogous to "standalone" performance testing for a physical product, demonstrating it meets its specifications independently.

7. The type of ground truth used

The "ground truth" for this device is based on compliance with established international standards for medical devices (ISO 10993 for biocompatibility, ISO 594-1, ISO 594-2, ISO 8536-4 for various performance aspects of injection and infusion equipment) and achieving a specific sterility assurance level (10-6). The performance claims are also against the intended use of the device for fluid delivery.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not Applicable. As above, this is not an AI model.

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI diagnostic tool. Therefore, many of the questions related to AI performance, human readers, and ground truth establishment for AI models are not relevant to this context. The "study" proving the device meets the criteria refers to the non-clinical performance testing and material testing conducted to ensure compliance with relevant ISO standards and the stated Sterility Assurance Level.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 10, 2015

Hospira, Incorporated Mr. David Blonski Director Regulatory Affairs 375 N. Field Drive Lake Forest, IL 60046

Re: K142622

Trade/Device Name: Burette Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 18, 2014 Received: December 19, 2014

Dear Mr. Blonski:

This letter corrects our substantially equivalent letter of January 15, 2015.

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

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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. 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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142622

Device Name Hospira Burette Set

Indications for Use (Describe)

Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products 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)

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/4/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a 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 representation of a plant or abstract design. The logo is presented in black and white.

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 Burette Sets.

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60046
Phone number	(224) 212-5010
Fax number	(224) 212-5401
Establishment RegistrationNumber	3005579246 (Owner/Operator #9063339)
Name of contact person	David Blonski, Director Regulatory Affairs
Date prepared	09/19/2014
Name of device
Trade or proprietary name	Burette 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	LifeShield Vision Infusion Sets - K113683
Reason for 510(k) submission	The changes addressed in this submission include:• Modification to Secure Lock Male Luer
Device description	The Hospira Burette Sets with Secure Lock are intended for use as gravity sets.Hospira Burette sets are comprised of various components including the following:male luer adapter with cap, tubing, flow control device, piercing pin assembly, buretteassembly and injection site assembly. Burette sets are configured to ensure theintended use of the device is met. Hospira Burette sets are intended for the delivery offluids from a container to a patient's vascular system. The sets are disposable devicesfor single patient use.
Intended Use of Device	Hospira Burette sets are indicated for the delivery of fluids including but not limited toblood and blood products from a container to a patient's vascular system.

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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 sans-serif font, with a stylized graphic above it. The graphic features three curved lines that converge at the top, resembling a stylized abstract shape. 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	LifeShield Infusion Sets are intendedfor the delivery of fluids including butnot limited to blood and blood productsfrom a container to a patient's vascularsystem.	Hospira Burette sets are indicated for thedelivery of fluids including but not limitedto blood and blood products from acontainer to a patient's vascular system.
Design and Materials of Contruction	The design and materials ofconstruction are as cleared under thepredicte 510(k)	The design and materials of constructionremain the same as the predicate productwith the following exceptions:1. The male luer adapter material ischanging to an alternate acrylic material.2. Minor dimensional modifications arebeing made to the male luer adapter toenhance connection with female luers.
Summary of non-clinical tests fordetermination of substantialequivalence	All materials of construction forHospira Burette Sets meet theapplicable material test requirementsfor ISO 10993	New data has been generated demonstratingthat all materials of construction for HospiraBurette Sets meet the applicable materialtest requirements for ISO 10993.
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 594-1, ISO 594-2, ISO8536-4. All testing is acceptable.The product Sterility Assurance Levelis 10-6.

Conclusion

Hospira Burette 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.

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.