K Number
K142974
Device Name
Extension Sets
Manufacturer
Date Cleared
2015-01-09

(87 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Device Description
The Hospira Extension Sets with Secure Lock 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, flow control device, in-line adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion 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.
More Information

Not Found

No
The device description and performance studies focus on the physical components and fluid delivery function of the extension set, with no mention of AI or ML.

No
The device is used for the delivery of fluids, which is a supportive function, not a direct treatment for a disease or condition.

No

Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for the delivery of fluids from a container to a patient's vascular system," which describes a therapeutic or delivery function, not a diagnostic one. There is no mention of disease detection, monitoring of physiological parameters for diagnostic purposes, or image processing, AI/ML, or imaging modalities that are typically associated with diagnostic devices.

No

The device description explicitly lists physical components such as tubing, luer adapters, flow control devices, etc., indicating it is a hardware medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for the delivery of fluids from a container to a patient's vascular system." This describes a device used for administering substances directly into the body, not for examining specimens from the body to provide diagnostic information.
  • Device Description: The description details components like tubing, luers, flow control, etc., which are typical for infusion sets used for fluid delivery. There is no mention of components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of providing diagnostic information about a patient's health status.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering fluids.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FPA

Device Description

The Hospira Extension Sets with Secure Lock 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, flow control device, in-line adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.
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 and ISO 8536-10. All testing is acceptable.
The product Sterility Assurance Level is $10^{-6}$ .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

LifeShield Vision Infusion Sets – K113683, Hospira Infusion Blood Sets – K101677

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 right, stacked one behind the other, with a wing-like shape extending from the back of the heads.

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

January 9.2015

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

Re: K142974

Trade/Device Name: Hospira Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 10, 2014 Received: October 14, 2014

Dear Mr. 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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Page 2 - Mr. Blonski

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 Russo, 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 Statement

K142974 510(k) Number:

Device Name: Hospira Extension Set

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

Prescription Use × (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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Image /page/3/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 appears to be three curved lines that converge at the top, creating a sense of movement or flow.

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 Extension Sets.

Submitter Information
NameHospira, Incorporated
AddressD-393, Bldg. H3
375 North Field Drive
Lake Forest, IL. 60046
Phone number(224) 212-5010
Mobile number(224) 515-6807
Fax number(224) 212-5401
Establishment Registration Number3005579246 (Owner/Operator #9063339)
Name of contact personDavid Blonski, Director Regulatory Affairs
Date preparedOct. 10, 2014
Name of device
Trade or proprietary nameExtension Sets
Common or usual nameI.V Administration Sets
Classification nameIntravascular Administration Set, 21 CFR 880.5440, Class II
Product Code(s)FPA
Legally marketed device(s) to
which equivalence is claimedLifeShield Vision Infusion Sets – K113683
Hospira Infusion Blood Sets – K101677
Reason for 510(k) submissionThe changes addressed in this submission include:
• Modification to Secure Lock Male Luer
Device descriptionThe Hospira Extension Sets with Secure Lock 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,flow control device, in-line
adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are
configured to ensure the intended use of the device is met. Hospira Externsion 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.
Intended Use of DeviceHospira Extension set is intended for the delivery of fluids from a container to a
patient's vascular 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 gray, sans-serif font. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized, modern design element.

Summary of the technological characteristics of the device compared to the predicate device
CharacteristicPredicateProposed Device
Indications for UseHospira Extension Set is intended for
the delivery of fluids from a container
to a patient's vascular system.Hospira Extension Set is indicated for the
delivery of fluids from a container to a
patient's vascular system.
Design and Materials of
ConstructionThe materials of construction for the
proposed device are exactly the same as
the materials for the predicate productThe design and materials of construction
remain the same as the predicate product
with the following exceptions:
  1. The male luer adapter material is
    changing to an alternate acrylic material.
  2. Minor dimensional modifications are
    being made to the male luer adapter to
    enhance connection with female luers. |
    | | | Summary of non-clinical tests for
    determination of substantial
    equivalence |
    | Summary of Performance Testing | Performance testing was conducted to
    ensure the device performs as intended
    in accordance with applicable
    standards. All testing is acceptable. | 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 and ISO 8536-10. All testing is
    acceptable. |
    | | The product Sterility Assurance Level
    is $10^{-6}$ . | The product Sterility Assurance Level
    is $10^{-6}$ . |

Conclusion

Hospira Extension 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.