K Number
K142433
Device Name
Hospira Extension Set
Manufacturer
Date Cleared
2014-12-08

(101 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 infusion sets are disposable devices for single patient use.
More Information

Not Found

No
The summary describes a standard medical device (infusion sets) with no mention of AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML algorithms.

No.
The device is described as an extension set for delivering fluids and is a disposable, single-patient use device, not one that treats or cures a condition.

No
The device, Hospira Extension Sets, is indicated for the delivery of fluids, which is a treatment or administration function, not a diagnostic one.

No

The device description clearly states it is a physical medical device (extension sets) used for fluid delivery, not a software application.

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 in vitro (outside the body) to diagnose or monitor a condition.
  • Device Description: The description reinforces its use as an "infusion set" for delivering fluids.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosis or monitoring through in vitro testing.

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 the physical delivery of fluids into the patient.

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

FPA

Device Description

The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira infusion 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

patient's vascular system

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. The product Sterility Assurance Leve is $10^{-6}$.

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

Not Found

Predicate Device(s)

K113683, K101677, K052722

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

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

May 22, 2015

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

Re: K142433 Trade/Device Name: Regulation Number: 21 CFR 880.5440 Regulation Name: IV Administration Sets Regulatory Class: II Product Code: FPA Dated: August 28, 2015 Received: August 29, 2015

Dear Mr. Blonski:

This letter corrects our substantially equivalent letter of December 8, 2014.

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/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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Indications for Use Statement

510(k) Number: K142433

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 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 K142433

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. H2
275 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 preparedAugust 28, 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
LifeShield Latex Free Microbore Set - K052722
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 infusion 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.

CONFIDENTIAL

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Image /page/4/Picture/1 description: The image shows the word "Hospira" in a serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the word is a stylized graphic consisting of four curved lines that converge at the top, resembling a stylized wing or abstract design. The image is in black and white.

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.Same
Materials of ContructionThe materials of construction for the proposed device are exactly the same as the
materials for the predicate productSame
Summary of non-clinical tests for
determination of substantial
equivalenceAll materials of constrction for Hospira
Extension Sets meet the applicable
material test requirements for ISO
10993Same
Summary of Performance TestingPerformance testing was conducted to
ensure the device performs as intended
in accordance with applicable
standards. All testing is acceptable.
The product Sterility Assurance Leve is
$10^{-6}$ .Same

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, Hospira Infusion Blood Sets cleared under K 101677 and LifeShield Latex Free Microbore Set cleared under K052722.