Hospira Administration Sets

• K Number: K160870
• Device Name: Hospira Administration Sets
• Manufacturer: HOSPIRA, INC.
• Date Cleared: 2016-06-01 ( 63 days)
• Product Code: FPA
• Regulation Number: 880.5440

Intended Use

Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.

Device Description

The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s. Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.

Predicate Devices

K142367, K143015, K142433, K142974, K142622, K143087

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a modification to existing administration sets, primarily involving the addition of a new connector. There is no mention of AI, ML, or any related computational processing for decision-making or analysis. The performance studies focus on material and mechanical properties.

Therapeutic

No
The device is an administration set intended for delivery of fluids, not for treating a disease or condition.

Diagnostic

No

The device is an administration set intended for the delivery of fluids to a patient's vascular system. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists various hardware components such as male luer adapter, tubing, flow control device, filter, injection site assembly, and a luer activated needleless valve. The performance studies also focus on material and mechanical properties of these physical components.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is clearly stated as "delivery of fluids from a container to a patient's vascular system." This describes a device used in vivo (within the body) for therapeutic or diagnostic purposes related to fluid administration, not for testing samples in vitro (outside the body).
• Device Description: The components listed (luer adapters, tubing, filters, valves, etc.) are typical of devices used for intravenous fluid delivery, not for performing diagnostic tests on biological samples.
• Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.

The device is an administration set used for delivering fluids directly into a patient's bloodstream. This falls under the category of medical devices used for treatment or direct patient care, not for in vitro diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Burette Sets, and Hospira Blood Sets

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

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

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

Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patients vascular system.

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

FPA

Device Description

The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s.
Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.

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)

Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:

All materials of construction for the proposed component Nuitiv™ Connector meet the applicable material test requirements for ISO 10993 as follows:

ISO Standard Biological Effect
10993-4 Hemocompatibility
10993-5 Cytotoxicity
10993-10 Sensitization
10993-11 Intracutaneous Irritation
Systemic Toxicity
Subacute Toxicity
Subchronic Toxicity
Pyrogenicity

Performance data has been generated for the proposed Nuitiv™ Connector in accordance with:

ISO 594-1 Section 4.1.1 Gauging
ISO 594-2 Section 4.2.1 Liquid Leakage
Section 4.2.2 Air Leakage
Section 4.3 Separation Force
Section 4.4 Unscrewing Torque
Section 4.5 Ease of Assembly
Section 4.6 Resistance to Overriding
Section 4.7 Stress Cracking
ISO 8536-4 Section 6.1 Particulate Matter
Section 6.2 Air Leakage
Section 6.3 Tensile Strength
ISO 8536-8 Section A.3.2 Air Leakage
Section A.3.3 Air Leakage
Section A.3.4 Liquid Leakage
ISO 1135-4 Section 5.1 Particulate Matter
Section 5.2 Air Leakage
Section 5.3 Tensile Strength

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.

K142367, K143015, K142433, K142974, K142622, K143087

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

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.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

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

June 1, 2016

Hospira, Inc. Mr. David Blonski Director Regulatory Affairs 375 Field Drive D-393, Building H3 Lake Forest, Illinois 60045

Re: K160870

Trade/Device Name: Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Burette Sets, and Hospira Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 2, 2016 Received: May 3, 2016

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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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 [phone] or [phone] 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 [phone] or [phone] 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

510(k) Number (if known) K160870

Device Name

Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Blood Sets

Indications for Use (Describe)

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

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

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

Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patients vascular system.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 features three curved lines that resemble an abstract representation of a medical symbol or a stylized wave pattern. The logo is presented in grayscale.

510(k) Summary-K160870

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

Submitter Information
Name	Hospira, Incorporated
Address	D-393, Bldg. H3
375 North Field Drive
Lake Forest, IL. 60045
Phone number	24-212-5010
Mobile number	224-515-6807
Fax number	[phone]
Establishment Registration
Number	3005579246 (Owner/Operator #9063339)
Name of contact person	David Blonski, Director Regulatory Affairs
Date prepared	May 24, 2016
Name of device
Trade or proprietary name	Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira
Burette Sets, Hospira Blood 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) to
which equivalence is claimed	Hospira Primary Sets - K142367
Hospira Primary Sets - K143015
Hospira Extension Sets - K142433
Hospira Extension Sets - K142974
Hospira Burette Sets - K142622
Hospira Blood Sets - K143087
Reason for 510(k) submission	Device modification adding an alternate luer activated needleless valve.
Device description	The subject of this Special 510(k): Device Modification is the addition of an alternate
luer activated needleless valve to existing Hospira Administration sets cleared under
the identified predicate 510(k)s.
Hospira Administration Sets are comprised of components in various combinations of
the following: male luer adapter with cap, female luer with cap, piercing pin
connector, tubing, flow control device, filter, in-line adapter, injection site assembly,
luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and
blood chamber.
Intended Use of Device	Hospira Administration Sets are intended for the delivery of fluids from a container to
a patient's vascular system. Hospira Administration sets are configured to ensure the
intended use of the device is met. The sets are disposable devices for single patient
use.
Hospira Administration sets are intended for the delivery of fluids, including blood
and blood products where indicated, 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 simple, sans-serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized arch or a representation of connectivity.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Predicates						Proposed Device
	K142367	K143015	K142433	K142974	K142622	K143087	K160870
Indications for Use	Indications for Use:
Hospira Primary sets are
indicated for the delivery
of fluids from a container
to a patient's vascular
system.	Indication
s for Use:
Hospira
Primary
sets are
indicated
for the
delivery
of fluids
from a
container
to a
patient's
vascular
system.	Indication
s for Use:
Hospira
Extension
sets are
indicated
for the
delivery
of fluids
from a
container
to a
patient's
vascular
system.	Indication
s for Use:
Hospira
Extension
sets are
indicated
for the
delivery
of fluids
from a
container
to a
patient's
vascular
system.	Indication
s for Use:
Hospira
Burette
sets are
indicated
for the
delivery
of fluids
from a
container
to a
patient's
vascular
system.	Indication
s for Use:
Hospira
Blood sets
are
indicated
for the
delivery
of fluids
including
but not
limited to
blood and
blood
products
from a
container
to a
patient's
vascular
system.	Indications for Use: Hospira Primary sets are
indicated for the delivery of fluids from a
container to a patient's vascular system.

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

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

Indications for Use: Hospira Blood sets are
indicated for the delivery of fluids including but
not limited to blood and blood products from a
container to a patient's vascular system. |
| Design and
Materials of
Construction | The predicate component,
the CLAVETM Connector
is a luer activated
needleless valve cleared
under predicate 510(k)
K142367

The CLAVETM
Connector consists of the
following materials:

Body:  PBT - GE Valox
215 or Valox
315
Spike:  MABS - Terlux
2812TR or
Polycarbonate –
Bayer Makrolon
RX 2530-
451118
Plug:  Silicone –
Wacker Elastosil
LR 3003/70
Lubricant:  Silicone,
Dow, FS- | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | The proposed alternate component, the NuitivTM
Connector is a luer activated needleless valve.

The NuitivTM Connector consists of the
following materals:

Body:  Polycarbonate, Makrolon
RX1805
Tritan MX731 copolyester
Spike:
Plug:  Silicone - Wacker Elastosil
LR3066/55 (gland)
Lubricant:  Silicone - Med400, nusil |
| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | |
| Characteristic | K142367 | K143015 | K142433 | K142974 | K142622 | K143087 | Proposed Device
K160870 |
| Summary of non-clinical tests for determination of substantial equivalence | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:

All materials of construction for the predicate component CLAVETM Connector meet the applicable material test requirements for ISO 10993 as demonstrated in the predicate 510(k). | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:

All materials of construction for the proposed component NuitivTM Connector meet the applicable material test requirements for ISO 10993 as follows:

ISO Standard Biological Effect
10993-4 Hemocompatibility
10993-5 Cytotoxicity
10993-10 Sensitization
10993-11 Intracutaneous Irritation
Systemic Toxicity
Subacute Toxicity
Subchronic Toxicity
Pyrogenicity |
| Summary of Performance Testing | Performance testing for predicate component CLAVETM Connector was conducted as indicated in the predicate 510(k) to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.

The product Sterility Assurance Level is for Hospira Administration sets is 10-6. | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | Same as
K142367 | Performance data has been generated for the proposed NuitivTM Connector in accordance with:

ISO 594-1 Section 4.1.1 Gauging
ISO 594-2 Section 4.2.1 Liquid Leakage
Section 4.2.2 Air Leakage
Section 4.3 Separation Force
Section 4.4 Unscrewing Torque
Section 4.5 Ease of Assembly
Section 4.6 Resistance to Overriding
Section 4.7 Stress Cracking
ISO 8536-4 Section 6.1 Particulate Matter
Section 6.2 Air Leakage
Section 6.3 Tensile Strength
ISO 8536-8 Section A.3.2 Air Leakage
Section A.3.3 Air Leakage
Section A.3.4 Liquid Leakage
ISO 1135-4 Section 5.1 Particulate Matter
Section 5.2 Air Leakage
Section 5.3 Tensile Strength

All testing is acceptable.

The product Sterility Assurance Level is 10-6. |

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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 appears to be three curved lines that converge at the top, creating an abstract shape. The logo is presented in grayscale.

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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a gray, sans-serif font. Above the word is an abstract graphic of three curved lines that converge at the bottom and spread out at the top, resembling an arch or a stylized representation of movement. The lines are also gray, matching the color of the text.

Conclusion

The proposed alternate component Nuitiv™ Connector in the subject devices meets the functional claims and intended use as described in the product labeling. The proposed component Nuitiv™ Connector in the subject devices is substantially equivalent to the predicate device component CLAVE™ Connector.