Extension Sets

K142974 · Hospira, Inc. · FPA · Jan 9, 2015 · General Hospital

Device Facts

• Record ID: K142974
• Device Name: Extension Sets
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Hospira Extension Sets are disposable, single-patient-use gravity-fed infusion sets. Components include male/female luer adapters, tubing, flow control devices, in-line adapters, injection site assemblies, stopcocks, and Dial-A-Flo. The device connects a fluid container to a patient's vascular system to facilitate fluid delivery. Used in clinical settings, the device is operated by healthcare professionals. The modification in this submission involves a change in the male luer adapter material to an alternate acrylic and minor dimensional adjustments to improve connection security with female luers. The device functions as a conduit for fluid administration; clinical decision-making relies on the provider's assessment of the patient's fluid requirements.

Clinical Evidence

Bench testing only. Performance testing was conducted 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 results were acceptable.

Technological Characteristics

Disposable gravity-fed intravascular administration set. Components include male/female luer adapters, tubing, flow control devices, injection sites, stopcocks, and Dial-A-Flo. Male luer adapter material is acrylic. Sterility Assurance Level (SAL) is 10^-6. Complies with ISO 594-1, ISO 594-2, ISO 8536-4, and ISO 8536-10.

Indications for Use

Indicated for the delivery of fluids from a container to a patient's vascular system.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LifeShield Vision Infusion Sets (K113683)
• Hospira Infusion Blood Sets (K101677)

Submission Summary (Full Text)

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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 [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,

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)

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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 | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3<br>375 North Field Drive<br>Lake Forest, IL. 60046 |
| Phone number | [phone] |
| Mobile number | [phone] |
| Fax number | [phone] |
| Establishment Registration Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | Oct. 10, 2014 |
| Name of device | |
| Trade or proprietary name | Extension 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<br>which equivalence is claimed | LifeShield Vision Infusion Sets – K113683<br>Hospira Infusion Blood Sets – K101677 |
| Reason for 510(k) submission | The changes addressed in this submission include: |
| | • Modification to Secure Lock Male Luer |
| Device description | The Hospira Extension Sets with Secure Lock are intended for use as gravity sets.<br>Hospira Extension sets are comprised of various components including the following:<br>male luer adapter with cap, tubing, female luer adapter,flow control device, in-line<br>adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are<br>configured to ensure the intended use of the device is met. Hospira Externsion sets are<br>intended for the delivery of fluids from a container to a patient's vascular system. The<br>sets are disposable devices for single patient use. |
| Intended Use of Device | Hospira Extension set is intended for the delivery of fluids from a container to a<br>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 | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate | Proposed Device |
| Indications for Use | Hospira Extension Set is intended for<br>the delivery of fluids from a container<br>to a patient's vascular system. | Hospira Extension Set is indicated for the<br>delivery of fluids from a container to a<br>patient's vascular system. |
| Design and Materials of<br>Construction | The materials of construction for the<br>proposed device are exactly the same as<br>the materials for the predicate product | The design and materials of construction<br>remain the same as the predicate product<br>with the following exceptions:<br>1. The male luer adapter material is<br>changing to an alternate acrylic material.<br>2. Minor dimensional modifications are<br>being made to the male luer adapter to<br>enhance connection with female luers. |
| | | Summary of non-clinical tests for<br>determination of substantial<br>equivalence |
| Summary of Performance Testing | Performance testing was conducted to<br>ensure the device performs as intended<br>in accordance with applicable<br>standards. All testing is acceptable. | New performance data has been generated<br>to ensure the device performs as intended in<br>accordance with ISO 594-1, ISO 594-2, ISO<br>8536-4 and ISO 8536-10. All testing is<br>acceptable. |
| | The product Sterility Assurance Level<br>is $10^{-6}$ . | The product Sterility Assurance Level<br>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.