Hospira Primary Sets

K142367 · Hospira, Inc. · FPA · Nov 25, 2014 · General Hospital

Device Facts

• Record ID: K142367
• Device Name: Hospira Primary Sets
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A Hospira Primary set is intended for the delivery of fluids from a container to a patient's vascular system.

Device Story

Hospira Primary Sets are disposable, single-patient-use gravity infusion sets. Device facilitates fluid delivery from container to patient vascular system. Modification includes Secure Lock male luer. Used in clinical settings by healthcare providers. Output is fluid delivery; clinical decision-making relies on provider assessment of patient fluid requirements. Benefits include reliable, sterile fluid administration.

Clinical Evidence

No clinical data. Bench testing only. Performance testing conducted to ensure device meets functional claims and applicable standards. Materials meet ISO 10993 requirements. Sterility Assurance Level is 10^-6.

Technological Characteristics

Disposable gravity-fed intravascular administration set. Materials of construction identical to predicate devices, meeting ISO 10993 requirements. Features Secure Lock male luer. Sterilization method achieves Sterility Assurance Level of 10^-6.

Indications for Use

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

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

November 25,2014

Hospira, Incorporated Dr. Catherine Kang Senior Associate. Global Regulatory Affairs 375 North Field Drive, D-393, Bldg. H3 Lake Forest, IL 60046

Re: K142367

Trade/Device Name: Hospira Primary Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 26, 2014 Received: August 27, 2014

### Dear Dr. Kang:

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 - Dr. Kang

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 Runno 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

510(k) Number (if known) K142367

Device Name

Hospira Primary Set

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Hospira. 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 representation of a plant or a network. The logo is presented in grayscale.

#### 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 Primary Sets.

| Submitter Information | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3<br>375 North Field Drive<br>Lake Forest, IL. 60046 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment Registration Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Catherine Kang, PhD, Senior Associate, Global Regulatory Affairs |
| Date prepared | August 22, 2014 |
| Name of device | |
| Trade or proprietary name | Hospira Primary 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 | Hospira Primary sets:<br>LifeShield Vision Infusion Sets - K113683<br>Hospira Infusion Blood Sets – K101677 |
| Reason for 510(k) submission | The changes addressed in this submission include:<br>• Modification to Secure Lock Male Luer |
| Device description | The Hospira Primary Sets with Secure Lock are intended for use as gravity sets.<br>Hospira infusion sets are disposable devices for single patient use. |
| Intended Use of Device | A Hospira Primary set is intended for the delivery of fluids from a container to a<br>patient's vascular system |

## CONFIDENTIAL

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Image /page/4/Picture/1 description: The image shows the logo for Hospira. 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, resembling a stylized representation of a plant or a medical symbol. The logo is in grayscale.

| Summary of the technological characteristics of the device compared to the predicate device | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate | Proposed Device |
| Indications for Use | Infusion sets are intended for the<br>delivery of fluids including but not<br>limited to blood and blood products<br>from a container into a patient's<br>vascular system. | Hospira Primary Set is intended for the<br>delivery of fluids from a container to a<br>patient's vascular system. |
| Materials of Contruction | The materials of construction for the proposed device are the same as the materials for<br>the predicate product. | |
| Summary of non-clinical tests for<br>determination of substantial<br>equivalence | All materials of construction for<br>Hospira Primary Sets meet the<br>applicable material test requirements<br>for ISO 10993. | Same |
| 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.<br>The product Sterility Assurance Level<br>is 10-6. | Same |

# Conclusion

Hospira Primary 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.