Hospira Primary Sets

K143015 · Hospira, Inc. · FPA · Feb 25, 2015 · General Hospital

Device Facts

• Record ID: K143015
• Device Name: Hospira Primary Sets
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Hospira Primary Sets are disposable gravity-fed IV administration sets used to deliver fluids from a container to a patient's vascular system. The device consists of a piercing pin assembly, drip chamber, tubing, injection site, flow control device (e.g., dial-a-flo), and a modified Secure Lock male luer adapter with a spin collar. The device is intended for single-patient use. Healthcare providers use the set to establish a fluid path for intravenous therapy. The modification to the Secure Lock male luer is the primary change from the predicate device.

Clinical Evidence

Bench testing only. Performance testing conducted to ensure the device meets intended functional claims and applicable standards (ISO 594-1, ISO 594-2, ISO 8536-4). Materials meet ISO 10993 requirements. Sterility Assurance Level is 10^-6.

Technological Characteristics

Gravity-fed IV administration set. Components include piercing pin, drip chamber, tubing, injection site, flow control, and Secure Lock male luer with spin collar. Materials are identical to the predicate. Sterilization method achieves a Sterility Assurance Level of 10^-6. Complies with ISO 594-1, ISO 594-2, ISO 8536-4, and ISO 10993.

Indications for Use

Indicated for 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

• Hospira Primary Sets (K142367)

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

February 25, 2015

Hospira, Inc. Ms. Anju Kurian Associate, Regulatory Affairs D- 0393 Bldg. H3 375 N. Field Drive Lake Forest, Illinois 60045

Re: K143015

Trade/Device Name: Hospira Primary Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: FPA Dated: January 23, 2015 Received: January 26, 2015

Dear Ms. Kurian:

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 [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 Industry and Consumer Education 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 Statement

K143015 510(k) Number:

Device Name: Hospira Primary Set

Indications for Use: Hospira Primary 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

| 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. 60045 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact<br>person | Anju Kurian, Associate, Global Regulatory Affairs |
| Date prepared | 10/17/2014 |
| Name of device | |
| Trade or proprietary<br>name | Hospira Primary Sets |
| Common or usual<br>name | I.V Administration Sets |
| Classification name | Intravascular Administration Set, 21 CFR 880.5440, Class II |
| Product Code(s) | FPA |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Hospira Primary Sets - K142367 |
| Reason for 510(k)<br>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. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. 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 patient's vascular system. |

## CONFIDENTIAL

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| Summary of the technological characteristics of the device compared to the predicate<br>device | | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate 510 (k) : K142367 | Proposed Device |
| Indications for Use | Hospira Primary Sets are indicated<br>for the delivery of fluids from a<br>container to a patient's vascular<br>system. | Hospira Primary Sets are 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<br>as the materials for the predicate<br>product | The design and materials of construction<br>remain the same as the predicate product. |
| Summary of non-clinical<br>tests for determination of<br>substantial equivalence | All materials of construction for<br>Hospira Primary Sets meet the<br>applicable material test requirements<br>for ISO 10993. | All materials of construction for Hospira<br>Primary Sets meet the applicable material<br>test requirements for ISO 10993. |
| Summary of Performance<br>Testing | Performance testing was conducted<br>to ensure the device performs as<br>intended in accordance with<br>applicable standards. All testing is<br>acceptable.<br><br>The product Sterility Assurance<br>Level is 10-6. | New performance data has been generated<br>to ensure the device performs as intended<br>in accordance with ISO 594-1, ISO 594-2<br>and ISO 8536-4. All testing is acceptable.<br><br>The product Sterility Assurance Level<br>is 10-6. |

## 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 Hospira Primary Sets cleared under K142367.

### CONFIDENTIAL

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