HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING

K103224 · Hospira, Inc. · FPA · Jan 7, 2011 · General Hospital

Device Facts

• Record ID: K103224
• Device Name: HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hospira infusion sets are intended for use in parenteral, enteral and epidural therapies and the administration of fluids, medications, nutritional fluids, blood and blood products. Safety features on these devices aid in prevention of needle-stick injuries. Indications for use may include hospital and other medical settings, ambulatory and home use,

Device Story

Hospira Infusion Sets are disposable fluid delivery tubing systems used with dedicated Hospira infusion pumps. Configurations include primary, secondary, extension, piggyback, gravity, microbore, and macrobore sets. Modifications include a transition from solvent-based bonding to laser welding and a change from DEHP-containing PVC to non-DEHP PVC tubing with yellow striping. Sets are used by clinicians or patients in hospitals, ambulatory, and home settings to deliver fluids and medications. The device facilitates controlled fluid administration; physical attributes like length, diameter, and priming volume are tailored to specific clinical needs. Safety features are integrated to prevent needle-stick injuries. The device is intended to maintain the same functional performance as previously cleared predicate sets.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility per ISO 10993), sterility (SAL 10^-6 per ISO 11137-2), and dimensional/connection compatibility (ISO 594-2). Results confirmed compliance with design inputs for sterility, particulate, leakage, tensile strength, and filter characteristics.

Technological Characteristics

Disposable infusion sets; materials include non-DEHP PVC with yellow colorant. Bonding process utilizes laser welding (replacing solvent bonding). Connectivity: dedicated to Hospira infusion pumps. Sterilization: validated to SAL 10^-6 per ISO 11137-2. Conforms to ISO 594-2 for Luer taper fittings.

Indications for Use

Indicated for patients requiring parenteral, enteral, or epidural therapy, including administration of fluids, medications, nutritional fluids, blood, and blood products. Suitable for use in hospital, medical, ambulatory, and home settings.

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 PlumA+ and A+3 Infusion System (K052052)
• Abbott Plum A+ Infusion Pump (K982159)
• Gemstar Infusion Pump (K060806)

Submission Summary (Full Text)

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Infusion Set Modification Special 510(k) Oct. 26, 2010

K103224 Hospira

Confidential

# Section 6:

# 510(k) SUMMARY

JAN - 7 2011

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Name | Hospira, Incorporated | |
| Address | D-389, Bldg. H2<br>375 N. Field Drive<br>Lake Forest, IL 60045 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration Number | 3005579246 | |
| Name of contact<br>person | Karen Keener/Rebecca Andersen | |
| Date prepared | October 26, 2010 | |
| Name of device | | |
| Trade or proprietary<br>name | Hospira Infusion Sets | |
| Common or usual<br>name | Fluid Delivery Tubing | |
| Classification name | Infusion Sets | |
| Classification panel | Class II | |
| Regulation | 21-CFR Part 880.5725 and 21 CFR Part 880.5440 | |
| Product Code(s) | 80-FRN and 80-FPA | |
| Legally marketed device(s)<br>to which equivalence is<br>claimed | K052052 Hospira PlumA+ and A+3 Infusion System<br>K982159 Abbott Plum A+Infusion Pump<br>K060806 Gemstar Infusion Pump | 08/24/2005<br>01/12/1999<br>04/21/2006 |
| Reason for 510(k)<br>submission | The changes addressed in this submission include:<br>1. A change in the bonding process<br>2. The conversion of tubing material from DEHP to Non-DEHP<br>PVC.<br>3. Other changes include evolutionary changes and previously<br>cleared components or accessories made by or for Hospira that are<br>used with or incorporated into Hospira Infusion sets. | |

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くし

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| Device description | The Hospira infusion sets, previously cleared in K052052 (Hospira Plum<br>A+,A+3) and K060806 (Gemstar infusion sets) are intended for use with<br>dedicated Hospira Infusion Pumps. Hospira infusion sets are disposable<br>devices for single patient use, which incorporate various set<br>configurations and components which may be shared across Hospira set<br>families.<br><br>These administration set families include primary sets, secondary sets,<br>extension sets, piggyback sets, gravity sets, microbore sets, macrobore<br>sets, and sets which allow concurrent delivery. These sets provide a range<br>of physical characteristics such as priming volume, length, diameter,<br>materials etc. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use of the device | Hospira infusion sets are intended for use in parenteral, enteral and epidural<br>therapies and the administration of fluids, medications, nutritional fluids,<br>blood and blood products. Safety features on these devices aid in prevention<br>of needle-stick injuries.<br><br>Indications for use may include hospital and other medical settings,<br>ambulatory and home use, |

# Summary of the technological characteristics of the device compared to the predicate device

| Characteristic | New Device | Predicate [Device Name]<br>[510(k) number] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 1. The Intended use | Same | Same |
| 2. The functionality | Same | Same |
| 3. Visual characteristics | Same | Same |
| 4. Bonding process | 6. Removal of the solvent used in the bonding process. | Solvent |
| 5. Tubing characteristics | 7. Addition of yellow striped tubing material to the product lines<br>a. Non-DEHP PVC<br>b. New colorant formulation | 1. DEHP<br>2. Clear or Yellow striped |

## PERFORMANCE DATA

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#### SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*

Performance Test Summary-New Device

| Characteristic | Standard/Test Method | Standard / Test Title | Device Performance |
|------------------|----------------------|-----------------------------|--------------------|
| Biocompatibility | ISO 10993-5: 2009 | Cytotoxicity | Pass |
| Biocompatibility | ISO 10993-10: 2002 | Sensitization | Pass |
| Biocompatibility | ISO 10993-10: 2002 | Irritation / Intracutaneous | Pass |

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| | | Reactivity | |
|------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------------------------|------|
| Biocompatibility | ISO 10993-11:2006 | Systemic Toxicity (Acute) | Pass |
| Biocompatibility | ISO 10993-4:2002 | Hemocompatibility | Pass |
| SAL 10-6 | ISO 11137-2:2006 | Sterility | Pass |
| Dimensional Conformance<br>and<br>Connection compatibility | ISO 594-2 | Conical Fittings with a 6%<br>(Luer) Taper for syringes,<br>needles, and certain other<br>equipment | Pass |

#### Summary Discussion of Bench Performance Data

The Hospira Infusion sets with laser welded access device passed all specified test requirements. Hospira Infusion sets with Non-DEHP PVC yellow striped tubing, passed all specified test requirements.

The validation and verification testing confirmed these devices meet sand design inputs for an Infusion set.

Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the 'Performance test summary' above. These standards address sterility, particulate, leakage, tensile strength, and filter characteristics.

## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The Hospira Infusion Sets with the modified bonding process meet the functional claims, and intended use as described in the product labeling. The safety and effectiveness, are substantially equivalent to the predicate Hospira Infusion Sets as cleared in K052052 (Hospira Plum A+,A+3) and K060806 (Gemstar infusion sets).

The claim for substantial equivalence is supported by the information provided in this Special 510(k) submission.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Ms. Karen Keener Associate Global Regulatory Affairs Hospira, Incorporated 375 North Field Drive Building 2 Lake Forest, Illinois 60045-5045

JAN - 7 2011

Re: K103224

Trade/Device Name: Hospira I.V Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 26 2010 Received: October 21, 2010

Dear Ms. Keener:

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- Ms. Keener

Enclosure

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jum.d. Ros

Ar

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Infusion Set Modification Special 510(k) Oct. 26, 2010

CONFIDENTIAL

K103224

#### Indications for use for the subject device Hospira I.V. Administration Sets

Hospira infusion sets are intended for use in parenteral, enteral and epidural therapies and the administration of fluids, medications, nutritional fluids, blood and blood products. Safety features on these devices aid in prevention of needle-stick injuries.

Indications for use may include hospital and other medical settings, ambulatory and home use,

JAN - 7 2011

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)

Nitin Shah
Arunb Ge
Rumano
CHAIRMAN

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103224

Section 5: Indications Page 2 of 2