INFUSION SETS

K103344 · Hospira, Inc. · FPA · Dec 10, 2010 · General Hospital

Device Facts

• Record ID: K103344
• Device Name: INFUSION SETS
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.

Device Story

Hospira Infusion Sets are disposable, single-patient-use devices designed for gravity administration or use with dedicated Hospira infusion pumps. The device incorporates various configurations and components, including a back check valve. The valve is a normally closed, one-way pressure differential mechanism housed in a two-piece assembly with a fixed silicone diaphragm. The device is operated by clinicians in hospital, acute, and non-acute care environments to facilitate fluid delivery. The back check valve prevents backflow, ensuring controlled fluid administration. The device is provided sterile.

Clinical Evidence

Bench testing only. Performance validation and verification testing confirmed the device meets design inputs and user needs, specifically regarding backflow reduction. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation/intracutaneous reactivity), ISO 10993-11 (acute systemic toxicity), and ISO 10993-4 (hemocompatibility) all passed. Sterility was validated per ISO 11137-2.

Technological Characteristics

Disposable infusion set with a one-way back check valve. Valve features a two-piece housing with a fixed silicone diaphragm. Materials meet ISO 10993 biocompatibility standards. Sterilization via ISO 11137-2 (SAL 10^-6). Connectivity: mechanical interface for gravity or pump-based infusion.

Indications for Use

Indicated for delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes in hospital, acute, and non-acute care 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

• Symbiq sets (K041550)

Submission Summary (Full Text)

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K103344

#### November 12, 2010

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### Section 6:

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## 510(k) SUMMARY

DEC 1 0 2010

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. Hospira Infusion Sets with alternate fixed diaphragm Back Check Valve

| Submitter Information | |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Rebecca Andersen |
| Address | 275 North Field Drive |
| Phone number | 224-212-5270 |
| Fax number | 224-212-5401 |
| Establishment<br>Registration Number | Owner/Operator #9063339 |
| Name of contact person | Rebecca Andersen |
| Date prepared | November 12, 2010 |
| Name of device | |
| Trade or proprietary<br>name | Hospira Infusion Sets |
| Common or usual name | IV Set |
| Classification name | Infusion Sets Class II |
| Classification panel | 80-FPA - General Hospital |
| Regulation | 21 CFR Part 880.5440 |
| Product Code(s) | 80-FPA |
| Legally marketed device(s) to<br>which equivalence is claimed | Symbiq sets as cleared in K041550 |
| Reason for 510(k) submission | Back Check Valve component |
| Device description | Hospira infusion sets are intended for use as gravity sets or with dedicated<br>Hospira Infusion Pumps. Hospira infusion sets are disposable devices for<br>single patient use, which incorporate various set configurations and<br>components. These components including the back check valve which is the<br>subject of this submission may be shared across Hospira set families and<br>used with sets designed for gravity or other pump platforms. |
| Intended use of the device | Infusion sets are intended for the delivery of fluids, solutions, drugs, agents,<br>nutritionals, electrolytes, blood and blood products via parenteral, enteral,<br>intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of<br>administration. These sets are intended for use primarily in the hospital setting and<br>can be used in other acute and non-acute care areas, such as, but not limited to<br>Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers,<br>Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term Care, Urgent<br>Care, Transport and in Physician offices. |
| Indications for use | These are general use sets which are intended for use primarily in the hospital<br>setting and can be used in other acute and non-acute care areas, such as, but not<br>limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion<br>Centers, Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term<br>Care, Urgent Care, Transport and in Physician offices. |

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# November 12, 2010

# Infusion Set Modification

Special 510(k)

# 510(k) SUMMARY

| Section 6: | 510(k) SUMMARY | |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of the technological characteristics of the device compared to the predicate device | | |
| Characteristic | Proposed Device<br>Hospira Infusion Set | Predicate Symbiq Infusion Set<br>K041550 |
| Intended Use | Same | These sets are intended for use primarily in<br>the hospital setting and can be used in other<br>acute and non-acute care areas, such as, but<br>not limited to Home Care, Nursing Homes,<br>Mobile Intensive Care, Ambulatory Infusion<br>Centers, Hospice, Subacute facilities,<br>Outpatient / Surgical Centers, Long Term<br>Care, Urgent Care, Transport and in<br>Physician offices. |
| Set Functionality | Same | Meets all performance V&V testing |
| Visual characteristics | Similar Back Check valve is of<br>similar size, but is blue and clear | Back check valve is clear / white |
| Back Check Valve | Normally closed - One way check<br>valve in two piece housing with<br>fixed silicone diaphragm | Normally closed - One way check valve in two<br>piece housing with floating silicone<br>diaphragm |
| Bonding processes | Same | Solvent bond / over post or socket bond |
| Biocompatibility | Same | External Communicating - Blood path indirect<br>-Prolonged contact |
| Principle of Operation | Same | One way pressure differential |
| 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<br>Reactivity Pass |
| 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 |

#### Summary discussion of Bench Performance Data

The Hospira Infusion sets with an alternate Back Check Valve passed all specified test requirements. Testing The Prospira Infosion sels with respect to reduction of backflow. The validation and verification testing acmonotiate oxeculier. Street user needs and design inputs for an Infusion set.

mod these doness most as attributes and device performance meet requirements of fire standards istead inthe

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### Section 6:

### 510(k) SUMMARY

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Statement of Safety and Efficacy:

The Hospira Infusion Sets with the alternate back check valve 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 K041550

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 U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

Ms. Rebecca Anderson Associate Director, Global Regulatory Affairs, Devices HOSPIRA, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

DEC 1 0 2000

Re: K103344

Trade/Device Name: Hospira Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 12, 2010 Received: November 15, 2010

Dear Ms. Anderson:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinente, or to arrivand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, lecturents for allinar regainst 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 (1 w/1), it thay of surfet is alla 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 Fleast oc advisod that 1 Dr. 5 lookines on that your device complies with other requirements Incall that FDA has made a decommanent in administered by other Federal agencies. of the Act of ally I oderal bates as requirements, including, but not limited to: registration 1 ou must comply with an the Fiel singles and 801); medical device reporting and fishing (21 CFR Pat 607), lacenad (21 CFR 803); good manufacturing (reporting of medical device the quality systems (QS) regulation (21 CFR Part 820); practice requirements as sectionic 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/ucm113809.htm for inttp://www.ida.gov//About Health's (CDRH's) Office of Compliance. Also, the Somer the regulation entitled, "Misbranding by reference to premarket notification" prease note the regarding the reporting 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 I ou him 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,

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

#### Enclosure

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Infusion Set Modification Special 510(k)

. !

November 12, 2010

# Section 5: Indications for Use

DEC 1 0 2010

K103344.

510(k) Number (unknown at this time)

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#### Device Name: Hospira Infusion Set

Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.

| Prescription Use<br>X | AND/OR | Over-The-Counter Use<br>______ |
|-----------------------------|--------|--------------------------------|
| (Part 21 CFR 801 Subpart D) | | (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)

Rill C. Chapman 12/10/10

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

510(k) Number: K103344