Hospira Extension Sets

K151969 · Icu Medical, Inc. · FPA · Jan 19, 2016 · General Hospital

Device Facts

• Record ID: K151969
• Device Name: Hospira Extension Sets
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hospira Extension set is intended 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 IV administration sets. Components include male/female luer adapters, tubing, flow control devices (e.g., Dial-A-Flo), in-line adapters, and injection sites. The device facilitates fluid delivery from a container to a patient's vascular system. This submission covers a change in tubing material formulation and the replacement of the Clave needleless valve with the MicroClave component. The device is used in clinical settings by healthcare providers to manage fluid therapy. The output is the controlled delivery of fluids to the patient, which supports clinical decision-making regarding hydration or medication administration.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 10993 biocompatibility (hemocompatibility, cytotoxicity, sensitization, intracutaneous reactivity, systemic/subacute/subchronic toxicity, pyrogenicity) and mechanical performance testing per ISO 594-1, ISO 594-2, and ISO 8536-4 (leakage, tensile strength, flow rate, etc.). Sterilization validated per ANSI/AAMI/ISO 11137-1 and 11737-1 to a Sterility Assurance Level of 10^-6.

Technological Characteristics

Disposable IV administration set. Components: male/female luer adapters, tubing, flow regulator (Dial-A-Flo), injection site. Materials meet ISO 10993. Sterilization: validated per ANSI/AAMI/ISO 11137-1. Connectivity: None (gravity-fed).

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

• Extension Sets (K142974)
• Hospira Extension Sets (K142433)

Reference Devices

• MicroClave (K970855)

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 19, 2016

Hospira, Inc. Mr. Charles Neitzel Senior Regulatory Affairs Specialist 375 Field Drive Lake Forest, Illinois 60045

Re: K151969

Trade/Device Name: Hospira Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: FPA Dated: December 15, 2015 Received: December 17, 2015

Dear Mr. Charles Neitzel:

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 vours.

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

510(k) Number (if known) K151969

Device Name Hospira Extension Sets

Indications for Use (Describe)

Hospira Extension 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)

X 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 gray, sans-serif font, with a stylized graphic above it. The graphic is composed of three curved lines that converge at the top, resembling a stylized leaf or abstract shape. The overall design is simple and modern.

#### 510(k) Summary Section 5

A summary of 510(k) substantial equivalence 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] |
| Fax number | [phone] |
| Establishment Registration<br>Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Charles Neitzel, Senior Regulatory Affairs Specialist |
| Date prepared | January 13, 2016 |
| Name of device | |
| Trade or proprietary name | Hospira 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 | Extension Sets - K142974<br>Hospira Extension Sets – K142433 |
| Reason for 510(k) submission | The changes addressed in this submission include:<br>1. Hospira is changing the tubing material formulation currently used in Hospira<br>Extension Sets.<br>2. Hospira is replacing the needleless valve Clave™ component on certain IV<br>administration Hospira Extension Sets with the MicroClave™ component. |
| Device description | The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension<br>sets are comprised of various components including the following: male luer adapter<br>with cap, tubing, female luer adapter, flow control device, in-line adapter, injection<br>site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended<br>use of the device is met. Hospira Extension sets are intended for the delivery of fluids<br>from a container to a patient's vascular system. The sets are disposable devices for<br>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 simple, sans-serif font. Above the name is an abstract graphic consisting of three curved lines that converge at a point, resembling stylized leaves or a modern arch. The logo is presented in grayscale.

| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Characteristic | Predicate | Proposed Device | | | | | | | | | | | | | | |
| Indications for Use | Hospira Extension Sets are indicated for the delivery of fluids from a container to a patient's vascular system. | Hospira Extension Sets are indicated for the delivery of fluids from a container to a patient's vascular system. | | | | | | | | | | | | | | |
| Design and Materials of Construction | The design and materials of construction are as cleared under the predicate 510(k) | The design and materials of construction remain the same as the predicate product with the following exceptions:<br><br>1. Hospira is changing the tubing material formulation currently used in Extension Sets.<br>2. Hospira is replacing the ClaveTM component on certain IV administration Extension Sets with the MicroClaveTM component.<br><br>The MicroClave performs functionally the same as the Clave, for the same intended use, and is comprised of similar materials. The Microclave is a cleared component under ICU Medical 510(k) K970855 establishing substantial equivalence. | | | | | | | | | | | | | | |
| Summary of non-clinical tests for determination of substantial equivalence | All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993 | New data has been generated demonstrating that all materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993.<br>ISO Standard Biological Effect Tested ISO 10993-4 Hemocompatibility ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-11 Intracutaneous Reactivity Systemic Toxicity Suacute Toxicity Subchronic Toxicity Pyrogenicity | | | | | | | | | | | | | | |

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font, with the letters in a light gray color. Above the name is an abstract graphic consisting of three curved lines that converge at a point, creating a sense of movement or flow. The lines are in varying shades of gray, with the central line being the darkest.

| Summary of Performance Testing | Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.<br><br>The product Sterility Assurance Level is 10-6. | New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, and ISO 8536-4. All testing is acceptable. | | | | | | | | | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| | | ISO Standard Section Tested ISO 594-1 4.1 Gauging<br>4.2 Liquid Leakage<br>4.3 Air Leakage<br>4.4 Separation Force<br>4.5 Stress Cracking ISO 594-2 4.1 Gauging<br>4.2 Liquid Leakage<br>4.3 Separation Force<br>4.4 Unscrewing Torque<br>4.5 Ease of Assembly<br>4.6 Resistance to Overriding<br>4.7 Stress Cracking ISO 8536-4 6.1 Particulate Contamination<br>6.2 Leakage<br>6.3 Tensile Strength<br>6.6 Tubing<br>6.7 Fluid Filter<br>6.9 Flow Regulator<br>6.10 Flow Rate<br>6.11 Injection Site<br>6.12 Male Conical Fitting<br>6.13 Protective Caps Sterilization validation has been conducted based on the ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11737-1 international standards for sterilization of medical devices. All testing is acceptable. The product Sterility Assurance Level is 10-6. | | | | | | | | | | |

# Conclusion

Hospira Extension Sets meet the functional claims and intended use as described in the product labeling. Hospira Extension Sets are substantially equivalent to the predicate device.