Hospira Extension Set, Hospira Primary Set

K161036 · Hospira, Inc. · FPA · Jan 6, 2017 · General Hospital

Device Facts

• Record ID: K161036
• Device Name: Hospira Extension Set, Hospira Primary Set
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Hospira Extension and Primary Sets are gravity-fed intravascular administration sets used to deliver fluids from a container to a patient's vascular system. The sets consist of tubing, luer adapters, injection sites, and a Dial-A-Flo flow control device. The device is a disposable, single-patient-use product. The primary modification in this submission is the replacement of the previous Dial-A-Flo flow control component with a new version manufactured by GVS, Italy, utilizing ABS plastic and SEBS thermoplastic elastomer. The device is operated by healthcare professionals in clinical settings to manage fluid delivery. The flow control device allows the clinician to manually adjust the fluid flow rate. The device functions as a passive delivery system; it does not provide automated monitoring or active infusion control. Clinical benefit is derived from the reliable, controlled administration of intravenous fluids.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 10993 biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, systemic/subacute/subchronic toxicity, pyrogenicity) and ISO 8536-4 mechanical testing (particulate contamination, leakage, tensile strength, tubing, fluid filter, flow regulator, flow rate, injection site, male conical fitting, protective caps). All testing met acceptance criteria.

Technological Characteristics

Gravity-fed IV administration sets. Components: male/female luer adapters, tubing, injection site, Dial-A-Flo flow regulator. Flow regulator materials: ABS plastic, SEBS thermoplastic elastomer. Sterility Assurance Level: 10^-6. Compliance: ISO 10993 (biocompatibility), ISO 8536-4 (performance), ISO 594-1/2 (fittings).

Indications for Use

Indicated for delivery of fluids from a container to a patient's vascular system. No specific patient population, age, or gender restrictions are stated.

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 Extension Sets (K142974)
• Hospira Primary Sets (K143015)

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 6, 2017

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

Re: K161036

Trade/Device Name: Hospira Extension Set and Hospira Primary Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA. ODA Dated: December 2, 2016 Received: December 5, 2016

Dear 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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Tina Kiang, Ph.D. Acting 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) K161036

Device Name Hospira Extension Set Hospira Primary Set

Indications for Use (Describe)

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

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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the Hospira logo. The logo features the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic consists of three curved lines that converge at the top, creating an abstract shape.

# 510(k) Summary – K161036

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Hospira Extension Sets and 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] |
| Mobile number | N/A |
| Fax number | [phone] |
| Establishment Registration<br>Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Charles Neitzel, Senior Regulatory Affairs Specialist |
| Date prepared | 12 April 2016 |
| Name of device | |
| Trade or proprietary name | Hospira Extension Set<br>Hospira Primary Set |
| Common or usual name | I.V. Administration Sets |
| Classification name | Intravascular Administration Set, 21 CFR 880.5440, Class II |
| Product Code(s) | FPA<br>OJA |
| Legally marketed device(s) to<br>which equivalence is claimed | Hospira Extension Sets - K142974<br>Hospira Primary Sets - K143015 |
| Reason for 510(k) submission | The change addressed in this submission is:<br>1. Hospira is replacing the current Dial-A-Flo flow control device with a new Dial-A-Flo flow control device. |
| Device description | The Hospira Extension Sets and the Hospira Primary Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. |
| Intended Use of Device | |

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Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the word, there is an abstract graphic element composed of three curved lines that converge at the top, resembling an arch or a stylized representation of a medical device. The logo is presented in grayscale.

| Summary of the technological characteristics of the device compared to the predicate device | | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicates<br>K142974 & K143015 | Proposed Device |
| Indications for Use | Hospira Extension Sets and Hospira Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system. | Hospira Extension Sets and Hospira Primary 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 exception:<br>• Hospira is changing the flow control device currently used in Extension Sets and Primary Sets. |
| Proposed Changes to Flow Control Device | | |
| Component | Predicate<br>Dial-A-Flo | Proposed<br>Dial-A-Flo |
| Manufacturer | ICU Medical, Utah | GVS, Italy |
| Assembly Materials | Acrylic receiving member<br>Ethylene Propylene Gasket<br>Acrylic metering plate<br>Delivery member | ABS Plastic<br>SEBS thermoplastic elastomer |
| Regulatory Length | 1.7 in | 34.3 mm |
| Regulator Diameter | 0.850 in | 29.8 mm |
| Delivery Member Length | 0.510 in | 9 mm |
| Delivery Member Diameter | 0.200 in | 3.5 mm |
| Tubing Inner Diameter (I.D.) and Outer Diameter (O.D.) | 0.100" I.D. x 0.138" O.D. | Same |
| Set Length | Available in 18", 79", and 89" | Same |

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" capitalized. Above the word, there is an abstract graphic element composed of three curved lines that resemble stylized leaves or arcs. The lines are arranged in a fan-like shape, with the central line being the darkest and the outer lines gradually fading to a lighter shade of gray.

| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Characteristic | Predicates<br>K142974 & K143015 | Proposed Device | | | | | | | | | | | | | | | |
| Summary of non-clinical tests for<br>determination of substantial<br>equivalence | All materials of construction for<br>Hospira I.V. Administration sets meet<br>the applicable material test<br>requirements for ISO 10993 | New data has been generated demonstrating<br>that all materials of construction for Hospira<br>I.V. Administration Sets meet the applicable<br>material test requirements for ISO 10993.<br><br>ISO Standard Biological Effect<br>Tested ISO 10993-4 Hemocompatibility ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-11 Intracutaneous<br>Irritation Systemic Toxicity Subacute Toxicity Subchronic Toxicity Pyrogenicity | | | | | | | | | | | | | | | |
| 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><br>The product Sterility Assurance Level<br>is 10-6. | New performance data has been generated<br>to ensure the device performs as intended in<br>accordance with ISO 8536-4. All testing is<br>acceptable. ISO 594-1 and ISO 594-2<br>compliance is covered with the predicate<br>510(k)s K142974 and K143015.<br><br>ISO Standard Section Tested ISO 8536-4 6.1 Particulate<br>Contamination 6.2 Leakage 6.3 Tensile Strength 6.6 Tubing 6.7 Fluid Filter 6.9 Flow Regulator 6.10 Flow Rate 6.11 Injection Site 6.12 Male Conical<br>Fitting 6.13 Protective Caps The product Sterility Assurance Level<br>is 10-6. | | | | | | | | | | | | | | | |

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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that resemble an arch or a stylized representation of movement.

## Conclusion

Hospira Extension Sets and Hospira Primary Sets meet the functional claims and intended use as described in the product labeling. The Hospira Extension Sets and Hospira Primary Sets are substantially equivalent to the Hospira Extension Sets and Hospira Primary Sets cleared under K142974 and K143015, respectively.