Hospira Administration Sets

K160870 · Hospira, Inc. · FPA · Jun 1, 2016 · General Hospital

Device Facts

• Record ID: K160870
• Device Name: Hospira Administration Sets
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.

Device Story

Hospira Administration Sets (Primary, Extension, Burette, Blood) facilitate fluid delivery from containers to patient vascular systems. Modification adds Nuitiv™ Connector, a luer-activated needleless valve. Device components include tubing, piercing pins, flow control, filters, and various connectors. Used in clinical settings by healthcare providers to manage intravenous therapy. Output is controlled fluid flow to the patient. Benefits include secure, needleless access for fluid/blood administration. Device is disposable and single-use.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 10993 biological evaluation (hemocompatibility, cytotoxicity, sensitization, irritation, systemic/subacute/subchronic toxicity, pyrogenicity) and mechanical testing per ISO 594-1/2, ISO 8536-4/8, and ISO 1135-4 (leakage, tensile strength, particulate matter, torque, stress cracking).

Technological Characteristics

Materials: Polycarbonate (Makrolon RX1805, Tritan MX731), Silicone (Wacker Elastosil LR3066/55), Silicone lubricant (Med400, Nusil). Luer-activated needleless valve design. Sterilization: SAL 10^-6. Standards: ISO 10993, ISO 594-1/2, ISO 8536-4/8, ISO 1135-4.

Indications for Use

Indicated for delivery of fluids (including blood/blood products) from container to patient 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)
• Hospira Primary Sets (K143015)
• Hospira Extension Sets (K142433)
• Hospira Extension Sets (K142974)
• Hospira Burette Sets (K142622)
• Hospira Blood Sets (K143087)

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

June 1, 2016

Hospira, Inc. Mr. David Blonski Director Regulatory Affairs 375 Field Drive D-393, Building H3 Lake Forest, Illinois 60045

Re: K160870

Trade/Device Name: Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Burette Sets, and Hospira Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 2, 2016 Received: May 3, 2016

Dear Mr. Blonski:

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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

#### 510(k) Number (if known) K160870

#### Device Name

Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Blood Sets

Indications for Use (Describe)

Hospira Primary 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.

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

Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patients vascular system.

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 Hospira logo. The logo consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic features three curved lines that resemble an abstract representation of a medical symbol or a stylized wave pattern. The logo is presented in grayscale.

# 510(k) Summary-K160870

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Hospira Administration Sets.

| Submitter Information | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3<br>375 North Field Drive<br>Lake Forest, IL. 60045 |
| Phone number | 24-212-5010 |
| Mobile number | 224-515-6807 |
| Fax number | [phone] |
| Establishment Registration<br>Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | May 24, 2016 |
| Name of device | |
| Trade or proprietary name | Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira<br>Burette Sets, Hospira Blood 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 | Hospira Primary Sets - K142367<br>Hospira Primary Sets - K143015<br>Hospira Extension Sets - K142433<br>Hospira Extension Sets - K142974<br>Hospira Burette Sets - K142622<br>Hospira Blood Sets - K143087 |
| Reason for 510(k) submission | Device modification adding an alternate luer activated needleless valve. |
| Device description | The subject of this Special 510(k): Device Modification is the addition of an alternate<br>luer activated needleless valve to existing Hospira Administration sets cleared under<br>the identified predicate 510(k)s.<br>Hospira Administration Sets are comprised of components in various combinations of<br>the following: male luer adapter with cap, female luer with cap, piercing pin<br>connector, tubing, flow control device, filter, in-line adapter, injection site assembly,<br>luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and<br>blood chamber. |
| Intended Use of Device | Hospira Administration Sets are intended for the delivery of fluids from a container to<br>a patient's vascular system. Hospira Administration sets are configured to ensure the<br>intended use of the device is met. The sets are disposable devices for single patient<br>use.<br>Hospira Administration sets are intended for the delivery of fluids, including blood<br>and blood products where indicated, from a container to a 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, with the "H" capitalized and the rest of the letters in lowercase. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized arch or a representation of connectivity.

| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicates | | | | | | Proposed Device |
| | K142367 | K143015 | K142433 | K142974 | K142622 | K143087 | K160870 |
| Indications for Use | Indications for Use:<br>Hospira Primary sets are<br>indicated for the delivery<br>of fluids from a container<br>to a patient's vascular<br>system. | Indication<br>s for Use:<br>Hospira<br>Primary<br>sets are<br>indicated<br>for the<br>delivery<br>of fluids<br>from a<br>container<br>to a<br>patient's<br>vascular<br>system. | Indication<br>s for Use:<br>Hospira<br>Extension<br>sets are<br>indicated<br>for the<br>delivery<br>of fluids<br>from a<br>container<br>to a<br>patient's<br>vascular<br>system. | Indication<br>s for Use:<br>Hospira<br>Extension<br>sets are<br>indicated<br>for the<br>delivery<br>of fluids<br>from a<br>container<br>to a<br>patient's<br>vascular<br>system. | Indication<br>s for Use:<br>Hospira<br>Burette<br>sets are<br>indicated<br>for the<br>delivery<br>of fluids<br>from a<br>container<br>to a<br>patient's<br>vascular<br>system. | Indication<br>s for Use:<br>Hospira<br>Blood sets<br>are<br>indicated<br>for the<br>delivery<br>of fluids<br>including<br>but not<br>limited to<br>blood and<br>blood<br>products<br>from a<br>container<br>to a<br>patient's<br>vascular<br>system. | Indications for Use: Hospira Primary sets are<br>indicated for the delivery of fluids from a<br>container to a patient's vascular system.<br><br>Indications for Use: Hospira Extension sets are<br>indicated for the delivery of fluids from a<br>container to a patient's vascular system.<br><br>Indications for Use: Hospira Burette sets are<br>indicated for the delivery of fluids from a<br>container to a patient's vascular system.<br><br>Indications for Use: Hospira Blood sets are<br>indicated for the delivery of fluids including but<br>not limited to blood and blood products from a<br>container to a patient's vascular system. |
| Design and<br>Materials of<br>Construction | The predicate component,<br>the CLAVETM Connector<br>is a luer activated<br>needleless valve cleared<br>under predicate 510(k)<br>K142367<br><br>The CLAVETM<br>Connector consists of the<br>following materials:<br><br>Body:  PBT - GE Valox<br>215 or Valox<br>315<br>Spike:  MABS - Terlux<br>2812TR or<br>Polycarbonate –<br>Bayer Makrolon<br>RX 2530-<br>451118<br>Plug:  Silicone –<br>Wacker Elastosil<br>LR 3003/70<br>Lubricant:  Silicone,<br>Dow, FS- | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | The proposed alternate component, the NuitivTM<br>Connector is a luer activated needleless valve.<br><br>The NuitivTM Connector consists of the<br>following materals:<br><br>Body:  Polycarbonate, Makrolon<br>RX1805<br>Tritan MX731 copolyester<br>Spike:<br>Plug:  Silicone - Wacker Elastosil<br>LR3066/55 (gland)<br>Lubricant:  Silicone - Med400, nusil |
| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | |
| Characteristic | K142367 | K143015 | K142433 | K142974 | K142622 | K143087 | Proposed Device<br>K160870 |
| Summary of non-clinical tests for determination of substantial equivalence | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:<br><br>All materials of construction for the predicate component CLAVETM Connector meet the applicable material test requirements for ISO 10993 as demonstrated in the predicate 510(k). | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:<br><br>All materials of construction for the proposed component NuitivTM Connector meet the applicable material test requirements for ISO 10993 as follows:<br><br>ISO Standard Biological Effect<br>10993-4 Hemocompatibility<br>10993-5 Cytotoxicity<br>10993-10 Sensitization<br>10993-11 Intracutaneous Irritation<br>Systemic Toxicity<br>Subacute Toxicity<br>Subchronic Toxicity<br>Pyrogenicity |
| Summary of Performance Testing | Performance testing for predicate component CLAVETM Connector was conducted as indicated in the predicate 510(k) to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.<br><br>The product Sterility Assurance Level is for Hospira Administration sets is 10-6. | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Same as<br>K142367 | Performance data has been generated for the proposed NuitivTM Connector in accordance with:<br><br>ISO 594-1 Section 4.1.1 Gauging<br>ISO 594-2 Section 4.2.1 Liquid Leakage<br>Section 4.2.2 Air Leakage<br>Section 4.3 Separation Force<br>Section 4.4 Unscrewing Torque<br>Section 4.5 Ease of Assembly<br>Section 4.6 Resistance to Overriding<br>Section 4.7 Stress Cracking<br>ISO 8536-4 Section 6.1 Particulate Matter<br>Section 6.2 Air Leakage<br>Section 6.3 Tensile Strength<br>ISO 8536-8 Section A.3.2 Air Leakage<br>Section A.3.3 Air Leakage<br>Section A.3.4 Liquid Leakage<br>ISO 1135-4 Section 5.1 Particulate Matter<br>Section 5.2 Air Leakage<br>Section 5.3 Tensile Strength<br><br>All testing is acceptable.<br><br>The product Sterility Assurance Level is 10-6. |

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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 sans-serif font, with a stylized graphic above it. The graphic appears to be three curved lines that converge at the top, creating an abstract shape. The logo is presented in grayscale.

1

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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a gray, sans-serif font. Above the word is an abstract graphic of three curved lines that converge at the bottom and spread out at the top, resembling an arch or a stylized representation of movement. The lines are also gray, matching the color of the text.

## Conclusion

The proposed alternate component Nuitiv™ Connector in the subject devices meets the functional claims and intended use as described in the product labeling. The proposed component Nuitiv™ Connector in the subject devices is substantially equivalent to the predicate device component CLAVE™ Connector.