Hospira Blood Set

K143087 · Hospira, Inc. · FPA · Mar 4, 2015 · General Hospital

Device Facts

• Record ID: K143087
• Device Name: Hospira Blood Set
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Gravity-fed intravascular administration set; delivers blood and blood products from container to patient vascular system. Components include male luer adapter, tubing, flow control device, piercing pin, burette/blood pump/cylinder assembly, and injection site. Disposable, single-patient use. Operated by clinicians in clinical settings. Modification includes alternate acrylic material for male luer adapter and minor dimensional changes to improve connection with female luers. Device ensures fluid delivery; supports clinical fluid management.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 1135-4 (particulate, leakage, tensile strength, flow rate, etc.) and ISO 594-1/2 (gauging, leakage, separation force, stress cracking). Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, reactivity, systemic/subacute/subchronic toxicity, pyrogenicity, hemocompatibility) confirmed safety.

Technological Characteristics

Gravity-fed IV administration set. Materials: Acrylic (male luer), Polycarbonate (spin collar), Polypropylene (cap), PVC (tubing), HDPE/ABS (flow control), ABS/Polyethylene/Acrylic/Nylon (piercing pin). Standards: ISO 594-1:1986, ISO 594-2:1998, ISO 1135-4:2012, ISO 10993. Sterility Assurance Level 10^-6.

Indications for Use

Indicated for delivery of fluids, including blood and blood products, 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

• Hospira Infusion Blood Sets (K101677)

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

March 4, 2015

Hospira, Inc. Charles Neitzel Senior Regulatory Affairs Associate D-0393 Bldg. H3 375 North Field Street Lake Forest, IL 60045

Re: K143087

Trade/Device Name: Hospira Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 29, 2015 Received: January 30, 2015

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 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.

# Erin | Keith -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K143087

## Device Name

Hospira Blood Sets

#### Indications for Use (Describe)

Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products 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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 sans-serif font, with a stylized graphic above it. The graphic features three curved lines that converge at a point, creating an abstract, modern design. The logo is presented in grayscale.

#### Section 5 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Hospira Blood 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 | 10/24/2014 |
| Name of device | |
| Trade or proprietary name | 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 Infusion Blood Sets – K101677 |
| Reason for 510(k) submission | The changes addressed in this submission include:<br>• Modification to Secure Lock Male Luer |
| Device description | The Hospira Blood Sets with Secure Lock are intended for use as gravity sets.<br>Hospira Blood sets are comprised of various components including the following:<br>male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette<br>assembly / blood pump assembly / or blood cylinder assembly, and injection site<br>assembly. Blood sets are configured to ensure the intended use of the device is met.<br>Hospira Blood sets are intended for the delivery of fluids from a container to a<br>patient's vascular system. The sets are disposable devices for single patient use. |
| Intended Use of Device | Hospira Blood sets are indicated for the delivery of fluids including but not limited to<br>blood and blood products from a container to a patient's vascular system. |

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name in a simple, sans-serif font, with the letters in gray. Above the name is an abstract graphic consisting of three curved lines that converge at the top, creating a sense of movement or flow. The lines are also in gray, complementing the text.

| Summary of the technological characteristics of the device compared to the predicate device | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Characteristic | Predicate | Proposed Device | | | | | | | | | | | | | | |
| Indications for Use | LifeShield Infusion Sets are intended for the delivery of fluids including but not limited to blood and blood products 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 patient's vascular system. | | | | | | | | | | | | | | |
| Design and Materials of Contruction | The design and materials of construction are as cleared under the predicte 510(k)<br><br>Hospira Blood Sets are comprised of the following minimum components: | The design and materials of construction remain the same as the predicate product with the following exceptions:<br>1. The male luer adapter material is changing to an alternate acrylic material. Minor dimensional modifications are being made to the male luer adapter to enhance connection with female luers. | | | | | | | | | | | | | | |
| | Component<br>Male Luer Adapter Male / Luer Adapter Acrylic Spin Collar Polycarbonate Hood / Cap Polypropylene Tubing PVC, Non-Pthalatae Flow Control Device High Density Polyethylene or ABS Piercing Pin Assembly ABS / Polyetylene / Acrylic / Nylon | | | | | | | | | | | | | | | |

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Hospira Blood Sets
Traditional 510(k)
Section 5: 510(k) Summary

Image /page/6/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" slightly larger than the other letters. Above the word, there is a stylized graphic element that resembles three curved lines or arcs, arranged in a way that suggests movement or a stylized representation of a plant. The logo is presented in grayscale.

| Summary of non-clinical tests for determination of substantial equivalence | All materials of construction for Hospira Blood Sets meet the applicable material test requirements for ISO 10993. | New data has been generated demonstrating that all materials of construction for Hospira Blood Sets meet the applicable material test requirements for ISO 10993. |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cytotoxicity<br>ISO 10993-5 | Cytotoxicity<br>ISO 10993-5 |
| | Sensitization<br>ISO 10993-10 | Sensitization<br>ISO 10993-10 |
| | Intracutaneous Reactivity<br>ISO 10993-10 | Intracutaneous Reactivity<br>ISO 10993-10 |
| | Systemic Toxicity<br>ISO 10993-11 | Systemic Toxicity<br>ISO 10993-11 |
| | Subacute Toxicity<br>ISO 10993-11 | Subacute Toxicity<br>ISO 10993-11 |
| | Subchronic Toxicity<br>ISO 10993-11 | Subchronic Toxicity<br>ISO 10993-11 |
| | Pyrogenicity<br>ISO 10993-11 | Pyrogenicity<br>ISO 10993-11 |
| | Hemocompatibility<br>ISO 10993-4 | Hemocompatibility<br>ISO 10993-4 |

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Image /page/7/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" slightly larger than the other letters. Above the word, there is a stylized graphic of three curved lines that converge at the top, resembling an abstract arch or a stylized representation of a medical device. The logo is presented in grayscale.

| 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. | New performance data has been generated<br>to ensure the device performs as intended in<br>accordance with ISO 594-1, ISO 594-2, ISO<br>1135-4. All testing is acceptable. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The product Sterility Assurance Level<br>is 10-6. | The product Sterility Assurance Level<br>is 10-6 |
| | ISO 1135-4:2012 | ISO 1135-4:2012 |
| | Particulate Contamination | Particulate Contamination |
| | Leakage | Leakage |
| | Tensile Strength | Tensile Strength |
| | Closure-piercing pin | Closure-piercing pin |
| | Tubing | Tubing |
| | Blood Filter | Blood Filter |
| | Drip chamber and drip tube | Drip chamber and drip tube |
| | Flow Regulator | Flow Regulator |
| | Flow Rate | Flow Rate |
| | Injection Site | Injection Site |
| | Male Conical Fitting | Male Conical Fitting |
| | Protective Caps | Protective Caps |
| | ISO 594 Part 1: 1986 | ISO 594 Part 1:1986 |
| | Gauging | Gauging |
| | Liquid Leakage | Liquid Leakage |
| | Air Leakage | Air Leakage |
| | Separation Force | Separation Force |
| | Stress Cracking | Stress Cracking |
| | ISO 594 Part 2: 1998 | ISO 594 Part 2: 1998 |
| | Gauging | Gauging |
| | Leakage (liquid) | Leakage (liquid) |
| | Leakage (air) | Leakage (air) |
| | Separation Force | Separation Force |
| | Unscrewing Torque | Unscrewing Torque |
| | Ease of Assembly | Ease of Assembly |
| | Resistance to Overriding | Resistance to Overriding |
| | Stress Cracking | Stress Cracking |

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Image /page/8/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" slightly larger than the other letters. Above the name is an abstract graphic element consisting of several curved lines that converge at the top, resembling a stylized, modern design.

# Conclusion

Hospira Blood Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the Infusion Blood Sets cleared under K101677.