IV Administration

K142622 · Hospira, Inc. · FPA · Jan 15, 2015 · General Hospital

Device Facts

• Record ID: K142622
• Device Name: IV Administration
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hospira Burette 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

Hospira Burette Sets are disposable gravity-fed intravascular administration sets used to deliver fluids, including blood products, from a container to a patient's vascular system. The device consists of a piercing pin assembly, burette assembly, tubing, flow control device, injection site, and a modified Secure Lock male luer adapter. The device is operated by healthcare professionals in clinical settings. The modification to the male luer adapter (material change to acrylic and dimensional adjustments) is designed to enhance connection security with female luers. The device functions as a standard gravity administration set; it does not involve electronic processing or automated decision-making. The healthcare provider uses the set to manage fluid therapy, directly impacting patient hydration or blood product administration.

Clinical Evidence

Bench testing only. No clinical data was required. Performance testing included material testing per ISO 10993 and mechanical performance testing per ISO 594-1, ISO 594-2, and ISO 8536-4 to verify the modified male luer adapter design.

Technological Characteristics

Gravity-fed intravascular administration set. Components include piercing pin, burette, tubing, flow control, injection site, and acrylic male luer adapter. Materials meet ISO 10993 requirements. Sterility Assurance Level 10^-6. Complies with ISO 594-1, ISO 594-2, and ISO 8536-4 for luer connections and administration set performance.

Indications for Use

Indicated for the 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

• LifeShield Vision Infusion Sets (K113683)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 10, 2015

Hospira, Incorporated Mr. David Blonski Director Regulatory Affairs 375 N. Field Drive Lake Forest, IL 60046

Re: K142622

Trade/Device Name: Burette Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 18, 2014 Received: December 19, 2014

Dear Mr. Blonski:

This letter corrects our substantially equivalent letter of January 15, 2015.

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

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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. 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/ResourcesforYou/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 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142622

Device Name Hospira Burette Set

Indications for Use (Describe)

Hospira Burette 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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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 is composed of three curved lines that converge at the top, resembling a stylized representation of a plant or abstract design. The logo is presented in black and white.

#### 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 Burette 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 | David Blonski, Director Regulatory Affairs |
| Date prepared | 09/19/2014 |
| Name of device | |
| Trade or proprietary name | Burette 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 | LifeShield Vision Infusion Sets - K113683 |
| Reason for 510(k) submission | The changes addressed in this submission include:<br>• Modification to Secure Lock Male Luer |
| Device description | The Hospira Burette Sets with Secure Lock are intended for use as gravity sets.<br>Hospira Burette 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 and injection site assembly. Burette sets are configured to ensure the<br>intended use of the device is met. Hospira Burette sets are intended for the delivery of<br>fluids from a container to a patient's vascular system. The sets are disposable devices<br>for single patient use. |
| Intended Use of Device | Hospira Burette 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 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 the top, resembling a stylized abstract shape. 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 | LifeShield Infusion Sets are intended<br>for the delivery of fluids including but<br>not limited to blood and blood products<br>from a container to a patient's vascular<br>system. | Hospira Burette sets are indicated for the<br>delivery of fluids including but not limited<br>to blood and blood products from a<br>container to a patient's vascular system. |
| Design and Materials of Contruction | The design and materials of<br>construction are as cleared under the<br>predicte 510(k) | The design and materials of construction<br>remain the same as the predicate product<br>with the following exceptions:<br>1. The male luer adapter material is<br>changing to an alternate acrylic material.<br>2. Minor dimensional modifications are<br>being made to the male luer adapter to<br>enhance connection with female luers. |
| Summary of non-clinical tests for<br>determination of substantial<br>equivalence | All materials of construction for<br>Hospira Burette Sets meet the<br>applicable material test requirements<br>for ISO 10993 | New data has been generated demonstrating<br>that all materials of construction for Hospira<br>Burette Sets meet the applicable material<br>test requirements for ISO 10993. |
| 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 594-1, ISO 594-2, ISO<br>8536-4. All testing is acceptable.<br><br>The product Sterility Assurance Level<br>is 10-6. |

# Conclusion

Hospira Burette Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683.