IV Administration Set

K173361 · B.Braun Medical, Inc. · FPA · Jun 26, 2018 · General Hospital

Device Facts

• Record ID: K173361
• Device Name: IV Administration Set
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Device Story

Gravity-fed, single-use, disposable IV administration set; delivers fluids from container to patient vascular system. Components include insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, and tubing. Used in clinical settings by healthcare providers. Device facilitates fluid therapy; ensures controlled delivery via gravity. Benefits patient by providing reliable intravenous access for fluid administration.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including ISO 8536-4 (infusion equipment), ISO 80369-7 (connectors), and ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility). Additional functional testing included tubing-slide clamp compatibility, chemical resistance, occlusion, dynamic tensile strength, and negative pressure leakage tests.

Technological Characteristics

Gravity-fed infusion set. Materials: PVC tubing with DEHT/hydrogenated castor oil, ABS spike/clamp/check valve, MABS/PC luer connections, acrylic/polyisoprene injection site. Standards: ISO 8536-4, ISO 80369-7, ISO 10993-1, ISO 11135. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for delivery of fluids from a container into a patient's vascular system. Suitable for any patient population, provided vascular anatomy and infusion solution are appropriate for the therapy duration.

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

• U & U Intravascular Administration Set (K151151)

Reference Devices

• K031923
• K931377
• K083723
• K140311

Submission Summary (Full Text)

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June 26, 2018

B.Braun Medical Inc. Nancy Skocypec Associate Director, Regulatory Affairs 901 Marcon Blvd Allentown, Pennsylvania 18109

Re: K173361

Trade/Device Name: IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 21, 2018 Received: May 22, 2018

Dear Nancy Skocypec:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Digitally signed by Alan M. Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Stevens - S - 0.9.2342.19200300.100.1.1=130 0.9.2342.19200300.100.1.1=1300 Date: 2018.06.26 15:15:00 -04'00' for 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) K173361

Device Name IV Administration Set

#### Indications for Use (Describe)

The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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B. Braun Medical Inc. 510(k) Premarket Notification, Traditional 510(k) IV Administration Sets

#### K173361 510(k) SUMMARY

| DATE: | June 26, 2018 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341 |
| | Contact: Nancy Skocypec<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| DEVICE NAME: | IV Administration Set |
| COMMON NAME: | IV Administration Set |
| CLASSIFICATION: | Class II, Product Code FPA, 21 CFR 880.5440 General Hospital |
| PREDICATE DEVICE: | U & U Intravascular Administration Set, U & U Medical<br>Technology Co., Ltd., K151151, Class II, FPA, 21 CFR 880.5440<br>General Hospital |

### Description

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.

### Indication for Use

The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

### Substantial Equivalence

The IV Administration Sets are substantially equivalent to the predicate device, U&U IV Administration Sets cleared with K151151.

### Technological Characteristics

The IV Administration Sets presented in this submission have similar indications for use, the same intended use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of similar component types, and meet the same relevant performance specifications as the predicate devices. Both sets are comprised

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of similar industry standard materials. The tubing material utilized with both sets is PVC. The proposed device tubing material contains hydrogenated castor oil within its formulation.

Successful completion of biocompatibility testing and chemical characterization testing per ISO 10993 confirmed that this difference in materials did not impact the biological or chemical safety of the IV Administration Sets. Additionally, performance testing was performed to ensure that this formulation did not impact the substantial equivalence of the device.

A table summarizing the comparison between the B. Braun IV Administration sets and the predicate device is provided below.

| Feature | Proposed Device<br>IV Administration Sets | Predicate Device (K151151)<br>U & U Intravascular Administration Set |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Delivery of fluids from a container into a patient's vascular system | Delivery of fluids from a container into a patient's vascular system |
| Indications for Use | The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. | The device is intended to administration fluids from a container into a patient's vascular system through a needle or catheter inserted into the vein. |
| Mode of Fluid Delivery | Gravity | Gravity |
| Materials | Tubing – PVC w/ DEHT and HCO<br>Spike – ABS<br>Back check valve - MABS<br>Roller clamp - ABS<br>Luer connections - MABS/PC<br>Drip chamber – PVC<br>Injection site - Acryllic/Polyisoprene<br>Needleless Y-site - PC | Tubing - PVC<br>Spike – ABS<br>Back check valve - ABS<br>Roller Clamp – ABS<br>Male Lure Lock - ABS<br>Drip Chamber – unknown<br>Needleless Y-Site - unknown |
| Summary of nonclinical tests for determination of substantial equivalence | ISO 8536-4 Physical Requirements Particulate contamination index ≤ 90 Leakage Flow Rate Tensile Strength Closure-piercing device Air-inlet device Tubing Drip chamber Flow Regulator Male Conical Fitting Protective Caps | ISO 8536-4 Physical Requirements Particulate Leakage Flow rate Tensile strength Closure-piercing device Air-inlet device Tubing Drip chamber |
| Feature | Proposed Device<br>IV Administration Sets | Predicate Device (K151151)<br>U & U Intravascular Administration Set |
| Patient Contact<br>category /<br>duration | Externally communicating blood path<br>indirect prolonged contact | unknown |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Pyrogenicity | <0.5 EU/mL | < 0.5EU |
| Sterilization | Ethylene Oxide, SAL 10-6 | unknown |

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The fundamental technology of the proposed device is equivalent to the predicate device. The differences between the subject device and predicate device do not raise different questions of safety and effectiveness.

## Performance Testing

Non-clinical performance testing was completed with the proposed IV Administration Sets to demonstrate that the sets perform as intended. The test results demonstrated that the proposed device complies with the following standards:

ISO 8536-4:2010/Amd. 1: 2013, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"

ISO 80369-7:2016, "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"

ISO 10993-1:2009(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Biocompatibility testing included cvtotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility testing

ISO 11135:2014. "Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"

In addition, the following functional and performance tests were successfully completed to demonstrate that the IV Administration Sets perform as intended.

- Tubing-Slide Clamp Compatibility
- Chemical resistance testing
- Occlusion
- Dynamic tensile strength
- Leakage - negative pressure test

Microbial ingress data for the needleless luer access devices and injection sites was referenced to the previously cleared 510(k)'s K031923, K931377, K083723, and K140311 for these components.

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B. Braun Medical Inc. 510(k) Premarket Notification, Traditional 510(k) IV Administration Sets

Results of the testing demonstrate that the proposed device can be used according to its intended use. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

# CONCLUSION

Results of functional and performance testing conducted on the proposed device demonstrate that the IV Administration Sets performance is equivalent to the predicate device. The differences, between subject device and predicate device do not raise any new issues of safety and effectiveness. The subject IV Administration Sets has demonstrated to be substantially equivalent to the predicate device.