MaxZero Extension Sets with Needle-Free Connector(s)

K193088 · Carefusion, Inc. · FPA · Oct 23, 2020 · General Hospital

Device Facts

• Record ID: K193088
• Device Name: MaxZero Extension Sets with Needle-Free Connector(s)
• Applicant: Carefusion, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

Device Story

MaxZero™ Extension Sets are sterile, single-patient-use intravascular administration sets. They facilitate delivery or aspiration of drugs, blood, and fluids to/from an IV catheter. The system includes a needle-free connector, tubing (clear or UV-resistant amber), filters, slide clamps, and various luer connectors (bifurcated/trifurcated). Used in hospital environments by clinicians. The device provides a closed system for IV access, reducing needlestick injury risk. The needle-free connector allows for up to 7 days and 200 activations. The amber tubing blocks >90% of UV light (250-450 nm) to protect light-sensitive drugs. Filters remove particulates. Output is the delivery/aspiration of fluids; healthcare providers use the device to manage IV therapy. Benefits include patient safety through needle-free access, protection of light-sensitive medications, and particulate filtration.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including functional performance (leakage, flow, pressure, microbial ingress), biocompatibility (ISO 10993), and sterilization/shelf-life validation.

Technological Characteristics

Materials: Polycarbonate, silicone rubber, non-DEHP PVC, acrylic, ABS. Components: Needle-free connector, amber/clear tubing, filters, slide clamps, luer locks. Sterilization: E-Beam. Connectivity: None (mechanical). Standards: ISO 594-1/2, ISO 8536-4/8/9/10/11, ISO 10993-1, ISO 14971, USP <788>.

Indications for Use

Indicated for single patient use, including pediatric and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion, or aspiration of drugs, blood, and fluids via an IV catheter.

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

• MaxZero™ Extension Sets with Needleless Connector (K140831)

Submission Summary (Full Text)

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October 23, 2020

Carefusion, Inc. Nesli Karakaya Sr. Manager, Regulatory Affairs 120 S State College Blvd, Suite 100 Brea, California 92821

Re: K193088

Trade/Device Name: MaxZero™ Extension Sets with Needle-Free Connector(s) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 22, 2020 Received: September 23, 2020

# Dear Nesli Karakaya:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Paval Patel

Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193088

Device Name

MaxZero™ Extension Sets with Needle-Free Connector(s)

#### Indications for Use (Describe)

The MaxZero™ extension set with needle-free connector(s) is for single use only. The

MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a yellow accent on the top right corner. The text is to the right of the circle.

Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)

#### 510(k) Summary K193088

#### Submitter Information

Submitter:

CareFusion, Inc.

| Contact Person: | Nesli Karakaya |
|-----------------|-------------------------------------------------|
| Phone: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | October 20, 2020 |
| | 120 S State College Blvd<br>Brea, CA 92821, USA |

#### Subject Device Identification

| Trade Name: | MaxZero™ Extension Sets with Needle-Free Connector(s) |
|-----------------------|-------------------------------------------------------|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |

Predicate Device Identification

| Trade Name: | MaxZero™ Extension Sets with Needleless Connector | | |
|-----------------------|---------------------------------------------------|--|--|
| Common Name: | Intravascular Administration Set | | |
| Classification Name: | Intravascular Administration Set | | |
| Classification Panel: | General Hospital | | |
| Regulation Number: | 21 CFR 880.5440 | | |
| Regulatory Class: | Class II | | |
| Product Code: | FPA | | |
| Manufacturer: | Carefusion, Inc. | | |
| 510k Number: | K140831 | | |
| 510K Clearance Date: | April 15, 2014 | | |

### Reason for Submission

The objective of this submission is to introduce new components such as amber tubing that is resistant to UV light, trifurcated adaptors that connects 3 legs of tubing to a single male luer and filters that help prevent particles from flowing through the IV fluid line to the MaxZero™ Extension Sets with Needleless Connector(s).

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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a yellow arrow pointing to the upper right. To the right of the logo is the word "CareFusion" in gray.

#### Device Description

The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.

| Components | Description |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------|
| MaxZero Needle-free<br>Connector | Needle-free connector used for the delivery or aspiration of<br>drugs, blood and fluids to/from an IV catheter |
| Amber tubing | Delivers fluid to/from patient while blocking UV light |
| Filters | Filters out particulate |
| Slide Clamp | To close fluid path along tubing |
| Male Luer (spin lock) | Connects distal end of set to female luer |
| Bifurcated connectors<br>(Y-connectors) | Merges two legs of tubing into single leg |

The following table lists the components that the device is comprised of.

### Indication for Use

Trifurcated adapter

The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

Connects 3 legs of tubing to a single male luer

### Technological Characteristics

The information provided in this premarket notification demonstrates that the subject MaxZero™ Extension Sets with Needle-Free Connector(s) is substantially equivalent to the leqally marketed predicated device. The subject device and the predicate device are intended to be used for the delivery or aspiration of drugs, blood and fluids to/from an IV catheter in a hospital environment. The subject and predicate devices are similar in physical properties, materials, and configuration. Each device includes connectors that allow for needle-free access to the IV line during IV therapy eliminating the risk of needlestick injury. The subject device incorporates the MaxZero™ Needle-Free Connector attached to IV tubing. Components of the subject devices are made of materials that are substantially equivalent to those of the predicate device.

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Image /page/5/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield-like shape inside, with a small portion of the shield colored yellow. To the right of the circle is the text "CareFusion" in a dark gray, sans-serif font.

Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)

# Proposed MaxZero Extension Sets

| Model<br>Number | Description | Tubing | ID | OD |
|-----------------|----------------------------------------------------------------------------------------------------------|-----------------|--------|--------|
| MZ9303 | Microbore amber extension set, IV<br>connector (70") | Microbore Amber | 0.023" | 0.079" |
| MZ9321 | Microbore amber extension set, IV<br>connector, 0.2 micron filter (81") | Microbore Amber | 0.023" | 0.079" |
| MZ9299 | Microbore quad-fuse extension set, 4 IV<br>connectors, 1 amber<br>tubing lead, 3 clear tubing leads (7") | Microbore Amber | 0.023" | 0.079" |
| | | Microbore Clear | 0.020" | 0.079" |
| MZ9328 | Minibore amber extension set, IV<br>connector, 1.2 micron filter (81") | Minibore Amber | 0.042" | 0.079" |

# Substantial Equivalence Table

| | MaxZero™ Extension<br>Sets with Needle-free<br>Connector(s)<br>(Subject Device) | CareFusion MaxZero™<br>Extension Sets with<br>Needleless Connector<br>(K140831) | Equivalence |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Reg.<br>Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| FDA Regulation<br>Name | Intravascular<br>Administration Set | Intravascular<br>Administration Set | Same |
| FDA Class | Class II | Class II | Same |
| FDA Product<br>Code | FPA | FPA | Same |
| Product<br>Description | MaxZero™ Extension Sets<br>with Needle-free<br>Connector(s) and the<br>predicate devices are<br>sterile, single patient use,<br>including pediatrics and<br>immunocompromised<br>patients for direct inject,<br>intermittent infusion,<br>continuous infusion or<br>aspiration of drugs, blood<br>and fluids | MaxZero™ Extension Sets<br>with Needleless Connector<br>and the predicate devices<br>are sterile, single patient<br>use, including pediatrics<br>and immunocompromised<br>patients for direct inject,<br>intermittent infusion,<br>continuous infusion or<br>aspiration of drugs, blood<br>and fluids | Same |
| Intended Use | The MaxZero™ Extension<br>Set with Needle-free<br>Connector(s) is a sterile<br>single patient use device<br>intended to be used for<br>the delivery or aspiration | The MaxZero™ Extension<br>Sets with Needleless<br>Connector is a sterile single<br>patient use device intended<br>to be used for the delivery | Equivalent<br>Clarified delivery or<br>aspiration of drugs,<br>bloods and fluids.<br>This is equivalent to |
| | | Traditional 510(k) Premarket Notification<br>MaxZero™ Extension Sets with Needle-Free Connector(s) | |
| | | CareFusion MaxZero™<br>Extension Sets with<br>Needleless Connector<br>(K140831) | Equivalence |
| Indication for<br>use | | | |
| | MaxZero™ Extension<br>Sets with Needle-free<br>Connector(s)<br>(Subject Device) | | |
| | of drugs, blood and fluids<br>to/from an IV catheter. | or aspiration of fluids<br>to/from an IV catheter. | the device<br>description of the<br>predicate device. |
| Indication for<br>use | The MaxZero™ extension<br>set with needle-free<br>connector(s) is for single<br>use only. The MaxZero™<br>extension set with needle-<br>free connector(s) may be<br>used for direct injection,<br>intermittent infusion,<br>continuous infusion or<br>aspiration of drugs, blood<br>and fluids. | Pressure Rated: The<br>MaxZero™ multi fuse<br>extension set with<br>needleless connector(s) is<br>for single use only. The<br>extension set may be used<br>for direct injection,<br>intermittent infusion,<br>continuous infusion or<br>aspiration. This set may be<br>used with power injector<br>procedures to a maximum<br>pressure of 325 psi at a<br>flow rate of 10mL per<br>second.<br><br>Non-Pressure Rated:<br>The MaxZero™ multi fuse<br>extension set with<br>needleless connector(s) is<br>for single use only. The<br>extension set may be used<br>for direct injection,<br>intermittent infusion,<br>continuous infusion or<br>aspiration. | Equivalent to non-<br>pressure rated sets<br><br>The subject device is<br>not indicated for<br>power injection. All<br>subject devices are<br>non-pressure rated<br>sets.<br><br>Clarified delivery<br>and/or aspiration of<br>drugs, bloods and<br>fluids. This is<br>equivalent to the<br>device description of<br>the predicate device. |
| Device Length | MZ9303<br>Microbore amber<br>extension set, IV<br>connector (70"<br>Total Length) MZ9321<br>Microbore amber<br>extension set, IV<br>connector, filter<br>(81" Total<br>Length) MZ9299<br>Microbore quad-<br>fuse extension<br>set, 4 IV<br>connectors, 1<br>amber tubing<br>lead (7" Total<br>Length) | MZ5301 Pressure<br>rated extension<br>set, MaxZero<br>connector, slide<br>clamp, spin male<br>luer lock (7" Total<br>Length) MZ5301 Pressure<br>rated extension<br>set, MaxZero<br>connector, slide<br>clamp, spin male<br>luer lock (7" Total<br>Length) MZ5304 Pressure<br>rated extension<br>set, MaxZero<br>connector, slide<br>clamp spin male | Different<br><br>New lengths added -<br>subject device has<br>the same intended<br>use as the predicate<br>device. Length<br>differences were<br>tested according to<br>applicable consensus<br>standards (same as<br>the predicate<br>device). |
| Traditional 510(k) Premarket Notification<br>MaxZero™ Extension Sets with Needle-Free Connector(s) | | | |
| MaxZero™ Extension Sets with Needle-free Connector(s) (Subject Device) | CareFusion MaxZero™ Extension Sets with Needleless Connector (K140831) | Equivalence | |
| MZ9328 Minibore amber extension set, IV connector, filter (81" Total Length) | luer lock (7" Total Length) MZ5305 Pressure rated extension set, MaxZero connector, spin make luer lock (7" Total Length) MZ5306 Pressure rated extension set, minibore tubing, MaxZero connector, spin make luer lock (7" Total Length) MZ5307 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) side clamps, spin male luer lock. (7" Total Length) MZ3508 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) slide clamps, spin make luer lock. (6" Total Length) MZ9284 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) check valves (2) slide clamps, spin make luer lock (7" Total Length) MZ9285 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors | | |
| | Traditional 510(k) Premarket Notification<br>MaxZero™ Extension Sets with Needle-Free Connector(s) | | |
| | MaxZero™ Extension<br>Sets with Needle-free<br>Connector(s)<br>(Subject Device) | CareFusion MaxZero™<br>Extension Sets with<br>Needleless Connector<br>(K140831) | Equivalence |
| Fluid Contacting<br>Material<br>Composition | <b>Needle-free Connector:</b><br>Polycarbonate, silicone<br>rubber<br><b>Tubing:</b> Non DEHP PVC<br><b>Bi-F Connector:</b> Rigid<br>PVC<br><b>Tri-F Connector:</b> Acrylic<br><b>Male Luer (Spinlock):</b><br>ABS<br><b>Amber Tubing:</b> Non<br>DEHP PVC<br><b>Filters:</b> Acrylic, Filter<br>Media | <b>Needle-free Connector:</b><br>Polycarbonate, silicone<br>rubber<br><b>Tubing:</b> Non DEHP PVC<br><b>Bi-F Connector:</b> Rigid PVC<br><b>Back Check Valve:</b> ABS,<br>silicon rubber<br><b>Male Luer Adapter:</b> ABS<br><b>Male Spinlock:</b> ABS<br><b>Female Luer:</b> Copolyester | Different<br><br>New Materials<br>included in subject<br>device:<br>Acrylic, Filter Media.<br>Design Control<br>activities have been<br>conducted and have<br>confirmed the<br>different<br>technological<br>characteristics of the<br>proposed device do<br>not raise different<br>questions of safety<br>and effectiveness |
| Configurations | MaxZero Needle-free<br>Connector, PVC tubing<br>with various length and<br>ID/OD, clear tubing,<br>amber tubing, in-line<br>filters of various sizes,<br>slide clamps, male luer<br>(spin lock), female luer<br>(female wing adapter),<br>bifurcated connectors (Y-<br>connectors) and<br>trifurcated adapter | MaxZero Needleless<br>Connector, tubing of<br>various length and ID/OD,<br>back check valve, slide<br>clamps, pinch clamps, Y<br>connectors, male spin lock<br>and female wing adapter<br>depending on configuration | Different<br><br>New Components<br>included in subject<br>device:<br>Amber tubing,<br>filters, trifurcated<br>adaptor. Design<br>Control activities<br>have been conducted<br>and have confirmed<br>the different<br>technological<br>characteristics of the<br>proposed device do<br>not raise different<br>questions of safety<br>and effectiveness |
| Physical<br>Specification | Up to quad-fuse extension<br>set. Lengths from 6" to<br>81" | Up to 2-piece extension set.<br>Average length 7" | Different<br><br>Design Control<br>activities have been<br>conducted and have<br>confirmed the<br>different<br>technological<br>characteristics of the<br>proposed device do<br>not raise different<br>questions of safety<br>and effectiveness |
| Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s) | | | |
| | MaxZero™ Extension Sets with Needle-free Connector(s) (Subject Device) | CareFusion MaxZero™ Extension Sets with Needleless Connector (K140831) | Equivalence |
| Filter Size | 0.2 Micron Filter<br>1.2 Micron Filter | NA | proposed device do not raise different questions of safety and effectiveness<br>Different<br>Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness |
| Tubing Bore | Micro Bore = .023 ID X .079 OD<br>Mini Bore = .042 ID X .079 OD | Standard Bore = .060 ID X 0.144 OD<br>Micro Bore = .023 ID X .079 OD | Different<br>New tubing added: Mini bore tubing<br>Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness |
| NON-DEHP tubing | Yes | Yes | Same |
| Bonding agent | Cyclohexanone, Methylene Chloride, and Methyl Ethyl Ketone | Cyclohexanone | Different Bonding Agents used<br>Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different |
| MaxZero™ Extension<br>Sets with Needle-free<br>Connector(s)<br>(Subject Device) | MaxZero™ Extension Sets with Needle-Free Connector(s)<br>CareFusion MaxZero™<br>Extension Sets with<br>Needleless Connector<br>(K140831) | Equivalence | |
| No natural<br>rubber latex | Yes | Yes | questions of safety<br>and effectiveness |
| Sterilization<br>Method | E-Beam | E-Beam | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Usable Life | Up to 7 days 200<br>activation | 7 days 200 activation | Equivalent<br>Clarification added<br>for up to 7 days |
| Disinfect with<br>70% Isopropyl<br>Alcohol | Disinfect with 70%…