CADD Yellow High Volume Administration Set with NRFit connector

K172592 · Smiths Medical Asd, Inc. · PWH · May 17, 2018 · General Hospital

Device Facts

• Record ID: K172592
• Device Name: CADD Yellow High Volume Administration Set with NRFit connector
• Applicant: Smiths Medical Asd, Inc.
• Product Code: PWH · General Hospital
• Decision Date: May 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors are intended for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid / spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility). The intended population is pediatrics and adults.

Device Story

Administration set for regional anesthetic/narcotic infusion; used with CADD pumps. Input: fluid from IV bag. Transformation: delivers fluid via tubing to patient site. Output: controlled infusion of medication. Used in clinical settings by healthcare providers. Features NRFit connectors (ISO 80369-6) to prevent misconnection with standard Luer systems; color-coded yellow for regional anesthesia identification. Benefits patient by reducing risk of medication delivery errors via incompatible ports.

Clinical Evidence

Bench testing only. Performance evaluated via biocompatibility (ISO 10993 series), packaging integrity, and mechanical testing (leakage, tensile strength, torque, connector compatibility per ISO 80369-1/6).

Technological Characteristics

Materials: PVC (TOTM plasticized), ABS, Polycarbonate, Silicone. Energy: None (gravity/pump-driven). Connectivity: None. Sterilization: Ethylene Oxide (EO). Connector: ISO 80369-6 compliant NRFit non-Luer system. Form factor: 130-inch tubing with bag spike, flow stop, and optional 0.2-micron filter.

Indications for Use

Indicated for delivery of regional anesthetics or narcotics in pediatric and adult populations. Contraindicated for subarachnoid/spinal block.

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

• CADD® High Volume Administration Set with Flow Stop (K031361)

Submission Summary (Full Text)

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May 17, 2018

Smiths Medical ASD, Inc. Sunny Teekasingh Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K172592

Trade/Device Name: CADD Yellow High Volume Administration Set with NRFit connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: PWH Dated: April 18, 2018 Received: April 19, 2018

Dear Sunny Teekasingh:

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

# Geeta K. Pamidimukkala -S

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) K172592

Device Name

CADD® Yellow High Volume Administration Set with NRFit™ connector

#### Indications for Use (Describe)

CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).

The intended population is pediatrics and adults.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| <span></span> | <span></span> |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 1. ADMINISTRATIVE INFORMATION

| 510(k) | K172592 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant's Name<br>and Address | Smiths Medical ASD, Inc.<br>6000 Nathan Lane North<br>Minneapolis, MN 55442 USA |
| Contact Person | Sunny Teekasingh<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date | May 10, 2018 |
| Regulation No.<br>Regulation Name | 21 CFR § 880.5440<br>Intravascular Administration Set |
| Primary Product<br>Codes | PWH |
| Trade Name | CADD® Yellow High Volume Administration Set with NRFit™ connector |

### 2. REASON FOR SUBMISSION

The purpose of this submission is to make a modification to the currently marketed Smiths Medical CADD® High Volume Administration Sets which are being updated to include an ISO 80369-6 compliant connector for regional anesthetic applications.

### 3. DEVICE INFORMATION

| | Predicate Device | Subject Device |
|------------------|--------------------------------------------------------|--------------------------------------------------------------------------|
| Trade Name | CADD® High Volume<br>Administration Set with Flow Stop | CADD® Yellow High Volume<br>Administration Set with NRFitTM<br>connector |
| Regulation No. | 21 CFR § 880.5440 | 21 CFR § 880.5440 |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set |
| Regulatory Class | II | II |
| Product Code | FPA | PWH |
| 510(k) | K031361 | K172592 |

### 4. DEVICE DESCRIPTION

The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.

The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™

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connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.

The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.

All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.

## 5. INDICATIONS FOR USE

The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors are intended for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid / spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility). The intended population is pediatrics and adults.

## 6. SUBSTANTIAL EQUIVALENCE DISCUSSION

The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors have the same technological characteristics as the predicate devices with the exception of the NRFit™ Connectors.

The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors and predicate devices are both designed to deliver local or regional anesthetics or narcotics, indicated for regional anesthetic infusion applications. They are both made of the same materials, have the same chemical composition, and have the same design features excluding the NRFit™ connector design.

The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors utilize connectors that comply with ISO 80369-6. These connectors are intentionally designed to be incompatible with Luer tapers such as those found on the predicate devices to mitigate the risks associated with connecting infusion lines to the incorrect infusion pump. The predicate devices utilize standard Luer connectors that comply with ISO 594, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment." A side-by-side characteristic analysis of Predicate and Subject Device is provided in Table 1.

| Characteristic | Subject Device<br>K172592 | Predicate Device<br>K031361 | Discussion |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | CADD® Yellow High<br>Volume<br>Administration Set<br>with NRFit™<br>connectors are<br>intended for use only<br>with NRFit™<br>components for<br>delivery of regional<br>anesthetics or<br>narcotics, excluding<br>subarachnoid / spinal | CADD® High-<br>Volume<br>Administration Sets<br>is designed for use<br>with the CADD-<br>Prism® pump to<br>allow fluid delivery<br>from an IV bag. | Both used with CADD<br>pump. |
| Characteristic | Subject Device<br>K172592 | Predicate Device<br>K031361 | Discussion |
| | block, and are<br>designed for use with<br>CADD® pumps (see<br>CADD® pump<br>Operator's Manual for<br>compatibility). The<br>intended population is<br>pediatrics and adults. | | |
| Sterility Method | EO | EO | Same |
| Single use | Yes | Yes | Same |
| Disposable | Yes | Yes | Same |
| Prescription | Yes | Yes | Same |
| Connections | ISO 80369-6<br>compliant NRFit™<br>non-Luer connectors | ISO 594 Luer<br>tapers | The NRFit™ connector<br>provides the same<br>clinical function (i.e.,<br>secure, non-leaking<br>connection), but<br>incorporates the ISO<br>80369-6 connector<br>design to mitigate the<br>risk of misconnections. |
| Model: CADD® High<br>Volume<br>Administration Sets<br>(with Air-Eliminating<br>Filter and Flow Stop<br>Free-Flow Protection) | 21-7685-24 | 21-7385-24 | N/A |
| Model: CADD® High<br>Volume<br>Administration Sets<br>(with Flow Stop Free-<br>Flow Protection) | 21-7684-24 | 21-7384-24 | N/A |
| Nominal Set Length | 130 inches | 130 inches | Same |
| Priming Volume for<br>CADD® High<br>Volume<br>Administration Sets<br>(with Flow Stop Free-<br>Flow Protection) | 16 mL | 16 mL | Same |
| Priming Volume for<br>CADD® High<br>Volume<br>Administration Sets<br>(with Air-Eliminating<br>Filter and Flow Stop<br>Free-Flow Protection) | 23 mL | 23 mL | Same |
| 0.2 micron filter, for<br>CADD® High | 0.2 micron filter | 0.2 micron filter | Same |
| Characteristic | Subject Device<br>K172592 | Predicate Device<br>K031361 | Discussion |
| Volume<br>Administration Sets<br>(with Air-Eliminating<br>Filter and Flow Stop<br>Free-Flow Protection) | | | |
| PVC Tubing<br>Plasticized with<br>TOTM | Yes | Yes | Same |
| Bag Spike | Yes | Yes | Same |
| Dimensions - Bag<br>Spike | Same | Same | Same |
| Materials - Bag Spike | Acrylonitrile<br>butadiene styrene<br>(ABS) - ABS - HI<br>121H-Natural<br>Granule 9700640000<br>Colorant: Yellow | Acrylonitrile<br>butadiene styrene<br>(ABS) - ABS White<br>Granule<br>9700670300<br>Colorant: White | Proposed materials are<br>color-coded yellow to<br>indicate medication<br>intended for regional<br>anesthetic delivery. |
| Male Taper with One-<br>Way Checkvalve | Male NRFit™<br>connector | Male ISO 594 Luer | The NRFit™ connector<br>provides the same<br>clinical function (i.e.,<br>secure, non-leaking<br>connection), but<br>incorporates the ISO<br>80369-6 connector<br>design to mitigate the<br>risk of misconnections. |
| Materials - One-Way<br>Checkvalve, Valve<br>Membrane | Silicone – Siloprene<br>LSR-4040<br>Colorant: None | Silicone– Siloprene<br>LSR-4040<br>Colorant: None | Same |
| Materials - One-Way<br>Checkvalve, Male<br>Taper Outlet Housing | Polycarbonate -<br>Makrolon RX-1805G<br>Colorant: Yellow,<br>Clariant<br>NC1M664867 | Polycarbonate -<br>Makrolon RX-1805G<br>Colorant: Purple<br>Tint | Proposed materials are<br>color-coded yellow to<br>indicate medication<br>intended for regional<br>anesthetic delivery. |
| Materials - One-Way<br>Checkvalve, Female<br>Luer Lock Inlet<br>Housing | Polycarbonate -<br>Makrolon RX-1805-<br>013771<br>Colorant: White | Polycarbonate -<br>Makrolon RX-1805-<br>013771<br>Colorant: White | Same |
| Flow Stop | Yes | Yes | Same |
| Packaging | Pouch | Pouch | Same |

### Table 1: Comparative Analysis of Subject and Predicate Devices by Characteristic

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### 510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector

Image /page/5/Picture/1 description: The image shows the logo for Smiths Medical. The text "smiths medical" is written in a sans-serif font. The word "smiths" is in a darker blue color, while the word "medical" is in a lighter blue color.

bringing technology to life

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#### 510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector

# smiths medical

bringing technology to life

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# 7. SUMMARY OF NON-CLINICAL TESTING

The CADD® Yellow High Volume Administration Set with NRFit™ connector was evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and performs as well as the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the CADD® Yellow High Volume Administration Set with NRFit™ connector device performed as intended. A summary of the testing is provided in Table 2.

| Category | Testing |
|--------------------|--------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity |
| | Sensitization |
| | Intracutaneous Reactivity (Irritation) |
| | Acute Systemic Toxicity |
| | Pyrogenicity (bacterial-mediated & material-mediated) |
| | Hemocompatibility |
| | Subchronic Toxicity |
| | Genotoxicity |
| | Extractables and Leachables |
| | Toxicological Risk Assessment |
| | Particulates |
| | Ethylene Oxide Residuals |
| Packaging | Sterile Barrier Integrity |
| | Seal Strength |
| | Packaging Stability |
| | Distribution Simulation |
| Device Performance | Connector compatibility and incompatibility |
| | Dimensional Testing |
| | Leakage |
| | Mechanical Requirements (resistance to cracking, tensile strength, |
| | over-riding threads, torque) |

### Table 2: Testing Type by Category

Biocompatibility and Bench testing was conducted to the Standards in Table 3:

Table 3: Testing Type by Standard Reference Number and Date

| Standards<br>Development<br>Organization | Reference<br>Number and Date | Title |
|------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ISO | 80369-1:2010 | Small-bore connectors for liquids and gases in<br>healthcare applications - Part 1: General<br>requirements |
| ISO | 80369-6:2016 | Small bore connectors for liquids and gases in<br>healthcare Applications - Part 6: Connectors for<br>Neuraxial Applications |
| ISO | 10993-1:2009 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process |

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### 510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector

| ISO | 10993-3:2014 | Biological evaluation of medical devices - Part 3:<br>Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity |
|-----|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| ISO | 10993-4:2017 | Biological evaluation of medical devices - Part 4:<br>Selection of tests for interactions with blood |
| ISO | 10993-5:2009 | Biological evaluation of medical devices - Part 5:<br>Tests<br>for in vitro cytotoxicity |
| ISO | 10993-7:2008 | Biological evaluation of medical devices - Part 7:<br>Ethylene oxide sterilization residuals |
| ISO | 10993-10:2010 | ISO 10993-10 Biological evaluation of medical<br>devices - Part 10: Tests for irritation and sensitization |
| ISO | 10993-11:2006 | Biological evaluation of medical devices - Part 11:<br>Tests for systemic toxicity |
| ISO | 10993-12:2012 | Biological evaluation of medical devices - Part 12:<br>Sample preparation and reference materials |
| ISO | 10993-<br>17:2002(R)2012 | Biological evaluation of medical devices - Part 17:<br>Establishment of allowable limits for leachable<br>substances |
| ISO | 10993-18:2005 | Biological evaluation of medical devices - Part 18:<br>Chemical characterization of materials |

# 8. SUBSTANTIAL EQUIVALENCE CONCLUSION

The evaluation of the Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connector device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices in regards to safety and effectiveness.