Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

K172410 · Smiths Medical Asd, Inc. · BSP · Jun 1, 2018 · Anesthesiology

Device Facts

• Record ID: K172410
• Device Name: Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
• Applicant: Smiths Medical Asd, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PORTEX® products and components with the NRFit™ Connector are intended for the injection or regional anesthetics or narcotics. The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with the NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ Connector is designed to be used with regional anesthesia systems only. The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector. The PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only. The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

Device Story

Portfolio of regional anesthesia components including LOR syringes, catheters, flat filters, filter needles, and filter straws; all featuring ISO 80369-6 compliant NRFit™ connectors. Used in ICU/OR settings by clinicians. LOR syringes (glass/plastic) assist in locating epidural space via air/saline resistance. Catheters facilitate anesthetic/narcotic infusion; include key tool for connector access. Filters minimize particulate contamination. Filter needles/straws assist in medication draw-up. NRFit™ connectors are color-coded yellow and non-compatible with standard luer connectors to prevent misconnections and accidental infusion of non-neuraxial medications. Devices are single-use, sterile, and disposable. Output is the delivery or preparation of regional anesthetic agents; clinical decision-making relies on clinician verification of needle placement and appropriate drug administration. Benefits include reduced risk of medication misconnection errors.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 80369-6 for connector integrity (leakage, axial load, unscrewing, overriding, stress cracking) and non-interconnectability. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, chemical characterization). Packaging and sterilization validated per ISO 11607 and ISO 11135.

Technological Characteristics

Materials: Polypropylene, isobutylene/isoprene rubber, glass, nickel/chrome-plated brass, ABS, DEHP-free PVC, polyether sulfone (PES) filter. Energy: Manual. Connectivity: None. Sterilization: Ethylene Oxide (EO). Connector: ISO 80369-6 (NRFit™) neuraxial small-bore connector. Form factor: Syringes (5, 7, 10 mL), catheters, flat filters (0.02 micron), filter needles/straws (5 micron).

Indications for Use

Indicated for patients requiring injection or infusion of regional anesthetics or narcotics via epidural or regional anesthesia systems. Includes use for verifying epidural needle tip placement via Loss of Resistance technique.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• CorrectInject Syringe (K110053)
• CorrectInject Catheter Connector (K110053)
• CorrectInject Filter (K110053)
• CorrectInject Filter Needle (K110053)
• CorrectInject Filter Straw (K110053)

Submission Summary (Full Text)

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June 1, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

### Re: K172410

Trade/Device Name: PORTEX® LOR Syringe with NRFit™ Connector PORTEX® EpiFuse Catheter with NRFit™ Connector PORTEX® Epidural Flat Filter with NRFit™ Connector PORTEX® Filter Needle with NRFit™ Connector PORTEX® Filter Straw with NRFit™ Connector Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ Dated: Mav 3. 2018 Received: May 4, 2018

Dear Sunita 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

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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); 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,

# Michael J. Ryan -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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Food and Drug Administration

## Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K172410

Device Name

PORTEX® LOR Syringe with NRFit™ Connector PORTEX® EpiFuse Catheter with NRFit™ Connector PORTEX® Epidural Flat Filter with NRFit™ Connector PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector Indications for Use (Describe)

PORTEX® products and components with the NRFit™ Connector are intended for the injection or regional anesthetics or narcotics.

The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with the NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ Connector is designed to be used with regional anesthesia systems only.

The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.

The PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.

The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) K172410 Applicant's Name Smiths Medical ASD, Inc. and Address 6000 Nathan Lane North Minneapolis, MN 55442 USA Contact Person Sunita Teekasingh RN, BSN, CCRN Senior Principal Regulatory Affairs Specialist Vascular Access and Infusion Regulatory Affairs Interim Manger Smiths Medical ASD. Inc. 6000 Nathan Lane North Minneapolis, MN 55442 [e-mail] Phone: [phone] May 31, 2018 Date Regulation No. 21 CFR 880.5140 Regulation Name Anesthesia conduction kit, and Anesthesia conduction needle Primary Product CAZ Codes PORTEX® LOR Syringe with NRFit™ Connector Trade Name PORTEX® EpiFuse Catheter with NRFit™ Connector PORTEX® Epidural Flat Filter with NRFit™ Connector PORTEX® Filter Needle with NRFit™ Connector PORTEX® Filter Straw with NRFit™ Connector

### 1. ADMINISTRATIVE INFORMATION

### 2. REASON FOR SUBMISSION

The purpose of this submission is to make a modification to the currently marketed Smiths Medical PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, PORTEX® Filter Straw with NRFit™ Connector are being updated to include an ISO 80369-6 compliant connector for neuraxial applications.

## 3. DEVICE INFORMATION

| | Predicate Device | Subject Device |
|------------------|----------------------------------|---------------------------------------------------|
| Trade Name | CorrectInject Syringe | PORTEX® LOR Syringe with<br>NRFit™ connector |
| Regulation No. | 21CFR868.5140 | 21CFR868.5140 |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit |
| Regulatory Class | II | II |
| Product Code | CAZ | CAZ |
| 510(k) | K110053 | K172410 |
| | Predicate Device | Subject Device |
| Trade Name | CorrectInject Catheter Connector | PORTEX® EpiFuse Catheter with<br>NRFit™ Connector |
| Regulation No. | 21CFR868.5140 | 21CFR868.5140 |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit |

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| Regulatory Class | II | II |
|------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Product Code | CAZ | CAZ |
| 510(k) | K110053 | K172410 |
| | Predicate Device | Subject Device |
| Trade Name | CorrectInject Filter | PORTEX® Filter Needle with NRFit Connector and PORTEX® Filter Straw with NRFit™ Connector |
| Regulation No. | 21CFR868.5140 | 21CFR868.5140 |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit |
| Regulatory Class | II | II |
| Product Code | CAZ | CAZ |
| 510(k) | K110053 | K172410 |
| | Predicate Device | Subject Device |
| Trade Name | CorrectInject Filter Needle,<br>CorrectInject Filter Straw | PORTEX® NRFit™ Filter Needle, |
| Regulation No. | 21CFR868.5140 | 21CFR868.5140 |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit |
| Regulatory Class | II | II |
| Product Code | CAZ | CAZ |
| 510(k) | K110053 | K172410 |

## 4. DEVICE DESCRIPTION

The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.

PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.

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

The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Regional Anesthesia Portfolio devices with NRFit™ Connector. A description of each configuration is provided in the table below.

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| Device Type | Description |
|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PORTEX® LOR<br>Syringe with<br>NRFit™ Connector | The Loss of Resistance (LOR) syringes are a range of sterile, single use syringes<br>used as an aid in locating the epidural space using the Loss of Resistance technique.<br>PORTEX® LOR syringes are available in glass or plastic, and 5, 7, and 10 mL sizes. |
| PORTEX® EpiFuse<br>Catheter with<br>NRFit™<br>Connector: | The Catheter Connector is designed to provide a secure interface between the<br>catheter and the delivery system. The key is a tool for re-opening the catheter<br>connector. The Catheter Connector includes a Thread Assist Guide which provides<br>support for the catheter threading. |
| PORTEX® Epidural<br>Flat Filter with<br>NRFit™ Connector: | The Epidural Flat Filter is a microporous filter used to minimize particulate (foreign<br>material) contamination of fluids and drugs. |
| PORTEX®<br>PORTEX® Filter<br>Needle with NRFit™<br>Connector and<br>PORTEX® Filter<br>Straw with NRFit™<br>Connector: | The PORTEX® NRFit™ Filter Needle and Filter Straw is used to draw up<br>medication when using an NRFit™ Syringe. |

## 5. INDICATIONS FOR USE

PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.

| Device Category | Indications for Use |
|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PORTEX® LOR<br>Syringe with<br>NRFit™ Connector: | The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with<br>NRFit™ compatible components to verify needle tip placement in the epidural space<br>by the Loss of Resistance technique using air or saline. The NRFit™ connector is<br>designed to be used with regional anesthesia systems only. |
| PORTEX® EpiFuse<br>Catheter with<br>NRFit™ Connector | The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with<br>the catheter and compatible components for the injection or infusion of regional<br>anesthetics or narcotics. The key is a tool for re-opening the catheter connector. |
| PORTEX® Epidural<br>Flat Filter with<br>NRFit™ Connector: | PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when<br>administering injections and/or infusions of regional anesthetics or narcotics to a<br>patient via compatible system components. The NRFit™ Connector is designed to<br>be used with regional anesthesia systems only. |
| PORTEX® Filter<br>Needle with<br>NRFit™ Connector<br>and PORTEX®<br>Filter Straw with<br>NRFit™ Connector | The PORTEX® Filter Needle with NRFit™ Connector<br>and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up<br>medication when using the PORTEX® LOR Syringe. |

## 6. SUBSTANTIAL EQUIVALENCE DISCUSSION

The Smiths Medical PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector have the same technological characteristics as the predicate devices with the exception of the NRFit TM Connectors.

The main difference is the NRFit™ connectors, which 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 are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for

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neuraxial or regional anesthetic use.

The Smiths Medical PORTEX® Regional Anesthesia Portfolio with NRFit™ and predicate devices are both designed for the injection or infusion of regional anesthetics or narcotics.

Subject and predicate are made of similar materials, similar size ranges, chemical composition, and have the same design features excluding the NRFit TM connector design.

Potential risks introduced by the differences are addressed through biocompatibility and bench testing and validation and verification data. The differences are not critical to the intended therapeutic use of the device and do not raise different questions of safety and effectiveness of the device when used as labeled.

A comparative analysis is provided in the following Tables;

| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product<br>Code & CFR | CAZ<br>21 CFR 868.5140 | CAZ<br>21 CFR 868.5140 | Same |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Syringe | PORTEX® LOR Syringe with<br>NRFit™ Connector | N/A |
| Common Name | Syringe | Loss of Resistance Syringe | Similar. Subject is a more<br>specific application type of<br>syringe. |
| Indications for<br>Use | The CorrectInject Syringe<br>is intended for use with<br>CorrectInject compatible<br>components for the injection<br>of medications. | The PORTEX® L.O.R. Syringe<br>with NRFit™ Connector is<br>intended for use with NRFit™<br>compatible components to<br>verify needle tip placement in<br>the epidural space by the Loss<br>of Resistance technique using<br>air or saline. NRFit™<br>connectors are designed to be<br>used with regional anesthesia<br>systems only. | Similar. Both are syringes<br>that are used with<br>compatible components for<br>injection.<br>Predicate is intended for<br>CorrectInject compatible<br>components for the<br>injection of medications.<br>Subject is intended for use<br>with NRFit™ compatible<br>components to verify needle<br>tip placement in the epidural<br>space by the Loss of<br>Resistance technique, and<br>designed to be used with<br>regional anesthesia systems<br>only. This difference does<br>not raise different questions<br>of safety and effectiveness. |
| Hospital Location<br>Use | ICU/OR | ICU/OR | Same |

#### Table 1: PORTEX® LOR Syringes with NRFit™ Connector

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## smiths medical

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| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|----------------|--------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connector | Neuraxial safety system | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM connector intended to reduce risk of misconnections. Both met the requirements of the respective standards and these standards are recognized by FDA. |
| Tip Design | Lock and slip tip | Lock and slip tip | Same |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| mL | 3, 5, 10, 20 | 5, 7 and 10 | Subject capacity is different than predicate's mL range due to the specific application of the LOR syringe. |
| Material | Polypropylene and poly -<br>isoprene | Polypropylene,<br>Isobutylene/isoprene rubber tip | Similar. Subject uses isoprene and predicate uses poly isoprene.<br>Plastic syringe contains Polypropylene in both Subject and predicate.<br>Glass syringe is different. Subject made of glass, predicate made of polypropylene. |

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## smiths medical

bringing technology to life

| 510(k) Summary |
|------------------------------------------------------------|
| K172410; PORTEX® Regional Anesthesia Portfolio with NRFit™ |

| Characteristics | Predicate<br>Device | Subject | SE Rationale | Risk Impact |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syringe Volume<br>capacity (ml) | Volume/size<br>of in<br>subject=5, 7,<br>10 ml<br>ml in<br>predicate = 3,<br>5, 10, 20 ml | Subject has a<br>7 ml size,<br>which is<br>within range<br>of the 5 and<br>10ml<br>predicate<br>device sizes. | Subject capacity is<br>different than<br>predicate's mL range<br>due to the specific<br>application of the LOR<br>syringe. | No risk: The<br>LOR is not used<br>clinically for a<br>precise injection<br>of fluids. The<br>physician will<br>add an<br>approximate<br>amount per their<br>preference to<br>perform the LOR<br>technique with.<br>As such, the<br>volume markings<br>are for reference. |
| Material in glass<br>syringe | Glass | Subject uses<br>glass with a<br>metal - nickel<br>and chrome<br>plated brass.<br>ISO 80369-6<br>tip | The body of the syringes<br>is the same glass<br>material. The NRFit™<br>LOR syringe has a metal<br>tip that meets ISO<br>80369-6 dimensions.<br>Biocompatibility testing<br>was performed on the<br>NRFit™ Glass LOR<br>with passing results. | No risk impact -<br>Materials were<br>verified through<br>biocompatibility<br>testing. |
| Connector | CorrectInject | NRFit™<br>connector in<br>subject | The difference is the<br>subject uses an ISO<br>80369-6 NRFit™<br>connector. This is an<br>industry standard design<br>as opposed to the<br>CorrectInject proprietary<br>standard. | Risk reduction to<br>avoid<br>misconnections. |
| Indications For<br>Use | The predicate<br>is intended<br>for<br>CorrectInject<br>compatible<br>components<br>for the<br>injection of<br>medications. | Subject and<br>predicate are<br>both syringes<br>that are used<br>with<br>compatible<br>components<br>for injection.<br>Subject is<br>intended for<br>NRFit™<br>compatible<br>components<br>to verify<br>needle tip | The subject IFU<br>contains additional<br>information to clarify<br>clinical use. | No risk.<br>Additional<br>information to<br>clarify use. |

#### Table 2: Syringe – Characteristic Comparison

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## smiths medical

bringing technology to life

| Characteristics | Predicate<br>Device | Subject | SE Rationale | Risk Impact |
|-----------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------|
| | | placement in<br>the epidural<br>space by the<br>Loss of<br>Resistance<br>technique<br>using air or<br>saline.<br>NRFit™<br>connectors<br>are designed<br>to be used<br>with regional<br>anesthesia<br>systems only. | | |

### Table 3: PORTEX® EpiFuse Catheter with NRFit™ Connector

| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product<br>Code & CFR | CAZ<br>21 CFR 868.5140 | CAZ<br>21 CFR 868.5140 | Same |
| Regulation<br>Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Catheter<br>Connector | PORTEX® EpiFuse Catheter<br>with NRFit™ Connector | N/A |
| Common Name | Catheter Connector | Catheter Connector | Same |
| Indications for<br>Use | The CorrectInject Catheter<br>Connector is intended for use<br>with an epidural anesthesia<br>catheter and CorrectInject<br>compatible components for<br>the injection of local or<br>regional anesthetics,<br>narcotics or other<br>medications indicated for<br>injection into the epidural<br>space. | The PORTEX® EpiFuse<br>Catheter with NRFit TM<br>Connector is intended for use<br>with a catheter and compatible<br>components for the injection or<br>infusion of regional anesthetics<br>or narcotics. The key is a tool<br>for re-opening the catheter<br>connector. | Similar. Both used with a<br>catheter. Both are indicated<br>for regional anesthetics or<br>narcotics, and both to be<br>used with compatible<br>components. This<br>difference does not raise<br>different questions of<br>safety and effectiveness. |
| Hospital<br>Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™<br>connector intended to<br>reduce risk of<br>misconnections. Both met<br>the requirements of the<br>respective standards and |

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## smiths medical

bringing technology to life

| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|-------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| | | | these standards are<br>recognized by FDA. |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| Compatible<br>Needle Length<br>(mm) | 16-19 | 16-19 | Same |
| Catheter<br>Connector -<br>Material | Polypropylene body with<br>a thermoplastic elastomer<br>tube | Polypropylene body with a<br>thermoplastic elastomer tube | Same |

#### Table 4: Catheter Connector – Characteristic Comparison

| Characteri<br>stic | Predicate | Subject<br>Device | SE Rationale | Risk Impact |
|-------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Catheter<br>connector : | The predicate<br>uses a luer tip<br>syringe to re-<br>open the<br>catheter<br>connector | Subject uses a<br>key as a tool<br>for re-opening<br>the catheter<br>connector | Both devices require the<br>use of a secondary tool to<br>open the connector The<br>NRFitTM connector<br>requires a specially<br>designed tool as the slip<br>NRFitTM connector has a<br>shroud that surrounds the<br>cone | Risk reduction as<br>Luer syringes<br>cannot open the<br>NRFitTM catheter<br>connector. |
| Connector | CorrectInject<br>Luer | NRFitTM<br>connector in<br>subject | Subject uses an ISO 80369-<br>6 NRFitTM connector,<br>which is designed to reduce<br>risk of misconnections. | Risk reduction to<br>avoid<br>misconnections. |

### Table 5: PORTEX® Epidural Flat Filter with NRFit™ Connector

| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|---------------------------|-----------------------------|-------------------------------------------------------|------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product<br>Code & CFR | CAZ<br>21 CFR 868.5140 | CAZ<br>21 CFR 868.5140 | Same |
| Regulation<br>Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Filter | PORTEX® Epidural Flat Filter<br>with NRFit™ Connector | N/A |
| Common Name | Flat Filter | Flat Filter | Same |

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## smiths medical

bringing technology to life

| Characteristic | Predicate Device | Subject Device | Discussion |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K110053 | | |
| Indications for<br>Use | The CorrectInject anesthesia<br>conduction filter is a<br>microporous filter used while<br>administering to a patient<br>injections of local<br>anesthetics to minimize<br>particulate (foreign material)<br>contamination of the injected<br>fluid when used with<br>CorrectInject compatible<br>components. | The PORTEX® Epidural Flat<br>Filter with NRFit™ connectors<br>is designed for use when<br>administering injections and/or<br>infusions of regional<br>anesthetics or narcotics to a<br>patient via compatible system<br>components. NRFit™<br>connectors are designed to be<br>used with regional anesthesia<br>systems only. | Similar. Both are indicated<br>for filter application for<br>injection of anesthetics.<br>This difference does not<br>raise different questions of<br>safety and effectiveness. |
| Hospital<br>Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™<br>connector intended to<br>reduce risk of<br>misconnections. Both met<br>the requirements of the<br>respective standards and<br>these standards are<br>recognized by FDA. |
| Filter Pore Size<br>(micron) | 0.02 | 0.02 | Same |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| Material | Polyether sulfone (PES) filter<br>enclosed in a modified<br>acrylic housing with a<br>polypropylene rotating collar.<br>The collar is colored yellow<br>using a Clariant colorant. | Polyether sulfone (PES) filter<br>enclosed in a modified acrylic<br>housing cover, with a<br>polypropylene rotating hub.<br>The hub is colored yellow using<br>a Clariant colorant. | Same |

#### Table 6: Flat Filter - Characteristic Comparison

| Characteristic | Predicate | Subject<br>Device | SE Rationale | Risk Impact |
|----------------|----------------|---------------------|-----------------------------|-----------------------------------------------|
| Connector | Luer connector | NRFit™<br>connector | Different<br>connector type | Risk reduction to<br>avoid<br>misconnections. |

#### Table 7: PORTEX® Filter Needle with NRFit™ Connector and Filter Straw with NRFit™ Connector

| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product<br>Code & CFR | CAZ<br>21 CFR 868.5140 | CAZ<br>21 CFR 868.5140 | Same |
| Characteristic | Predicate Device<br>K110053 | Subject Device | Discussion |
| Regulation<br>Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject<br>Filter Needle<br>Filter Straw | PORTEX®<br>NRFit™ Filter Needle with<br>NRFit™ Connector and<br>PORTEX®<br>Filter Straw with NRFit™<br>Connector | N/A |
| Common Name | Anesthesia Conduction Kit | Anesthesia Conduction Kit | Same |
| Indications for<br>Use – Filter<br>Straw | The CorrectInject filter straw<br>is intended to adapt a Luer<br>draw-up device to the<br>CorrectInject syringe. | The PORTEX® NRFit™ Filter<br>Needle and Filter Straw is<br>intended to draw up medication<br>when using the PORTEX®<br>Regional Anaesthesia Portfolio<br>with NRFit™ Syringe. | Similar.<br>Both connect to a syringe,<br>and both draw up<br>medication. This difference<br>does not raise different<br>questions of safety and<br>effectiveness. |
| Indications for<br>Use – Filter<br>Needle | The CorrectInject filter<br>needle is intended to draw<br>up medication when using<br>the CorrectInject Syringe. | The PORTEX® NRFit™ Filter<br>Needle and Filter Straw is<br>intended to draw up medication<br>when using the PORTEX®<br>Regional Anaesthesia Portfolio<br>with NRFit™ Syringe. | Similar.<br>Both connect to a syringe,<br>and both draw up<br>medication. This difference<br>does not raise different<br>questions of safety and<br>effectiveness. |
| Hospital<br>Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFit™<br>connector intended to<br>reduce risk of<br>misconnections. Both met<br>the requirements of the<br>respective standards and<br>these standards are<br>recognized by FDA. |
| Filter Pore Size<br>(micron) | 5 | 5 | Same |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| Filter Needle<br>Material | Stainless steel needle with a<br>polycarbonate hub and a<br>polybutylene terephthalate<br>adaptor. | Stainless steel needle with an<br>ABS hub. | Similar. Both use stainless<br>steel needle. Difference is<br>hub materials with predicate<br>made of polycarbonate and<br>subject made of ABS. |
| Filter Straw<br>Material | Polycarbonate and an acrylic<br>copolymer attached to a<br>polybutylene terephthalate<br>(PBT) adaptor. | DEHP-free PVC straw tubing<br>with an ABS hub. | Similar. Predicate hub is<br>made of acrylic copolymer<br>attached to a BPT adaptor<br>and subject made from a<br>DEHP-free PVC with ABS<br>hub. |

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Image /page/12/Picture/1 description: The image shows the logo for Smiths Medical. The text "smiths" is in a dark blue color, while the text "medical" is in a lighter blue color. The logo is simple and modern.

bringing technology to life

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## smiths medical

bringing technology to life

| Characteristic | Predicate | Subject<br>Device | SE<br>Rationale | Risk Impact |
|----------------|----------------|----------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polycarbonate | ABS | Needle and filter<br>materials are<br>similar. | Risk mitigated -<br>The materials<br>incorporated in<br>the NRFitTM<br>Filter Needle are<br>suitable for the<br>devices' intended<br>use and do not<br>pose a biological<br>risk to clinical<br>subjects. |
| Connector | Luer connector | NRFitTM<br>connector | Different<br>connector type | Risk reduction to<br>avoid<br>misconnections. |

#### Table 8: Filter Needle – Characteristic Comparison

#### Table 9: Filter Straw – Characteristic Comparison

| Characteristic | Predicate | Subject<br>Device | SE<br>Rationale | Risk Impact |
|----------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | PVC straw and a<br>polycarbonate filter<br>housing with a PBT<br>CorrectInject<br>connector. | PVC straw<br>with an ABS<br>NRFitTM<br>hub/filter<br>housing | Different<br>material type | No risk impact –<br>The materials<br>incorporated in the<br>NRFitTM Filter<br>Straw are suitable<br>for the devices'<br>intended use and do<br>not pose a<br>biological risk to<br>clinical subjects. |
| Connector | Luer connector | NRFitTM<br>connector | Different<br>connector type | Risk reduction to<br>avoid<br>misconnections. |

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## 7. SUMMARY OF NON-CLINICAL TESTING

The PORTEX® Regional Anesthesia Portfolio with NRFit™ Connector were evaluated via nonclinical performance testing to demonstrate the devices are as safe, as effective, and perform as well as or better than the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Regional Anesthesia Portfolio with NRFit™ connectors performed as intended. A summary of the evaluation is provided below in Table 10.

| Category | Evaluation | Test Criteria |
|---------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------…