(296 days)
Not Found
No
The document describes a portfolio of physical medical devices (syringes, catheters, filters, etc.) with a specific connector type (NRFit). There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on physical characteristics and functionality, not algorithmic performance.
No
The device is described as being used for the injection or infusion of regional anesthetics or narcotics, and for verifying needle tip placement in the epidural space. These actions relate to drug delivery and procedure guidance, not direct therapeutic treatment of a disease or condition.
Yes
The PORTEX® LOR Syringe with NRFit™ Connector is specifically intended "to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline," which is a diagnostic function to confirm correct positioning.
No
The device description clearly outlines physical components such as syringes, catheters, filters, and straws, all of which are hardware. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the products are for the "injection or infusion of regional anesthetics or narcotics" and for verifying needle placement in the epidural space. These are therapeutic and procedural uses, not diagnostic testing performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the physical components, connectors, and their function in delivering medications or verifying placement. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used for administering regional anesthesia and related procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.
The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
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.
PORTEX® LOR Syringe with NRFit™ Connector: The Loss of Resistance (LOR) syringes are a range of sterile, single use syringes used as an aid in locating the epidural space using the Loss of Resistance technique. PORTEX® LOR syringes are available in glass or plastic, and 5, 7, and 10 mL sizes.
PORTEX® EpiFuse Catheter with NRFit™ Connector: The Catheter Connector is designed to provide a secure interface between the catheter and the delivery system. The key is a tool for re-opening the catheter connector. The Catheter Connector includes a Thread Assist Guide which provides support for the catheter threading.
PORTEX® Epidural Flat Filter with NRFit™ Connector: The Epidural Flat Filter is a microporous filter used to minimize particulate (foreign material) contamination of fluids and drugs.
PORTEX® PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector: The PORTEX® NRFit™ Filter Needle and Filter Straw is used to draw up medication when using an NRFit™ Syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ICU/OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Non-clinical testing included:
- Functional Performance: Resistance to overriding, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding (repeated), Leakage by Pressure Decay, Subatmospheric Pressure, Stress Cracking, Verifying Non-interconnectable characteristics physical force. All evaluated against ISO 80369-6.
- Packaging: Package integrity, sterile barrier, evaluated against ISO 11607.
- Sterilization: Sterility, evaluated against ISO 11135.
- Biocompatibility: Residuals, Intracutaneous Reactivity, Systemic Toxicity, Sensitization, Cytotoxicity, Genotoxicity, carcinogenicity and reproductive toxicity, Leachable substances, Chemical characterization of materials. Evaluated against ISO 10993 series.
- Bacterial endotoxins: Evaluated against ANSI/AAMI ST72.
- Particulate matter: Evaluated against USP 788.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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 sunny.teekasingh@smiths-medical.com Phone: (763) 383-3336 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 |
| 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 |
| NRFit™ Connector | ||
| Regulation No. | 21CFR868.5140 | 21CFR868.5140 |
| Regulation Name | Anesthesia conduction kit | Anesthesia conduction kit |
4
bringing technology to life
| 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, | |
| 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.
5
| Device Type | Description |
|---|---|
| PORTEX® LOR | |
| Syringe with | |
| NRFit™ Connector | The Loss of Resistance (LOR) syringes are a range of sterile, single use syringes |
| used as an aid in locating the epidural space using the Loss of Resistance technique. | |
| PORTEX® LOR syringes are available in glass or plastic, and 5, 7, and 10 mL sizes. | |
| PORTEX® EpiFuse | |
| Catheter with | |
| NRFit™ | |
| Connector: | The Catheter Connector is designed to provide a secure interface between the |
| catheter and the delivery system. The key is a tool for re-opening the catheter | |
| connector. The Catheter Connector includes a Thread Assist Guide which provides | |
| support for the catheter threading. | |
| PORTEX® Epidural | |
| Flat Filter with | |
| NRFit™ Connector: | The Epidural Flat Filter is a microporous filter used to minimize particulate (foreign |
| material) contamination of fluids and drugs. | |
| PORTEX® | |
| PORTEX® Filter | |
| Needle with NRFit™ | |
| Connector and | |
| PORTEX® Filter | |
| Straw with NRFit™ | |
| Connector: | The PORTEX® NRFit™ Filter Needle and Filter Straw is used to draw up |
| 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 | |
| Syringe with | |
| NRFit™ Connector: | The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with |
| 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. | |
| PORTEX® EpiFuse | |
| Catheter with | |
| NRFit™ Connector | 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. | |
| PORTEX® Epidural | |
| Flat Filter with | |
| NRFit™ Connector: | 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. | |
| PORTEX® Filter | |
| Needle with | |
| NRFit™ Connector | |
| and PORTEX® | |
| Filter Straw with | |
| NRFit™ Connector | 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. |
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
6
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
K110053 | Subject Device | Discussion |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product
Code & CFR | CAZ
21 CFR 868.5140 | CAZ
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
NRFit™ Connector | N/A |
| Common Name | Syringe | Loss of Resistance Syringe | Similar. Subject is a more
specific application type of
syringe. |
| Indications for
Use | The CorrectInject Syringe
is intended for use with
CorrectInject compatible
components for the injection
of medications. | The PORTEX® L.O.R. Syringe
with NRFit™ Connector is
intended for use with NRFit™
compatible components to
verify needle tip placement in
the epidural space by the Loss
of Resistance technique using
air or saline. NRFit™
connectors are designed to be
used with regional anesthesia
systems only. | Similar. Both are syringes
that are used with
compatible components for
injection.
Predicate is intended for
CorrectInject compatible
components for the
injection of medications.
Subject is intended for use
with NRFit™ compatible
components to verify needle
tip placement in the epidural
space by the Loss of
Resistance technique, and
designed to be used with
regional anesthesia systems
only. This difference does
not raise different questions
of safety and effectiveness. |
| Hospital Location
Use | ICU/OR | ICU/OR | Same |
Table 1: PORTEX® LOR Syringes with NRFit™ Connector
7
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| Characteristic | Predicate Device
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 -
isoprene | Polypropylene,
Isobutylene/isoprene rubber tip | Similar. Subject uses isoprene and predicate uses poly isoprene.
Plastic syringe contains Polypropylene in both Subject and predicate.
Glass syringe is different. Subject made of glass, predicate made of polypropylene. |
8
smiths medical
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| 510(k) Summary |
|---|
| K172410; PORTEX® Regional Anesthesia Portfolio with NRFit™ |
| Characteristics | Predicate
Device | Subject | SE Rationale | Risk Impact |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syringe Volume
capacity (ml) | Volume/size
of in
subject=5, 7,
10 ml
ml in
predicate = 3,
5, 10, 20 ml | Subject has a
7 ml size,
which is
within range
of the 5 and
10ml
predicate
device sizes. | Subject capacity is
different than
predicate's mL range
due to the specific
application of the LOR
syringe. | No risk: The
LOR is not used
clinically for a
precise injection
of fluids. The
physician will
add an
approximate
amount per their
preference to
perform the LOR
technique with.
As such, the
volume markings
are for reference. |
| Material in glass
syringe | Glass | Subject uses
glass with a
metal - nickel
and chrome
plated brass.
ISO 80369-6
tip | The body of the syringes
is the same glass
material. The NRFit™
LOR syringe has a metal
tip that meets ISO
80369-6 dimensions.
Biocompatibility testing
was performed on the
NRFit™ Glass LOR
with passing results. | No risk impact -
Materials were
verified through
biocompatibility
testing. |
| Connector | CorrectInject | NRFit™
connector in
subject | The difference is the
subject uses an ISO
80369-6 NRFit™
connector. This is an
industry standard design
as opposed to the
CorrectInject proprietary
standard. | Risk reduction to
avoid
misconnections. |
| Indications For
Use | The predicate
is intended
for
CorrectInject
compatible
components
for the
injection of
medications. | Subject and
predicate are
both syringes
that are used
with
compatible
components
for injection.
Subject is
intended for
NRFit™
compatible
components
to verify
needle tip | The subject IFU
contains additional
information to clarify
clinical use. | No risk.
Additional
information to
clarify use. |
Table 2: Syringe – Characteristic Comparison
9
smiths medical
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| Characteristics | Predicate
Device | Subject | SE Rationale | Risk Impact |
|-----------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------|
| | | placement in
the epidural
space by the
Loss of
Resistance
technique
using air or
saline.
NRFit™
connectors
are designed
to be used
with regional
anesthesia
systems only. | | |
Table 3: PORTEX® EpiFuse Catheter with NRFit™ Connector
| Characteristic | Predicate Device
K110053 | Subject Device | Discussion |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product
Code & CFR | CAZ
21 CFR 868.5140 | CAZ
21 CFR 868.5140 | Same |
| Regulation
Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Catheter
Connector | PORTEX® EpiFuse Catheter
with NRFit™ Connector | N/A |
| Common Name | Catheter Connector | Catheter Connector | Same |
| Indications for
Use | The CorrectInject Catheter
Connector is intended for use
with an epidural anesthesia
catheter and CorrectInject
compatible components for
the injection of local or
regional anesthetics,
narcotics or other
medications indicated for
injection into the epidural
space. | The PORTEX® EpiFuse
Catheter with NRFit TM
Connector is intended for use
with a 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. | Similar. Both used with a
catheter. Both are indicated
for regional anesthetics or
narcotics, and both to be
used with compatible
components. This
difference does not raise
different questions of
safety and effectiveness. |
| Hospital
Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™
connector intended to
reduce risk of
misconnections. Both met
the requirements of the
respective standards and |
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smiths medical
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| Characteristic | Predicate Device
K110053 | Subject Device | Discussion |
|-------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------|
| | | | these standards are
recognized by FDA. |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| Compatible
Needle Length
(mm) | 16-19 | 16-19 | Same |
| Catheter
Connector -
Material | Polypropylene body with
a thermoplastic elastomer
tube | Polypropylene body with a
thermoplastic elastomer tube | Same |
Table 4: Catheter Connector – Characteristic Comparison
| Characteri
stic | Predicate | Subject
Device | SE Rationale | Risk Impact |
|-------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Catheter
connector : | The predicate
uses a luer tip
syringe to re-
open the
catheter
connector | Subject uses a
key as a tool
for re-opening
the catheter
connector | Both devices require the
use of a secondary tool to
open the connector The
NRFitTM connector
requires a specially
designed tool as the slip
NRFitTM connector has a
shroud that surrounds the
cone | Risk reduction as
Luer syringes
cannot open the
NRFitTM catheter
connector. |
| Connector | CorrectInject
Luer | NRFitTM
connector in
subject | Subject uses an ISO 80369-
6 NRFitTM connector,
which is designed to reduce
risk of misconnections. | Risk reduction to
avoid
misconnections. |
Table 5: PORTEX® Epidural Flat Filter with NRFit™ Connector
| Characteristic | Predicate Device
K110053 | Subject Device | Discussion |
|---------------------------|-----------------------------|-------------------------------------------------------|------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product
Code & CFR | CAZ
21 CFR 868.5140 | CAZ
21 CFR 868.5140 | Same |
| Regulation
Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Filter | PORTEX® Epidural Flat Filter
with NRFit™ Connector | N/A |
| Common Name | Flat Filter | Flat Filter | Same |
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| Characteristic | Predicate Device | Subject Device | Discussion |
|---|---|---|---|
| K110053 | |||
| Indications for | |||
| Use | The CorrectInject anesthesia | ||
| conduction filter is a | |||
| microporous filter used while | |||
| administering to a patient | |||
| injections of local | |||
| anesthetics to minimize | |||
| particulate (foreign material) | |||
| contamination of the injected | |||
| fluid when used with | |||
| CorrectInject compatible | |||
| components. | The PORTEX® Epidural Flat | ||
| Filter with NRFit™ connectors | |||
| is designed for use when | |||
| administering injections and/or | |||
| infusions of regional | |||
| anesthetics or narcotics to a | |||
| patient via compatible system | |||
| components. NRFit™ | |||
| connectors are designed to be | |||
| used with regional anesthesia | |||
| systems only. | Similar. Both are indicated | ||
| for filter application for | |||
| injection of anesthetics. | |||
| This difference does not | |||
| raise different questions of | |||
| safety and effectiveness. | |||
| Hospital | |||
| Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™ |
| connector intended to | |||
| reduce risk of | |||
| misconnections. Both met | |||
| the requirements of the | |||
| respective standards and | |||
| these standards are | |||
| recognized by FDA. | |||
| Filter Pore Size | |||
| (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 | ||
| enclosed in a modified | |||
| acrylic housing with a | |||
| polypropylene rotating collar. | |||
| The collar is colored yellow | |||
| using a Clariant colorant. | Polyether sulfone (PES) filter | ||
| enclosed in a modified acrylic | |||
| housing cover, with a | |||
| polypropylene rotating hub. | |||
| The hub is colored yellow using | |||
| a Clariant colorant. | Same |
Table 6: Flat Filter - Characteristic Comparison
| Characteristic | Predicate | Subject
Device | SE Rationale | Risk Impact |
|----------------|----------------|---------------------|-----------------------------|-----------------------------------------------|
| Connector | Luer connector | NRFit™
connector | Different
connector type | Risk reduction to
avoid
misconnections. |
Table 7: PORTEX® Filter Needle with NRFit™ Connector and Filter Straw with NRFit™ Connector
| Characteristic | Predicate Device
K110053 | Subject Device | Discussion |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product
Code & CFR | CAZ
21 CFR 868.5140 | CAZ
21 CFR 868.5140 | Same |
| Characteristic | Predicate Device
K110053 | Subject Device | Discussion |
| Regulation
Name | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject
Filter Needle
Filter Straw | PORTEX®
NRFit™ Filter Needle with
NRFit™ Connector and
PORTEX®
Filter Straw with NRFit™
Connector | N/A |
| Common Name | Anesthesia Conduction Kit | Anesthesia Conduction Kit | Same |
| Indications for
Use – Filter
Straw | The CorrectInject filter straw
is intended to adapt a Luer
draw-up device to the
CorrectInject syringe. | The PORTEX® NRFit™ Filter
Needle and Filter Straw is
intended to draw up medication
when using the PORTEX®
Regional Anaesthesia Portfolio
with NRFit™ Syringe. | Similar.
Both connect to a syringe,
and both draw up
medication. This difference
does not raise different
questions of safety and
effectiveness. |
| Indications for
Use – Filter
Needle | The CorrectInject filter
needle is intended to draw
up medication when using
the CorrectInject Syringe. | The PORTEX® NRFit™ Filter
Needle and Filter Straw is
intended to draw up medication
when using the PORTEX®
Regional Anaesthesia Portfolio
with NRFit™ Syringe. | Similar.
Both connect to a syringe,
and both draw up
medication. This difference
does not raise different
questions of safety and
effectiveness. |
| Hospital
Location Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFit™
connector intended to
reduce risk of
misconnections. Both met
the requirements of the
respective standards and
these standards are
recognized by FDA. |
| Filter Pore Size
(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
Material | Stainless steel needle with a
polycarbonate hub and a
polybutylene terephthalate
adaptor. | Stainless steel needle with an
ABS hub. | Similar. Both use stainless
steel needle. Difference is
hub materials with predicate
made of polycarbonate and
subject made of ABS. |
| Filter Straw
Material | Polycarbonate and an acrylic
copolymer attached to a
polybutylene terephthalate
(PBT) adaptor. | DEHP-free PVC straw tubing
with an ABS hub. | Similar. Predicate hub is
made of acrylic copolymer
attached to a BPT adaptor
and subject made from a
DEHP-free PVC with ABS
hub. |
12
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.
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13
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| Characteristic | Predicate | Subject
Device | SE
Rationale | Risk Impact |
|----------------|----------------|----------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Polycarbonate | ABS | Needle and filter
materials are
similar. | Risk mitigated -
The materials
incorporated in
the NRFitTM
Filter Needle are
suitable for the
devices' intended
use and do not
pose a biological
risk to clinical
subjects. |
| Connector | Luer connector | NRFitTM
connector | Different
connector type | Risk reduction to
avoid
misconnections. |
Table 8: Filter Needle – Characteristic Comparison
Table 9: Filter Straw – Characteristic Comparison
| Characteristic | Predicate | Subject
Device | SE
Rationale | Risk Impact |
|----------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | PVC straw and a
polycarbonate filter
housing with a PBT
CorrectInject
connector. | PVC straw
with an ABS
NRFitTM
hub/filter
housing | Different
material type | No risk impact –
The materials
incorporated in the
NRFitTM Filter
Straw are suitable
for the devices'
intended use and do
not pose a
biological risk to
clinical subjects. |
| Connector | Luer connector | NRFitTM
connector | Different
connector type | Risk reduction to
avoid
misconnections. |
14
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 |
|---|---|---|
| Functional | ||
| Performance | Resistance to | |
| overriding | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Resistance to | ||
| separation from | ||
| axial load | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Resistance to | ||
| separation from | ||
| unscrewing | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Resistance to | ||
| overriding | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Leakage by Pressure | ||
| Decay | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Subatmospheric | ||
| Pressure | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Verifying Non- | ||
| interconnectable | ||
| characteristics | ||
| physical force | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Packaging | Package integrity, | |
| sterile barrier | ISO 11607, Packaging for terminally sterilized medical | |
| devices - Part 1: Requirements for materials, sterile barrier | ||
| systems and packaging systems | ||
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethylene |
| oxide - Requirements for development, validation and | ||
| routine control of a sterilization process for medical | ||
| devices. | ||
| Biocompatibility | Residuals | ISO 10993-7, Biological evaluation of medical devices - |
| Part 7: Ethylene oxide sterilization residuals | ||
| Intracutaneous | ||
| Reactivity | ISO 10993-10, Biological evaluation of medical devices - | |
| Part 10: Tests for irritation and skin sensitization | ||
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - | |
| Part 11: Tests for systemic toxicity | ||
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - | |
| Part 10: Tests for irritation and skin sensitization | ||
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - | |
| Part 5: Tests for in vitro cytotoxicity | ||
| Genotoxicity, | ||
| carcinogenicity and | ||
| reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - | |
| Part 3: Tests for genotoxicity, carcinogenicity, and | ||
| reproductive toxicity | ||
| Leachable | ||
| substances | ISO 10993-17, Biological evaluation of medical devices - | |
| Part 17: Establishment of allowable limits for leachable | ||
| substances | ||
| Category | Evaluation | Test Criteria |
| Chemical | ||
| characterization of | ||
| materials | ISO 10993-18, Biological evaluation of medical devices - | |
| Part 18: Chemical characterization of materials | ||
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, | |
| routine monitoring, and alternatives to batch testing | ||
| Particulate matter | USP 788, Particulate Matter in Injections |
Table 10: Summary of Non-Clinical Testing
15
Image /page/15/Picture/1 description: The image shows the logo for Smiths Medical. The logo is written in a sans-serif font, with the word "smiths" in a darker blue color and the word "medical" in a lighter blue color. The logo is simple and modern, and it is likely used to represent the company's brand.
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8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of the Smiths Medical PORTEX® Regional Anesthesia Portfolio with NRFit™ connector device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices. The differences in technological characteristics do not raise different questions, and testing meets the acceptance criteria and demonstrates Substantial Equivalence.