(296 days)
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.
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 looks like a 510(k) summary for a medical device modification, specifically for the 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.
This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.
Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.
| Category | Evaluation | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Functional Performance (NRFit™ Connector) | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended |
| 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 | Met pre-established specifications and performed as intended | |
| Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| 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 | Met pre-established specifications and performed as intended | |
| Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | Met pre-established specifications and performed as intended |
| 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. | Met pre-established specifications and performed as intended |
| Biocompatibility | Residuals (Ethylene Oxide) | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met pre-established specifications and performed as intended |
| Intracutaneous Reactivity | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met pre-established specifications and performed as intended | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met pre-established specifications and performed as intended | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Met pre-established specifications and performed as intended | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | Met pre-established specifications and performed as intended | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | Met pre-established specifications and performed as intended | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | Met pre-established specifications and performed as intended | |
| Particulate matter | USP 788, Particulate Matter in Injections | Met pre-established specifications and performed as intended |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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 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 withNRFit™ 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 withNRFit™ 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,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® LORSyringe withNRFit™ Connector | The Loss of Resistance (LOR) syringes are a range of sterile, single use syringesused 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® EpiFuseCatheter withNRFit™Connector: | The Catheter Connector is designed to provide a secure interface between thecatheter and the delivery system. The key is a tool for re-opening the catheterconnector. The Catheter Connector includes a Thread Assist Guide which providessupport for the catheter threading. |
| PORTEX® EpiduralFlat Filter withNRFit™ Connector: | The Epidural Flat Filter is a microporous filter used to minimize particulate (foreignmaterial) contamination of fluids and drugs. |
| PORTEX®PORTEX® FilterNeedle with NRFit™Connector andPORTEX® FilterStraw with NRFit™Connector: | The PORTEX® NRFit™ Filter Needle and Filter Straw is used to draw upmedication 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® LORSyringe withNRFit™ Connector: | The PORTEX® LOR Syringe with NRFit™ Connector is intended for use withNRFit™ compatible components to verify needle tip placement in the epidural spaceby the Loss of Resistance technique using air or saline. The NRFit™ connector isdesigned to be used with regional anesthesia systems only. |
| PORTEX® EpiFuseCatheter withNRFit™ Connector | The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use withthe catheter and compatible components for the injection or infusion of regionalanesthetics or narcotics. The key is a tool for re-opening the catheter connector. |
| PORTEX® EpiduralFlat Filter withNRFit™ Connector: | PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use whenadministering injections and/or infusions of regional anesthetics or narcotics to apatient via compatible system components. The NRFit™ Connector is designed tobe used with regional anesthesia systems only. |
| PORTEX® FilterNeedle withNRFit™ Connectorand PORTEX®Filter Straw withNRFit™ Connector | The PORTEX® Filter Needle with NRFit™ Connectorand PORTEX® Filter Straw with NRFit™ Connector are intended to draw upmedication 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 DeviceK110053 | Subject Device | Discussion |
|---|---|---|---|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA ProductCode & CFR | CAZ21 CFR 868.5140 | CAZ21 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 withNRFit™ Connector | N/A |
| Common Name | Syringe | Loss of Resistance Syringe | Similar. Subject is a morespecific application type ofsyringe. |
| Indications forUse | The CorrectInject Syringeis intended for use withCorrectInject compatiblecomponents for the injectionof medications. | The PORTEX® L.O.R. Syringewith NRFit™ Connector isintended for use with NRFit™compatible components toverify needle tip placement inthe epidural space by the Lossof Resistance technique usingair or saline. NRFit™connectors are designed to beused with regional anesthesiasystems only. | Similar. Both are syringesthat are used withcompatible components forinjection.Predicate is intended forCorrectInject compatiblecomponents for theinjection of medications.Subject is intended for usewith NRFit™ compatiblecomponents to verify needletip placement in the epiduralspace by the Loss ofResistance technique, anddesigned to be used withregional anesthesia systemsonly. This difference doesnot raise different questionsof safety and effectiveness. |
| Hospital LocationUse | ICU/OR | ICU/OR | Same |
Table 1: PORTEX® LOR Syringes with NRFit™ Connector
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smiths medical
bringing technology to life
| Characteristic | Predicate DeviceK110053 | 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. |
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bringing technology to life
| 510(k) Summary |
|---|
| K172410; PORTEX® Regional Anesthesia Portfolio with NRFit™ |
| Characteristics | PredicateDevice | Subject | SE Rationale | Risk Impact |
|---|---|---|---|---|
| Syringe Volumecapacity (ml) | Volume/sizeof insubject=5, 7,10 mlml inpredicate = 3,5, 10, 20 ml | Subject has a7 ml size,which iswithin rangeof the 5 and10mlpredicatedevice sizes. | Subject capacity isdifferent thanpredicate's mL rangedue to the specificapplication of the LORsyringe. | No risk: TheLOR is not usedclinically for aprecise injectionof fluids. Thephysician willadd anapproximateamount per theirpreference toperform the LORtechnique with.As such, thevolume markingsare for reference. |
| Material in glasssyringe | Glass | Subject usesglass with ametal - nickeland chromeplated brass.ISO 80369-6tip | The body of the syringesis the same glassmaterial. The NRFit™LOR syringe has a metaltip that meets ISO80369-6 dimensions.Biocompatibility testingwas performed on theNRFit™ Glass LORwith passing results. | No risk impact -Materials wereverified throughbiocompatibilitytesting. |
| Connector | CorrectInject | NRFit™connector insubject | The difference is thesubject uses an ISO80369-6 NRFit™connector. This is anindustry standard designas opposed to theCorrectInject proprietarystandard. | Risk reduction toavoidmisconnections. |
| Indications ForUse | The predicateis intendedforCorrectInjectcompatiblecomponentsfor theinjection ofmedications. | Subject andpredicate areboth syringesthat are usedwithcompatiblecomponentsfor injection.Subject isintended forNRFit™compatiblecomponentsto verifyneedle tip | The subject IFUcontains additionalinformation to clarifyclinical use. | No risk.Additionalinformation toclarify use. |
Table 2: Syringe – Characteristic Comparison
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| Characteristics | PredicateDevice | Subject | SE Rationale | Risk Impact |
|---|---|---|---|---|
| placement inthe epiduralspace by theLoss ofResistancetechniqueusing air orsaline.NRFit™connectorsare designedto be usedwith regionalanesthesiasystems only. |
Table 3: PORTEX® EpiFuse Catheter with NRFit™ Connector
| Characteristic | Predicate DeviceK110053 | Subject Device | Discussion |
|---|---|---|---|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA ProductCode & CFR | CAZ21 CFR 868.5140 | CAZ21 CFR 868.5140 | Same |
| RegulationName | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject CatheterConnector | PORTEX® EpiFuse Catheterwith NRFit™ Connector | N/A |
| Common Name | Catheter Connector | Catheter Connector | Same |
| Indications forUse | The CorrectInject CatheterConnector is intended for usewith an epidural anesthesiacatheter and CorrectInjectcompatible components forthe injection of local orregional anesthetics,narcotics or othermedications indicated forinjection into the epiduralspace. | The PORTEX® EpiFuseCatheter with NRFit TMConnector is intended for usewith a catheter and compatiblecomponents for the injection orinfusion of regional anestheticsor narcotics. The key is a toolfor re-opening the catheterconnector. | Similar. Both used with acatheter. Both are indicatedfor regional anesthetics ornarcotics, and both to beused with compatiblecomponents. Thisdifference does not raisedifferent questions ofsafety and effectiveness. |
| HospitalLocation Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™connector intended toreduce risk ofmisconnections. Both metthe requirements of therespective standards and |
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bringing technology to life
| Characteristic | Predicate DeviceK110053 | Subject Device | Discussion |
|---|---|---|---|
| these standards arerecognized by FDA. | |||
| Packaging | Tyvek pouch | Tyvek pouch | Same |
| Sterility | Sterile, EO | Sterile, EO | Same |
| Use | Single Use Disposable | Single Use Disposable | Same |
| CompatibleNeedle Length(mm) | 16-19 | 16-19 | Same |
| CatheterConnector -Material | Polypropylene body witha thermoplastic elastomertube | Polypropylene body with athermoplastic elastomer tube | Same |
Table 4: Catheter Connector – Characteristic Comparison
| Characteristic | Predicate | SubjectDevice | SE Rationale | Risk Impact |
|---|---|---|---|---|
| Catheterconnector : | The predicateuses a luer tipsyringe to re-open thecatheterconnector | Subject uses akey as a toolfor re-openingthe catheterconnector | Both devices require theuse of a secondary tool toopen the connector TheNRFitTM connectorrequires a speciallydesigned tool as the slipNRFitTM connector has ashroud that surrounds thecone | Risk reduction asLuer syringescannot open theNRFitTM catheterconnector. |
| Connector | CorrectInjectLuer | NRFitTMconnector insubject | Subject uses an ISO 80369-6 NRFitTM connector,which is designed to reducerisk of misconnections. | Risk reduction toavoidmisconnections. |
Table 5: PORTEX® Epidural Flat Filter with NRFit™ Connector
| Characteristic | Predicate DeviceK110053 | Subject Device | Discussion |
|---|---|---|---|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA ProductCode & CFR | CAZ21 CFR 868.5140 | CAZ21 CFR 868.5140 | Same |
| RegulationName | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInject Filter | PORTEX® Epidural Flat Filterwith NRFit™ Connector | N/A |
| Common Name | Flat Filter | Flat Filter | Same |
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| Characteristic | Predicate Device | Subject Device | Discussion |
|---|---|---|---|
| K110053 | |||
| Indications forUse | The CorrectInject anesthesiaconduction filter is amicroporous filter used whileadministering to a patientinjections of localanesthetics to minimizeparticulate (foreign material)contamination of the injectedfluid when used withCorrectInject compatiblecomponents. | The PORTEX® Epidural FlatFilter with NRFit™ connectorsis designed for use whenadministering injections and/orinfusions of regionalanesthetics or narcotics to apatient via compatible systemcomponents. NRFit™connectors are designed to beused with regional anesthesiasystems only. | Similar. Both are indicatedfor filter application forinjection of anesthetics.This difference does notraise different questions ofsafety and effectiveness. |
| HospitalLocation Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™connector intended toreduce risk ofmisconnections. Both metthe requirements of therespective standards andthese standards arerecognized 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) filterenclosed in a modifiedacrylic housing with apolypropylene rotating collar.The collar is colored yellowusing a Clariant colorant. | Polyether sulfone (PES) filterenclosed in a modified acrylichousing cover, with apolypropylene rotating hub.The hub is colored yellow usinga Clariant colorant. | Same |
Table 6: Flat Filter - Characteristic Comparison
| Characteristic | Predicate | SubjectDevice | SE Rationale | Risk Impact |
|---|---|---|---|---|
| Connector | Luer connector | NRFit™connector | Differentconnector type | Risk reduction toavoidmisconnections. |
Table 7: PORTEX® Filter Needle with NRFit™ Connector and Filter Straw with NRFit™ Connector
| Characteristic | Predicate DeviceK110053 | Subject Device | Discussion |
|---|---|---|---|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA ProductCode & CFR | CAZ21 CFR 868.5140 | CAZ21 CFR 868.5140 | Same |
| Characteristic | Predicate DeviceK110053 | Subject Device | Discussion |
| RegulationName | Anesthesia conduction kit | Anesthesia conduction kit | Same |
| Regulatory Class | II | II | Same |
| Trade Name | CorrectInjectFilter NeedleFilter Straw | PORTEX®NRFit™ Filter Needle withNRFit™ Connector andPORTEX®Filter Straw with NRFit™Connector | N/A |
| Common Name | Anesthesia Conduction Kit | Anesthesia Conduction Kit | Same |
| Indications forUse – FilterStraw | The CorrectInject filter strawis intended to adapt a Luerdraw-up device to theCorrectInject syringe. | The PORTEX® NRFit™ FilterNeedle and Filter Straw isintended to draw up medicationwhen using the PORTEX®Regional Anaesthesia Portfoliowith NRFit™ Syringe. | Similar.Both connect to a syringe,and both draw upmedication. This differencedoes not raise differentquestions of safety andeffectiveness. |
| Indications forUse – FilterNeedle | The CorrectInject filterneedle is intended to drawup medication when usingthe CorrectInject Syringe. | The PORTEX® NRFit™ FilterNeedle and Filter Straw isintended to draw up medicationwhen using the PORTEX®Regional Anaesthesia Portfoliowith NRFit™ Syringe. | Similar.Both connect to a syringe,and both draw upmedication. This differencedoes not raise differentquestions of safety andeffectiveness. |
| HospitalLocation Use | ICU/OR | ICU/OR | Same |
| Connector | CorrectInject Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFit™connector intended toreduce risk ofmisconnections. Both metthe requirements of therespective standards andthese standards arerecognized 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 NeedleMaterial | Stainless steel needle with apolycarbonate hub and apolybutylene terephthalateadaptor. | Stainless steel needle with anABS hub. | Similar. Both use stainlesssteel needle. Difference ishub materials with predicatemade of polycarbonate andsubject made of ABS. |
| Filter StrawMaterial | Polycarbonate and an acryliccopolymer attached to apolybutylene terephthalate(PBT) adaptor. | DEHP-free PVC straw tubingwith an ABS hub. | Similar. Predicate hub ismade of acrylic copolymerattached to a BPT adaptorand subject made from aDEHP-free PVC with ABShub. |
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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 | SubjectDevice | SERationale | Risk Impact |
|---|---|---|---|---|
| Material | Polycarbonate | ABS | Needle and filtermaterials aresimilar. | Risk mitigated -The materialsincorporated inthe NRFitTMFilter Needle aresuitable for thedevices' intendeduse and do notpose a biologicalrisk to clinicalsubjects. |
| Connector | Luer connector | NRFitTMconnector | Differentconnector type | Risk reduction toavoidmisconnections. |
Table 8: Filter Needle – Characteristic Comparison
Table 9: Filter Straw – Characteristic Comparison
| Characteristic | Predicate | SubjectDevice | SERationale | Risk Impact |
|---|---|---|---|---|
| Material | PVC straw and apolycarbonate filterhousing with a PBTCorrectInjectconnector. | PVC strawwith an ABSNRFitTMhub/filterhousing | Differentmaterial type | No risk impact –The materialsincorporated in theNRFitTM FilterStraw are suitablefor the devices'intended use and donot pose abiological risk toclinical subjects. |
| Connector | Luer connector | NRFitTMconnector | Differentconnector type | Risk reduction toavoidmisconnections. |
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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 |
|---|---|---|
| FunctionalPerformance | Resistance tooverriding | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications |
| Resistance toseparation fromaxial load | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Resistance toseparation fromunscrewing | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Resistance tooverriding | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Leakage by PressureDecay | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| SubatmosphericPressure | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Verifying Non-interconnectablecharacteristicsphysical force | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Packaging | Package integrity,sterile barrier | ISO 11607, Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barriersystems and packaging systems |
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethyleneoxide - Requirements for development, validation androutine control of a sterilization process for medicaldevices. |
| Biocompatibility | Residuals | ISO 10993-7, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals |
| IntracutaneousReactivity | 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 andreproductive toxicity | ISO 10993-3, Biological evaluation of medical devices -Part 3: Tests for genotoxicity, carcinogenicity, andreproductive toxicity | |
| Leachablesubstances | ISO 10993-17, Biological evaluation of medical devices -Part 17: Establishment of allowable limits for leachablesubstances | |
| Category | Evaluation | Test Criteria |
| Chemicalcharacterization ofmaterials | 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
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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.
§ 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).