(261 days)
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).
The intended population is pediatrics and adults.
The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.
All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.
The provided text describes a 510(k) premarket notification for a medical device called the "CADD® Yellow High Volume Administration Set with NRFit™ connector." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way one might evaluate a diagnostic or AI-driven device.
Therefore, the requested information points, particularly those pertaining to acceptance criteria and studies specifically designed to prove device performance in a comparative effectiveness or standalone clinical context with human interaction or disease detection, are not directly addressed in this type of regulatory submission. This submission primarily focuses on bench testing and biocompatibility to show that the new device, with its modified connector, is as safe and effective as the previously approved device.
However, I can extract information related to the non-clinical testing performed and the standards met, which serve as the "acceptance criteria" for this type of device modification.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (an administration set), the "acceptance criteria" are defined by compliance with recognized international standards for medical device safety, biocompatibility, and connector functionality, as well as pre-established internal specifications for certain tests. The "reported device performance" is that all testing met these pre-established specifications.
| Category | Specific Test / Criterion | Reported Device Performance (Met Acceptance Criteria) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Met pre-established specifications |
| Sensitization (ISO 10993-10) | Met pre-established specifications | |
| Intracutaneous Reactivity (Irritation) (ISO 10993-10) | Met pre-established specifications | |
| Acute Systemic Toxicity (ISO 10993-11) | Met pre-established specifications | |
| Pyrogenicity (bacterial-mediated & material-mediated) | Met pre-established specifications | |
| Hemocompatibility (ISO 10993-4) | Met pre-established specifications | |
| Subchronic Toxicity (ISO 10993-11) | Met pre-established specifications | |
| Genotoxicity (ISO 10993-3) | Met pre-established specifications | |
| Extractables and Leachables (ISO 10993-17, ISO 10993-18) | Met pre-established specifications | |
| Toxicological Risk Assessment (ISO 10993-1) | Met pre-established specifications | |
| Particulates | Met pre-established specifications | |
| Ethylene Oxide Residuals (ISO 10993-7) | Met pre-established specifications | |
| Packaging | Sterile Barrier Integrity | Met pre-established specifications |
| Seal Strength | Met pre-established specifications | |
| Packaging Stability | Met pre-established specifications | |
| Distribution Simulation | Met pre-established specifications | |
| Device Performance | Connector compatibility and incompatibility (ISO 80369-1, -6) | Met pre-established specifications |
| Dimensional Testing | Met pre-established specifications | |
| Leakage | Met pre-established specifications | |
| Mechanical Requirements (resistance to cracking, tensile strength, over-riding threads, torque) | Met pre-established specifications |
The core "acceptance criterion" for the primary modification (the NRFit™ connector) is its compliance with ISO 80369-6:2016 (Small bore connectors for liquids and gases in healthcare Applications - Part 6: Connectors for Neuraxial Applications) and its intentional incompatibility with standard Luer connectors (addressed by adherence to ISO 80369-1:2010 for general requirements). The reported performance is that the device conforms to these standards and the connectors are not compatible with standard luer connectors, achieving the risk mitigation objective.
The remaining information requested is largely not applicable or not explicitly stated for this type of 510(k) submission, which evaluates a physical administration set largely through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies involving patient outcomes, diagnostic accuracy, or human reader performance.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided in the document. The testing described is primarily non-clinical (bench and lab testing for physical properties and biocompatibility). Sample sizes for these types of tests are typically determined by relevant ISO standards or internal quality procedures and are not usually detailed in this summary document. Data provenance is not specified for these lab tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a physical administration set, not a diagnostic tool requiring expert interpretation for ground truth establishment. Engineering and lab technicians perform the non-clinical tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies, particularly those involving human reviewers of data like medical images. This document describes non-clinical testing.
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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 device is a medical administration set, not an AI-driven diagnostic or assistive technology for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established by the international standards (e.g., ISO 80369-6 for connector dimensions and functionality, ISO 10993 series for biocompatibility) and internal engineering specifications. There is no expert consensus or pathology involved in this context.
-
The sample size for the training set
- Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set."
-
How the ground truth for the training set was established
- Not applicable. As above, no training set.
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Image /page/0/Picture/0 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.
May 17, 2018
Smiths Medical ASD, Inc. Sunny Teekasingh Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K172592
Trade/Device Name: CADD Yellow High Volume Administration Set with NRFit connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: PWH Dated: April 18, 2018 Received: April 19, 2018
Dear Sunny Teekasingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172592
Device Name
CADD® Yellow High Volume Administration Set with NRFit™ connector
Indications for Use (Describe)
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).
The intended population is pediatrics and adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. ADMINISTRATIVE INFORMATION
| 510(k) | K172592 |
|---|---|
| Applicant's Nameand Address | Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442 USA |
| Contact Person | Sunny TeekasinghPrincipal Regulatory Affairs SpecialistPhone: 763-383-3336Fax: 763-383-3679Email: Sunny.Teekasingh@smiths-medical.com |
| Date | May 10, 2018 |
| Regulation No.Regulation Name | 21 CFR § 880.5440Intravascular Administration Set |
| Primary ProductCodes | PWH |
| Trade Name | CADD® Yellow High Volume Administration Set with NRFit™ connector |
2. REASON FOR SUBMISSION
The purpose of this submission is to make a modification to the currently marketed Smiths Medical CADD® High Volume Administration Sets which are being updated to include an ISO 80369-6 compliant connector for regional anesthetic applications.
3. DEVICE INFORMATION
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | CADD® High VolumeAdministration Set with Flow Stop | CADD® Yellow High VolumeAdministration Set with NRFitTMconnector |
| Regulation No. | 21 CFR § 880.5440 | 21 CFR § 880.5440 |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set |
| Regulatory Class | II | II |
| Product Code | FPA | PWH |
| 510(k) | K031361 | K172592 |
4. DEVICE DESCRIPTION
The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™
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connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.
All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.
5. INDICATIONS FOR USE
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors are intended for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid / spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility). The intended population is pediatrics and adults.
6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors have the same technological characteristics as the predicate devices with the exception of the NRFit™ Connectors.
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors and predicate devices are both designed to deliver local or regional anesthetics or narcotics, indicated for regional anesthetic infusion applications. They are both made of the same materials, have the same chemical composition, and have the same design features excluding the NRFit™ connector design.
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors utilize connectors that comply with ISO 80369-6. These connectors are intentionally designed to be incompatible with Luer tapers such as those found on the predicate devices to mitigate the risks associated with connecting infusion lines to the incorrect infusion pump. The predicate devices utilize standard Luer connectors that comply with ISO 594, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment." A side-by-side characteristic analysis of Predicate and Subject Device is provided in Table 1.
| Characteristic | Subject DeviceK172592 | Predicate DeviceK031361 | Discussion |
|---|---|---|---|
| Indications | CADD® Yellow HighVolumeAdministration Setwith NRFit™connectors areintended for use onlywith NRFit™components fordelivery of regionalanesthetics ornarcotics, excludingsubarachnoid / spinal | CADD® High-VolumeAdministration Setsis designed for usewith the CADD-Prism® pump toallow fluid deliveryfrom an IV bag. | Both used with CADDpump. |
| Characteristic | Subject DeviceK172592 | Predicate DeviceK031361 | Discussion |
| block, and aredesigned for use withCADD® pumps (seeCADD® pumpOperator's Manual forcompatibility). Theintended population ispediatrics and adults. | |||
| Sterility Method | EO | EO | Same |
| Single use | Yes | Yes | Same |
| Disposable | Yes | Yes | Same |
| Prescription | Yes | Yes | Same |
| Connections | ISO 80369-6compliant NRFit™non-Luer connectors | ISO 594 Luertapers | The NRFit™ connectorprovides the sameclinical function (i.e.,secure, non-leakingconnection), butincorporates the ISO80369-6 connectordesign to mitigate therisk of misconnections. |
| Model: CADD® HighVolumeAdministration Sets(with Air-EliminatingFilter and Flow StopFree-Flow Protection) | 21-7685-24 | 21-7385-24 | N/A |
| Model: CADD® HighVolumeAdministration Sets(with Flow Stop Free-Flow Protection) | 21-7684-24 | 21-7384-24 | N/A |
| Nominal Set Length | 130 inches | 130 inches | Same |
| Priming Volume forCADD® HighVolumeAdministration Sets(with Flow Stop Free-Flow Protection) | 16 mL | 16 mL | Same |
| Priming Volume forCADD® HighVolumeAdministration Sets(with Air-EliminatingFilter and Flow StopFree-Flow Protection) | 23 mL | 23 mL | Same |
| 0.2 micron filter, forCADD® High | 0.2 micron filter | 0.2 micron filter | Same |
| Characteristic | Subject DeviceK172592 | Predicate DeviceK031361 | Discussion |
| VolumeAdministration Sets(with Air-EliminatingFilter and Flow StopFree-Flow Protection) | |||
| PVC TubingPlasticized withTOTM | Yes | Yes | Same |
| Bag Spike | Yes | Yes | Same |
| Dimensions - BagSpike | Same | Same | Same |
| Materials - Bag Spike | Acrylonitrilebutadiene styrene(ABS) - ABS - HI121H-NaturalGranule 9700640000Colorant: Yellow | Acrylonitrilebutadiene styrene(ABS) - ABS WhiteGranule9700670300Colorant: White | Proposed materials arecolor-coded yellow toindicate medicationintended for regionalanesthetic delivery. |
| Male Taper with One-Way Checkvalve | Male NRFit™connector | Male ISO 594 Luer | The NRFit™ connectorprovides the sameclinical function (i.e.,secure, non-leakingconnection), butincorporates the ISO80369-6 connectordesign to mitigate therisk of misconnections. |
| Materials - One-WayCheckvalve, ValveMembrane | Silicone – SilopreneLSR-4040Colorant: None | Silicone– SilopreneLSR-4040Colorant: None | Same |
| Materials - One-WayCheckvalve, MaleTaper Outlet Housing | Polycarbonate -Makrolon RX-1805GColorant: Yellow,ClariantNC1M664867 | Polycarbonate -Makrolon RX-1805GColorant: PurpleTint | Proposed materials arecolor-coded yellow toindicate medicationintended for regionalanesthetic delivery. |
| Materials - One-WayCheckvalve, FemaleLuer Lock InletHousing | Polycarbonate -Makrolon RX-1805-013771Colorant: White | Polycarbonate -Makrolon RX-1805-013771Colorant: White | Same |
| Flow Stop | Yes | Yes | Same |
| Packaging | Pouch | Pouch | Same |
Table 1: Comparative Analysis of Subject and Predicate Devices by Characteristic
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510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
Image /page/5/Picture/1 description: The image shows the logo for Smiths Medical. The text "smiths medical" is written in a sans-serif font. The word "smiths" is in a darker blue color, while the word "medical" is in a lighter blue color.
bringing technology to life
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510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
smiths medical
bringing technology to life
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7. SUMMARY OF NON-CLINICAL TESTING
The CADD® Yellow High Volume Administration Set with NRFit™ connector was evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and performs as well as the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the CADD® Yellow High Volume Administration Set with NRFit™ connector device performed as intended. A summary of the testing is provided in Table 2.
| Category | Testing |
|---|---|
| Biocompatibility | Cytotoxicity |
| Sensitization | |
| Intracutaneous Reactivity (Irritation) | |
| Acute Systemic Toxicity | |
| Pyrogenicity (bacterial-mediated & material-mediated) | |
| Hemocompatibility | |
| Subchronic Toxicity | |
| Genotoxicity | |
| Extractables and Leachables | |
| Toxicological Risk Assessment | |
| Particulates | |
| Ethylene Oxide Residuals | |
| Packaging | Sterile Barrier Integrity |
| Seal Strength | |
| Packaging Stability | |
| Distribution Simulation | |
| Device Performance | Connector compatibility and incompatibility |
| Dimensional Testing | |
| Leakage | |
| Mechanical Requirements (resistance to cracking, tensile strength, | |
| over-riding threads, torque) |
Table 2: Testing Type by Category
Biocompatibility and Bench testing was conducted to the Standards in Table 3:
Table 3: Testing Type by Standard Reference Number and Date
| StandardsDevelopmentOrganization | ReferenceNumber and Date | Title |
|---|---|---|
| ISO | 80369-1:2010 | Small-bore connectors for liquids and gases inhealthcare applications - Part 1: Generalrequirements |
| ISO | 80369-6:2016 | Small bore connectors for liquids and gases inhealthcare Applications - Part 6: Connectors forNeuraxial Applications |
| ISO | 10993-1:2009 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
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510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
| ISO | 10993-3:2014 | Biological evaluation of medical devices - Part 3:Tests for genotoxicity, carcinogenicity andreproductive toxicity |
|---|---|---|
| ISO | 10993-4:2017 | Biological evaluation of medical devices - Part 4:Selection of tests for interactions with blood |
| ISO | 10993-5:2009 | Biological evaluation of medical devices - Part 5:Testsfor in vitro cytotoxicity |
| ISO | 10993-7:2008 | Biological evaluation of medical devices - Part 7:Ethylene oxide sterilization residuals |
| ISO | 10993-10:2010 | ISO 10993-10 Biological evaluation of medicaldevices - Part 10: Tests for irritation and sensitization |
| ISO | 10993-11:2006 | Biological evaluation of medical devices - Part 11:Tests for systemic toxicity |
| ISO | 10993-12:2012 | Biological evaluation of medical devices - Part 12:Sample preparation and reference materials |
| ISO | 10993-17:2002(R)2012 | Biological evaluation of medical devices - Part 17:Establishment of allowable limits for leachablesubstances |
| ISO | 10993-18:2005 | Biological evaluation of medical devices - Part 18:Chemical characterization of materials |
8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of the Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connector device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices in regards to safety and effectiveness.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.