(346 days)
CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.
The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.
CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.
CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility).
The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.
The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.
The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.
The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion.
The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. 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 neuraxial or regional anesthetic use.
The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors.
The provided document describes a 510(k) premarket notification for the CADD® Infusion Disposables Portfolio with NRFit™ connectors. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The core change in the subject device is the incorporation of NRFit™ connectors, compliant with ISO 80369-6, for neuraxial applications, intended to reduce misconnection risks.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a summary of non-clinical testing categories, the evaluations performed, and the test criteria. The reported device performance is a general statement that "All testing met pre-established specifications, and successfully demonstrated that the CADD Infusion Disposables Portfolio with NRFit™ connectors performed as intended." Specific quantitative results or direct performance values are not provided in this summary.
| Category | Evaluation | Test Criteria (Acceptance Criteria) | Reported Performance |
|---|---|---|---|
| Functional Performance | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met specifications |
| 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 specifications | |
| 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 specifications | |
| Separation force of fitting assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | Met specifications | |
| Unscrewing torque of fitting assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | Met specifications | |
| Ease of assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | Met specifications | |
| Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met specifications | |
| Air Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | Met specifications | |
| Liquid Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | Met specifications | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met specifications | |
| Subatmospheric Pressure Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met specifications | |
| 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 specifications | |
| 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 specifications |
| 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 specifications |
| Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met specifications | |
| Biocompatibility | Intracutaneous | ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Met specifications |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met specifications | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met specifications | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met specifications | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Met specifications | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances. | Met specifications | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | Met specifications | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | Met specifications | |
| Particulate matter | USP 788. Particulate Matter in Injections | Met specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests. The tests are purely technical/engineering assessments of physical characteristics, sterility, and biocompatibility, not clinical studies involving patient data. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in this context.
3. 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)
This information is not applicable. The studies conducted are non-clinical, laboratory-based tests against established international standards (ISO, ANSI/AAMI, USP). "Ground truth" in the sense of expert medical diagnosis or interpretation is not relevant for these types of engineering and biological safety evaluations. The "ground truth" would be the specifications outlined in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as the tests are non-clinical and do not involve human judgment or adjudication in the way clinical studies requiring ground truth establishment would.
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
A multi-reader, multi-case comparative effectiveness study was not done. This document pertains to the clearance of medical device disposables based on physical properties, materials, and safety, not on the performance of an AI algorithm or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This submission is for physical medical devices (infusion disposables), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests conducted is defined by the specific parameters and acceptance limits set forth in the referenced international standards (e.g., ISO 80369-6, ISO 594-2, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). These are objective, measurable standards for device characteristics such as fluid leakage, separation forces, sterility, and biocompatibility.
8. The sample size for the training set
This information is not applicable. There is no AI component or machine learning model described that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable, as no training set for an AI/ML model is mentioned in the document.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2017
Smiths Medical ASD, Inc. Michael Johnson Sr. Manager, Regulatory Affairs 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K162219
Trade/Device Name: CADD® Infusion Disposables Portfolio with NRFit™ connectors Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA, LHI Dated: June 15, 2017 Received: June 19, 2017
Dear Mr. Michael Johnson:
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. Isting 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.
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tara A. Ryan -S
for
Lori A. Wiggins, MPT, CLT 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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Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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Indications for Use
510(k) Number (if known) K162219
Device Name
CADD® Infusion Disposables Portfolio with NRFit™ connector
Indications for Use (Describe)
CADD Yellow Medication Cassette Reservoirs with NRFit™ connector
CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.
CADD Filling Adapter with male NRFit™ connector and female Luer
The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.
CADD Yellow Extension Sets with NRFit™ connector
CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.
CADD Yellow Administration Sets with NRFit™ connector
CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility).
Male Yellow Cap with NRFit™ connector
The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.
Female Yellow Cap with NRFit™ connector
The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.
CADD Infusion Adapter with male NRFit™ connector and female Luer
The CADD Infusion Adapter with male NRFit™ connector and female to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.
The Intended population is pediatrics and adults.
Type of Use (Select one or both, as applicable)
X 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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1. ADMINISTRATIVE INFORMATION
| 510(k) | K162219 |
|---|---|
| Applicant's Nameand Address | Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442 USA |
| Contact Person | Michael R. JohnsonSr. Regulatory SpecialistPhone: 763-383-3341Fax: 763-383-3679Email: mike.johnson@smiths-medical.com |
| Date | July 15, 2017 |
| Regulation No. | 21 CFR 880.5440 |
| Regulation Name | Intravascular administration set |
| Primary ProductCode | FPA |
| Secondary ProductCode | LHI |
| Trade Name | CADD® Infusion Disposables Portfolio with NRFit™ connectors |
2. REASON FOR SUBMISSION
The purpose of this submission is to make a modification to the currently marketed Smiths Medical CADD Yellow Infusion components which are being updated to include an ISO 80369-6 compliant connector for neuraxial applications.
| Subject Device | Predicate Device | |
|---|---|---|
| Trade Name | CADD Yellow Medication CassetteReservoir with NRFitTM connector | CADD Medication Cassette Reservoir |
| 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 | FPA |
| 510(k) | K162219 | K040636 (100ml), K081156 (250ml) |
| Subject Device | Predicate Device | |
| Trade Name | CADD Filling Adapter with NRFitTMconnector | CorrectInjectTM Safety SystemInfusion Adapter Component: TheInfusion Adapter is a component of theCorrectInject Safety System which canbe considered a transfer device oraccessory to a syringe. |
| Regulation No. | 21 CFR 880.5440 | 21 CFR 868.5140 |
| Regulation Name | Intravascular administration set | Anesthesia Conduction Kit |
| Regulatory Class | II | II |
| Product Code | LHI | CAZ |
| 510(k) | K162219 | K110053 |
| Subject Device | Predicate Device | |
| Trade Name | CADD Infusion Adapter with maleNRFitTM connector and female Luer | CADD Administration Set with FlowStop, Medication cassette reservoirwith flow stop and extension set |
| 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 | FPA |
| 510(k) | K162219 | K040636 |
| Trade Name | CADD Yellow Extension Set withNRFitTM connectors | Pharmacia Deltec, Extension Set withAnti-Siphon Valve |
| 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 | FPA |
| 510(k) | K162219 | K942046 |
| Trade Name | CADD Yellow Extension Set withNRFitTM connectors and Air-Eliminating Filter | Extension Set with Microbore Tubingand Filter |
| 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 | FPA |
| 510(k) | K162219 | K974013 |
| Trade Name | CADD Yellow Administration Setswith NRFitTM connector | CADD Administration Set |
| 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 | FPA |
| 510(k) | K162219 | K040636 |
| Trade Name | Yellow Cap with NRFitTM connector | CADD Medication Cassette Reservoir |
| 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 | FPA |
| 510(k) | K162219 | K040636 |
3. DEVICE INFORMATION
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smiths medical
bringing technology to life
4. DEVICE DESCRIPTION
The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion.
The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. The NRFit™ connectors conform to ISO 80369-6, Small
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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 neuraxial or regional anesthetic use.
The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors. A description of each configuration is provided in the table below.
| Configuration | Description |
|---|---|
| CADD Yellow Medication CassetteReservoirs with NRFit™ connector | Self-contained, proprietary medication cassette reservoirsfor use only with NRFit ™ components for delivery ofregional anesthetics or narcotics, and are designed for usewith CADD pumps. Available in 100ml or 250ml. |
| CADD Filling Adapter with maleNRFit™ connector and female Luer | An accessory used to fill the CADD Medication CassetteReservoirs with NRFit ™ connectors. |
| CADD Infusion Adapter with maleNRFit™ connector and femaleLuer | Used to convert administration sets or extension sets withLuer connectors into permanently dedicated line for use onlywith NRFit ™ connectors. |
| CADD Yellow Extension Sets withNRFit™ connector | Used only with CADD Yellow Medication CassetteReservoirs with NRFit ™ connectors for the delivery ofregional anesthetics or narcotics. Used to extend the distancebetween pump and patient. The extension set is configuredwith or without an air-eliminating filter. |
| CADD Yellow Administration Setswith NRFit™ connector | Dedicated administration set for use only with NRFit ™components for delivery of regional anesthetics or narcotics,and are designed for use with CADD pumps. The YellowAdministration sets are configured with or without an air-eliminating filter. |
| Male Yellow Cap with NRFit™connector/Female Yellow Cap with NRFit™connector | The cap has an NRFit ™ thread design and is soldindividually as an accessory that can be used to cap theMedication Cassette or Administration Set. The cap isavailable as a male yellow cap intended to fit the femaleNRFit ™ side or female yellow cap intended to fit the maleNRFit™ side. |
5. INDICATIONS FOR USE
| Configuration | Indication for Use |
|---|---|
| CADD Yellow Medication CassetteReservoirs with NRFitTM connector | CADD Yellow Medication Cassette Reservoirs with NRFitTM connectors are designed for use only with NRFitTM componentsfor delivery of regional anesthetics or narcotics, and are designedfor use with CADD pumps (see CADD pump Operator's Manualfor compatibility) and CADD Yellow Extension Sets withNRFitTM connectors. |
| CADD Filling Adapter with maleNRFitTM connector and female Luer | CADD Filling Adapter with male NRFitTM connector and femaleLuer is an accessory for use in filling of the CADD MedicationCassette Reservoirs with NRFitTM connector. |
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bringing technology to life
| Configuration | Indication for Use |
|---|---|
| CADD Infusion Adapter with male NRFitTM connector and female Luer | The CADD Infusion Adapter with male NRFitTM connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFitTM connectors. The NRFitTM connector with non-Luer taper is intended for the injection or infusion of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection. |
| CADD Yellow Extension Sets with NRFitTM connector | CADD Yellow Extension Sets with NRFitTM connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFitTM connectors for the delivery of regional anesthetics or narcotics. |
| CADD Yellow Administration Sets with NRFitTM connector | CADD Yellow Administration Sets with NRFitTM connectors are designed for use only with NRFitTM components for delivery of regional anesthetics or narcotics, and are designed for use with CADD® pumps (see CADD pump Operator's Manual for compatibility). |
| Male Yellow Cap with NRFitTM connector/Female Yellow Cap with NRFitTM connector | The Male Yellow Cap with NRFitTM connector is intended for use as an accessory with the CADD Yellow Medication Reservoirs.The Female Yellow Cap with NRFitTM connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFitTM connectors and the CADD Yellow Administration sets with NRFitTM connector. |
6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The Smiths Medical CADD Infusion Disposables Portfolio with NRFit™ connectors have the same technological characteristics as the predicate devices with the exception of the NRFit ™ Connectors.
The Smiths Medical CADD Infusion Disposables Portfolio with NRFit™ connectors and predicate devices are both designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or 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.
A comparative analysis is provided in the following Tables;
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The CADD MedicationCassette Reservoir withFlow Stop is designed foruse with the CADD pumps(except CADD-Micro andCADD-TPN) for deliveryof medications and fluids.The CADD administrationSet with Flow Stop isdesigned for use with theCADD pumps (exceptCADD-Micro and CADD-TPN) for delivery ofmedications and fluids. | CADD Yellow MedicationCassette Reservoirs withNRFitTM connectors aredesigned for use only withNRFitTM components fordelivery of regionalanesthetics or narcotics,and are designed for usewith CADD pumps (seeCADD pump Operator'sManual for compatibility)and CADD YellowExtension Sets withNRFitTM connectors. | Similar |
| Extension SetLength | 8 inches | Same | N/A |
| Priming Volume | 0.2 mL | Same | N/A |
Table 1: CADD Yellow Medication Cassette Reservoir, 100mL with NRFit™ connector
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bringing technology to life
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion | |
|---|---|---|---|---|
| Connector | ISO 594 Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™ connector intended to reduce risk of misconnections. | |
| Materials | Female Connector;Polyvinyl chloride (PVC) | Female Connector;Polycarbonate | Subject device materials meet functional and biocompatibility requirements. Yellow indicates neuraxial or regional anesthetic application. | |
| Male Connector;Polypropylene | Male Connector;Polybutylene terephthalate (PBT) | |||
| Housing;Polypropylene | Housing;Polypropylene | |||
| Packaging | Tyvek Pouch | Same | N/A | |
| Sterility | Sterile, EO | Same | N/A | |
| Use | Single Use Disposable | Same | N/A |
Table 2: CADD Yellow Medication Cassette Reservoir, 250mL with NRFit™ connector
| Characteristic | Predicate (K081156) | Subject (K162219) | Discussion | |||
|---|---|---|---|---|---|---|
| Indication forUse | The CADD MedicationCassette reservoirs areintended for the delivery ofmedications and fluids forsubcutaneous,intramuscular, intravenous,intra-arterial,intraperitoneal, orintraspinal infusion. | CADD Yellow MedicationCassette Reservoirs withNRFitTM connectors aredesigned for use only withNRFitTM components fordelivery of regionalanesthetics or narcotics,and are designed for usewith CADD pumps (seeCADD pump Operator'sManual for compatibility)and CADD YellowExtension Sets withNRFitTM connectors. | Similar | |||
| Extension SetLength | 8 inches | Same | N/A | |||
| Priming Volume | 0.2 mL | Same | N/A | |||
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections | |||
| Materials | Female Connector;Polyvinyl chloride (PVC) | Female Connector;Polycarbonate | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. | |||
| Male Connector;Polypropylene | Male Connector;Polybutylene terephthalate(PBT) | |||||
| Housing;Polypropylene | Housing;Polypropylene | |||||
| Packaging | Tyvek Pouch | Same | N/A | |||
| Sterility | Sterile, EO | Same | N/A | |||
| Use | Single Use Disposable | Same | N/A |
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bringing technology to life
| Characteristic | Predicate (K110053) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The CorrectInjectTM SafetySystem is intended for theinjection of local orregional anesthetics,narcotics or othermedications indicated forneuraxial injection. Thesystem consists ofcomponents that have aunique non-Luer taper thatallows connection ofcompatible CorrectInjectTMcomponents that, whenused together as a system,help reduce the risk of mis-connection that may resultin the injection ofmedications not intendedfor neuraxial use. | CADD Filling Adapterwith male NRFit TMconnector and female Lueris an accessory for use infilling of the CADDMedication CassetteReservoirs with NRFit TMconnector. | Similar. The predicateInfusion Adapter is acomponent of theCorrectInject SafetySystem which can beconsidered a transferdevice or accessory to asyringe. The subjectFilling Adapter is anaccessory used to fill theCADD Medical CassetteReservoir and isconsidered a transferdevice. |
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections. |
| Materials | Polybutylene terephthalate(PBT) | Polycarbonate - BayerPolycarbonate Makrolon;Acrylonitrile butadienestyrene (ABS) – TerluxColorant: Orange, Clariantand Clariant | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. |
| Packaging | Tyvek Pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
Table 3: CADD Filling Adapter with male NRFit ™ connector and female Luer
Table 4: CADD Infusion Adapter with male NRFit ™ connector and female Luer
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The CADD MedicationCassette Reservoir withFlow Stop is designed foruse with the CADD pumps(except CADD-Micro andCADD-TPN) for deliveryof medications and fluids.The CADD administrationSet with Flow Stop isdesigned for use with theCADD pumps (exceptCADD-Micro and CADD-TPN) for delivery ofmedications and fluids. | The CADD InfusionAdapter with male NRFitTMconnector and female Lueris intended to be used byclinicians to convertadministration sets withLuer connectors intopermanently dedicated linesfor use only with NRFitTMconnectors. The NRFitTMconnector with non-Luertaper is intended for theinjection or infusion ofregional anesthetics ornarcotics and may helpreduce the risk ofmisconnection ormisinjection. | Similar |
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| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM connector intended to reduce risk of misconnections. |
| Materials | Polybutylene terephthalate (PBT) | Polybutylene Terephthalate (PBT)Arnite;PolypropylenePolycarbonate (PC) | Subject device materials meet functional and biocompatibility requirements. Yellow indicates neuraxial or regional anesthetic application. |
| Packaging | Tyvek Pouch | Form Fill Seal | Form Fill Seal packaging is an appropriate alternative to the pouch packaging configuration. |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
Table 5: CADD Yellow Extension Set with NRFit ™ connectors
| Characteristic | Predicate (K942046) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The Extension Set withAnti-Siphon Valve is anaccessory for use withadministration sets that areused in conjunction withelectromechanical infusionpumps that do not haveanti-siphon valves. It isintended to protect againstunregulated gravityinfusion ("free-flow") fromimproperly attachedadministration sets. | CADD Yellow ExtensionSets with NRFit ™connectors are designed foruse only with CADDYellow MedicationCassette Reservoirs withNRFit ™ connectors for thedelivery of regionalanesthetics or narcotics. | Similar |
| Set Length | 90 inches | Same | N/A |
| Priming Volume | 2.4 mL | Same | N/A |
| Connector | ISO 594 Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit ™connector intended toreduce risk ofmisconnections. |
| Materials | Connectors;PolycarbonateAnti-Siphon Valve;Silicone-Elastosil | Connectors;PolycarbonateAnti-Siphon Valve;Silicone-Elastosil | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. |
| Packaging | Tyvek Pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
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| Characteristic | Predicate (K974013) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication for Use | The Extension Set with microbore tubing attachesto the Micro Medication Reservoir for use with theCADD-Micropump. The Extension Set with Anti-Siphon Valve must be used with the MedicationCassette reservoir to protect against unregulated gravityinfusion that can result from an improperlyattached reservoir. | CADD Yellow ExtensionSets with NRFitTMconnectors are designed foruse only with CADDYellow MedicationCassette Reservoirs withNRFitTM connectors for thedelivery of regionalanesthetics or narcotics. | Similar |
| Set Length | 90 inches | Same | N/A |
| Priming Volume | 2.4 mL | Same | N/A |
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections. |
| Materials | Female Connector;Polyvinyl chloride (PVC)Male Connector;Acrylonitrile butadienestyrene (ABS)Housing and Valve;Polycarbonate, ValveMembrane; Elastosil | Female Connector;PolycarbonateMale Connector;Acrylonitrile butadienestyrene (ABS)Housing and Valve;Polycarbonate,Valve Membrane; Elastosil | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. |
| Packaging | Tyvek Pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
Table 6: CADD Yellow Extension Set with NRFit ™ connectors and Air-Eliminating Filter
Table 7: CADD Yellow Administration Sets
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion | |
|---|---|---|---|---|
| Indication forUse | The CADD MedicationCassette Reservoir withFlow Stop is designed foruse with the CADD pumps(except CADD-Micro andCADD-TPN) for deliveryof medications and fluids.The CADD administrationSet with Flow Stop isdesigned for use with theCADD pumps (exceptCADD-Micro and CADD-TPN) for delivery ofmedications and fluids. | CADD YellowAdministration Sets withNRFitTM connectors aredesigned for use only withNRFitTM components fordelivery of regionalanesthetics or narcotics,and are designed for usewith CADD pumps (seeCADD pump Operator'sManual for compatibility). | Similar | |
| Set Length(nominal) | 123 – 130 inches | Same | N/A | |
| Priming Volume | 3.2 - 6.2 mL | Same | N/A |
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| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Flow Type | Flowstop | Same | N/A |
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM connector intended to reduce risk of misconnections. |
| Materials | Bag Spike; Acrylonitrile butadiene styreneValve; Siloprene, Housing; Polycarbonate | Bag Spike; Acrylonitrile butadiene styreneValve; Siloprene, Housing; Polycarbonate | Subject device materials meet functional and biocompatibility requirements. Yellow indicates neuraxial or regional anesthetic application. |
| Packaging | Tyvek Pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
Table 8: Male Yellow Cap with NRFit ™ connector
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The CADD MedicationCassette Reservoir withFlow Stop is designed foruse with the CADD pumps(except CADD-Micro andCADD-TPN) for deliveryof medications and fluids.The CADD administrationSet with Flow Stop isdesigned for use with theCADD pumps (exceptCADD-Micro and CADD-TPN) for delivery ofmedications and fluids. | The Male Yellow Cap withNRFitTM connector isintended for use as anaccessory with the CADDYellow MedicationCassette reservoirs. | Similar. The Cap is partof the CADD MedicationCassette Reservoirsystem. |
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections. |
| Materials | Polybutylene Terephthalate | Polybutylene Terephthalate | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. |
| Packaging | Form Fill Seal | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
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Table 9: Female Yellow Cap with NRFit ™ connector
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication forUse | The CADD MedicationCassette Reservoir withFlow Stop is designed foruse with the CADD pumps(except CADD-Micro andCADD-TPN) for deliveryof medications and fluids.The CADD administrationSet with Flow Stop isdesigned for use with theCADD pumps (exceptCADD-Micro and CADD-TPN) for delivery ofmedications and fluids. | The Female Yellow Capwith NRFitTM connector isintended for use as anaccessory with the CADDYellow Extension Sets withNRFitTM connectors andthe CADD YellowAdministration sets withNRFitTM connector. | Similar. The Cap is partof the CADD Extensionset and Administrationsets. |
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections. |
| Materials | Acrylonitrile ButadieneStyrene | Polybutylene Terephthalate | Subject device materialsmeet functional andbiocompatibilityrequirements. Yellowindicates neuraxial orregional anestheticapplication. |
| Packaging | Form Fill Seal | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
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7. SUMMARY OF NON-CLINICAL TESTING
The CADD Infusion Disposables Portfolio with NRFit ™ connectors were evaluated via non-clinical 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 CADD Infusion Disposables Portfolio with NRFit ™ connectors performed as intended. A summary of the evaluation is provided below.
| 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 | |
| Separation force offitting assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment -Part 2: Lock Fittings | |
| Unscrewing torqueof fitting assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment -Part 2: Lock Fittings | |
| Ease of assembly | ISO 594-2, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment -Part 2: Lock Fittings | |
| Resistance tooverriding | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| Air Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment -Part 2: Lock Fittings | |
| Liquid Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment -Part 2: Lock Fittings | |
| Leakage by PressureDecay | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| SubatmosphericPressureStress 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. |
| Residuals | ISO 10993-7, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals | |
| Biocompatibility | Intracutaneous | ISO 10993-10, Biological evaluation of medical devices |
| Category | Evaluation | Test Criteria |
| Toxicity | 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. | |
| 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 |
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8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of the Smiths Medical CADD® Infusion Disposables Portfolio with NRFit™ connectors device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices in regards to safety and effectiveness. Device testing met pre-defined acceptance criteria and did not raise new question of safety or 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.