(346 days)
Not Found
No
The summary describes infusion devices and accessories with specific connectors designed for safety and compatibility, with no mention of AI or ML capabilities.
Yes.
The device is intended to deliver local or regional anesthetics or narcotics for neuraxial or regional anesthetic infusion applications, which are therapeutic interventions.
No
These devices are designed for the delivery of regional anesthetics or narcotics, functioning as infusion devices and accessories, not for diagnosing conditions.
No
The device description and intended use clearly describe physical components such as medication cassette reservoirs, extension sets, administration sets, and caps, all with specific physical connectors (NRFit™). There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of regional anesthetics or narcotics for neuraxial or regional anesthetic infusion applications. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description focuses on the mechanical components for delivering medication (pumps, reservoirs, sets, connectors). It does not mention any components or processes for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis of biological samples," "in vitro," etc.
- Anatomical Site: The anatomical site is related to the delivery of medication to specific areas of the body for pain management or anesthesia, not for obtaining or analyzing samples for diagnosis.
In summary, the device is designed for administering medication, which is a therapeutic function, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA, LHI
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 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.
CADD Yellow Medication Cassette Reservoirs with NRFit™ connector: Self-contained, proprietary medication cassette reservoirs for use only with NRFit ™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps. Available in 100ml or 250ml.
CADD Filling Adapter with male NRFit™ connector and female Luer: An accessory used to fill the CADD Medication Cassette Reservoirs with NRFit ™ connectors.
CADD Infusion Adapter with male NRFit™ connector and female Luer: Used to convert administration sets or extension sets with Luer connectors into permanently dedicated line for use only with NRFit ™ connectors.
CADD Yellow Extension Sets with NRFit™ connector: Used only with CADD Yellow Medication Cassette Reservoirs with NRFit ™ connectors for the delivery of regional anesthetics or narcotics. Used to extend the distance between pump and patient. The extension set is configured with or without an air-eliminating filter.
CADD Yellow Administration Sets with 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 Yellow Administration 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 sold individually as an accessory that can be used to cap the Medication Cassette or Administration Set. The cap is available as a male yellow cap intended to fit the female NRFit ™ side or female yellow cap intended to fit the male NRFit™ side.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuraxial or regional anesthetic infusion applications
Indicated Patient Age Range
The Intended population is pediatrics and adults.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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. Summary of evaluation provided for:
Functional Performance: Resistance to overriding, Resistance to separation from axial load, Resistance to separation from unscrewing, Separation force of fitting assembly, Unscrewing torque of fitting assembly, Ease of assembly, Air Leakage, Liquid Leakage, Leakage by Pressure Decay, Subatmospheric Pressure Stress Cracking, Verifying Non-interconnectable characteristics physical force. All aligned with ISO standards.
Packaging: Package integrity, sterile barrier, aligned with ISO 11607.
Sterilization: Sterility, Residuals, aligned with ISO 11135 and ISO 10993-7.
Biocompatibility: Intracutaneous, Toxicity, Systemic Toxicity, Sensitization, Cytotoxicity, Genotoxicity, carcinogenicity and reproductive toxicity, Leachable substances, Chemical characterization of materials, Bacterial endotoxins, Particulate matter. All aligned with ISO 10993 standards, ANSI/AAMI ST72, and USP 788.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K040636, K081156, K110053, K942046, K974013
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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.
3
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.
4
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.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
1. ADMINISTRATIVE INFORMATION
| 510(k) | K162219 |
|---|---|
| Applicant's Name | |
| and Address | Smiths Medical ASD, Inc. |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 USA | |
| Contact Person | Michael R. Johnson |
| Sr. Regulatory Specialist | |
| Phone: 763-383-3341 | |
| Fax: 763-383-3679 | |
| Email: mike.johnson@smiths-medical.com | |
| Date | July 15, 2017 |
| Regulation No. | 21 CFR 880.5440 |
| Regulation Name | Intravascular administration set |
| Primary Product | |
| Code | FPA |
| Secondary Product | |
| Code | 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 Cassette | |
| Reservoir 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 NRFitTM | |
| connector | CorrectInjectTM Safety System | |
| Infusion Adapter Component: The | ||
| Infusion Adapter is a component of the | ||
| CorrectInject Safety System which can | ||
| be considered a transfer device or | ||
| accessory 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 male | |
| NRFitTM connector and female Luer | CADD Administration Set with Flow | |
| Stop, Medication cassette reservoir | ||
| with 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 with | |
| NRFitTM connectors | Pharmacia Deltec, Extension Set with | |
| Anti-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 with | |
| NRFitTM connectors and Air- | ||
| Eliminating Filter | Extension Set with Microbore Tubing | |
| and 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 Sets | |
| with 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
6
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
7
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 Cassette | |
| Reservoirs with NRFit™ connector | Self-contained, proprietary medication cassette reservoirs |
| for use only with NRFit ™ components for delivery of | |
| regional anesthetics or narcotics, and are designed for use | |
| with CADD pumps. Available in 100ml or 250ml. | |
| CADD Filling Adapter with male | |
| NRFit™ connector and female Luer | An accessory used to fill the CADD Medication Cassette |
| Reservoirs with NRFit ™ connectors. | |
| CADD Infusion Adapter with male | |
| NRFit™ connector and female | |
| Luer | Used to convert administration sets or extension sets with |
| Luer connectors into permanently dedicated line for use only | |
| with NRFit ™ connectors. | |
| CADD Yellow Extension Sets with | |
| NRFit™ connector | Used only with CADD Yellow Medication Cassette |
| Reservoirs with NRFit ™ connectors for the delivery of | |
| regional anesthetics or narcotics. Used to extend the distance | |
| between pump and patient. The extension set is configured | |
| with or without an air-eliminating filter. | |
| CADD Yellow Administration Sets | |
| with 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 Yellow | |
| Administration 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 sold |
| individually as an accessory that can be used to cap the | |
| Medication Cassette or Administration Set. The cap is | |
| available as a male yellow cap intended to fit the female | |
| NRFit ™ side or female yellow cap intended to fit the male | |
| NRFit™ side. |
5. INDICATIONS FOR USE
| Configuration | Indication for Use |
|---|---|
| CADD Yellow Medication Cassette | |
| Reservoirs with NRFitTM connector | CADD Yellow Medication Cassette Reservoirs 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) and CADD Yellow Extension Sets with | |
| NRFitTM connectors. | |
| CADD Filling Adapter with male | |
| NRFitTM connector and female Luer | CADD Filling Adapter with male NRFitTM connector and female |
| Luer is an accessory for use in filling of the CADD Medication | |
| Cassette Reservoirs with NRFitTM connector. |
8
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 for | |||
| Use | The CADD Medication | ||
| Cassette Reservoir with | |||
| Flow Stop is designed for | |||
| use with the CADD pumps | |||
| (except CADD-Micro and | |||
| CADD-TPN) for delivery | |||
| of medications and fluids. | |||
| The CADD administration | |||
| Set with Flow Stop is | |||
| designed for use with the | |||
| CADD pumps (except | |||
| CADD-Micro and CADD- | |||
| TPN) for delivery of | |||
| medications and fluids. | CADD Yellow Medication | ||
| Cassette Reservoirs 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) | |||
| and CADD Yellow | |||
| Extension Sets with | |||
| NRFitTM connectors. | Similar | ||
| Extension Set | |||
| Length | 8 inches | Same | N/A |
| Priming Volume | 0.2 mL | Same | N/A |
Table 1: CADD Yellow Medication Cassette Reservoir, 100mL with NRFit™ connector
9
smiths medical
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 for | ||||||
| Use | The CADD Medication | |||||
| Cassette reservoirs are | ||||||
| intended for the delivery of | ||||||
| medications and fluids for | ||||||
| subcutaneous, | ||||||
| intramuscular, intravenous, | ||||||
| intra-arterial, | ||||||
| intraperitoneal, or | ||||||
| intraspinal infusion. | CADD Yellow Medication | |||||
| Cassette Reservoirs 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) | ||||||
| and CADD Yellow | ||||||
| Extension Sets with | ||||||
| NRFitTM connectors. | Similar | |||||
| Extension Set | ||||||
| Length | 8 inches | Same | N/A | |||
| Priming Volume | 0.2 mL | Same | N/A | |||
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM | |||
| 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 |
10
al
bringing technology to life
| Characteristic | Predicate (K110053) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication for | |||
| Use | The CorrectInjectTM Safety | ||
| System is intended for the | |||
| injection of local or | |||
| regional anesthetics, | |||
| narcotics or other | |||
| medications indicated for | |||
| neuraxial injection. The | |||
| system consists of | |||
| components that have a | |||
| unique non-Luer taper that | |||
| allows connection of | |||
| compatible CorrectInjectTM | |||
| components that, when | |||
| used together as a system, | |||
| help reduce the risk of mis- | |||
| connection that may result | |||
| in the injection of | |||
| medications not intended | |||
| for neuraxial use. | CADD Filling Adapter | ||
| with male NRFit TM | |||
| connector and female Luer | |||
| is an accessory for use in | |||
| filling of the CADD | |||
| Medication Cassette | |||
| Reservoirs with NRFit TM | |||
| connector. | Similar. The predicate | ||
| Infusion Adapter is a | |||
| component of the | |||
| CorrectInject Safety | |||
| System which can be | |||
| considered a transfer | |||
| device or accessory to a | |||
| syringe. The subject | |||
| Filling Adapter is an | |||
| accessory used to fill the | |||
| CADD Medical Cassette | |||
| Reservoir and is | |||
| considered a transfer | |||
| device. | |||
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM |
| connector intended to | |||
| reduce risk of | |||
| misconnections. | |||
| Materials | Polybutylene terephthalate | ||
| (PBT) | Polycarbonate - Bayer | ||
| Polycarbonate Makrolon; | |||
| Acrylonitrile butadiene | |||
| styrene (ABS) – Terlux | |||
| Colorant: Orange, Clariant | |||
| and Clariant | 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 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 for | |||
| Use | The CADD Medication | ||
| Cassette Reservoir with | |||
| Flow Stop is designed for | |||
| use with the CADD pumps | |||
| (except CADD-Micro and | |||
| CADD-TPN) for delivery | |||
| of medications and fluids. | |||
| The CADD administration | |||
| Set with Flow Stop is | |||
| designed for use with the | |||
| CADD pumps (except | |||
| CADD-Micro and CADD- | |||
| TPN) for delivery of | |||
| medications and fluids. | 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 | |||
| misconnection or | |||
| misinjection. | Similar |
11
smiths medical
bringing technology to life
| 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; | |||
| Polypropylene | |||
| Polycarbonate (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 for | |||
| Use | The Extension Set with | ||
| Anti-Siphon Valve is an | |||
| accessory for use with | |||
| administration sets that are | |||
| used in conjunction with | |||
| electromechanical infusion | |||
| pumps that do not have | |||
| anti-siphon valves. It is | |||
| intended to protect against | |||
| unregulated gravity | |||
| infusion ("free-flow") from | |||
| improperly attached | |||
| administration sets. | 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. | 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 to | |||
| reduce risk of | |||
| misconnections. | |||
| Materials | Connectors; | ||
| Polycarbonate | |||
| Anti-Siphon Valve; | |||
| Silicone-Elastosil | Connectors; | ||
| Polycarbonate | |||
| Anti-Siphon Valve; | |||
| Silicone-Elastosil | 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 |
12
| Characteristic | Predicate (K974013) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication for Use | The Extension Set with microbore tubing attaches | ||
| to the Micro Medication Reservoir for use with the | |||
| CADD-Micropump. The Extension Set with Anti- | |||
| Siphon Valve must be used with the Medication | |||
| Cassette reservoir to protect against unregulated gravity | |||
| infusion that can result from an improperly | |||
| attached reservoir. | 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. | 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 NRFitTM |
| connector intended to | |||
| reduce risk of | |||
| misconnections. | |||
| Materials | Female Connector; | ||
| Polyvinyl chloride (PVC) | |||
| Male Connector; | |||
| Acrylonitrile butadiene | |||
| styrene (ABS) | |||
| Housing and Valve; | |||
| Polycarbonate, Valve | |||
| Membrane; Elastosil | Female Connector; | ||
| Polycarbonate | |||
| Male Connector; | |||
| Acrylonitrile butadiene | |||
| styrene (ABS) | |||
| Housing and Valve; | |||
| Polycarbonate, | |||
| Valve Membrane; Elastosil | 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 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 for | ||||
| Use | The CADD Medication | |||
| Cassette Reservoir with | ||||
| Flow Stop is designed for | ||||
| use with the CADD pumps | ||||
| (except CADD-Micro and | ||||
| CADD-TPN) for delivery | ||||
| of medications and fluids. | ||||
| The CADD administration | ||||
| Set with Flow Stop is | ||||
| designed for use with the | ||||
| CADD pumps (except | ||||
| CADD-Micro and CADD- | ||||
| TPN) for delivery of | ||||
| medications and fluids. | 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). | Similar | |||
| Set Length | ||||
| (nominal) | 123 – 130 inches | Same | N/A | |
| Priming Volume | 3.2 - 6.2 mL | Same | N/A |
13
smiths medical
bringing technology to life
| 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 styrene | ||
| Valve; Siloprene, Housing; Polycarbonate | Bag Spike; Acrylonitrile butadiene styrene | ||
| Valve; 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 for | |||
| Use | The CADD Medication | ||
| Cassette Reservoir with | |||
| Flow Stop is designed for | |||
| use with the CADD pumps | |||
| (except CADD-Micro and | |||
| CADD-TPN) for delivery | |||
| of medications and fluids. | |||
| The CADD administration | |||
| Set with Flow Stop is | |||
| designed for use with the | |||
| CADD pumps (except | |||
| CADD-Micro and CADD- | |||
| TPN) for delivery of | |||
| medications and fluids. | The Male Yellow Cap with | ||
| NRFitTM connector is | |||
| intended for use as an | |||
| accessory with the CADD | |||
| Yellow Medication | |||
| Cassette reservoirs. | Similar. The Cap is part | ||
| of the CADD Medication | |||
| Cassette Reservoir | |||
| system. | |||
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM |
| connector intended to | |||
| reduce risk of | |||
| misconnections. | |||
| Materials | Polybutylene Terephthalate | Polybutylene Terephthalate | Subject device materials |
| meet functional and | |||
| biocompatibility | |||
| requirements. Yellow | |||
| indicates neuraxial or | |||
| regional anesthetic | |||
| application. | |||
| Packaging | Form Fill Seal | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
14
Table 9: Female Yellow Cap with NRFit ™ connector
| Characteristic | Predicate (K040636) | Subject (K162219) | Discussion |
|---|---|---|---|
| Indication for | |||
| Use | The CADD Medication | ||
| Cassette Reservoir with | |||
| Flow Stop is designed for | |||
| use with the CADD pumps | |||
| (except CADD-Micro and | |||
| CADD-TPN) for delivery | |||
| of medications and fluids. | |||
| The CADD administration | |||
| Set with Flow Stop is | |||
| designed for use with the | |||
| CADD pumps (except | |||
| CADD-Micro and CADD- | |||
| TPN) for delivery of | |||
| medications and fluids. | 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. | Similar. The Cap is part | ||
| of the CADD Extension | |||
| set and Administration | |||
| sets. | |||
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM |
| connector intended to | |||
| reduce risk of | |||
| misconnections. | |||
| Materials | Acrylonitrile Butadiene | ||
| Styrene | Polybutylene Terephthalate | Subject device materials | |
| meet functional and | |||
| biocompatibility | |||
| requirements. Yellow | |||
| indicates neuraxial or | |||
| regional anesthetic | |||
| application. | |||
| Packaging | Form Fill Seal | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
15
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 |
|---|---|---|
| Functional | ||
| Performance | Resistance to | |
| overriding | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Resistance to | ||
| separation from | ||
| axial load | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Resistance to | ||
| separation from | ||
| unscrewing | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| 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 | ||
| 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 | ||
| 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 | ||
| Resistance to | ||
| overriding | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Air Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper for | |
| syringes, needles and certain other medical equipment - | ||
| Part 2: Lock Fittings | ||
| Liquid Leakage | ISO 594-2, Conical fittings with a 6% (Luer) taper for | |
| syringes, needles and certain other medical equipment - | ||
| Part 2: Lock Fittings | ||
| Leakage by Pressure | ||
| Decay | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Subatmospheric | ||
| Pressure | ||
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Verifying Non- | ||
| interconnectable | ||
| characteristics | ||
| physical force | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Packaging | Package integrity, | |
| sterile barrier | ISO 11607, Packaging for terminally sterilized medical | |
| devices - Part 1: Requirements for materials, sterile barrier | ||
| systems and packaging systems | ||
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethylene |
| oxide - Requirements for development, validation and | ||
| routine control of a sterilization process for medical | ||
| devices. | ||
| 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 and | ||
| reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - | |
| Part 3: Tests for genotoxicity, carcinogenicity, and | ||
| reproductive toxicity | ||
| Leachable | ||
| substances | ISO 10993-17, Biological evaluation of medical devices - | |
| Part 17: Establishment of allowable limits for leachable | ||
| substances. | ||
| Chemical | ||
| characterization of | ||
| materials | ISO 10993-18, Biological evaluation of medical devices - | |
| Part 18: Chemical characterization of materials | ||
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, | |
| routine monitoring, and alternatives to batch testing | ||
| Particulate matter | USP 788. Particulate Matter in Injections |
16
smiths medical
bringing technology to life
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.