(261 days)
Not Found
No
The summary describes a passive administration set with mechanical features (NRFit connectors, color coding) for safety, with no mention of computational or learning capabilities.
Yes.
The device is used for the delivery of regional anesthetics or narcotics for pain management, which falls under therapeutic intervention.
No
This device is an administration set designed for the delivery of regional anesthetics or narcotics, not for diagnostic purposes.
No
The device description clearly outlines physical components like administration sets and connectors, and the performance studies focus on physical properties and biocompatibility, not software functionality.
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 using a pump. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and their function in delivering medication, specifically highlighting the NRFit™ connector for safety in administration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly designed for the administration of medication, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).
The intended population is pediatrics and adults.
Product codes (comma separated list FDA assigned to the subject device)
PWH
Device Description
The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.
All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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® Yellow High Volume Administration Set with NRFit™ connector was evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and performs as well as the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the CADD® Yellow High Volume Administration Set with NRFit™ connector device performed as intended.
Testing categories included:
- Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity (Irritation), Acute Systemic Toxicity, Pyrogenicity (bacterial-mediated & material-mediated), Hemocompatibility, Subchronic Toxicity, Genotoxicity, Extractables and Leachables, Toxicological Risk Assessment, Particulates, Ethylene Oxide Residuals)
- Packaging (Sterile Barrier Integrity, Seal Strength, Packaging Stability, Distribution Simulation)
- Device Performance (Connector compatibility and incompatibility, Dimensional Testing, Leakage, Mechanical Requirements (resistance to cracking, tensile strength, over-riding threads, torque))
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2018
Smiths Medical ASD, Inc. Sunny Teekasingh Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K172592
Trade/Device Name: CADD Yellow High Volume Administration Set with NRFit connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: PWH Dated: April 18, 2018 Received: April 19, 2018
Dear Sunny Teekasingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172592
Device Name
CADD® Yellow High Volume Administration Set with NRFit™ connector
Indications for Use (Describe)
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).
The intended population is pediatrics and adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. ADMINISTRATIVE INFORMATION
| 510(k) | K172592 |
|---|---|
| Applicant's Name | |
| and Address | Smiths Medical ASD, Inc. |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 USA | |
| Contact Person | Sunny Teekasingh |
| Principal Regulatory Affairs Specialist | |
| Phone: 763-383-3336 | |
| Fax: 763-383-3679 | |
| Email: Sunny.Teekasingh@smiths-medical.com | |
| Date | May 10, 2018 |
| Regulation No. | |
| Regulation Name | 21 CFR § 880.5440 |
| Intravascular Administration Set | |
| Primary Product | |
| Codes | PWH |
| Trade Name | CADD® Yellow High Volume Administration Set with NRFit™ connector |
2. REASON FOR SUBMISSION
The purpose of this submission is to make a modification to the currently marketed Smiths Medical CADD® High Volume Administration Sets which are being updated to include an ISO 80369-6 compliant connector for regional anesthetic applications.
3. DEVICE INFORMATION
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | CADD® High Volume | |
| Administration Set with Flow Stop | CADD® Yellow High Volume | |
| Administration Set with NRFitTM | ||
| connector | ||
| Regulation No. | 21 CFR § 880.5440 | 21 CFR § 880.5440 |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set |
| Regulatory Class | II | II |
| Product Code | FPA | PWH |
| 510(k) | K031361 | K172592 |
4. DEVICE DESCRIPTION
The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™
4
connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.
All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.
5. INDICATIONS FOR USE
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors are intended for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid / spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility). The intended population is pediatrics and adults.
6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors have the same technological characteristics as the predicate devices with the exception of the NRFit™ Connectors.
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors and predicate devices are both designed to deliver local or regional anesthetics or narcotics, indicated for regional anesthetic infusion applications. They are both made of the same materials, have the same chemical composition, and have the same design features excluding the NRFit™ connector design.
The Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connectors utilize connectors that comply with ISO 80369-6. These connectors are intentionally designed to be incompatible with Luer tapers such as those found on the predicate devices to mitigate the risks associated with connecting infusion lines to the incorrect infusion pump. The predicate devices utilize standard Luer connectors that comply with ISO 594, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment." A side-by-side characteristic analysis of Predicate and Subject Device is provided in Table 1.
| Characteristic | Subject Device
K172592 | Predicate Device
K031361 | Discussion |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | CADD® Yellow High
Volume
Administration Set
with NRFit™
connectors are
intended for use only
with NRFit™
components for
delivery of regional
anesthetics or
narcotics, excluding
subarachnoid / spinal | CADD® High-
Volume
Administration Sets
is designed for use
with the CADD-
Prism® pump to
allow fluid delivery
from an IV bag. | Both used with CADD
pump. |
| Characteristic | Subject Device
K172592 | Predicate Device
K031361 | Discussion |
| | block, and are
designed for use with
CADD® pumps (see
CADD® pump
Operator's Manual for
compatibility). The
intended population is
pediatrics and adults. | | |
| Sterility Method | EO | EO | Same |
| Single use | Yes | Yes | Same |
| Disposable | Yes | Yes | Same |
| Prescription | Yes | Yes | Same |
| Connections | ISO 80369-6
compliant NRFit™
non-Luer connectors | ISO 594 Luer
tapers | The NRFit™ connector
provides the same
clinical function (i.e.,
secure, non-leaking
connection), but
incorporates the ISO
80369-6 connector
design to mitigate the
risk of misconnections. |
| Model: CADD® High
Volume
Administration Sets
(with Air-Eliminating
Filter and Flow Stop
Free-Flow Protection) | 21-7685-24 | 21-7385-24 | N/A |
| Model: CADD® High
Volume
Administration Sets
(with Flow Stop Free-
Flow Protection) | 21-7684-24 | 21-7384-24 | N/A |
| Nominal Set Length | 130 inches | 130 inches | Same |
| Priming Volume for
CADD® High
Volume
Administration Sets
(with Flow Stop Free-
Flow Protection) | 16 mL | 16 mL | Same |
| Priming Volume for
CADD® High
Volume
Administration Sets
(with Air-Eliminating
Filter and Flow Stop
Free-Flow Protection) | 23 mL | 23 mL | Same |
| 0.2 micron filter, for
CADD® High | 0.2 micron filter | 0.2 micron filter | Same |
| Characteristic | Subject Device
K172592 | Predicate Device
K031361 | Discussion |
| Volume
Administration Sets
(with Air-Eliminating
Filter and Flow Stop
Free-Flow Protection) | | | |
| PVC Tubing
Plasticized with
TOTM | Yes | Yes | Same |
| Bag Spike | Yes | Yes | Same |
| Dimensions - Bag
Spike | Same | Same | Same |
| Materials - Bag Spike | Acrylonitrile
butadiene styrene
(ABS) - ABS - HI
121H-Natural
Granule 9700640000
Colorant: Yellow | Acrylonitrile
butadiene styrene
(ABS) - ABS White
Granule
9700670300
Colorant: White | Proposed materials are
color-coded yellow to
indicate medication
intended for regional
anesthetic delivery. |
| Male Taper with One-
Way Checkvalve | Male NRFit™
connector | Male ISO 594 Luer | The NRFit™ connector
provides the same
clinical function (i.e.,
secure, non-leaking
connection), but
incorporates the ISO
80369-6 connector
design to mitigate the
risk of misconnections. |
| Materials - One-Way
Checkvalve, Valve
Membrane | Silicone – Siloprene
LSR-4040
Colorant: None | Silicone– Siloprene
LSR-4040
Colorant: None | Same |
| Materials - One-Way
Checkvalve, Male
Taper Outlet Housing | Polycarbonate -
Makrolon RX-1805G
Colorant: Yellow,
Clariant
NC1M664867 | Polycarbonate -
Makrolon RX-1805G
Colorant: Purple
Tint | Proposed materials are
color-coded yellow to
indicate medication
intended for regional
anesthetic delivery. |
| Materials - One-Way
Checkvalve, Female
Luer Lock Inlet
Housing | Polycarbonate -
Makrolon RX-1805-
013771
Colorant: White | Polycarbonate -
Makrolon RX-1805-
013771
Colorant: White | Same |
| Flow Stop | Yes | Yes | Same |
| Packaging | Pouch | Pouch | Same |
Table 1: Comparative Analysis of Subject and Predicate Devices by Characteristic
5
510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
Image /page/5/Picture/1 description: The image shows the logo for Smiths Medical. The text "smiths medical" is written in a sans-serif font. The word "smiths" is in a darker blue color, while the word "medical" is in a lighter blue color.
bringing technology to life
6
510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
smiths medical
bringing technology to life
7
7. SUMMARY OF NON-CLINICAL TESTING
The CADD® Yellow High Volume Administration Set with NRFit™ connector was evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and performs as well as the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the CADD® Yellow High Volume Administration Set with NRFit™ connector device performed as intended. A summary of the testing is provided in Table 2.
| Category | Testing |
|---|---|
| Biocompatibility | Cytotoxicity |
| Sensitization | |
| Intracutaneous Reactivity (Irritation) | |
| Acute Systemic Toxicity | |
| Pyrogenicity (bacterial-mediated & material-mediated) | |
| Hemocompatibility | |
| Subchronic Toxicity | |
| Genotoxicity | |
| Extractables and Leachables | |
| Toxicological Risk Assessment | |
| Particulates | |
| Ethylene Oxide Residuals | |
| Packaging | Sterile Barrier Integrity |
| Seal Strength | |
| Packaging Stability | |
| Distribution Simulation | |
| Device Performance | Connector compatibility and incompatibility |
| Dimensional Testing | |
| Leakage | |
| Mechanical Requirements (resistance to cracking, tensile strength, | |
| over-riding threads, torque) |
Table 2: Testing Type by Category
Biocompatibility and Bench testing was conducted to the Standards in Table 3:
Table 3: Testing Type by Standard Reference Number and Date
| Standards
Development
Organization | Reference
Number and Date | Title |
|------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ISO | 80369-1:2010 | Small-bore connectors for liquids and gases in
healthcare applications - Part 1: General
requirements |
| ISO | 80369-6:2016 | Small bore connectors for liquids and gases in
healthcare Applications - Part 6: Connectors for
Neuraxial Applications |
| ISO | 10993-1:2009 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |
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510(k) Summary K172592; CADD® Yellow High Volume Administration Set with NRFit™ connector
| ISO | 10993-3:2014 | Biological evaluation of medical devices - Part 3:
Tests for genotoxicity, carcinogenicity and
reproductive toxicity |
|-----|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| ISO | 10993-4:2017 | Biological evaluation of medical devices - Part 4:
Selection of tests for interactions with blood |
| ISO | 10993-5:2009 | Biological evaluation of medical devices - Part 5:
Tests
for in vitro cytotoxicity |
| ISO | 10993-7:2008 | Biological evaluation of medical devices - Part 7:
Ethylene oxide sterilization residuals |
| ISO | 10993-10:2010 | ISO 10993-10 Biological evaluation of medical
devices - Part 10: Tests for irritation and sensitization |
| ISO | 10993-11:2006 | Biological evaluation of medical devices - Part 11:
Tests for systemic toxicity |
| ISO | 10993-12:2012 | Biological evaluation of medical devices - Part 12:
Sample preparation and reference materials |
| ISO | 10993-
17:2002(R)2012 | Biological evaluation of medical devices - Part 17:
Establishment of allowable limits for leachable
substances |
| ISO | 10993-18:2005 | Biological evaluation of medical devices - Part 18:
Chemical characterization of materials |
8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of the Smiths Medical CADD® Yellow High Volume Administration Set with NRFit™ connector device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices in regards to safety and effectiveness.