(385 days)
No
The device description and performance studies focus on the physical components and standard testing for gravity-feed IV administration sets, with no mention of AI or ML.
No
The device is used for the delivery of fluids, medications, blood, and blood products rather than directly treating a disease or condition.
No
The device is described as administration sets used for delivering fluids, medications, blood, and blood products to a patient's vascular system. This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is comprised of various physical components like tubing, spike assemblies, drip chambers, valves, clamps, etc., and is intended for gravity flow administration, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of fluids (including blood and blood products) from a container to a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details components for fluid administration (tubing, spike assemblies, drip chambers, etc.). There is no mention of components or functions related to analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical and functional aspects of fluid delivery (flow rates, sterility, biocompatibility, etc.), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to administer substances into the body, not to analyze substances from the body.
N/A
Intended Use / Indications for Use
Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
general patient population
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)
Non-clinical testing of the components comprised in each configuration of the subject devices were assessed and tested appropriately to design controls; i.e., design verification, design validations. The test results conclude that the Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets to be substantially equivalent to the predicate device. Testing listed below passed and results were verified against requirements:
- ISO 8536-4, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"
- ISO 1135-4, "Transfusion equipment for medical use - part 4 Transfusion sets for single use, gravity feed"
- ISO 594-1, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements"
- ISO 594-2, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other ● medical equipment - Part 2: Lock fittings"
- Particulate assessment (USP )
- Microbial Ingress (Internal test method)
- Pinch Clamp (Internal test method) ●
- Check Valve (ISO 8536-12)
- Needleless Access Connector (Internal test method)
- Hydrostatic pressure
- Translucency
- Inspection
- Burette Chamber (ISO 8536-5) ●
- Biocompatibility (ISO 10993-1)
- In addition, biocompatibility of needleless connector for K163172 was leveraged for o needleless access connector
- Pyrogenicity (material mediated/bacterial endotoxins)
- Sterilization - SAL 10-6
- ISO 11135, "Sterilization of health care Products Ethylene Oxide Requirements for o development, validation and routine control of a sterilization process for medical devices
- Packaging (transport and distribution) ●
- ISO 11607-1, "Packaging for terminally sterilized medical devices Part 1: o Requirements for materials, sterile barrier systems and packaging systems
Clinical testing was not necessary for the determination of substantial equivalence.
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.
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 18, 2020
Smiths Medical ASD. Inc. % Danielle Besal Principal Consultant MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial. CO 80112
Re: K192375
Trade/Device Name: Intellifuse™ Administration and Intellifuse™ Blood Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 9, 2020 Received: September 11, 2020
Dear Danielle Besal:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192375
Device Name
Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets
Indications for Use (Describe)
Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
smiths medical
bringing technology to life
510(k) Summary K192375
| Date: | September 18, 2020 |
|---|---|
| Sponsor: | Smiths Medical |
| 6000 Nathan Lane North, Minneapolis, MN 55442, USA | |
| Phone: 763.383.3000 | |
| Establishment Registration: | 3012307300 |
| Primary Contact: | Danielle Besal |
| Principal Consultant MRC Global | |
| Phone: 901.827.8670 | |
| Proprietary Name: | Intellifuse™ Administration Sets and Intellifuse™ Blood Administration |
| Sets | |
| Regulation Name: | Intravascular administration set |
| Regulation: | 21 CFR 880.5440 |
| Product Codes: | FPA |
| Device Class: | II |
| Panel: | General Hospital |
| Predicate Device: | Hospira Administration Sets: Hospira Primary Sets, Hospira |
| Extension Sets, Hospira Burette Sets, and Hospira Blood Sets | |
| (K160870, 21 CFR 880.5440, FPA) |
Device Description:
Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.
Indications for Use:
Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Substantial Equivalence:
The technology for Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets is similar between the subject and the predicate devices as described in the table below.
4
| | Subject:
Intellifuse™ Administration
Sets & Intellifuse Blood
Administration Sets
(K192375) | Predicate:
Hospira Administration
Sets
(K160870) | Substantial Equivalence
Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Smiths Medical | Hospira | N/A |
| Indications
for Use | Intellifuse™ Administration Sets
are indicated for the delivery of
fluids from a container to a
patient's vascular system.
Intellifuse™ Blood
Administration Sets are indicated
for the delivery of fluids
including but not limited to blood
and blood products from a
container to a patient's vascular
system. | Hospira Primary sets are
indicated for the delivery of
fluids from a container to a
patient's vascular system.
Hospira Extension sets are
indicated for the delivery of
fluids from a container to a
patient's vascular system.
Hospira Burette sets are
indicated for the delivery of
fluids from a container to a
patient's vascular system.
Hospira Blood sets are
indicated for the delivery of
fluids including but not
limited to blood and blood
products from a container to
a patient's vascular system | The subject Intellifuse™
Administration Sets encompass
various configurations (including
primary, secondary, and burette
sets) that differ slightly from the
predicate set configurations, but all
are equivalently intended for the
delivery of fluids from a container
to a patient's vascular system.
The subject blood sets have the
same indications as the blood sets
for the predicate device.
Substantially equivalent. |
| Usage | Single Patient Use, Disposable | Single Patient Use,
Disposable | Identical; substantially equivalent |
| Available
Design
Features | PVC tubing, low light absorption
tubing, bag spike and cap drip
chamber, bag spike handle, drip
chamber, burette subassembly,
check valve, pinch clamp, roller
clamp, injection site assembly,
needleless access connector
(nSyte™), filter, male luer
adapter with cap, blood chamber
Gravity Flow | Male and female luer adapter
with cap, piercing pin
connector, tubing, flow
control device, filter, in-line
adapter, injection site
assembly, luer activated
needleless valve connector
(Nuitiv™ Connector), check
valve, burette chamber,
blood chamber
Gravity Flow | Equivalent common components are
used in all sets and performance
testing shows compliance with ISO
requirements and acceptability for
device's intended use. Substantially
equivalent |
| Priming
Volume | Primary Sets: 24-29 mL
Blood Sets: 29-30 mL
Secondary Set: 14 mL | Not disclosed | Priming testing supports
acceptability of device for its
intended use. Substantially
equivalent. |
| Drops / mL | Burette Sets: 60 drops/mL
All other sets: 20 drops/mL | Not disclosed | Performance testing supports
acceptability of device for its
intended use. Substantially
equivalent. |
| | Subject:
Intellifuse™ Administration
Sets & Intellifuse Blood
Administration Sets
(K192375) | Predicate:
Hospira Administration
Sets
(K160870) | Substantial Equivalence
Discussion |
| Materials | ABS, DEHT, PVC
HDPE, Acrylic & Nylon
LDPE, MABS, PC, Silicone,
Flurosilicone, Clear ABS, LDPE,
Polyisoprene, Acrylic, E-PTFE,
Polyurethane (biocompatible,
non-DEHP, not manufactured
with natural rubber latex) | Polycarbonate, copolyester,
silicone, acrylic,
polypropylene, non-phthalate
PVC, HDPE, ABS, nylon | Similar, all differences supported by
ISO 10993 biocompatibility testing.
Substantially Equivalent |
| Sterility | Sterile fluid path, EO
SAL 10⁻⁶ | Sterile,
method not disclosed,
SAL 10⁻⁶ | Predicate sterilization method not
disclosed; however, both devices
are validated to the same sterility
assurance level and the subject
sterilization has been validated and
is acceptable for its intended use;
substantially equivalent. |
5
The differences between the subject and predicate devices are minimal and include differences in the material construction of the various subcomponents. The predicate device also comprises extension sets, which are not part of this submission. Smiths Medical has determined materials differences do not affect the device's intended use, indication for use, or alter the device's fundamental scientific technology for fluid, blood, or blood product administration. In addition, the performance requirements were met by the tests performed on the device.
Non-Clinical Performance Data:
Non-clinical testing of the components comprised in each configuration of the subject devices were assessed and tested appropriately to design controls; i.e., design verification, design validations. The test results conclude that the Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets to be substantially equivalent to the predicate device. Testing listed below passed and results were verified against requirements:
- ISO 8536-4, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"
- . ISO 1135-4. " Transfusion equipment for medical use - part 4 Transfusion sets for single use, gravity feed"
- . ISO 594-1, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements"
- ISO 594-2, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other ● medical equipment - Part 2: Lock fittings"
- Particulate assessment (USP )
- Microbial Ingress (Internal test method)
- Pinch Clamp (Internal test method) ●
- Check Valve (ISO 8536-12)
- Needleless Access Connector (Internal test method) .
- Hydrostatic pressure O
- Translucency O
- O Inspection
- Burette Chamber (ISO 8536-5) ●
6
- Biocompatibility (ISO 10993-1) .
- In addition, biocompatibility of needleless connector for K163172 was leveraged for o needleless access connector
- Pyrogenicity (material mediated/bacterial endotoxins) o
- Sterilization - SAL 10-6
- ISO 11135, "Sterilization of health care Products Ethylene Oxide Requirements for o development, validation and routine control of a sterilization process for medical devices
- Packaging (transport and distribution) ●
- ISO 11607-1, "Packaging for terminally sterilized medical devices Part 1: o Requirements for materials, sterile barrier systems and packaging systems
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusion:
Smiths Medical concludes the differences between the subject and predicate device do not impact the indications for use, intended use, and do not raise new questions of safety or effectiveness imposed on the patient or device use; therefore, the subject device, for Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets, is considered substantially equivalent to the predicate.