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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for Smiths Medical's Intellifuse™ Administration and Intellifuse™ Blood Administration Sets. This document from the FDA clears medical devices based on substantial equivalence to legally marketed predicate devices, rather than through extensive clinical trials for effectiveness like drugs. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of an "AI/algorithm-only" or "human-in-the-loop" device is not applicable to this submission.

This device is an intravascular administration set, which is a physical medical device for delivering fluids. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and testing to ensure the device functions as intended and is safe, not a comparative effectiveness study involving human readers or AI.

Therefore, many of the requested points, such as AI performance, human expert adjudication, MRMC studies, and ground truth for AI model training, are not relevant to this type of device clearance.

Here's the relevant information based on the provided text, focused on the device's technical specifications and non-clinical testing:

Acceptance Criteria and Device Performance for Smiths Medical Intellifuse™ Administration Sets

The "acceptance criteria" for this device are primarily met through demonstrating substantial equivalence to a predicate device (Hospira Administration Sets K160870) and by non-clinical performance data demonstrating compliance with relevant ISO standards and internal test methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for AI/algorithm performance. Instead, it relies on demonstrating compliance with established standards and the equivalence of functional characteristics.

Criterion Type	Specific Criteria (Implied / Stated)	Reported Device Performance
Indications for Use	Delivery of fluids from a container to a patient's vascular system (Administration Sets). Delivery of fluids including blood and blood products (Blood Administration Sets).	Subject Device (K192375) Indications: 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 Discussion: The subject sets' indications encompass and are substantially equivalent to the predicate's indications (Hospira Primary, Extension, Burette, and Blood sets). Differences in configurations do not alter the fundamental intended use.
Usage	Single Patient Use, Disposable	Reported: Single Patient Use, Disposable. Substantial Equivalence: Identical; substantially equivalent.
Priming Volume	Adequate for intended use (no specific numerical limit provided, but comparison to predicate is implicit).	Reported: Primary Sets: 24-29 mL; Blood Sets: 29-30 mL; Secondary Set: 14 mL. Substantial Equivalence: "Priming testing supports acceptability of device for its intended use. Substantially equivalent." (Predicate priming volume was not disclosed).
Drops / mL	Standardized drip rates for different set types.	Reported: Burette Sets: 60 drops/mL; All other sets: 20 drops/mL. Substantial Equivalence: "Performance testing supports acceptability of device for its intended use. Substantially equivalent." (Predicate drops/mL was not disclosed).
Materials	Biocompatible for patient contact.	Reported (Subject): 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). Substantial Equivalence: "Similar, all differences supported by ISO 10993 biocompatibility testing. Substantially Equivalent."
Sterility	Sterile fluid path, Sterility Assurance Level (SAL) 10⁻⁶	Reported: Sterile fluid path, EO, SAL 10⁻⁶. Substantial Equivalence: "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."
Non-Clinical Testing	Compliance with relevant ISO standards and internal test methods.	Reported: All listed tests passed and results were verified against requirements. This includes compliance with: ISO 8536-4, ISO 1135-4, ISO 594-1, ISO 594-2, USP <788> (Particulate assessment), Microbial Ingress (Internal), Pinch Clamp (Internal), Check Valve (ISO 8536-12), Needleless Access Connector (Internal - Hydrostatic pressure, Translucency, Inspection), Burette Chamber (ISO 8536-5), Biocompatibility (ISO 10993-1, including Pyrogenicity), Sterilization (ISO 11135 - SAL 10⁻⁶), and Packaging (ISO 11607-1).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many sets were tested for priming volume, sterility, etc.). These sizes would typically be determined by statistical methods for validation but are not explicitly stated in this summary.
Data Provenance: The data is generated from non-clinical laboratory testing performed by Smiths Medical. There is no information about country of origin or whether it's retrospective/prospective data as these terms are usually applicable to clinical studies.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This question is not applicable. This device is a physical medical device, not an AI or imaging diagnostic tool that requires human expert interpretation or "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for this device's performance is established by objective engineering and biological testing standards.

4. Adjudication Method for the Test Set

This question is not applicable. As there is no human interpretation or diagnostic decision involved that requires expert consensus or adjudication. The non-clinical tests have predefined acceptance criteria based on engineering specifications and international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This device is an administration set, and its clearance is based on demonstrating functional equivalence and safety through non-clinical testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a physical, non-AI medical product. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Compliance with international standards (e.g., various ISO standards for infusion and transfusion equipment, luer fittings, biocompatibility, sterilization, packaging).
Compliance with USP <788> for particulate assessment.
Results from internal test methods for specific functions like Microbial Ingress, Pinch Clamp, and Needleless Access Connector performance, which would be validated against engineering specifications.
The fundamental physical and chemical properties of the materials used.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/machine learning product, so there is no "training set" in the computational sense. The "development" of the device involves engineering design, prototyping, and testing of physical units.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as point 8.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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

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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)

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smiths medical

bringing technology to life

510(k) Summary K192375

Date:	September 18, 2020
Sponsor:	Smiths Medical6000 Nathan Lane North, Minneapolis, MN 55442, USAPhone: 763.383.3000
Establishment Registration:	3012307300
Primary Contact:	Danielle BesalPrincipal Consultant MRC GlobalPhone: 901.827.8670
Proprietary Name:	Intellifuse™ Administration Sets and Intellifuse™ Blood AdministrationSets
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, HospiraExtension Sets, Hospira Burette Sets, and Hospira Blood Sets(K160870, 21 CFR 880.5440, FPA)

Device Description:

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.

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	Subject:Intellifuse™ AdministrationSets & Intellifuse BloodAdministration Sets(K192375)	Predicate:Hospira AdministrationSets(K160870)	Substantial EquivalenceDiscussion
Manufacturer	Smiths Medical	Hospira	N/A
Indicationsfor Use	Intellifuse™ Administration Setsare indicated for the delivery offluids from a container to apatient's vascular system.Intellifuse™ BloodAdministration Sets are indicatedfor the delivery of fluidsincluding but not limited to bloodand blood products from acontainer to a patient's vascularsystem.	Hospira Primary sets areindicated for the delivery offluids from a container to apatient's vascular system.Hospira Extension sets areindicated for the delivery offluids from a container to apatient's vascular system.Hospira Burette sets areindicated for the delivery offluids from a container to apatient's vascular system.Hospira Blood sets areindicated for the delivery offluids including but notlimited to blood and bloodproducts from a container toa patient's vascular system	The subject Intellifuse™Administration Sets encompassvarious configurations (includingprimary, secondary, and burettesets) that differ slightly from thepredicate set configurations, but allare equivalently intended for thedelivery of fluids from a containerto a patient's vascular system.The subject blood sets have thesame indications as the blood setsfor the predicate device.Substantially equivalent.
Usage	Single Patient Use, Disposable	Single Patient Use,Disposable	Identical; substantially equivalent
AvailableDesignFeatures	PVC tubing, low light absorptiontubing, bag spike and cap dripchamber, bag spike handle, dripchamber, burette subassembly,check valve, pinch clamp, rollerclamp, injection site assembly,needleless access connector(nSyte™), filter, male lueradapter with cap, blood chamberGravity Flow	Male and female luer adapterwith cap, piercing pinconnector, tubing, flowcontrol device, filter, in-lineadapter, injection siteassembly, luer activatedneedleless valve connector(Nuitiv™ Connector), checkvalve, burette chamber,blood chamberGravity Flow	Equivalent common components areused in all sets and performancetesting shows compliance with ISOrequirements and acceptability fordevice's intended use. Substantiallyequivalent
PrimingVolume	Primary Sets: 24-29 mLBlood Sets: 29-30 mLSecondary Set: 14 mL	Not disclosed	Priming testing supportsacceptability of device for itsintended use. Substantiallyequivalent.
Drops / mL	Burette Sets: 60 drops/mLAll other sets: 20 drops/mL	Not disclosed	Performance testing supportsacceptability of device for itsintended use. Substantiallyequivalent.
	Subject:Intellifuse™ AdministrationSets & Intellifuse BloodAdministration Sets(K192375)	Predicate:Hospira AdministrationSets(K160870)	Substantial EquivalenceDiscussion
Materials	ABS, DEHT, PVCHDPE, Acrylic & NylonLDPE, MABS, PC, Silicone,Flurosilicone, Clear ABS, LDPE,Polyisoprene, Acrylic, E-PTFE,Polyurethane (biocompatible,non-DEHP, not manufacturedwith natural rubber latex)	Polycarbonate, copolyester,silicone, acrylic,polypropylene, non-phthalatePVC, HDPE, ABS, nylon	Similar, all differences supported byISO 10993 biocompatibility testing.Substantially Equivalent
Sterility	Sterile fluid path, EOSAL 10⁻⁶	Sterile,method not disclosed,SAL 10⁻⁶	Predicate sterilization method notdisclosed; however, both devicesare validated to the same sterilityassurance level and the subjectsterilization has been validated andis acceptable for its intended use;substantially equivalent.

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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 <788>)
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) ●

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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.

Regulation Number and Section

§ 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.