Intellifuse Administration and Intellifuse Blood Administration Sets

K192375 · Smiths Medical Asd, Inc. · FPA · Sep 18, 2020 · General Hospital

Device Facts

• Record ID: K192375
• Device Name: Intellifuse Administration and Intellifuse Blood Administration Sets
• Applicant: Smiths Medical Asd, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Intellifuse™ Administration and Blood Administration Sets are single-use, sterile, disposable gravity-flow devices; used to deliver fluids, medications, blood, and blood products from a container to a patient's vascular system. Components include tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connectors, injection sites, in-line filters, and luer connectors. Operated by healthcare professionals in clinical settings; device facilitates fluid administration via gravity. Output is the controlled delivery of fluids to the patient; clinical benefit is the safe, sterile infusion of necessary therapeutic substances.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 8536-4 (infusion sets), ISO 1135-4 (transfusion sets), ISO 594-1/2 (luer fittings), USP <788> (particulate assessment), ISO 8536-12 (check valves), ISO 8536-5 (burette chambers), ISO 10993-1 (biocompatibility), and ISO 11135 (sterilization).

Technological Characteristics

Materials: ABS, DEHT, PVC, HDPE, Acrylic, Nylon, LDPE, MABS, PC, Silicone, Flurosilicone, Polyisoprene, E-PTFE, Polyurethane. Gravity-fed fluid path. Components: spike, drip chamber, check valve, clamp, needleless connector, filter, luer lock. Sterilization: Ethylene Oxide (SAL 10⁻⁶). Standards: ISO 8536-4, ISO 1135-4, ISO 594-1/2, ISO 8536-12, ISO 8536-5, ISO 10993-1, ISO 11135, ISO 11607-1.

Indications for Use

Indicated for the delivery of fluids, blood, and blood products from a container to the vascular system of the general patient population.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Burette Sets, and Hospira Blood Sets (K160870)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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): |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> 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 Medical<br>6000 Nathan Lane North, Minneapolis, MN 55442, USA<br>Phone: [phone] |
| Establishment Registration: | 3012307300 |
| Primary Contact: | Danielle Besal<br>Principal Consultant MRC Global<br>Phone: [phone] |
| Proprietary Name: | Intellifuse™ Administration Sets and Intellifuse™ Blood Administration<br>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<br>Extension Sets, Hospira Burette Sets, and Hospira Blood Sets<br>(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.

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| | Subject:<br>Intellifuse™ Administration<br>Sets & Intellifuse Blood<br>Administration Sets<br>(K192375) | Predicate:<br>Hospira Administration<br>Sets<br>(K160870) | Substantial Equivalence<br>Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Smiths Medical | Hospira | N/A |
| Indications<br>for Use | Intellifuse™ Administration Sets<br>are indicated for the delivery of<br>fluids from a container to a<br>patient's vascular system.<br><br>Intellifuse™ Blood<br>Administration Sets are indicated<br>for the delivery of fluids<br>including but not limited to blood<br>and blood products from a<br>container to a patient's vascular<br>system. | Hospira Primary sets are<br>indicated for the delivery of<br>fluids from a container to a<br>patient's vascular system.<br><br>Hospira Extension sets are<br>indicated for the delivery of<br>fluids from a container to a<br>patient's vascular system.<br><br>Hospira Burette sets are<br>indicated for the delivery of<br>fluids from a container to a<br>patient's vascular system.<br><br>Hospira Blood sets are<br>indicated for the delivery of<br>fluids including but not<br>limited to blood and blood<br>products from a container to<br>a patient's vascular system | The subject Intellifuse™<br>Administration Sets encompass<br>various configurations (including<br>primary, secondary, and burette<br>sets) that differ slightly from the<br>predicate set configurations, but all<br>are equivalently intended for the<br>delivery of fluids from a container<br>to a patient's vascular system.<br><br>The subject blood sets have the<br>same indications as the blood sets<br>for the predicate device.<br><br>Substantially equivalent. |
| Usage | Single Patient Use, Disposable | Single Patient Use,<br>Disposable | Identical; substantially equivalent |
| Available<br>Design<br>Features | PVC tubing, low light absorption<br>tubing, bag spike and cap drip<br>chamber, bag spike handle, drip<br>chamber, burette subassembly,<br>check valve, pinch clamp, roller<br>clamp, injection site assembly,<br>needleless access connector<br>(nSyte™), filter, male luer<br>adapter with cap, blood chamber<br>Gravity Flow | Male and female luer adapter<br>with cap, piercing pin<br>connector, tubing, flow<br>control device, filter, in-line<br>adapter, injection site<br>assembly, luer activated<br>needleless valve connector<br>(Nuitiv™ Connector), check<br>valve, burette chamber,<br>blood chamber<br>Gravity Flow | Equivalent common components are<br>used in all sets and performance<br>testing shows compliance with ISO<br>requirements and acceptability for<br>device's intended use. Substantially<br>equivalent |
| Priming<br>Volume | Primary Sets: 24-29 mL<br>Blood Sets: 29-30 mL<br>Secondary Set: 14 mL | Not disclosed | Priming testing supports<br>acceptability of device for its<br>intended use. Substantially<br>equivalent. |
| Drops / mL | Burette Sets: 60 drops/mL<br>All other sets: 20 drops/mL | Not disclosed | Performance testing supports<br>acceptability of device for its<br>intended use. Substantially<br>equivalent. |
| | Subject:<br>Intellifuse™ Administration<br>Sets & Intellifuse Blood<br>Administration Sets<br>(K192375) | Predicate:<br>Hospira Administration<br>Sets<br>(K160870) | Substantial Equivalence<br>Discussion |
| Materials | ABS, DEHT, PVC<br>HDPE, Acrylic & Nylon<br>LDPE, MABS, PC, Silicone,<br>Flurosilicone, Clear ABS, LDPE,<br>Polyisoprene, Acrylic, E-PTFE,<br>Polyurethane (biocompatible,<br>non-DEHP, not manufactured<br>with natural rubber latex) | Polycarbonate, copolyester,<br>silicone, acrylic,<br>polypropylene, non-phthalate<br>PVC, HDPE, ABS, nylon | Similar, all differences supported by<br>ISO 10993 biocompatibility testing.<br>Substantially Equivalent |
| Sterility | Sterile fluid path, EO<br>SAL 10⁻⁶ | Sterile,<br>method not disclosed,<br>SAL 10⁻⁶ | Predicate sterilization method not<br>disclosed; however, both devices<br>are validated to the same sterility<br>assurance level and the subject<br>sterilization has been validated and<br>is acceptable for its intended use;<br>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.