LifeFlow Blood System

K191362 · 410 Medical, Inc. · FPA · May 20, 2020 · General Hospital

Device Facts

• Record ID: K191362
• Device Name: LifeFlow Blood System
• Applicant: 410 Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a container to a patient's vascular system. These devices may be used for any adult or pediatric patient, greater than 28 days old and greater than 3kg, with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy. The delivery of blood products is intended for patients requiring volume replacement for hemorrhagic shock or life-threatening bleeding. *Capable of rates greater than 100ml/min

Device Story

LifeFlow® Blood System is a single-use, disposable IV administration set for rapid fluid/blood delivery. Input: blood, blood components, or resuscitative fluids from a container. Operation: manual hand pump (handle and syringe) forces fluid through tubing to patient; includes force reduction tubing to manage peak pressure/flow. Output: rapid fluid infusion (>100mL/min). Used in clinical settings by healthcare providers. Features 'AirCheck™' chamber: ball float descends if air enters, sealing chamber to stop flow and provide tactile feedback to user. Blood filter (200μm polyamide) removes particulates. Benefits: enables rapid volume resuscitation in shock/bleeding scenarios. Provider monitors infusion and AirCheck™ status during manual operation.

Clinical Evidence

Bench testing only. Testing included design verification per ISO 594-1/2 and ISO 1135-4, mechanical hemolysis comparison, functional reliability, human packed red blood cell infusion capability, flow rate verification, and human factors usability testing. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Single-use IV administration set. Materials: Non-DEHP PVC, TPE, polyamide (filter). Sensing/Actuation: Manual hand pump (handle/syringe), passive force reduction tubing, ball-float air-stop chamber. Connectivity: None. Sterilization: Gamma (tubing set), handle non-sterile. Standards: ISO 594-1/2, ISO 1135-4:2015, ISO 10993-1, ANSI/AAMI/ISO 11137-2:2013.

Indications for Use

Indicated for adult and pediatric patients >28 days old and >3kg requiring rapid delivery of blood, blood components (RBCs/plasma), or crystalloid/colloid resuscitative fluids for volume replacement in hemorrhagic shock or life-threatening bleeding.

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

• LifeFlow™ Rapid Infusion System (K153731)

Reference Devices

• IV Administration Sets with 200µm Blood Filter (K143082)

Submission Summary (Full Text)

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May 20, 2020

410 Medical, Inc. % Danielle Besal Principal Consultant MRC Global 6075 Poplar Ave. Memphis, Tennessee 38119

Re: K191362

Trade/Device Name: LifeFlow® Blood System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 14, 2020 Received: May 15, 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.

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

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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 (QS) 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 Tina Kiang Ph.D. 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) K191362

Device Name LifeFlow® Blood System

#### Indications for Use (Describe)

The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a containt's vascular system. These devices may be used for any adult or pediatric patient, greater than 28 days old and greater than 3kg, with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy.

The delivery of blood products is intended for patients requiring volume replacement for hemorrhagic shock or lifethreatening bleeding.

*Capable of rates greater than 100ml/min

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

LifeFlow® Blood System K191362 May 19, 2020

| Company: | 410 Medical, Inc.<br>201 West Main St, Suite 207, Durham, NC 27701<br>Phone: [phone] |
|--------------------------------|---------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | 3012969104 |
| Primary Contact: | Danielle Besal<br>Principal Consultant MRC Global<br>Phone: [phone] |
| Trade Name: | LifeFlow® Blood System |
| Common Name: | IV Administration Set |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.5440 |
| Panel: | General Hospital |
| Product Code: | FPA |
| Predicate Device: | LifeFlow™ Rapid Infusion System (K153731) |
| Reference Device: | IV Administration Sets with 200µm Blood Filter (K143082) |

### Device Description:

The LifeFlow® Blood System is a single use, disposable, intravenous administration set that is intended to deliver blood, blood components (red blood cells or plasma), and IV fluids from a container to a patient's vascular system rapidly using a hand pump. The set includes the handle, syringe, and tubing. The blood tubing features two IV spikes with roller clamps, blood filter chamber, force reduction tubing, and luer connector.

#### Indications for Use:

The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a container to a patient's vascular system. These devices may be used for any adult or pediatric patient greater than 28 days old and greater than 3kg with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy.

The delivery of blood products is intended for patients reguiring volume replacement for hemorrhagic shock or life-threatening bleeding.

*Capable of rates greater than 100ml/min

#### Technological Characteristics Summary:

The subject LifeFlow® Blood System is substantially equivalent to the predicate device: LifeFlow™ Rapid Infusion System. The subject device components are similar to the predicate in terms of intended use,

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geometry, and materials. The handle and syringe components are identical to the predicate, while the tubing differs to accommodate delivery of blood and blood components (red blood cells or plasma). The table below provides a comparison of technological characteristics. The minor differences in technological characteristics do not raise new questions of safety or effectiveness.

| | SUBJECT | PREDICATE | REFERENCE | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LifeFlow® Blood<br>System<br>K191362 | LifeFlow™ Rapid<br>Infusion Device<br>(K153731) | IV Administration<br>Sets with 200 μm<br>Blood Filter<br>(K143082) | Discussion | |
| Product Code<br>Intended Use | FPA<br>Administration of<br>blood, blood<br>components (red<br>blood cells or<br>plasma), &<br>crystalloid and<br>colloid resuscitative<br>fluids | FPA<br>Administration of<br>crystalloid and<br>colloid resuscitative<br>fluids | FPA<br>Administration of<br>blood, blood<br>components, & IV<br>fluids | Identical<br>Difference in<br>compatible fluids;<br>however, use of the<br>product remains<br>identical to the<br>predicate. Reference<br>device is intended for<br>use with blood and<br>blood components. | |
| Indications for Use | The LifeFlow®<br>Blood System is an<br>intravenous<br>administration set<br>that is intended for<br>the rapid* delivery<br>of blood, blood<br>components (red<br>blood cells or<br>plasma), and<br>crystalloid and<br>colloid resuscitative<br>fluids from a<br>container to a<br>patient's vascular<br>system. These<br>devices may be<br>used for any adult<br>or pediatric patient,<br>greater than 28<br>days old and<br>greater than 3kg,<br>with consideration<br>given to adequacy<br>of vascular<br>anatomy,<br>appropriateness for<br>the solution being<br>infused, and<br>duration of<br>therapy. | The LifeFlow™<br>Rapid Infusion<br>Device is an<br>intravenous<br>administration set<br>with Handle<br>intended for rapid*<br>delivery of fluids<br>from a container<br>into a patient's<br>vascular system.<br>The device is<br>intended to deliver<br>only crystalloid and<br>colloid resuscitative<br>fluids. These<br>devices may be<br>used for any<br>pediatric or adult<br>patient population<br>with consideration<br>given to adequacy<br>of vascular<br>anatomy,<br>appropriateness for<br>the solution being<br>infused and<br>duration of<br>therapy. *Capable<br>of rates greater<br>than 150 mL/min | The IV<br>Administration<br>Sets with 200μm<br>Blood Filter are<br>used to deliver<br>blood, blood<br>components, and<br>IV fluids from a<br>container to a<br>patient's vascular<br>system. When the<br>hand pump<br>component is<br>activated, the<br>device is intended<br>to deliver blood,<br>blood products<br>and crystalloid<br>and colloid<br>resuscitative<br>fluids. These<br>devices may be<br>used for any<br>patient<br>population with<br>consideration<br>given to adequacy<br>of vascular<br>anatomy and<br>appropriateness<br>for the solution<br>being infused and | Difference to the<br>addition of blood and<br>blood components as<br>compatible fluids;<br>however, the use of<br>the product remains<br>identical to the<br>predicate. Identical<br>to the subject device,<br>the reference device<br>is indicated for<br>delivery of blood and<br>blood components.<br>Difference in<br>quantified flow rate<br>versus predicate;<br>however, the<br>indicated subject<br>device flow rate is<br>supported by<br>performance testing.<br>Both subject and<br>predicate devices are<br>indicated for similar<br>patient populations.<br>The subject device<br>provides a more<br>specific patient<br>population than the<br>predicate. | |
| The delivery of<br>blood products is<br>intended for<br>patients requiring<br>volume<br>replacement for<br>hemorrhagic shock<br>or life-threatening<br>bleeding.<br>*Capable of rates<br>greater than<br>100mL/min. | | | through a 20G<br>needle. | the duration of<br>therapy. | |
| Patient Population | Adults & pediatrics<br>(greater than 28<br>days old and<br>greater than 3kg) | | Adults & pediatrics | | Same as the<br>predicate with<br>additional<br>clarification of<br>pediatrics definition<br>for subject device,<br>which aligns with the<br>patient populations<br>evaluated in the<br>subject device<br>performance testing. |
| Uses | Single | | Identical | | Identical to predicate |
| Administration<br>Method | Hand pump<br>activation | | Identical | | Identical to predicate |
| Hand Pump Design | Handle actuates a<br>syringe to deliver<br>fluid, which<br>automatically refills<br>when handle is<br>released | | Identical | | Identical to predicate |
| Biocompatibility | ISO 10993-1 | | ISO 10993-1 | | Identical to predicate |
| Sterilization Method | Gamma (tubing set<br>only, handle is non-<br>sterile) | | Identical | | Identical to predicate |
| Sterility Assurance<br>Level (SAL) | 10-6 | | Identical | | Identical to predicate |
| Components | | | | | |
| Blood<br>Filter | Material | Polyamide | N/A | Polyamide | Difference from<br>predicate due to<br>subject compatibility<br>with blood; however,<br>similar to reference<br>device. The minor<br>difference in filter<br>surface area versus<br>the reference device<br>does not raise<br>different questions<br>of safety or |
| | Pore Size | 200μm | | 200μm | |
| | Surface<br>Area | 40cm2 | | 60cm2 | |
| | | | | | effectiveness as the |
| | | | | | subject filter design |
| | | | | | complies with ISO |
| | | | | | 1135-4 and was |
| | | | | | verified through |
| | | | | | bench testing. |
| Tubing | Length | 84" | 60" | 85" | Identical diameters |
| | ID…