Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical, hand-pumped intravenous administration set and makes no mention of AI or ML technology.

Therapeutic

No.

The device is an intravenous administration set used for the rapid delivery of blood and fluids. It does not provide any therapeutic benefit itself, but rather facilitates the delivery of therapeutic substances (blood, blood components, resuscitative fluids).

Diagnostic

No

Explanation: The device is an intravenous administration set designed for the rapid delivery of blood, blood components, and fluids. Its purpose is therapeutic (delivery of substances to the patient), not diagnostic (identifying or characterizing a disease or condition).

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single use, disposable, intravenous administration set" that includes physical components like a handle, syringe, tubing, spikes, roller clamps, filter chamber, and luer connector. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the LifeFlow® Blood System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the delivery of blood, blood components, and fluids to a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
Device Description: The device is an intravenous administration set with components designed for fluid delivery (spikes, tubing, filter, pump). It does not perform any tests on biological samples in vitro (outside the body).
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The LifeFlow® Blood System's function is to administer substances into the body, which is a different category of medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 requiring volume replacement for hemorrhagic shock or life-threatening bleeding.

*Capable of rates greater than 100ml/min

Product codes (comma separated list FDA assigned to the subject device)

FPA

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.

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

adult or pediatric patient, greater than 28 days old and greater than 3kg

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)

Bench testing has verified the performance of the subject device is substantially equivalent to the predicate device. This testing included:

Design verification in compliance to the following FDA recognized standards:
- ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain o other medical equipment - Part 1: General requirements
- ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain o other medical equipment - Part 2: Lock fittings
- ISO 1135-4: 2015 Transfusion equipment for medical use, Part 4: Transfusion sets for o single use, gravity feed
Mechanical Hemolysis in comparison to the reference device
Functional testing included reliability, human packed red blood cell infusion capability, flow rate with LifeFlow® Handle activation
Human Factors usability testing
Guidance for Industry and FDA Staff – Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008

Biocompatibility evaluation was completed per ISO 10993-1, which included testing for cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, acute systemic toxicity, hemocompatibility, particulates, and risk assessment.

Sterilization testing were completed according to the FDA recognized ANSI/AAMI/ISO 11137-2:2013, Sterilization of healthcare products - Radiation - Part 2: Establishing the Sterilization Dose. Pyrogenicity (bacterial endotoxins), packaging, and shelf life testing were performed.

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.

LifeFlow™ Rapid Infusion System (K153731)

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.

IV Administration Sets with 200µm Blood Filter (K143082)

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

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.

Summary

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
201 West Main St, Suite 207, Durham, NC 27701
Phone: (844) 435-5450 |
|--------------------------------|---------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3012969104 |
| Primary Contact: | Danielle Besal
Principal Consultant MRC Global
Phone: (901)827-8670 |
| 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
System
K191362	LifeFlow™ Rapid
Infusion Device
(K153731)	IV Administration
Sets with 200 μm
Blood Filter
(K143082)	Discussion
Product Code
Intended Use	FPA
Administration of
blood, blood
components (red
blood cells or
plasma), &
crystalloid and
colloid resuscitative
fluids	FPA
Administration of
crystalloid and
colloid resuscitative
fluids	FPA
Administration of
blood, blood
components, & IV
fluids	Identical
Difference in
compatible fluids;
however, use of the
product remains
identical to the
predicate. Reference
device is intended for
use with blood and
blood components.
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 LifeFlow™
Rapid Infusion
Device is an
intravenous
administration set
with Handle
intended for rapid*
delivery of fluids
from a container
into a patient's
vascular system.
The device is
intended to deliver
only crystalloid and
colloid resuscitative
fluids. These
devices may be
used for any
pediatric or adult
patient population
with consideration
given to adequacy
of vascular
anatomy,
appropriateness for
the solution being
infused and
duration of
therapy. *Capable
of rates greater
than 150 mL/min	The IV
Administration
Sets with 200μm
Blood Filter are
used to deliver
blood, blood
components, and
IV fluids from a
container to a
patient's vascular
system. When the
hand pump
component is
activated, the
device is intended
to deliver blood,
blood products
and crystalloid
and colloid
resuscitative
fluids. These
devices may be
used for any
patient
population with
consideration
given to adequacy
of vascular
anatomy and
appropriateness
for the solution
being infused and	Difference to the
addition of blood and
blood components as
compatible fluids;
however, the use of
the product remains
identical to the
predicate. Identical
to the subject device,
the reference device
is indicated for
delivery of blood and
blood components.
Difference in
quantified flow rate
versus predicate;
however, the
indicated subject
device flow rate is
supported by
performance testing.
Both subject and
predicate devices are
indicated for similar
patient populations.
The subject device
provides a more
specific patient
population than the
predicate.
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.			through a 20G
needle.	the duration of
therapy.
Patient Population	Adults & pediatrics
(greater than 28
days old and
greater than 3kg)		Adults & pediatrics		Same as the
predicate with
additional
clarification of
pediatrics definition
for subject device,
which aligns with the
patient populations
evaluated in the
subject device
performance testing.
Uses	Single		Identical		Identical to predicate
Administration
Method	Hand pump
activation		Identical		Identical to predicate
Hand Pump Design	Handle actuates a
syringe to deliver
fluid, which
automatically refills
when handle is
released		Identical		Identical to predicate
Biocompatibility	ISO 10993-1		ISO 10993-1		Identical to predicate
Sterilization Method	Gamma (tubing set
only, handle is non-
sterile)		Identical		Identical to predicate
Sterility Assurance
Level (SAL)	10-6		Identical		Identical to predicate
Components
Blood
Filter	Material	Polyamide	N/A	Polyamide	Difference from
predicate due to
subject compatibility
with blood; however,
similar to reference
device. The minor
difference in filter
surface area versus
the reference device
does not raise
different questions
of safety or
	Pore Size	200μm		200μm
	Surface
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	0.094-0.170"	0.094-0.170"	0.120" & 0.190"	to predicate,
	Material	Non-DEHP PVC &	Non-DEHP PVC	PVC	increase in length for
		TPE			compatibility with
					blood (similar to
					reference device).
Air Chamber (Air		Yes	No		Difference due to
Check)					addition of air
					chamber versus the
					predicate. Reference
					device has a drip
					chamber; whereas,
					the subject device air
					chamber will stop
					the flow of air if it
					enters the chamber;
					however, does not
					raise new questions
					of safety and
					effectiveness.
Force Reduction		Yes	No		Difference from
Tubing (Force					predicate; however,
Reducer)
					does not raise new
					questions of safety or
					effectiveness and
					subject device has
					been verified to yield
					substantially
					equivalent
					performance to
					predicate and
					reference devices.
Spikes		2	1	2	Identical to predicate
					spikes, only
					difference is in
					quantity to allow use
					with two bags, which
					is the same as the
					reference device.
Clamps		2 roller clamps & 1	1 pinch clamp	3 roller clamps	Difference due to
		pinch clamp			subject device ability
					to connect to two IV
					bags, similar to the
					reference device.
					The pinch clamp
					component is

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7

| | | | identical to that of
the predicate device
Two roller clamps
were added, which
matches the 3 total
clamps of the
reference device.
This minor change
does not raise new
questions of safety or
effectiveness. |
|----------------------------------|-----|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dual check valve | Yes | Yes | Identical to predicate |
| Luer connector | Yes | Yes | Identical to predicate |
| Needleless access Y
connector | Yes | Yes | Identical to predicate |

Difference In Technology:

. Air chamber - The subject device contains an air chamber ('AirCheck™') to prevent air from being delivered to the patient. AirCheck™ is located on the inlet tubing and assists the user in stopping the infusion if air trapped in the fluid bag enters the tubing. If a significant amount of air (approximately 20mL) enters the tubing, the ball float within AirCheck™ descends and forms a seal at the bottom of the chamber ('activates'). This activation prevents the LifeFlow® syringe from refilling and the handle from moving further (which provides a tactile indication to the user), while causing the flow of fluid to cease. The AirCheck™ chamber may be squeezed to purge any small volume of air. Since the subject device design requires constant user engagement, it has the advantage of the user immediately observing any activation of AirCheck™.
Force Reduction mechanism - The subject device's force reduction tubing, also known as the Force Reducer, allows for a more consistent flow of fluid through the IV catheter while the LifeFlow® Handle is cycled. The Force Reducer is a section of flexible tubing located in the outlet tubing that is designed to decrease the peak force applied by the user and reduce the peak pressure applied to fluid being infused. The Force Reducer is a passive mechanism that does not require conscious effort from the user to operate.
. Blood filter - The subject device blood chamber on the inlet tubing whereby blood enters and passes through a filter before flowing through the remaining tubing for administration to the patient. The filter is made from polyamide with a 200μm pore size and 40cm² surface area. The filter is compliant to section 5.6 of ISO 1135-4:2015 regarding filters for blood and blood components.

Performance Testing Summary:

Bench testing has verified the performance of the subject device is substantially equivalent to the predicate device. This testing included:

. Design verification in compliance to the following FDA recognized standards:
- ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain o other medical equipment - Part 1: General requirements
- ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain o other medical equipment - Part 2: Lock fittings

8

ISO 1135-4: 2015 Transfusion equipment for medical use, Part 4: Transfusion sets for o single use, gravity feed
Mechanical Hemolysis in comparison to the reference device
Functional testing included reliability, human packed red blood cell infusion capability, flow rate with LifeFlow® Handle activation
Human Factors usability testing
Guidance for Industry and FDA Staff – Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008

Biocompatibility

A biocompatibility evaluation was completed per ISO 10993-1, which included testing for cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, acute systemic toxicity, hemocompatibility, particulates, and risk assessment.

Sterilization

The LifeFlow® Handle is not sterile, but the tubing is gamma sterilized. Sterilization testing were completed according to the FDA recognized ANSI/AAMI/ISO 11137-2:2013, Sterilization of healthcare products - Radiation - Part 2: Establishing the Sterilization Dose. Pyrogenicity (bacterial endotoxins), packaging, and shelf life testing were performed.

Substantial Equivalence Conclusions:

In conclusion, there are no changes in the use of the subject device compared to the predicate and the minor design changes do not raise new questions of safety and effectiveness; thus, the is substantially equivalent to the predicate.