Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and intended use of an empty IV bag, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is an empty container for administering intravenous solutions, not a therapeutic agent itself. It serves as a delivery vehicle rather than providing any direct therapeutic effect.

Diagnostic

No

The device is an empty container used for the administration of intravenous solutions and medications, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical, single-use IV container (bag) with ports, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the SmartSite™ Bag is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the administration of intravenous solutions to a patient using an administration set. This is a direct therapeutic or delivery function, not a diagnostic one.
Device Description: The description focuses on its function as an empty container for holding and transferring fluids for patient administration.
Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Performance Studies: The performance studies listed are related to the physical and functional integrity of the bag for fluid administration (biocompatibility, sterility, leakage, etc.), not diagnostic accuracy or performance.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The SmartSite™ Bag's purpose is to facilitate the delivery of substances into the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

Product codes

KPE

Device Description

The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Pharmacists, pharmacy technicians, hospital staff nurses, and homecare nurses

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 tests were conducted:

Biocompatibility: Evaluated in accordance with ISO 10993-1, including Extractable and Leachables testing and toxicological risk evaluation, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Material-Mediated Pyrogenicity, and Hemocompatibility.
Bacterial Endotoxin: Demonstrated the product meets endotoxin requirements of .
Additional testing: Maintenance of performance requirements after infusate exposure, Luer connection performance, Bag integrity (leakage), Performance after simulated shipping, Shelf life, SmartSite Microbial Ingress Testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181393

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5025 I.V. container.

(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2021

Gilero, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K201936

Trade/Device Name: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. container Regulatory Class: Class II Product Code: KPE Dated: March 29, 2021 Received: March 30, 2021

Dear Prithul Bom:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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,

CAPT Alan Stevens Director (acting) 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) K201936

Device Name SmartSite™ Bag

Indications for Use (Describe)

The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

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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Image /page/3/Picture/0 description: The image shows the logo for Gilero. The logo consists of a geometric shape on the left and the word "Gilero" on the right. The geometric shape is a hexagon made up of smaller triangles in shades of blue and yellow. The word "Gilero" is written in a sans-serif font in a shade of blue that matches the triangles in the geometric shape.

510(k) Summary

Company Name:	Gilero, LLC
Company Address:	635 Davis Drive Suite 100
	Morrisville, NC 27560
Company Phone:	+1 (919) 595-8220
Official Contact:	Kristin Benokraitis
Phone:	+1 (919) 595-8223
E-mail:	kristinh@gilero.com

May 5, 2021 Submission Date:

Device Identification:

Trade Name:	SmartSite™ Bag
Common Name:	Container, I.V.
Device Class:	II
Regulation Number:	21 CFR 880.5025
Regulation Name:	I.V. Container
Product Code:	KPE
Review Panel:	General Hospital

Predicate Device:

Manufacturer:	Valmed s.r.l
Trade Name:	Empty EVA Bag
510(k):	K181393

Device Description:

The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.

Indications for Use:

The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

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Image /page/4/Picture/0 description: The image shows the logo for Gilero. The logo consists of a geometric shape on the left and the word "Gilero" on the right. The geometric shape is a hexagon with a smaller hexagon inside it, and it is colored in shades of blue, green, and yellow. The word "Gilero" is written in a sans-serif font and is colored in blue.

Technological Characteristics and Substantial Equivalence:

The following chart presents an overview of comparisons between the subject device (SmartSite™ Bag), and the predicate device (Valmed s.r.1 Empty EVA Bag):

| Device Attribute | SUBJECT: [Gilero]
SmartSite™ Bag | PREDICATE: [Valmed]
Empty EVA Bag | Assessment of
Equivalence |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II | Equivalent |
| Device
Classification
Name | I.V. Container | I.V. Container | Equivalent |
| Regulation
Number | 21 CFR 880.5025 | 21 CFR 880.5025 | Equivalent |
| Product Code | KPE | KPE | Equivalent |
| Indications for use | The SmartSite™ Bag is an
empty container used for
administration of intravenous
solutions to the patient using an
intravascular administration set.
Medication transfer in and out
of the container is done using
aseptic technique. | The Empty EVA Bag is an
empty container used for
administration of
intravenous solutions to the
patient using an
intravascular administration
set. Medication transfer in
and out of the container is
done using aseptic
technique. | Equivalent
The indications for use of
the Subject SmartSite™
Bag and predicate device
are identical |
| Intended use | The SmartSite™ Bag is an
empty container used for
administration of intravenous
solutions to the patient using an
intravascular administration set.
Medication transfer in and out
of the container is done using
aseptic technique. | The Empty EVA Bag is an
empty container used for
administration of
intravenous solutions to the
patient using an
intravascular administration
set. Medication transfer in
and out of the container is
done using aseptic
technique. | Equivalent
The intended use for the
Subject SmartSite™ Bag
is identical to the
predicate and is also the
same as the indications
for use. |
| Intended Users | Pharmacists, pharmacy
technicians, hospital staff
nurses, and homecare nurses | Adequately trained staff | Equivalent.
Both the subject device
and the predicate device
are intended to be used by
personnel appropriately
trained and authorized to
use bags for medication
preparation and delivery. |
| Principles of
Operation | Empty bags are filled by
connecting to containers
containing one or more
solutions through the add port.
The self-closing add port does
not require clamping to secure
the contents. Contents are
secured through the passive
action of the add port.
IV sets can be attached to the | Empty bags are filled by
connecting to containers
containing one or more
solutions through standard
spikes and tubing.
After filling, the bags are
clamped to secure the
contents prior to
administration.
IV sets are attached through
the spike port and twist-off | Equivalent.
Both the subject device
and predicate device are
filled by the user through
an add port. The subject
device contains a single
add port; whereas the
predicate device contains
two add ports.
Both the subject device
and predicate device can |
| Device Attribute | SUBJECT: [Gilero]
SmartSite™ Bag | PREDICATE: [Valmed]
Empty EVA Bag | Assessment of
Equivalence |
| | facilitate delivery of the
medication to the patient. | connector. | contain a spike port to
connect an IV
administration set for
delivery of the medication
to the patient. The subject
device also allows the
user to connect the IV
administration set to the
add port. |
| | | | These differences present
no new questions of
safety or effectiveness
when compared to the
predicate, since both the
subject and predicate
devices provide a
mechanism for safe filling
of the bag and
administration of the
medication to the patient
using an IV
administration set. |
| Technology and
Design | The device includes a spike
port and the add port. The add
port allows for medication(s) to
be added to the bag. An IV
administration set can be
connected to the bag to
dispense medication. | The EVA bags include an
outflow tube and a
connector to the transfer set.
Additional medications can
be added to the container
using the medication port.
A capsule closes the
medication port after use.
The bags are clamped after
filling by the means of
inviolable clamps. An IV
set is connected to the bag
to dispense medications. | Equivalent.

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Image /page/5/Picture/0 description: The image contains the logo for Gilero. The logo consists of a geometric shape on the left and the word "Gilero" on the right. The geometric shape is a hexagon made up of smaller triangles in shades of yellow, green, and gray. The word "Gilero" is written in a teal sans-serif font.

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Image /page/6/Picture/0 description: The image shows the logo for Gilero. The logo consists of a geometric shape on the left and the word "Gilero" on the right. The geometric shape is a hexagon with a smaller hexagon inside of it, and it is colored with a gradient of yellow, green, and blue. The word "Gilero" is written in a sans-serif font and is colored in teal.

Substantial Equivalence Discussion:

The SmartSite™ Bag is substantially equivalent to the predicate Valmed s.r.l. Empty EVA Bag. The subject device and the predicate device have identical indications for use, and a similar intended use. Both devices are labeled as sterile fluid path, and are single-use devices. Any difference in materials between the two products has been evaluated through ISO 10993 testing, which demonstrates material safety.

Both the subject and predicate devices include add ports, which allow the user to fill the bag. Similarly, both the subject device and predicate device include a means for attaching an IV administration set for delivering medication to the patient. The two primary technological differences between the subject and predicate devices are the number of add ports and their function. The predicate device contains two add ports. The first add port is for initial bulk fill of the bag. Since this port is designed only to be used once, it is not disinfectable, and is sealed using an inviolable clamp. The second add port is used for additional fill or additions (e.g. a drug is added to the initial fill of saline diluent).

The subject device has only a single add port. Since this port is disinfectable, however, it can be safely used multiple times. The empty SmartSite™ Bag can be filled with diluent using the add port, disinfected, and then the same port used to add a drug for dilution.

The second technological difference also arises from the add port. Since the subject device add port is disinfectable, and is co-located with the spike port relative to the filled drug in the bag, it can be used to administer the drug using an IV set equipped with a ISO 594 compatible male Luer.

Although the SmartSite™ Bag contains minor differences in design when compared to the predicate device these differences do not change the intended use and do not raise new questions of safety and effectiveness.

Discussion of Non-clinical Tests:

The following non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.

Biocompatibility:

The SmartSite™ Bag. like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (type and duration), in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:

Extractable and Leachables testing and toxicological risk evaluation ●
Cytotoxicity
Sensitization ●
Irritation or Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Subacute/Subchronic Toxicity ●
Material-Mediated Pyrogenicity ●

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Image /page/7/Picture/0 description: The image contains the logo for Gilero. The logo consists of a stylized hexagon shape on the left and the word "Gilero" on the right. The hexagon is colored with a gradient of yellow, teal, and gray. The word "Gilero" is written in a teal sans-serif font.

Hemocompatibility

Bacterial Endotoxin:

Bacterial Endotoxin testing was conducted to demonstrate the product meets endotoxin requirements of

Additional testing was conducted to demonstrate:

Maintenance of performance requirements after infusate exposure ●
Luer connection performance ●
Bag integrity (leakage)
Performance after simulated shipping
Shelf life ●
. SmartSite Microbial Ingress Testing

Conclusion

The information in this submission supports the safety and efficacy of the subject device for its intended use, and demonstrates substantial equivalence with the predicate device. The SmartSite"10 Bag differences in materials, technology and operation from the predicate device do not raise new questions about safety and effectiveness.