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.

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.

AI/ML Overview

The provided text describes the 510(k) submission for the SmartSite Bag, an empty IV container. It outlines the device's indications for use, comparison to a predicate device, and non-clinical tests conducted to demonstrate substantial equivalence. However, the document does NOT contain a formal "study" proving the device meets acceptance criteria in the sense of a clinical trial or a structured performance study with defined acceptance criteria and reported numerical performance measures like sensitivity, specificity, or accuracy for a diagnostic device.

Instead, the document details various engineering and biocompatibility tests designed to ensure the SmartSite Bag functions as intended and is safe for its stated use, thereby demonstrating equivalence to the predicate device. The acceptance criteria are implicitly met by passing these tests and standards.

Here's a breakdown of the information that is present, organized as requested where applicable, and noting where the requested information is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in a table format with corresponding numerical performance for the device for a specific clinical outcome. Instead, it lists various non-clinical tests and standards the device was evaluated against, implying that meeting these standards constitutes "acceptance."

Test Category	Specific Test/Standard	Acceptance Criteria (Implied by standard compliance)	Reported Device Performance
Biocompatibility	ISO 10993-1 (Evaluation and testing within a risk management process)	Acceptable biological risk demonstrated by meeting ISO 10993 requirements for contact characterization.	"Acceptable biological risk established by demonstrating that the device meets ISO 10993."
	- Extractable and Leachables testing and toxicological risk evaluation	Compliance with toxicological risk assessment.	Passed
	- Cytotoxicity	Non-cytotoxic.	Passed
	- Sensitization	Non-sensitizing.	Passed
	- Irritation or Intracutaneous Reactivity	Non-irritating.	Passed
	- Acute Systemic Toxicity	No acute systemic toxic effects.	Passed
	- Subacute/Subchronic Toxicity	No subacute/subchronic toxic effects.	Passed
	- Material-Mediated Pyrogenicity	Non-pyrogenic related to materials.	Passed
	- Hemocompatibility	Biocompatible with blood.	Passed
Bacterial Endotoxin	Bacterial Endotoxin testing	Endotoxin requirements of <0.5EU/mL.	Meets endotoxin requirements.
Sterilization	ANSI/AAMI/ISO 11137-1:2006/(R) 2015&A1 2013 (Sterilization of Health Care Products - Radiation - Part 1)	Sterility Assurance Level (SAL) of 10^-6.	"Sterilized using irradiation in accordance with a validated sterilization cycle." (SAL of 10^-6 reported as equivalent to predicate)
	ANSI/AAMI/ISO 11137-2:2013/(R) 2019 (Sterilization of Health Care Products - Radiation - Part 2)	Establishment of sterilization dose.	Referenced for validation.
	ANSI/AAMI/ISO TIR 13004:2013 (Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD)	Substantiation of selected sterilization dose.	Referenced for validation.
Performance Testing	ISO 15747 (2018) Plastic containers for intravenous injections	Compliance with relevant sections for plastic containers for IV injections.	"Tested to verify compliance with relevant sections."
Particulate Testing	USP <788>	Meets particulate requirements.	"Tested to demonstrate the product meets particulate requirements."
Additional Testing	- Maintenance of performance requirements after infusate exposure	Maintained performance after exposure.	Passed
	- Luer connection performance	Acceptable Luer connection performance.	Passed
	- Bag integrity (leakage)	No leakage.	Passed
	- Performance after simulated shipping	Maintained performance after simulated shipping.	Passed
	- Shelf life	Maintained performance for specified shelf life.	Passed
	- SmartSite Microbial Ingress Testing	No microbial ingress.	Passed

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for each test in a numerical format (e.g., "n=X bags"). It refers to "testing" performed. The data provenance is internal to Gilero, LLC as it refers to non-clinical laboratory testing. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not available in the document. The tests described are non-clinical, laboratory-based evaluations against established standards (e.g., ISO, USP), not assessments requiring expert "ground truth" establishment in a diagnostic context.

4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the tests are objective, laboratory-based measurements against defined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (IV bag), not an AI/diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (IV bag), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established industry standards and specifications (e.g., ISO 10993, USP <788>, ISO 15747, and internal performance specifications for factors like leakage, Luer connection, and shelf life).

8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning product that requires a training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.

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)

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:

Indications for Use:

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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 ofEquivalence
Device Class	II	II	Equivalent
DeviceClassificationName	I.V. Container	I.V. Container	Equivalent
RegulationNumber	21 CFR 880.5025	21 CFR 880.5025	Equivalent
Product Code	KPE	KPE	Equivalent
Indications for use	The SmartSite™ Bag is anempty container used foradministration of intravenoussolutions to the patient using anintravascular administration set.Medication transfer in and outof the container is done usingaseptic technique.	The Empty EVA Bag is anempty container used foradministration ofintravenous solutions to thepatient using anintravascular administrationset. Medication transfer inand out of the container isdone using aseptictechnique.	EquivalentThe indications for use ofthe Subject SmartSite™Bag and predicate deviceare identical
Intended use	The SmartSite™ Bag is anempty container used foradministration of intravenoussolutions to the patient using anintravascular administration set.Medication transfer in and outof the container is done usingaseptic technique.	The Empty EVA Bag is anempty container used foradministration ofintravenous solutions to thepatient using anintravascular administrationset. Medication transfer inand out of the container isdone using aseptictechnique.	EquivalentThe intended use for theSubject SmartSite™ Bagis identical to thepredicate and is also thesame as the indicationsfor use.
Intended Users	Pharmacists, pharmacytechnicians, hospital staffnurses, and homecare nurses	Adequately trained staff	Equivalent.Both the subject deviceand the predicate deviceare intended to be used bypersonnel appropriatelytrained and authorized touse bags for medicationpreparation and delivery.
Principles ofOperation	Empty bags are filled byconnecting to containerscontaining one or moresolutions through the add port.The self-closing add port doesnot require clamping to securethe contents. Contents aresecured through the passiveaction of the add port.IV sets can be attached to the	Empty bags are filled byconnecting to containerscontaining one or moresolutions through standardspikes and tubing.After filling, the bags areclamped to secure thecontents prior toadministration.IV sets are attached throughthe spike port and twist-off	Equivalent.Both the subject deviceand predicate device arefilled by the user throughan add port. The subjectdevice contains a singleadd port; whereas thepredicate device containstwo add ports.Both the subject deviceand predicate device can
Device Attribute	SUBJECT: [Gilero]SmartSite™ Bag	PREDICATE: [Valmed]Empty EVA Bag	Assessment ofEquivalence
	facilitate delivery of themedication to the patient.	connector.	contain a spike port toconnect an IVadministration set fordelivery of the medicationto the patient. The subjectdevice also allows theuser to connect the IVadministration set to theadd port.
			These differences presentno new questions ofsafety or effectivenesswhen compared to thepredicate, since both thesubject and predicatedevices provide amechanism for safe fillingof the bag andadministration of themedication to the patientusing an IVadministration set.
Technology andDesign	The device includes a spikeport and the add port. The addport allows for medication(s) tobe added to the bag. An IVadministration set can beconnected to the bag todispense medication.	The EVA bags include anoutflow tube and aconnector to the transfer set.Additional medications canbe added to the containerusing the medication port.A capsule closes themedication port after use.The bags are clamped afterfilling by the means ofinviolable clamps. An IVset is connected to the bagto dispense medications.	Equivalent.Both the subject andpredicate device includedesign features to allowthe user to fill the bag andattach an IVadministration set fordelivery of themedication.
Biocompatibility	Acceptable biological riskestablished by demonstratingthat the device meets ISO10993. See Section 15 –Biocompatibility.	Acceptable biological riskestablished bydemonstrating that thedevice meets ISO 10993	Equivalent.
Sterilization	SAL of 10-6	SAL of 10-6	Equivalent.
Reuse	Single-use only	Single-use only	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 <0.5EU/mL.

Sterilization Validation:

The SmartSite™ Bag is sterilized using irradiation in accordance with a validated sterilization cycle. The following standards were referenced during the sterilization validation process:

ANSI/AAMI/ISO 11137-1:2006/(R) 2015&A1 2013 Sterilization of Health Care Products-Radiation-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
· ANSI/AAMI/ISO 11137-2:2013/(R) 2019 Sterilization of Health Care Products-Radiation-Part 2: Establishing the sterilization dose
· ANSI/AAMI/ISO TIR 13004:2013 Sterilization of health care products -Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

Performance Testing:

The SmartSite™ Bag is tested to verify compliance with relevant sections of:

· ISO 15747 (2018) Plastic containers for intravenous injections

Particulate Testing:

The SmartSite™ Bag was tested to demonstrate the product meets particulate requirements of USP <788>

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.

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).