The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

Device Description

The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube:

bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.
bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.

AI/ML Overview

The provided text is a 510(k) summary for the Haemotronic S.p.a. Empty EVA Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested elements for an acceptance criteria study report are not explicitly available in the provided document.

However, I can extract the information related to the non-clinical tests performed to support the substantial equivalence claim, which serves a similar purpose in demonstrating device safety and performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with corresponding performance results in a table format. Instead, it lists standards the device meets or tests that were performed to confirm performance. The general acceptance criterion for all these tests is that the device meets the requirements of the specified standards, implying successful completion without adverse findings.

Acceptance Criteria (Implied from Standards Met)	Reported Device Performance
Biocompatibility: Meet requirements of ISO 10993-1 (covering Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Systemic Toxicity, Material-Mediated Pyrogenicity, Bacterial Endotoxin, Hemolysis)	The subject device meets requirements for ISO 10993-1. Specific tests performed: Cytotoxicity (ISO 10993-5), Sensitization and Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Subchronic Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (USP 43 <151>), Bacterial Endotoxin (USP 42 NF 37), Hemolysis (ISO 10993-4, ASTM F756-17).
Performance (per ISO 15747:2018): Resistance to temperature, pressure, leakage, dropping, transparency, cover, penetration ability of insertion port, adhesion strength, impermeability, tightness of injection point, tensile strength of hanger, identification legibility, resistance to hot printing removal, hydraulic seal, pneumatic seal, pinch clamp flow rate, UV transmission, mechanical resistance of bonding, impermeability for microorganisms.	Performed to confirm that differences in materials and technological characteristics do not affect safety or effectiveness. The document states "The performances of all models of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device."
Luer Connection: Meet requirements of ISO 80369-7	Performed and results support substantial equivalence.
Filling Test: (No specific standard mentioned, but a required test)	Performed.
Visible Particulates in Injections: Meet requirements of USP <790>	Performed.
Particulate Matter in Injections: Meet requirements of USP <788> (Method 1)	Performed.
Package Integrity: Meet requirements of ISO 11607-1, ASTM D4332-01, ASTM D4169-16, ASTM F1980-02	Tested according to these standards.
Chemical Testing (per ISO 15747:2018 & USP <643>): Requirements for raw container, test fluid, identification by FT-IR, Total Organic Carbon (TOC), DEHP analysis.	Performed.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the non-clinical tests. The data provenance is associated with laboratory testing to "demonstrate substantial equivalence," implying a prospective nature (testing performed specifically for this submission). The country of origin of the data is not specified, but the company is based in Italy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as the study is a non-clinical, laboratory-based testing of a medical device, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

This is not applicable for non-clinical, laboratory-based testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the performance of diagnostic devices or AI algorithms where human interpretation is a factor.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this is a purely physical medical device (an empty bag), not an algorithm or software-based device.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in documents like ISO 10993, ISO 15747, ISO 80369-7, and USP monographs. Compliance with these established scientific and regulatory benchmarks forms the basis of the "truth" for device performance.

8. The Sample Size for the Training Set:

This is not applicable. There is no training set as the device is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established:

This is not applicable. There is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.

August 19, 2021

Haemotronic S.p.a. Paola Franciosi QA Manager Via Carreri 16 Mirandola. 41037 Italy

Re: K210749

Trade/Device Name: Empty EVA Bag Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. container Regulatory Class: Class II Product Code: KPE Dated: July 16, 2021 Received: July 21, 2021

Dear Paola Franciosi:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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 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,

Paval Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210749

Device Name Empty EVA 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary - K210749

Company Name: Company Address:

Company Phone: Company Fax: Company e-mail: Official Contact for Correspondence:

Phone: E-mail:

Date Summary Prepared:

DEVICE IDENTIFICATION Trade name:

Generic/ Common Name: Regulation number:

Regulation name: Product Code: Panel:

Haemotronic S.p.a. Via Carreri 16 41037 - Mirandola (Modena) Italy +39 0535 619611 +39 0535 619619 E-mail: regulatory@haemotronic.it Franciosi Paola - QA Manager Haemotronic S.p.a. +39 0535 619632 E-mail: regulatory@haemotronic.it

August 18, 2021

Empty EVA Bag

I.V. Container 21 CFR §880.5025 Class II I.V. container KPE General Hospital

PREDICATE DEVICES:

Manufacturer: Haemotronic S.p.a.

Trade Name: Empty EVA Bag

510(k): K193528

DEVICE DESCRIPTION:

bag with 3 tubes:

The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.

{4}------------------------------------------------

- bag with 1 tube:

the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.

INDICATIONS FOR USE:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL E Q U I V A L E N C E:

The side by side comparison between the subject and the predicate device shows that the two devices are similar in indications for use and in technological characteristics, and substantially equivalent in material composition. The minor differences in design and materials do not raise any concerns for safety and effectiveness.

Feature	EMPTY EVA BAG(Submitted Product)	PREDICATE DEVICE	COMPARISON
510(k) Number	K210749	K193528
Proprietary /Trade Name	Empty EVA Bag	Empty EVA Bag
Manufacturer	HAEMOTRONIC S.p.a.	HAEMOTRONIC S.p.a.
Regulation Number	880.5025	880.5025	same
Product code	KPE	KPE	same
Classification name	I.V. Container	I.V. Container	same
Indications For Use	The Empty EVA Bag is an emptycontainer used for administration ofsolutions to the patients using anintravascular administration set.Medication transfer in and out of thecontainer is done using aseptictechnique.	The Empty EVA Bag is an emptycontainer used for administrationof TPN (Total Parenteral Nutrition)solutions to the patient using anintravascular administration set.Medication transfer in and out of thecontainer is done using aseptictechnique.	DifferentThe subject device and the predicatedevice are similar in their indications foruse, they are both used inadministration of solutions to patientusing an intravascular administrationset. The IFU for general use of thesubject device - in comparison to thenarrower IFU (parenteral nutritionsolutions) of the predicate device. Non-clinical testing was performed todemonstrate substantial equivalence.The biocompatibility tests as well as thefunctional and chemical tests performeddemonstrate that the proposed largerIFU of the subject device raises noadditional safety and effectivenessissues as compared to itspredicate device.

{5}------------------------------------------------

Design	The Empty EVA bag is provided in twoconfigurations:- with three tubes: a fill port to fill thecontainer, injection port for additionsof other medications and a spike portto connect intravascularadministration set; after filling the bagis clamped by means of non re-opening clamp to secure the contentsbefore administration;- with one tube, used both for thefilling of the bag and theadministration of the solution to thepatient; after filling the bag isclamped by means of a pinch clampand closed with the sealing cap tosecure the contents prior toadministration	The Empty EVA bag is providedwith three tubes: a fill port to fillthe container, injection port foradditions of other medications anda spike port to connectintravascular administration set.After filling, the bag is clamped bymeans of non re-opening clamp tosecure the contents beforeadministration.	DifferentThe 3-tube configuration of the subjectdevice has exactly the sametechnological characteristics and designof the predicate device, whereas the 1-tube configuration of the subject devicehas a different design. Biocompatibilityper ISO 10993-1, chemical andperformance testing per ISO15747:2018, and luer connection per ISO80369-7 were performed. Theperformances of all models of the subjectdevice is substantially equivalent in termsof critical performance characteristics tothe predicate device.
Materials	EVA (Ethylene-vinyl acetate)PVC (Polyvinyl Chloride)ABS (Acrylonitrile butadiene styrene)PP (Polypropylene)SBC (Styrene Butadiene Copolymer)MABS (Methyl Methacrylate AcrylonitrileButadiene Styrene)Thermoplastic ElastomerYellow DyeBlu Dye	EVA (Ethylene-vinyl acetate)PVC (Polyvinyl Chloride)ABS (Acrylonitrile butadiene styrene)PP (Polypropylene)SBC (Styrene Butadiene Copolymer)MABS (Methyl Methacrylate AcrylonitrileButadiene Styrene)Thermoplastic Elastomer	DifferentThe subject device includes somedifferent materials in comparison to thepredicate device, but they are allmaterials largely used for other legallymarketed devices under the sameproduct code.The biocompatibility and performancetesting shows that differences inmaterials of construction do not raise anyquestions of safety or effectiveness.
Biocompatibility	Meet requirements for ISO 10993-1	Meet requirements for ISO 10993-1	substantially equivalent
Sterilization	SAL 10-6, Radiation	SAL 10-6, Radiation	same
Reusable	No	No	same
Packing Pouch	Polyethylene (LDPE) for gammasterilized bags	Polyethylene (LDPE) for gammasterilized bags	same

The subject device and the predicate device have similar indications for use; the subject device is indicated for general fluids whereas the predicate device is indicated for TPN only: the Indications for Use (IFU) for the predicate device (TPN solution) are narrower in comparison to the proposed indications for use for the subject device (general intravenous solution).

This difference in the IFU between the subject and the predicate device is not critical since both the devices are empty containers made of Ethylene Vinyl Acetate (EVA) material intended for administration of solutions to patient using an intravascular administration set. EVA is a stable material generally used in the administration of IV solutions to patients in hospitals and pharmacies. Expanding the IFU from TPN to general use does not affect the safety and effectiveness of the device, as supported by Biocompatibility per ISO 10993-1, chemical and performance testing per ISO 15747:2018, and luer connection per ISO 80369-.

The materials used to manufacture the subject device are the same or similar to those used for the predicate device. The subject device includes additional materials in comparison to the predicate device; however, these differences do not raise new questions of safety and effectiveness as they have been assessed through biocompatibility testing.

The subject device with the 3-tube configuration has the same technological characteristics and design as the predicate device. The subject device also has a 1-tube configuration, where the filling of the bag and the administration of the solution to the patient are performed in the

{6}------------------------------------------------

same tube, this different design does not affect the basic design principle and usage of the subject device and does not raise additional safety and effectiveness issue compared to the predicate device.

SUBSTANTIAL EQUIVALENCE DISCUSSION:

DISCUSSION OF NONCLINICAL TESTS

Nonclinical tests were conducted to demonstrate substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the applicable sections of the standards listed below:

Biocompatibility:

The materials used to manufacture the subject device are similar to those used for the predicate device. All the materials used to manufacture the subject device are largely used for other legally marketed devices under the same product code.

Biocompatibility has been tested according to the requirements of

ISO 10993-1:2018 Biological evaluation of medical devices, Evaluation and testing within a risk management process.

The following biocompatibility tests were performed:

Cytotoxicity, ISO 10993-5: 2009 Biological evaluation of medical devices, Tests for in vitro cytotoxicity;
Sensitization and Intracutaneous Reactivity, ISO 10993-10: 2010 Biological

evaluation of medical devices, Tests for irritation and skin sensitization;

Acute Systemic Toxicity, ISO 10993-11:2017 Biological evaluation of medical devices, Tests for systemic toxicity:
Subchronic Systemic Toxicity, ISO 10993-11:2017 Biological evaluation of medical devices, Tests for systemic toxicity:
Material-Mediated Pyrogenicity, USP 43 <151>;
Bacterial Endotoxin (LAL test), USP 42 NF 37;
Hemolysis direct and indirect, ISO 10993-4: 2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood, ASTM F756-17

The subject device meets requirements for ISO 10993-1 as the predicate device.

Performance tests:

The following non-clinical tests were performed to confirm that differences in materials and technological characteristics do not affect the safety or effectiveness of the device:

ISO 15747:2018 Plastic containers for intravenous injections
Resistance to temperature, pressure and leakage
Resistance to leakage in storage
Resistance to dropping
Transparency

{7}------------------------------------------------

Cover
Penetration ability of the insertion port
Adhesion strength of the infusion device and impermeability of the insertion port
Tightness of the injection point
Tensile strength of the hanger
Identification legibility
Resistance to hot printing removal
Hydraulic seal and mechanical resistance of the non-re-opening clamp
Pneumatic seal of the pinch (on/off) clamp and tubing/clamp damage
Pinch (on/off) clamp flow rate
UV transmission
Mechanical resistance of bonding (tensile strength)
Impermeability for microorganisms
Luer Connection, ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Filling test
Visible Particulates in Injections according to USP <790>
Particulate matter according to USP <788> Particulate Matter in Injections (Method 1)

The package integrity was tested according to:

ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems
ASTM D4332-01 (2006) Standard Practice for Conditioning Containers, Packages, or Packaging Component for Testing
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages

Chemical testing according to:

-ISO 15747:2018 Plastic containers for intravenous injections
-USP <643>

The following tests were performed:

Requirements for the raw container or the sheeting (Sulphated ashes)
-Requirements for the test fluid
Identification by FT-IR spectrometry Total organic carbon (TOC)
DEHP (Di(2-ethylhexyl) phthalate) analysis quantification

CONCLUSION:

All the necessary safety and performance tests in substantial equivalence determination were conducted. The tests demonstrate that the subject Empty EVA Bag is substantially equivalent to the predicate device with respect to the intended use, target populations, treatment method, and technological characteristics.. The minor differences between the devices do not raise any new issues of safety or 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).