The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) 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 device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad 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 already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.

AI/ML Overview

This document describes the premarket notification (510(k)) for the "Empty EVA Bag" device. It is not an AI/ML medical device submission, so the questions regarding AI/ML-specific study design (training/test sets, expert adjudication, MRMC studies) are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device ("Empty EVA Solution Container, Acta Medical, K121161") through non-clinical testing of the physical properties and biocompatibility of the device.

Here's an attempt to answer the questions based on the provided text, noting where AI/ML specific criteria do not apply:

1. A table of acceptance criteria and the reported device performance

The document does not provide explicit numerical acceptance criteria values for each performance test. Instead, it states that "All the necessary safety and performance tests in support of substantial equivalence to the predicate device were conducted" and implies that the device met the requirements of the listed standards and internal specifications. The "Conclusion" for each "Feature" in the "TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE" table effectively serves as the "reported device performance" in relation to the predicate.

Acceptance Criteria (Implied by standard compliance/internal spec)	Reported Device Performance (as stated in document)
Biocompatibility (ISO 10993-1, -4, -5, -10, -11)	Meet requirements for ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, Haemolysis, Subacute/sub-chronic systemic toxicity, Pyrogenicity performed)
Bag Volume Capacity (per internal specification)	Tests conducted, implies met internal specification.
Resistance to hot printing removal (per internal specification)	Tests conducted, implies met internal specification.
Hangar Tensile Force (Internal Specification)	Tests conducted, implies met internal specification.
Hydraulic seal and mechanical resistance of the non-re-opening clamp (per internal specification)	Tests conducted, implies met internal specification.
Particulate matter (USP<788>)	Tests conducted, implies met USP<788> requirements.
Sterility (SAL 10-6, ISO 11137-1, 11137-2)	SAL 10-6 via radiation. Tests conducted, implies met ISO requirements.
Package integrity (ISO 11607-1)	Tests conducted, implies met ISO 11607-1 requirements.
Design Similarity to Predicate	Similar in design to predicate (single chamber, fill port, injection port, spike port, inviolable clamp).
Material Safety	Includes additional materials, but they are "largely used for other legally marketed devices under the same product code." Biocompatibility and performance testing "show that differences in materials of construction do not raise any questions of safety or effectiveness."

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of bags tested for volume capacity, tensile strength, etc.). It only indicates that "Nonclinical tests were conducted."

Data provenance: The testing was conducted to support an FDA 510(k) submission, suggesting it was performed by the manufacturer (Haemotronic S.p.a. in Italy) or a qualified testing lab. The data would be prospective, as it was generated specifically for this submission to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of medical device submission. Ground truth in this context refers to meeting engineering and biocompatibility standards, not clinical diagnostic accuracy assessed by experts.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process for this type of non-clinical, physical, and biocompatibility testing. The "ground truth" is determined by established engineering and biological 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 not an AI/ML driven diagnostic device, and no human reader studies were conducted or required.

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

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 15747 for plastic containers, ISO 11137 for sterilization, ISO 11607 for packaging).
Compliance with internal specifications for various physical properties (Bag Volume Capacity, Resistance to hot printing removal, Hangar Tensile Force, Hydraulic seal and mechanical resistance of the non-re-opening clamp).
Pharmacopeial standards (USP<788> for Particulate Matter).

Essentially, the device meeting the specified quantitative and qualitative criteria defined by these standards and internal specifications constitutes the "ground truth" for its safety and performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set for an algorithm. Device manufacturing processes would involve quality control and validation using samples, but not like an AI training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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July 22, 2020

Haemotronic, S.p.a. Paola Franciosi QA Manager Via Carreri 16 Mirandola (Modena), 41037 Italy

Re: K193528

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: June 26, 2020 Received: July 1, 2020

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 Actinclude 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 (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-devices/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 (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 Payal Patel Acting 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

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Indications for Use

510(k) Number (if known) K193528

Device Name Empty EVA Bag

Indications for Use (Describe)

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

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

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510(k) Summary - K193528

Company Name:	Haemotronic S.p.a.
Company Address:	Via Carreri 1641037 - Mirandola (Modena)Italy
Company Phone:	+39 0535 619611
Company Fax:	+39 0535 619619
Company e-mail:	E-mail: regulatory@haemotronic.it
Official Contact for Correspondence:	Franciosi Paola - QA ManagerHaemotronic S.p.a.
Phone:	+39 0535 619632
E-mail:	E-mail: regulatory@haemotronic.it
Date Summary Prepared:	June 25, 2020
DEVICE IDENTIFICATION
Trade name:	Empty EVA Bag
Generic/ Common Name:	empty I.V. bag
Regulation number:	21 CFR §880.5025
Regulation name:	I.V. container.
Product Code:	KPE
Panel:	General Hospital

PREDICATE DEVICES:

Empty EVA Solution Container, Acta Medical, K121161

DEVICE DESCRIPTION:

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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, in material composition and technological characteristics. The minor differences in design and materials do not raise any concerns for safety and effectiveness.

Feature	EMPTY EVA BAG(Submitted Product)	PREDICATE DEVICE	CONCLUSION

K number	K193528	K121161
Proprietary /Trade Name	Empty EVA Bag	Empty EVA Solution Container
Manufacturer	HAEMOTRONICS.p.a.	ACTA MEDICAL
CFR Section	880.5025	880.5025	substantially equivalent
Product code	KPE	KPE	substantially equivalent
Classificationname	I.V. Container, General Hospital	I.V. Container, General Hospital	substantially equivalent
Indications forUse / IntendedUse	The Empty EVA Bag is an emptycontainer used for administration of TPN(Total Parenteral Nutrition) solutions tothe patient using an intravascularadministration set. Medication transferin and out of the container is done usingaseptic technique.	An Empty Container with sterile fluidpathway used to store intraven ou ssolution for administration topatient. Medication transfer in andout of the container is done usingaseptic technique	The subject device and the predicatedevice have a similar intended use; thesubject device has a narrower intendeduse in comparison to the predicatedevice: the specific solution (TPN)proposed for the intended use of thesubject device is included in the moregeneral indications stated for thepredicate device ('intravenoussolution'). This change of the subjectdevice into a specific use (TPN only) doe snot affect the safety and effectiveness ofthe subject device, as proved by the testsperformed on the subject device.
Design	The Empty EVA bag is provided withthree tubes: a fill port to fill thecontainer, injection port for additions ofother medications and a spike port toconnect intravascular administrationset. After filling, the bag is clamped bymeans of non-re-opening clamp tosecure the contents beforeadministration.	Empty EVA Solution Container hasa fill port to fill the container,injection port for additions ofinjectable additives and a spikeport to connect intravascularadministration tubing. The fill porttubing has a sealing clamp tosecure the contents duringstorage post filling and prior totheir administration.	The subject device is similar in design tothe predicate device (single chamber),with fill port, injection port for additionalmedications, spike port foradministration and inviolable clamp to beused after filling the bag. The subjectdevice and the reference device havethe same design.
Materials	EVA (Ethylene-vinyl acetate)PVC (Polyvinyl Chloride)ABS (Acrylonitrile butadiene styrene)PP (Polypropylene)SBC (Styrene Butadiene Copolymer)MABS (Methyl Methacrylate AcrylonitrileButadiene Styrene)Thermoplastic Elastomer	EVA,ABS,Silicone	substantially equivalentThe subject device includes additionalmaterials in comparison to the predicatedevice, but they are all materials largelyused for other legally marketed devicesunder the same product code.The biocompatibility and performancetesting show that differences in materials ofconstruction do not raise any questions ofsafety 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	substantially equivalent
Packing Pouch	Polyethylene (LDPE) for gammasterilized bags	Polyethylene terephthalate (PET)/paper	similar;the minor difference in the material ofthe pouches does not impact on safetyand effectiveness of the device, as theSterility assurance level is 10-6, the samecompared to the predicate device.

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The subject device and the predicate device have intended use. The indication for use of subject device is narrower and included in the indications for use of predicate device. The narrower indication for use of the subject device, which is within the scope of the predicate, does not raise any additional questions of safety and effectiveness.

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, but they are all materials largely used for other legally marketed devices under the same product code as the submitted Empty EVA bags.

Both the devices are comprised of ethylene vinyl acetate (EVA) which is a well know material used in the manufacturing of I.V. container bags, typically these types of bags are used for Total Parental Nutrition (TPN).

The subject device is similar in technological characteristics and design to the predicate device (in the single chamber configuration): both the devices include a tube and a connector to the transfer set, an inviolable clamp that closes the bag outflow after transfer, an injection port which allows injection of fluids when the bag is already filled and a spike port which allows the fluid to outflow from the bag towards the patient for administration.

The use of the subject device is limited to less than 24 hours and it is intended for qualified staff only, just as 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 with the applicable sections of the standards listed below:

Biocompatibility :

The materials used to manufacture the subject device are the same/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: 2009 Biological evaluation of medical devices, Evaluation and testing within a risk management process.

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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;
Haemolysis direct and indirect, ISO 10993-4:2009 "Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood"
Subacute/sub- chronic systemic toxicity according to ISO 10993-11" Biological evaluation of medical devices, Test for systemic toxicity"

Pyrogenicity - Material Mediated/Bacterial Mediated

Performance tests:

According to

-ISO 15747:2018 'Plastic containers for intravenous injections'

Bag Volume Capacity (per internal specification),
Resistance to hot printing removal (per internal specification),
Hangar Tensile Force Internal Specification
Hydraulic seal and mechanical resistance of the non-re-opening clamp (per internal specification ),
Particulate matter according to USP<788>Particulate Matter in Injection (Method 1)

Sterility:

Gamma Radiation per ISO 11137-1:2006 " Sterilization of health care products- Radiation- Patt 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO11137-2:2013" Sterilization of healthcare products- Radiation- Part 2: Establishing the sterilization dose

The package integrity was tested according to:

ISO 11607-1:2019 "Packaging for terminally sterilized medica devices Requirements for materials, sterile barrier systems and packaging systems"

CONCLUSION:

All the necessary safety and performance tests in support of substantial equivalence to the predicate device were conducted. The minor differences between the devices do not raise any new question s 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).