Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, materials, and sterile packaging of an empty bag for intravenous solutions. There is no mention of any computational or analytical functions, let alone AI/ML.

Therapeutic

No

The device is an empty container used for the administration of solutions, acting as a holding and delivery mechanism for therapeutic solutions rather than providing a therapeutic effect itself.

Diagnostic

No

Explanation: The device is described as an empty container for administering solutions, not for diagnosing conditions or diseases. Its function is to hold and facilitate the delivery of fluids, not to analyze or provide information about a patient's health status.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, sterile, flexible container (bag) made of plastic material with tubes and connectors for administering intravenous solutions. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the "administration of solutions to the patients using an intravascular administration set." This describes a device used in vivo (within the body) for delivering substances directly to a patient's bloodstream.
Device Description: The description details a container for holding and administering intravenous infusion solutions. This aligns with an in vivo application.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., outside the body.

Therefore, the Empty EVA Bag is an in vivo medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KPE

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.

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

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Nonclinical tests were conducted to demonstrate substantial equivalence to the predicate device.
Biocompatibility tests performed: Cytotoxicity, Sensitization and Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Systemic Toxicity, Material-Mediated Pyrogenicity, Bacterial Endotoxin (LAL test), Hemolysis direct and indirect.
Performance tests performed: Resistance to temperature, pressure and leakage, Resistance to leakage in storage, Resistance to dropping, Transparency, 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, Filling test, Visible Particulates in Injections, Particulate matter.
Package integrity tests performed: ISO 11607-1:2019, ASTM D4332-01 (2006), ASTM D4169-16, ASTM F1980-02.
Chemical testing performed: ISO 15747:2018, USP including 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.
Key Results: 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.

Key Metrics

Not Found

Predicate Device(s)

K193528

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 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)

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.

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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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:

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.

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:

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.

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 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. | 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. | Different
The subject device and the predicate
device are similar in their indications for
use, they are both used in
administration of solutions to patient
using an intravascular administration
set. The IFU for general use of the
subject device - in comparison to the
narrower IFU (parenteral nutrition
solutions) of the predicate device. Non-
clinical testing was performed to
demonstrate substantial equivalence.
The biocompatibility tests as well as the
functional and chemical tests performed
demonstrate that the proposed larger
IFU of the subject device raises no
additional safety and effectiveness
issues as compared to its
predicate device. |

5

| Design | The Empty EVA bag is provided in two
configurations:

with three tubes: a fill port to fill the
container, injection port for additions
of other medications and a spike port
to connect intravascular
administration set; after filling the bag
is clamped by means of non re-
opening clamp to secure the contents
before administration;
with one tube, used both for the
filling of the bag and the
administration of the solution to the
patient; after filling the bag is
clamped by means of a pinch clamp
and closed with the sealing cap to
secure the contents prior to
administration | The Empty EVA bag is provided
with three tubes: a fill port to fill
the container, injection port for
additions of other medications and
a spike port to connect
intravascular administration set.
After filling, the bag is clamped by
means of non re-opening clamp to
secure the contents before
administration. | Different
The 3-tube configuration of the subject
device has exactly the same
technological characteristics and design
of the predicate device, whereas the 1-
tube configuration of the subject device
has a different design. Biocompatibility
per ISO 10993-1, chemical and
performance testing per ISO
15747:2018, and luer connection per ISO
80369-7 were performed. The
performances of all models of the subject
device is substantially equivalent in terms
of critical performance characteristics to
the predicate device. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | EVA (Ethylene-vinyl acetate)
PVC (Polyvinyl Chloride)
ABS (Acrylonitrile butadiene styrene)
PP (Polypropylene)
SBC (Styrene Butadiene Copolymer)
MABS (Methyl Methacrylate Acrylonitrile
Butadiene Styrene)
Thermoplastic Elastomer
Yellow Dye
Blu Dye | EVA (Ethylene-vinyl acetate)
PVC (Polyvinyl Chloride)
ABS (Acrylonitrile butadiene styrene)
PP (Polypropylene)
SBC (Styrene Butadiene Copolymer)
MABS (Methyl Methacrylate Acrylonitrile
Butadiene Styrene)
Thermoplastic Elastomer | Different
The subject device includes some
different materials in comparison to the
predicate device, but they are all
materials largely used for other legally
marketed devices under the same
product code.
The biocompatibility and performance
testing shows that differences in
materials of construction do not raise any
questions 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 gamma
sterilized bags | Polyethylene (LDPE) for gamma
sterilized 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 ;
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
Particulate matter according to USP 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

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.