(216 days)
Not Found
No
The device is a simple empty bag for TPN administration and the description focuses on its physical properties and function, with no mention of AI/ML.
No.
The device is an empty container for holding TPN solutions, not a device that directly treats or diagnoses a medical condition.
No
Explanation: The device is described as an "empty container" or "empty flexible container (bag)" used for "administration of TPN (Total Parenteral Nutrition) solutions." Its function is to hold and facilitate the delivery of solutions to a patient, not to diagnose a condition.
No
The device description clearly describes a physical container (bag) made of EVA material with tubes and ports for filling and administration of solutions. There is no mention of any software component.
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 TPN solutions to a patient using an intravascular administration set. This is a direct interaction with the patient's body for therapeutic purposes (delivering nutrition).
- Device Description: The device is an empty container designed to hold and facilitate the delivery of solutions into the patient's bloodstream. It's a delivery system, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health condition, disease, or congenital abnormality. This is the core function of an IVD.
In summary, this device is a medical device used for the administration of therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
KPE
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.
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
qualified staff only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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 USPParticulate 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"
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K193528
Device Name Empty EVA Bag
Indications for Use (Describe)
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.
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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3
510(k) Summary - K193528
| Company Name: | Haemotronic S.p.a. |
|---|---|
| Company Address: | Via Carreri 16 |
| 41037 - 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 Manager |
| Haemotronic 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:
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.
4
INDICATIONS FOR USE:
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.
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 |
| Classification
name | I.V. Container, General Hospital | I.V. Container, General Hospital | substantially equivalent |
| Indications for
Use / Intended
Use | 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. | An Empty Container with sterile fluid
pathway used to store intraven ou s
solution for administration to
patient. Medication transfer in and
out of the container is done using
aseptic technique | The subject device and the predicate
device have a similar intended use; the
subject device has a narrower intended
use in comparison to the predicate
device: the specific solution (TPN)
proposed for the intended use of the
subject device is included in the more
general indications stated for the
predicate device ('intravenous
solution'). This change of the subject
device into a specific use (TPN only) doe s
not affect the safety and effectiveness of
the subject device, as proved by the tests
performed on the subject device. |
| Design | 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. | Empty EVA Solution Container has
a fill port to fill the container,
injection port for additions of
injectable additives and a spike
port to connect intravascular
administration tubing. The fill port
tubing has a sealing clamp to
secure the contents during
storage post filling and prior to
their administration. | The subject device is similar in design to
the predicate device (single chamber),
with fill port, injection port for additional
medications, spike port for
administration and inviolable clamp to be
used after filling the bag. The subject
device and the reference device have
the same design. |
| 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 | EVA,
ABS,
Silicone | substantially equivalent
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.
The biocompatibility and performance
testing show 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 | substantially equivalent |
| Packing Pouch | Polyethylene (LDPE) for gamma
sterilized bags | Polyethylene terephthalate (PET)/
paper | similar;
the minor difference in the material of
the pouches does not impact on safety
and effectiveness of the device, as the
Sterility assurance level is 10-6, the same
compared to the predicate device. |
5
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.
6
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 USPParticulate 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.