Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

K181393 · Valmed S.R.L. · KPE · Feb 15, 2019 · General Hospital

Device Facts

• Record ID: K181393
• Device Name: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
• Applicant: Valmed S.R.L.
• Product Code: KPE · General Hospital
• Decision Date: Feb 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Intended Use

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

Device Story

Empty EVA bag serves as a container for intravenous solutions; filled by connecting to solution-containing bottles via standard spikes/tubing; features injection port for medication additives and spike port for patient administration; secured with inviolable clamps after filling. Used in clinical settings by qualified staff. Device facilitates controlled fluid delivery to patients; ensures aseptic medication transfer. Single-use, sterile, non-reusable.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1, -4, -5, -7, -10, -11; ASTM F756), sterilization validation (ISO 11135-1), bacterial endotoxin/pyrogen testing (USP <85>, <161>, <151>), and performance testing (ISO 15747, ISO 8536-4, drug compatibility/stability with OLIOCLINOMEL N4-550E).

Technological Characteristics

Materials: EVA (bag body), ABS (connectors/caps), Polyisoprene/Polypropylene (injection port), PVC (spike port), Polypropylene (clamp). Sterilization: ETO (SAL 10^-6). Connectivity: None. Form factor: 150ml to 5000ml capacity bags. Standards: ISO 10993, ISO 11135-1, ISO 15747, ISO 8536-4, USP <85>/<161>/<151>.

Indications for Use

Indicated for use as an empty container for the administration of intravenous solutions to patients via an intravascular administration set. Intended for use by qualified staff.

Regulatory Classification

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.

Predicate Devices

• EVA TPN Bags (K101412)

Submission Summary (Full Text)

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February 15, 2019

Valmed SRL % Tiziana Baggio Consultant Studio Baggio Tiziana Via Marzia 9 Abano Terme, Padova 35031 Italy

Re: K181393

Trade/Device Name: Empty Eva Bag, models FVM0135BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: Class II Product Code: KPE Dated: January 16, 2019 Received: January 18, 2019

Dear Tiziana Baggio:

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181393

#### Device Name

Empty EVA Bag, models FVM0134BP, FVM0136BP , FVM0137BP, FVM0138BP, FVM0138BP, FVM0140BP, FVM0141BP

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary K181393

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/CommonName: Regulation number:

Regulationname: ProductCode: Panel:

#### PREDICATE DEVICE:

Valmedidentified the following legally marketed device as substantially equivalent: 0 EVA TPN Bags, Valmed S.R.L., K101412

### DEVICE DESCRIPTION:

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

The empty bags are filled by connecting them to containers - generally glass bottles closed by a pierceable membrane - containing one or more solutions through standard spikes and tubing. After filling, the transfer set is removed and the bags are clamped by means of inviolable clamps to secure the contents prior to their administration. To make the fluid outflow from the bag towards the patient, the container can be then attached to an intravascular administration set via the spike port and twist - off connector.

When the bag is already filled, other medications can be added using the injection port. The bags range in volume capacity from 150 ml to 5000 ml.

The device is sold sterile and cannot be re-used or re-sterilized; it is discarded after use. The Empty EVA Bag is intended for use by qualified staff.

Valmeds.r.l Via dell'Industria 3 23030 Tovo di Sant'Agata (SO) -Italy [phone] [phone] [e-mail] Tiziana Baggio [phone] [e-mail]

January 16, 2019

Empty EVA Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

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

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### INDICATIONS FOR USE:

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

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQU I VALENCE : In support of a substantial equivalence determination, hereunder is a comparison chart with the submitted device and the predicate device.

| Feature | EMPTY EVA BAG<br>(Submitted Product) | PREDICATE DEVICE | CONCLUSION |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K181393 | K101412 | |
| Proprietary /<br>Trade Name | Empty EVA Bag | EVA TPN Bags | |
| Manufacturer | VALMED S.R.L. | VALMED S.R.L. | |
| CFR Section | 880.5025 | 880.5025 | substantially equivalent |
| Product code | KPE | KPE | substantially equivalent |
| Classification | I.V.Container,GeneralHospital | I.V.Container,General | substantially equivalent |
| Indications For Use | The Empty EVA Bag is an empty container<br>used for administration of intravenous<br>solutions to the patient using an<br>intravascular administration set. Medication<br>transfer in and out of the container is done<br>using aseptic technique. | The EVA TPN bag is for use in<br>compounding and storage of parenteral<br>nutrition solutions prior to and during<br>administration to a patient using an<br>intravascular administration set. | The subject device and the<br>predicate device are similar in<br>their intended use, they are<br>both used in administration of<br>solutions to patient using an<br>intravascular administration<br>set. The IFU for general use of<br>the subject device – in<br>comparison to the narrower<br>IFU (parenteral nutrition<br>solutions) of the predicate<br>device - does not impact on<br>safety and effectiveness of the<br>device, as both the devices are<br>made of the same material. The<br>additional biocompatibility tests<br>performed on the subject<br>device to assess the<br>subacute/subchronic toxicity<br>endpoints as well as the variety<br>of non-clinical tests performed<br>on the Empty Eva Bags<br>demonstrate that the proposed<br>general IFU raises no<br>different safety and<br>effectiveness questions as<br>compared to its predicate<br>device. |
| Intended Users | Adequately trained staff | Adequately trained staff | substantially equivalent |
| Design | The EVA bags include an outflow tube<br>and a connector to the transfer set.<br>Additional medications can be added to the<br>container using the medication port. A<br>capsule closes the medication port after<br>use. The bags are clamped after filling by<br>means of inviolable clamps. | The TPN bag includes an outflow tube<br>and a connector to the transfer set.<br>Additional medications can be added to<br>the container using the medication port.<br>A capsule closes the medication port<br>after use. The bags are clamped after<br>filling by means of inviolable clamps. | The subject device and the<br>predicate device have the<br>same design, with fill port,<br>injection port for additional<br>medications, spike port for<br>administration and inviolable<br>clamp to be used after filling<br>the bag. |
| MATERIALS: | | | |
| Bag body | EVA (not made with plasticizer<br>Diethylhexylphthalate DEHP) | EVA (not made with plasticizer<br>Diethylhexylphthalate DEHP) | same |
| Female connector | ABS (Acrylonitrile Butadiene Styrene) | ABS (Acrylonitrile Butadiene Styrene) | same |
| Male cap | ABS | ABS | same |
| Injection port | ABS (not made with natural<br>rubber latex ), Polyisoprene,<br>Polypropylene | ABS (not made with natural<br>rubber latex ) Polyisoprene,<br>Polypropylene | same |
| Spikeport | PVC (not made with plasticizer<br>Diethylhexylphthalate DEHP) | PVC (not made with plasticizer<br>Diethylhexylphthalate DEHP) | same |
| Inviolable clamp | Polypropylene | Polypropylene | same |
| Biocompatibility | Meet requirements for ISO 10993-1 | Meet requirements for ISO 10993-1 | substantially equivalent |
| Sterilization | SAL 10-6, ETO | SAL 10-6, ETO | same |
| Reusable | No | No | same |
| Packing Blister<br>Pouch | Polyester / Polypropylene (PET / PP) -<br>medical grade paper | Polyester / Polypropylene (PET / PP) -<br>medical grade paper | same |

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### SUBSTANTIAL EQUIVALENCE DISCUSSION:

The Empty EVA Bags are same or similar in materials, design and intended use to the predicate device (K101412).

The indications for use for the predicate device (TPN solution) are narrow er in comparison to the proposed indications for use for the subject device (general intravenous solution). This difference in the indications for use between the subject device and the predicate devices 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.

Expanding the IFU from TPN to general use does not affect the safety and effectiveness of the device, as also proved by the additional biocompatibility tests performed on the subject device to assess the subacute/subchronic toxicity endpoints considering that patients may repeatedly use the Empty EVA Bag and its replacements for general intravenous solutions.

The non-clinical tests performed on the Empty Eva Bags demonstrate that the proposed general IFU raises no different questions of safety and effectiveness as compared to its predicate device.

The subject device has the same technological characteristics and design as the predicate device: 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 Empty EVA Bags cannot be used for more than 24 hours and are intended for use by qualified staff, just as the predicate device.

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#### DISCUSSION OF NON CLINICAL TESTS

Non clinical 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 the same as those used for the predicate device.

Biocompatibility has been tested according to the requirements of ISO 10993-1, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing"

The following biocompatibility tests were performed:

- Cytotoxicity, ISO 10993-5:2009: "Biological evaluation of medical devices Part 5: Tests for in o vitro cytotoxicity"
- ロ Sensitization and Intracutaneous reactivity, ISO 10993-10: 2010: "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"
- ם Haemolysis, ASTM F756-13: "Standard Practice for Assessment of Haemolytic Properties of Material
- Hemocompatibility, ISO 10993-4:2009: "Biological evaluation of medical devices Part 4: Selection ם of tests for interactions with blood"
- ם Subacute/Subchronic Toxicity, ISO 10993-11: "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity"

### Sterilization Validation:

Sterilization validation process was performed on the subject EVA Empty Bag according to Recognized Consensus Standard:

- AAMI / ANSI / ISO 11135-1:2014, Sterilization of health care products -Ethylene oxide Part 1: ロ Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The subject device was tested for EO and ECH residuals according to:

- ם ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals.
### Bacterial Endotoxin and Rabbit Pyrogen Testing:

LAL test was performed according to:

- USP 39th ed. 2016: <85> Bacterial Endotoxins Test 0
- ם USP 39th ed. 2016: < 161> Transfusion and infusion assemblies and similar medical devices
- ם USP 38 <151> Pyrogen Test
- ם ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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#### Performance tests:

The subject device was tested in order to verify compliance with:

- ロ ISO 15747:2010 "Plastic containers for intravenous injections", as follows: Resistance to temperature stability and pressure, Resistance to leakage, Transparency, Water vapour permeability, Removal of injection site protection ability, Tightness of the injection point, Tightness of the Hanger, Legibility of the characters, Particle Leak Test
- ロ ISO 8536-4:2013 "Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed"
- Evaluation of functional conformity in contact with "Sodium Chloride 0.9% water for injections"
- Evaluation of compatibility test (plastic migration) in contact with parenteral solution "ALL-IN-ONE solution" (OLIOCLINOMEL N4-550E-Baxter Healthcare)
- Evaluation of compatibility test (drug stability) in contact with parenteral solution "ALL-IN-ONE solution" (OLIOCLINOMEL N4-550E-Baxter Healthcare)

### CONCLUSION:

Valmed believes that the submitted Empty EVA bag is substantially equivalent in its intended use, design, component materials, function, biocompatibility, sterility assurance level and packaging to the currently cleared predicate device based on the supported nonclinical testing.