EVA TPN BAG

K101412 · Valmed S.R.L. · KPE · Apr 13, 2011 · General Hospital

Device Facts

• Record ID: K101412
• Device Name: EVA TPN BAG
• Applicant: Valmed S.R.L.
• Product Code: KPE · General Hospital
• Decision Date: Apr 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Intended Use

The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

Device Story

EVA TPN bags are empty containers used for compounding and storing sterile parenteral nutrition solutions. The bags, ranging from 150 mL to 5000 mL, are constructed from ethylene vinyl acetate (EVA) copolymer. They feature a medication port and are supplied with either single-lead or three-lead transfer sets made of PVC. During use, the bag is filled by connecting to a source container via the transfer set; once filled, the bag is sealed using non-reopening clamps. The container is then attached to an intravascular administration set for patient delivery. The device is intended for single-use and is discarded after administration. It is used in clinical settings by healthcare professionals to manage patient nutrition. The EVA material is selected to preserve fat stability in nutritional blends. The device provides a sterile, biocompatible, and phthalate-free environment for solution storage.

Clinical Evidence

Bench testing only. The device underwent biological, chemical, and physical testing to demonstrate compliance with ISO 15747:2003 (Plastics containers for intravenous injection). Functional testing confirmed correct operation. No clinical data was required or provided.

Technological Characteristics

Materials: Ethylene vinyl acetate (EVA) bag, phthalate-free; PVC tubing with DEHP plasticizer or DEHP-free PVC. Capacity: 150 mL to 5000 mL. Features: Medication port, single or three-lead transfer sets, non-reopening clamps. Sterilization: Ethylene oxide (ETO) to SAL 10^-6. Biocompatible. Complies with ISO 15747:2003.

Indications for Use

Indicated for compounding and storage of parenteral nutrition solutions prior to and during administration to a patient via an intravascular administration set.

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

• B.BRAUN MEDICAL INC.: EVA TPN Container (K041415)
• BAXTER HEALTHCARE CORPORATION: ALL-IN-ONE CONTAINER (K090096, K983294)

Submission Summary (Full Text)

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510(K) NOTIFICATION

EVA TPN bags

101412

- ۱۰

APR 1 3 2011

# 510 (k) Summary of safety and effectiveness

#### SUBMITTER INFORMATION

- A. Company Name: Valmed s.r.l.
- в. Company Address: Via Provinciale, 10 Mazzo di Valtellina (SO), Italy 23030
- ். Company Phone: [phone] Company Fax: [phone]
- D. Contact Person: Walter Svanosio QA Manager Valmed s.r.l. E-mail: [e-mail]
- E. Date Summary Prepared: March 14, 2011

## DEVICE IDENTIFICATION

- A. Device name: EVA TPN bag B. Trade/Proprietary Name: EVA TPN bag ். I.V. Container, General Hospital (21 CFR §880.5025) Classification name: Product Code: KPE D.
#### LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

- B.BRAUN MEDICAL INC .: EVA TPN Container, K041415 -
- BAXTER HEALTHCARE CORPORATION: ALL-IN-ONE CONTAINER, K090096, -K983294

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## DEVICE DESCRIPTION

The EVA TPN bags are empty containers for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

The empty bags are filled by connecting them to containers through standard spikes .A transfer set in different configurations, ranging from one-lead to three-lead sets, can be provided with the empty bag. The bags are clamped after filling by means of non-reopening clamps. Additional medications can be added to the container using a medication port. After filling, the containers can be attached to an intravascular administration set via the set port. The bags range in volume capacity from 150 mL to 5000 mL. The bag is discarded after use

The EVA TPN bags are made of a copolymer of ethylene and vinyl acetate. The tubings of the transfer set are made of a polyviny! chloride material.

#### INTENDED USE

The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

#### SUBSTANTIAL EQUIVALENCE

Following comparison chart summarizes the technological characteristics of the Eva TPN bags compared with those of the predicate devices:

| ATTRIBUTE /<br>CHARACTERISTICS | EVA TPN bag<br>(Submitted Product) | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>B. Braun Medical Inc. | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>Baxter Healthcare<br>Corporation |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 'K" numbers | K | K041415 | K090096, K983294 |
| Proprietary / Trade<br>Name | | EVA TPN Container | All-In-One Container |
| CFR Section | 880.5025 | SAME | SAME |
| Pro-code | KPE | SAME | SAME |
| Classification name | I.V. container | SAME | SAME |
| Intended /<br>Indications For Use | The EVA TPN bag is for use<br>in compounding and<br>storage of parenteral<br>nutrition solutions prior to<br>and during administration to<br>a patient using an<br>intravascular administration<br>set. | The EVA TPN container is<br>for use in compounding and<br>storage of parenteral<br>nutrition solutions prior to<br>and during administration to<br>a patient using an<br>intravascular administration<br>set. | The All-In-One Container is<br>intended for use in the<br>compounding and storage<br>of parenteral nutrition<br>solutions prior to and during<br>intravascular administration<br>to a patient. |

Confidential

Section 14 Summary of safety and effectiveness rev 2

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VALMED s.r.l.

#### 510(K) NOTIFICATION

EVA TPN bags

| ATTRIBUTE / | EVA TPN bag | LEGALLY MARKETED | LEGALLY MARKETED |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTICS | (Submitted Product) | PREDICATE DEVICES OF | PREDICATE DEVICES OF |
| | | B. Braun Medical Inc. | Baxter Healthcare |
| | | | Corporation |
| 'K" numbers | K | K041415 | K090096, K983294 |
| Description | Bags are made of Ethylene<br>vinyl acetate (EVA) to<br>preserve the stability of fat.<br>in the nutritional blend<br>longer. The presentations<br>are available in volume<br>capacity from 150ml to<br>5000ml | Ethylene vinyl acetate<br>(EVA) is a suitable material<br>to preserve the stability of<br>fat in the nutritional blend<br>longer. The bags for the<br>preparation of PN B Braun<br>sold in USA are<br>manufactured in EVA and<br>presentations are available<br>in volume capacity from<br>250ml to 4000ml | Ethylene vinyl acetate<br>(EVA) is a suitable material<br>to preserve the stability of<br>fat in the nutritional blend<br>longer. The bags for the<br>preparation of PN Baxter<br>sold in USA are<br>manufactured in EVA and<br>presentations are available<br>for up to 1L, 2L, 3L and 4L. |
| Bag material | EVA, phthalate-free ethyl<br>vinyl acetate plastic | EVA, phthalate-free ethyl<br>vinyl acetate plastic | EVA, phthalate-free ethyl<br>vinyl acetate plastic |
| Connector | Plastic, no components<br>made of natural rubber latex<br>(use of isoprene). | Plastic, no components<br>made of natural rubber latex<br>(isoprene). | Plastic, no components<br>made of natural rubber latex<br>(isoprene). |
| Injection site | Plastic, no components<br>made of natural rubber latex<br>(use of isoprene). | Plastic, no components<br>made of natural rubber latex<br>(isoprene). | Plastic, no components<br>made of natural rubber latex<br>(isoprene). |
| Tubing material | PVC with DEHP plasticizer<br>DEHP FREE PVC | PVC with DEHP plasticizer<br>DEHP FREE PVC | PVC |
| Transfer set | Three lead transfer set,<br>single lead transfer set | Three lead transfer set | Three lead transfer set,<br>single lead transfer set |
| Medication port | Yes | Yes | Yes |
| Biocompatible | Yes | Yes | Yes |
| Sterility | SAL 10-6, ETO | SAL 10-6 | SAL 10-6 |
| Single-use | Yes | Yes | Yes |

Materials and intended use of the EVA TPN bags and the predicate devices are essentially the same. Design is similar, depending on the various models and options. Valmed believes that there are no differences between the submitted product and the legally marketed predicate devices that arise issues of safety and effectiveness.

Based on the available 510(k) summaries, the marketing literature and the information provided herein, Valmed concludes that the EVA TPN bags are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

Confidential

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### NON CLINICAL TESTS SUMMARY

Biological, chemical and physical testing performed on the final product demonstrate that the device fulfills the requirements set out in International Standard ISO 15747:2003 Plastics containers for intravenous injection.

Functional testing showed correct operation of the device.

### CONCLUSIONS

Results of the non clinical and bench tests performed demonstrate safety and effectiveness of the devices. Based on the results of the testing performed, Valmed believes that the device is as safe and effective as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three stylized lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Walter Svanosio Quality Assurance Manager Valmed S.R.L Via Provinciale 10 Mazzo Di Valtellina (SO) ITALY 123030

Re: K101412

Trade/Device Name: EVA TPN Bags Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: March 21, 2011 Received: March 25, 2011

APR 1 3 2011

Dear Mr. Svanosio:

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. 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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Page 2 - Mr. Svanosio

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 reprting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasc go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Antrome V.m.

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

K101412

Device Name:

EVA TPN bags

Indications for Use:

The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ri C. Chape 4/13/14

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number K101412

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