(328 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a container for parenteral nutrition, with no mention of AI or ML.
No
The device is an empty container used for compounding and storage of parenteral nutrition solutions, not for directly treating a disease or condition.
No
Explanation: The device is an empty container used for compounding and storage of parenteral nutrition solutions. It is not designed to diagnose any condition.
No
The device description clearly outlines a physical container (bag) made of specific materials (EVA copolymer) and associated hardware (tubing, clamps, ports). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set." This describes a container for preparing and holding solutions that will be directly administered to a patient's bloodstream.
- Device Description: The description details an empty bag for holding sterile medical solutions like parenteral nutrition. It describes how it's filled, how medications can be added, and how it connects to an administration set. This is consistent with a container for intravenous solutions.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the EVA TPN bag does not involve any such testing or analysis of bodily specimens.
- Predicate Devices: The listed predicate devices (K041415, K090096, K983294) are also described as containers for parenteral nutrition or "all-in-one" containers, further supporting that this device falls under the category of medical devices for administering solutions, not IVDs.
In summary, the EVA TPN bag is a container used in the preparation and administration of intravenous solutions, which is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KPE
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: +39 0342 052382 Company Fax: +39 0342 052383
- D. Contact Person: Walter Svanosio QA Manager Valmed s.r.l. E-mail: ag@valmedsrl.com
- 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
1
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 /
CHARACTERISTICS | EVA TPN bag
(Submitted Product) | LEGALLY MARKETED
PREDICATE DEVICES OF
B. Braun Medical Inc. | LEGALLY MARKETED
PREDICATE DEVICES OF
Baxter Healthcare
Corporation |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 'K" numbers | K | K041415 | K090096, K983294 |
| Proprietary / Trade
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 /
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. | The EVA TPN container is
for use in compounding and
storage of parenteral
nutrition solutions prior to
and during administration to
a patient using an
intravascular administration
set. | The All-In-One Container is
intended for use in the
compounding and storage
of parenteral nutrition
solutions prior to and during
intravascular administration
to a patient. |
Confidential
Section 14 Summary of safety and effectiveness rev 2
2
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 | ||
| vinyl acetate (EVA) to | |||
| preserve the stability of fat. | |||
| in the nutritional blend | |||
| longer. The presentations | |||
| are available in volume | |||
| capacity from 150ml to | |||
| 5000ml | Ethylene vinyl acetate | ||
| (EVA) is a suitable material | |||
| to preserve the stability of | |||
| fat in the nutritional blend | |||
| longer. The bags for the | |||
| preparation of PN B Braun | |||
| sold in USA are | |||
| manufactured in EVA and | |||
| presentations are available | |||
| in volume capacity from | |||
| 250ml to 4000ml | Ethylene vinyl acetate | ||
| (EVA) is a suitable material | |||
| to preserve the stability of | |||
| fat in the nutritional blend | |||
| longer. The bags for the | |||
| preparation of PN Baxter | |||
| sold in USA are | |||
| manufactured in EVA and | |||
| presentations are available | |||
| for up to 1L, 2L, 3L and 4L. | |||
| Bag material | EVA, phthalate-free ethyl | ||
| vinyl acetate plastic | EVA, phthalate-free ethyl | ||
| vinyl acetate plastic | EVA, phthalate-free ethyl | ||
| vinyl acetate plastic | |||
| Connector | Plastic, no components | ||
| made of natural rubber latex | |||
| (use of isoprene). | Plastic, no components | ||
| made of natural rubber latex | |||
| (isoprene). | Plastic, no components | ||
| made of natural rubber latex | |||
| (isoprene). | |||
| Injection site | Plastic, no components | ||
| made of natural rubber latex | |||
| (use of isoprene). | Plastic, no components | ||
| made of natural rubber latex | |||
| (isoprene). | Plastic, no components | ||
| made of natural rubber latex | |||
| (isoprene). | |||
| Tubing material | PVC with DEHP plasticizer | ||
| DEHP FREE PVC | PVC with DEHP plasticizer | ||
| DEHP FREE PVC | PVC | ||
| Transfer set | Three lead transfer set, | ||
| single lead transfer set | Three lead transfer set | Three lead transfer set, | |
| 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
3
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.
4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
INDICATIONS FOR USE
510(k) Number (if known):
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
Section 5
Page 5-2