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 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 polyvinyl chloride material.

AI/ML Overview

The provided text is a 510(k) summary for the EVA TPN bags. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed device performance results in the way clinical studies for diagnostic or AI-based devices would.

Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of medical device submission.

Here's an attempt to extract relevant information and explain why other parts are not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly that the device performs functionally and safely, demonstrating substantial equivalence to the predicate devices, as per the international standard ISO 15747:2003.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Fulfill requirements of ISO 15747:2003 (Plastics containers for intravenous injection)	"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."
Correct functional operation	"Functional testing showed correct operation of the device."
Safety and Effectiveness comparable to predicate devices	"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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document refers to "testing performed" and "biological, chemical and physical testing" on the final product, but does not provide numbers for items tested.
Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective). This refers to bench and non-clinical laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth for TPN bags (material safety, sterility, functional integrity) is established through standardized laboratory tests and adherence to international standards, not expert consensus on images or clinical cases.
Qualifications of Experts: Not specified, but implied to be standard laboratory personnel qualified to perform the cited tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is for clinical interpretation discrepancies, which is not relevant for materials and functional testing of TPN bags.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This device is a medical container, not a diagnostic imaging device or an AI algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This refers to an AI algorithm's performance, which is not relevant here. The device itself is standalone in terms of its function as a container.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on objective measurements and adherence to established international standards (ISO 15747:2003) for material properties (e.g., biocompatibility, specified materials like EVA, phthalate-free status), sterility (SAL 10-6), and functional performance (e.g., no leaks, proper connector function).

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no AI model being trained for this device. The "training" for a physical device involves design, manufacturing, and quality control processes to meet specifications.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable as there is no training set in the AI sense. The manufacturing processes and material selection are validated against industry standards and regulatory requirements, which serve as the "ground truth" for ensuring the product meets its design intent.

Summary

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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: +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

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DEVICE DESCRIPTION

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 MARKETEDPREDICATE DEVICES OFB. Braun Medical Inc.	LEGALLY MARKETEDPREDICATE DEVICES OFBaxter HealthcareCorporation
'K" numbers	K	K041415	K090096, K983294
Proprietary / TradeName		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 usein compounding andstorage of parenteralnutrition solutions prior toand during administration toa patient using anintravascular administrationset.	The EVA TPN container isfor use in compounding andstorage of parenteralnutrition solutions prior toand during administration toa patient using anintravascular administrationset.	The All-In-One Container isintended for use in thecompounding and storageof parenteral nutritionsolutions prior to and duringintravascular administrationto 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 Ethylenevinyl acetate (EVA) topreserve the stability of fat.in the nutritional blendlonger. The presentationsare available in volumecapacity from 150ml to5000ml	Ethylene vinyl acetate(EVA) is a suitable materialto preserve the stability offat in the nutritional blendlonger. The bags for thepreparation of PN B Braunsold in USA aremanufactured in EVA andpresentations are availablein volume capacity from250ml to 4000ml	Ethylene vinyl acetate(EVA) is a suitable materialto preserve the stability offat in the nutritional blendlonger. The bags for thepreparation of PN Baxtersold in USA aremanufactured in EVA andpresentations are availablefor up to 1L, 2L, 3L and 4L.
Bag material	EVA, phthalate-free ethylvinyl acetate plastic	EVA, phthalate-free ethylvinyl acetate plastic	EVA, phthalate-free ethylvinyl acetate plastic
Connector	Plastic, no componentsmade of natural rubber latex(use of isoprene).	Plastic, no componentsmade of natural rubber latex(isoprene).	Plastic, no componentsmade of natural rubber latex(isoprene).
Injection site	Plastic, no componentsmade of natural rubber latex(use of isoprene).	Plastic, no componentsmade of natural rubber latex(isoprene).	Plastic, no componentsmade of natural rubber latex(isoprene).
Tubing material	PVC with DEHP plasticizerDEHP FREE PVC	PVC with DEHP plasticizerDEHP 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

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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 (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

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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

Section 5

Page 5-2

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).