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.

Device Description

The All-In-One™ Container is an empty, EVA container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient. The container will be marketed in sizes ranging from 150 mL to 4000 mL. The proposed container is similar to Baxter Healthcare Corporation's currently marketed All-In-One™ Container cleared on June 10, 1994 under K932477.

There is one solution contact material in the proposed All-In-One™ Container which is new to Baxter. It is an ethy ene vinyl acetate (EVA) film which is used to fabricate the container body. The other solution materials used in the proposed device were previously tested and used in other Baxter devices for similar IV container applications.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified All-In-One™ Container:

No specific acceptance criteria or detailed study results are provided in the given 510(k) summary.

The document predominantly focuses on establishing substantial equivalence to a predicate device (K932477) by highlighting that the new device is nearly identical, with the only change being a new EVA film for the container body. The testing described is primarily for the new material's biological and physicochemical properties and the overall functional performance of the device.

However, based on the information provided, we can infer some general aspects of the testing and its outcomes.

Implied Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
1. Biological Reactivity: New EVA film must be biocompatible.	The material was found to be acceptable for its intended use, based on ISO 10993-1.
2. Chemical Reactivity: New EVA film must be chemically stable and inert.	The material was found to be acceptable for its intended use, based on USP 23 General Chapter <661>.
3. Functional Performance: The proposed container must meet or exceed all functional requirements for its intended use.	Data indicates that the proposed All-In-One™ Container meets or exceeds all functional requirements.

Study Information (Based on Available Text)

Sample Size Used for Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Data regarding the functional performance... have been generated and submitted" and refers to "biological methods specified in ISO Standard 10993-1 and USP physicochemical tests described in General Chapter <661>". These standards typically outline testing methodologies which would involve a certain number of samples or replicates, but the exact sample sizes used in this specific submission are not detailed.
- Data Provenance: Not explicitly stated, but given that Baxter Healthcare Corporation is a U.S. company submitting to the FDA, it is highly likely the studies were conducted in the U.S. and are retrospective analyses of internal testing.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not specified. This device is a medical container, and the testing described is material and functional performance testing, not diagnostic performance where "ground truth" is established by human experts. The ground truth (or reference standard) would be defined by the specifications of the materials and the functional design, and evaluated by laboratory instruments and standardized protocols.
Adjudication Method for the Test Set:
- Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or diagnostic performance evaluations where human interpretation is involved. For material and functional testing, the results are objectively measured against pre-defined specifications.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The device described is a medical container, not a diagnostic tool requiring human readability or interpretation.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, this is not relevant for this device. "Standalone" performance refers to the capability of an algorithm without human intervention, which applies to AI/software as a medical device. This is a physical medical container.
Type of Ground Truth Used:
- Material Testing: The ground truth for the biological and chemical reactivity testing would be the standards themselves (ISO 10993-1 and USP 23 General Chapter <661>) and the pass/fail criteria defined within those standards or Baxter's internal specifications derived from them.
- Functional Testing: The ground truth for functional performance would be the engineering and design specifications for the container (e.g., leak integrity, tensile strength, clarity, sterility maintenance, compatibility with parenteral nutrition solutions over time).
Sample Size for the Training Set:
- Not applicable/Not specified. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's development or validation.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set for this type of device.

Summary

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K983294

510(k) Premarket Notification Modified All-In-One™ Container

NOV 3 1998

510(k) SUMMARY

Modified All-In-One™ Container

Submitted by:

Linda Coleman Manager, Regulatory Affairs Baxter Healthcare Cc rporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 6007 3

Date Prepared:

September 18, 1998

Proposed Device: Modified All-In-One™ Container

Predicate Device: All-In-One™ Container

Proposed Device Description:

Statement of Intended Use:

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.

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Summary of Technological Characteristics of New Device to Predicate Devices

Except for the EVA film used to construct the body of the modified All-In-One™ Container, the proposed container is identical with respect to materials, components and design to the existing All-In-One™ Container described in K932477. Like the existing product, the proposed All-In-One™ Container will be used in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

The biological and cl emical reactivity of the new solution contact material have been assessed using biological methods specified in ISO Standard 10993-1 and USP physicochemical test: described in General Chapter <661> of USP 23. The material was found to be acceptable for its intended use.

Data regarding the functional performance of the proposed All-In-One™ Container have been generated and submitted. The data indicate that the proposed All-In-One™ Container meets or exceeds all functic nal requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Ms. Linda Coleman Manager, Requlatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

K983294 Re : All-In-One™ Container CAT#'s 2B8114, Trade Name: 2B8124, 2B8134, 2B8144 Requlatory Class: II Product Code: KPE September 18, 1998 Dated: September 21, 1998 Received:

Dear Ms. Coleman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Coleman

through 542 of the Act for devices under the Electronic enrough Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamaip.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

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Indication for Use

510(k) Number: No : Available

All-In-One™ Container Device Name:

. . . .

Indication for Use:

The All-In-One™ Container is intended for use in the compounding and storage of parenteral The All-In-One™ Container is intended for use in the compounding and working in
nutrition solutions prior to and during intravascular administration to a patient.

Patricia Guess

k.
K

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).