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 (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

AI/ML Overview

The provided text describes a traditional 510(k) premarket notification for an "All-In-One Container" manufactured by Baxter Healthcare Corporation. This submission focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific statistical acceptance criteria that one might find for a more complex diagnostic or AI-driven device.

Based on the information provided, here's what can be inferred about acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it makes a general statement:

Acceptance Criteria (Implied)	Reported Device Performance
Device is appropriately designed for its intended use and meets safety/functional requirements.	"All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance. It only refers to "risk analyses and design verification tests." These are typically internal tests, and details about sample size or origin are not usually disclosed in a 510(k) summary for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided. The testing described for this device (an empty container for compounding and storage) would involve engineering and quality control assessments, not expert-adjudicated ground truth like in a medical image analysis study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials or diagnostic studies, not for the design verification of a medical container.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially AI-powered ones) in conjunction with human readers. This device is a passive medical container, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. A standalone algorithm performance study is relevant for AI-powered devices. This device is an empty container and does not have an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of this device. The "ground truth" for a medical container involves meeting established engineering specifications, material properties, sterility, and functional requirements. It would be determined through validated testing methods, not expert consensus or pathology.

8. The sample size for the training set

This information is not applicable and not provided. The "All-In-One Container" is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as above.

Summary of the "Study" (Nonclinical Tests) Mentioned:

The document states:

"Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."
"All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."

This indicates that Baxter performed internal nonclinical testing to ensure the device met its design specifications and safety requirements. These tests are typically related to:

Material properties: Ensuring the EVA material is suitable for parenteral nutrition solutions (e.g., chemical compatibility, extractables/leachables).
Physical integrity: Testing the container for leaks, burst strength, and resistance to damage during storage and handling.
Sterility: Verifying the container can be sterilized and maintains sterility until use.
Functional aspects: Ensuring the transfer sets (single or three lead) function correctly with the container.

The "acceptance criteria" would be internally defined specifications for these tests (e.g., "no leaks when subjected to X pressure," "material compatible with Y solution for Z duration"). The "study" is the execution of these design verification tests, and the "proof" is that all results met the predetermined acceptance criteria. The 510(k) process in this instance relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K983294), implying that the established testing methods and acceptance criteria for the predicate device would also apply to the new device.

Summary

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Traditional 510(k) Premarket Notification All-In-One Container

11:12 PM

Section 5, 510(k) Summary

న్నారు.

KORDAL 1822

5. 510(k) SUMMARY

December 12, 2008

OWNER:

باب تيان لا

JAN 3 0 2009

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Nanette Hedden Sr. Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116

DEVICE NAME:

Trade name: All-In-One Container Name

Code number	Size	Name
2B8114	1000 mL	All-In-One Empty Container, (Three Lead Transfer Set)
2B8124	2000 mL	All-In-One Empty Container, (Three Lead Transfer Set)
2B8134	3000 mL	All-In-One Empty Container, (Three Lead Transfer Set)
2B8144	4000 mL	All-In-One Empty Container, (Three Lead Transfer Set)
2B8112	1000 mL	All-In-One Empty Container, (Single Lead Transfer Set)
2B8122	2000 mL	All-In-One Empty Container, (Single Lead Transfer Set)
2B8132	3000 mL	All-In-One Empty Container, (Single Lead Transfer Set)
2B8142	4000 mL	All-In-One Empty Container, (Single Lead Transfer Set)
2B8152	500 mL	All-In-One Empty Container, (Single Lead Transfer Set)
2B8172	250 mL	All-In-One Empty Container, (Single Lead Transfer Set)

Table 5-1. Product Codes for All-In-One Container

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Image /page/1/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The top line seems to read 'K090096', while the bottom line reads '2011'. The handwriting is somewhat stylized, with some characters being more distinct than others.

Traditional 510(k) Premarket Notification All-In-One Container

Section 5, 510(k) Summary

Common Name: Compounding Container

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Classification Name: Intravenous Container (21 CFR 880.5025, Product Code KPE)

Predicate Device:

Table 5-2. Predicate Device

Device	Company	Previous 510(k)	Clearance date
Modified All-In-One Container	BaxterHealthcare	K983294	November 3,1998

DESCRIPTION OF THE DEVICE:

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.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The All-In-One Container is substantially equivalent to Baxter's current legally marketed All-In-One Container cleared November 3, 1998 (K983294).

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

CONCLUSION:

The All-In-One Container is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxter Healthcare Corporation C/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JAN 3 0 2009

Re: K090096

Trade/Device Name: All-In-One Container Regulation Number: 21 CFR 880.5025 Regulation Name; I.V. Container Regulatory Class: II Product Code: KPE Dated: January 15, 2009 Received: January 15, 2009

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Devine

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. ask for

Ginette Y. Michaud, M.D. Acting 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

11:22:

510(k) Number (if known):

Device Name: All-In-One Container

Indications for Use:

1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

મન્તરમાન

K090096

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K090090 510(k) Number:

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).