The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.

AI/ML Overview

This document describes a 510(k) submission for a medical device called an "Additive Cap." The submission is for a modification to an existing device, specifically a label change to expand its indications for use. As such, the "study" conducted is a performance test to ensure the modified device still functions as intended.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions one specific performance test.

Acceptance Criteria	Reported Device Performance
All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use. (Implied acceptance for "force to remove" and "biocompatibility")	Test results met acceptance criteria. (Specific force values or biocompatibility results are not provided but are stated to have met criteria).

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

Sample Size: Not explicitly stated for the "force to remove" test.
Data Provenance: The study was conducted internally by Baxter Healthcare Corporation. It is a prospective test conducted for this 510(k) submission to evaluate the modified device. The country of origin for the data is implied to be the United States, given Baxter's location and the FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is generally not applicable to a performance test for a mechanical device like an "Additive Cap," especially when the change is a label modification. The "ground truth" for such a device is its mechanical function and material properties, which are assessed through engineering and biocompatibility testing, not through expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review and consensus, typically in diagnostic imaging studies or clinical trials, not for mechanical performance tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a non-fluid path, non-sterile Additive Cap whose only change is a label modification.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a passive mechanical component, not an algorithm.

7. Type of Ground Truth Used

For the "force to remove" test, the "ground truth" is the measured mechanical force required, compared against predefined engineering specifications or performance benchmarks for the device's functionality. For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-5 in this case) and the pass/fail criteria defined by those standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical component, not an AI or algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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JUN 1 4 2011

5. 510(k) SUMMARY

March 25, 2010

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

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

DEVICE NAME:

Trade name: Additive Cap

Common name: Additive Cap

Classification name: Container I.V., 21 CFR 880.5025, KPE, Class II

PREDICATE DEVICE:

Table 5-1. Previous 510(k)s

Device	Company	Previous 510(k)	Clearance date
Additive Cap	Baxter Healthcare	K760880	December 30, 1976

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DESCRIPTION OF THE DEVICE:

STATEMENT OF INTENDED USE:

Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Additive Cap is an injection molded, polypropylene component. The intended use and function of the proposed Additive Cap is identical to the predicate device. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement by adding compatibility with the AVIVA container.

Performance Data: A protocol was conducted to evaluate the force to remove the Additive Cap from the medication port when used with AVIVA and VIAFLEX containers.

Biocompatibility: The subject device does not contact the patient's body directly or indirectly. Baxter assessed the biocompatibility testing requirements for the device based on FDA Blue Book Memorandum G-95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and internal Baxter procedures. Based on this assessment, a biocompatibility assay for the Additive Cap was performed per test method described in Biological Evaluation of Medical Devices ISO 10993-5: Tests for cytotoxicity: in vitro methods. The polypropylene material used to mold the Additive Cap was determined to be biocompatible and appropriate for its intended use.

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DISCUSSION OF NONCLINICAL TESTS:

All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use.

CONCLUSION:

The Additive Cap is substantially equivalent to Baxter's current legally marketed Additive Cap, cleared December 30, 1976 (K760880).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 4 2011

Ms. Nanette Hedden Senior Manager Baxter Healthcare Corporation Medical Products 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K111217

Trade/Device Name: Additive Cap Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: June 6, 2011 Received: June 8, 2011

Dear Ms. Hedden:

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 - Ms. Hedden

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 reporting (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), please 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

An Thuong, D. Nhatban

Anthony D. 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): ¥ | | 乙 | 7

Device Name: Additive Cap

Indications for Use:

Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acting for
RICHARD CHAPMAN

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

510(k) Number: K111217

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).