The Solution Administration Sets with a 0.2 micron filter product line consists of sterile, non-pyrogenic, single use disposable devices used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They are indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids. The filter consists of a 0.2 micron polyethersulfone (PES) solution membrane and 0.1 micron polyvinylidene fluoride air vent membrane enclosed in a copolyester housing.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Solution Administration Sets with 0.2 Micron Filter) and, as such, focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a comprehensive study evaluating device performance against established acceptance criteria in a research context.

This document does not contain the kind of detailed information about a study that would rigorously prove a device meets acceptance criteria in the typical scientific sense (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies). It is a regulatory submission, so the "studies" are verification tests to ensure the modified device is equivalent to the predicate.

However, I can extract the acceptance criteria mentioned and the reported "performance" based on the provided text, while noting the limitations in the depth of information available.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Performance Data
Air diffusion	All tests met the acceptance criteria.
Bubble point	All tests met the acceptance criteria.
Gravity flow rate	All tests met the acceptance criteria.
Flow rate post sterile water conditioning	All tests met the acceptance criteria.
Flow rate post parenteral nutrition conditioning	All tests met the acceptance criteria.
Bacterial retention	All tests met the acceptance criteria.
Biocompatibility
Cytotoxicity	All tests met the acceptance criteria.
Systemic Toxicity	All tests met the acceptance criteria.
Intracutaneous	All tests met the acceptance criteria.
Hemolysis	All tests met the acceptance criteria.
Pyrogen	All tests met the acceptance criteria.
Sensitization	All tests met the acceptance criteria.
USP Physicochemical	All tests met the acceptance criteria.

Note: The document only states that "All tests met the acceptance criteria" without providing the specific numerical or qualitative thresholds for those criteria. It implies that these criteria were pre-established internally by Baxter Healthcare Corporation for their risk analysis and design verification.

Here's why the other requested information is largely not present in this type of regulatory document:

2. Sample size used for the test set and the data provenance:

Not explicitly stated. The document is a summary and does not include the detailed protocols, sample sizes, or statistical analysis reports from the bench tests or biocompatibility assessments.
Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document doesn't specify the country of origin for the data beyond that. These are typically internal corporate studies (retrospective in the sense that they are conducted on manufactured samples, but prospective in terms of the test design).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical evaluations). For bench tests and biocompatibility tests of a physical device, the "ground truth" is typically defined by scientific principles, international standards (e.g., ISO-10993), and validated test methodologies. There's no "expert ground truth" in the sense of consensus from adjudicators.

4. Adjudication method for the test set:

Not applicable/Not mentioned. As above, adjudication is not a standard part of these types of engineering and biological safety tests. The results are typically quantitative measurements against defined specifications.

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:

No. This is a completely different type of study, relevant for AI/radiology devices. This document is a 510(k) for an administration set with a filter, not an AI diagnostic tool.

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

Not applicable. This question pertains to AI algorithms. The device discussed is a physical medical device.

7. The type of ground truth used:

For Performance Data (e.g., flow rate, bacterial retention): The "ground truth" would be established by the validated test methods themselves, based on physical and microbiological principles, often referenced to international standards or established industry practices for filter performance.
For Biocompatibility: The "ground truth" is defined by the requirements of international standards like ISO-10993-1 and FDA guidance, which specify the types of biological responses that are considered acceptable or unacceptable.

8. The sample size for the training set:

Not applicable. This question refers to machine learning models. This device does not involve a "training set" in that context.

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

Not applicable. As above, no training set for an AI model is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of nonclinical bench tests and biocompatibility assessments conducted by Baxter Healthcare Corporation.

Objective: To evaluate the effect of a material modification (change in solution membrane material from one hydrophilic polyethersulfone to another hydrophilic polyethersulfone) in the 0.2 micron filter within their Solution Administration Sets. The goal was to establish substantial equivalence to the previously cleared predicate device (K964850).
Tests Performed:
- Performance Data: Air diffusion, bubble point, gravity flow rate, flow rate post sterile water conditioning, flow rate post parenteral nutrition conditioning, and bacterial retention.
- Biocompatibility: Cytotoxicity, Systemic Toxicity, Intracutaneous, Hemolysis, Pyrogen, Sensitization, and USP Physicochemical. These were conducted in accordance with ISO-10993 and FDA guidance.
Results: The document states that "All tests met the acceptance criteria."
Conclusion: Based on these tests, Baxter concluded that "The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use."

This is a regulatory study designed to show equivalence, not an independent research study to establish novel performance claims.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be made of flowing lines.

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

December 28, 2015

Baxter Healthcare Corporation Mr. Gary Chumbimune Manager, Regulatory Affairs 32650 N Wilson Road Round Lake. Illinois 60073

Re: K153158

Trade/Device Name: Solution Administration Sets with 0.2 Micron Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 2, 2015 Received: December 3, 2015

Dear Mr. Chumbimune:

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.

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K153158

Device Name

Solution Administration Sets with 0.2 Micron Filter

Indications for Use (Describe)

For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is colored in a dark blue. The image is simple and only contains the company name.

Section 5. 510(k) Summary K153158

October 30, 2015

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Gary Chumbimune Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-3312 Fax: (224) 270-4119

IDENTIFICATION OF THE DEVICE:

Common Name: Intravascular Administration Set Trade Name or Proprietary Name: Solution Administration Sets with 0.2 Micron Filter Classification Panel: 80 General Hospital Classification: Set, Administration, Intravascular (21 CFR 880.5440) Class: Class II

Product Code: FPA

Table 1. Product Codes for Solution Administration Sets with 0.2 Micron Filter

Code Number	Name
2C6572	INTERLINK System CONTINU-FLO Solution Set
2H6480	INTERLINK System Non-DEHP Solution Set with DUO-VENT Spike
2H8671	CLEARLINK System Non-DEHP Extension Set
1C8363	Extension Set

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The color of the text is a dark blue. The text is slightly slanted to the right, giving it a dynamic appearance. The background is plain white, which makes the text stand out.

PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date
Solution Administration Sets with 0.22Micron Filter	Baxter HealthcareCorporation	K964850	February 25,1997

Table 2. Predicate Device

DESCRIPTION OF THE DEVICE:

The basis for this premarket notification is a modification to the 0.2 micron filter currently used in this product line. The modification consists of a change to the solution membrane material. The solution membrane material is changing from a hydrophilic polyethersulfone (PES) to another hydrophilic polyethersulfone (PES). The solution membrane currently used is no longer available and will be replaced with an equivalent material.

These modifications do not impact the intended use or the fundamental scientific technology of the devices. No other materials of construction are being introduced into these devices as part of this update. The product labels are also being updated to revise statements regarding latex and pump device references, add the indications for use statement of the device, and implement other modifications to comply with Baxter's labeling standards.

INDICATIONS FOR USE:

For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The letters are slightly italicized, giving the word a sense of movement. The color of the text is a vibrant blue, which stands out against the white background.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices have equivalent technological characteristics as Baxter's currently legally marketed devices cleared under 510(k) premarket notification K964850 (cleared on February 25, 1997). The intended use, design and function of the proposed devices are equivalent to the predicate devices.

DEVICE COMPARISON TABLE:

Table 3 is a device comparison table outlining the differences between the current (predicate) devices and the proposed devices.

Features		Current Devices(Cleared under K964850)	Proposed Devices
Intended Use		For the retention of microorganisms and removalof air and particulate matter from infusion fluids.	Same
Indications for Use		For the retention of microorganisms and removalof air and particulate matter from infusion fluids.	Same
Sterile		Yes	Same
Non-Pyrogenic		Yes	Same
Single Use		Yes	Same
Materials
Spike		Acrylonitrile Butadiene Styrene	Same
Blue Plug		Synthetic Polyisoprene	Same
Cannula		304 Stainless Steel	Same
Drip Chamber		Polyvinyl Chloride	Same
Check Valve		Polymethyl Methacrylate and Silicone Rubber	Same
0.2 MicronFilter	Housing	Copolyester	Same
	SolutionMembrane	Polyethersulfone (PES)	Same
	Air VentMembrane	Polyvinylidene (PVDF)	Same
TrilayerTubing	Inner Layer	Linear Low Density Polyethylene	Same
	MiddleLayer	Polyolefin Adhesive	Same
	Outer Layer	Polyvinyl Chloride	Same
Tubing		Polyvinyl Chloride	Same
Bushing		Polyvinyl Chloride	Same
Interlink Y-Site		Copolyester and Synthetic Polyisoprene	Same
Clearlink Y-Site		Polycarbonate and Silicone	Same
Male Luer Lock Connector		Acrylonitrile Butadiene Styrene	Same

Table 3. Device Comparison

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "Baxter" in a stylized, bold, blue font. The font appears to be italicized, with the letters slightly slanted to the right. The color of the text is a vibrant blue, and the background is white.

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 their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

Performance Data:

The following bench tests were conducted to evaluate the effect of the modification to the 0.2 micron filter:

Air diffusion test ●
Bubble point test
Gravity flow rate test ●
Flow rate test post sterile water conditioning ●
Flow rate test post parenteral nutrition conditioning
Bacterial retention test

All tests met the acceptance criteria.

Biocompatibility:

The basis for this premarket notification is a modification to the 0.2 micron filter solution membrane material. The solution membrane material is changing from a hydrophilic polyethersulfone (PES) to another hydrophilic polyethersulfone (PES). No other materials of construction are being introduced into these devices as part of this update.

Biocompatibility assessments were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," for prolonged duration, external communicating device, indirect blood path, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993" as recommended in the IV Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]''. The battery of testing included the following tests:

. Cytotoxicity
Systemic Toxicity ●
Intracutaneous ●

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The background is plain white.

Hemolysis ●
Pyrogen ●
Sensitization ●
USP Physicochemical ●

All other materials found in these devices, that are the subject of this submission, have been previously cleared under Baxter's 510(k) premarket notifications K123868 (cleared January 8, 2013) and K150860 (cleared April 16, 2015).

CONCLUSION:

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.