Cathivex®-GV filter units are in-line 0.22um, sterilizing-grade filters for use with intravenously administered aqueous solutions. The filters remove particulates, microbial contamination, and air bubbles in applications where venting and low protein binding membranes are required or desired.

Device Description

Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterile filtration of aqueous solutions for intravenous infusions. Cathivex®-GV filter units are designed with a Female Luer Lok™ inlet and a Male Luer Lok™ outlet. Cathivex®-GV filter units contain a 0.22um Durapore® hydrophilic filter membrane constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks and air emboli by automatically venting air introduced upstream. The filter housing material is molded from PVC.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Cathivex®-GV Filter Units, not an AI/ML powered device. As such, the requested information regarding AI/ML-specific acceptance criteria, study methodologies, and expertise for ground truth is not applicable to this document. The document focuses on performance data for a non-AI medical device.

However, I can extract the information relevant to a traditional medical device's performance criteria and testing, as presented in the document:

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

The document states: "The following performance data were provided in support of the substantial equivalence determination. All specified performance requirements were met." It then lists the tests performed, implying that meeting the requirements of these tests constitutes the acceptance criteria. Specific numerical acceptance criteria values are not provided in this summary, only the categories of tests.

Test Category	Specific Test	Reported Performance
Device Testing	Visual Inspection	Met specified performance requirements
	Filter Integrity Test	Met specified performance requirements
	Burst Test	Met specified performance requirements
	Gravity Flow Test	Met specified performance requirements
	Bubble Point Test	Met specified performance requirements
	Water Intrusion Test	Met specified performance requirements
	Endotoxin LAL Test	Met specified performance requirements
	Particle Count Downstream Test	Met specified performance requirements
	Gravimetric Test	Met specified performance requirements
	Luer Insertion Test	Met specified performance requirements
	Bacterial Retention Test	Demonstrated to perform as intended and meet user needs and intended uses. Met 10^-6 SAL criteria for sterilizing grade filters.
	Hold Up Volume Test	Met specified performance requirements
	USP Mouse Safety Test	Met specified performance requirements
	Physical Testing (ISO 8436-4)	Met specified performance requirements
	Chemical Testing (ISO 8536-4)	Met specified performance requirements
Packaging Testing	Peelability Test	Met specified performance requirements
	Dye Test	Met specified performance requirements
	Strength of Blister Seal and Burst Strength Test	Met specified performance requirements
	Blister Seal Width	Met specified performance requirements
	Unit Packaging including Print Inspection	Met specified performance requirements
Biocompatibility	Cytotoxicity	Demonstrated acceptable results (in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1)
	Sensitization	Demonstrated acceptable results (in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1)
	Intracutaneous reactivity	Demonstrated acceptable results (in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1)
	Systemic toxicity (acute)	Demonstrated acceptable results (in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1)
	Haemocompatibility	Demonstrated acceptable results (in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1)
Sterilization	Sterility Assurance Level Rating	Achieved a Sterility Assurance Level (SAL) of 10^-6 (validated to ISO 11135-1:2007)
Shelf Life	3-year shelf life	Device maintains performance and sterility throughout the duration of the study

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 exact sample sizes for each test in the summary. It mentions that Merck Millipore Ltd. is located in Ireland, implying that the testing was conducted either there or overseen by them, but doesn't explicitly state the country of origin of the raw data. The studies are described as "bench testing" and "performance data provided in support of the substantial equivalence determination," which generally implies prospective testing conducted for regulatory submission.

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 question is not applicable as this is a physical medical device, not an AI/ML powered device where expert ground truth is typically established for image or data interpretation. The "ground truth" for this device would be defined by validated physical and biological measurement standards and laboratory procedures.

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

Not applicable as this is a physical medical device. Decisions would be based on objective passes/fails against pre-defined test specifications, not on expert adjudication of interpretations.

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

Not applicable. This is not an AI-powered device, so MRMC studies and human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is not an AI-powered device. The device's performance (e.g., filtration efficacy, burst strength) is tested directly, not via an algorithm.

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

The "ground truth" for this device's performance testing would be based on established scientific and engineering standards, physical measurements, and biological assays. For instance:

Bacterial Retention Test: Ground truth is defined by the sterility assurance level (SAL) of 10^-6, determined by standard microbiological methods.
Filter Integrity/Bubble Point/Water Intrusion tests: Ground truth based on physical principles and instrument readings (e.g., pressure, flow rates) against pre-defined specifications.
Biocompatibility: Ground truth from standardized assays (e.g., cytotoxicity assays, sensitization studies) following ISO 10993 standards and a comprehensive risk assessment.
Endotoxin LAL Test: Ground truth from laboratory quantification of endotoxins using Limulus Amebocyte Lysate (LAL) reagents against established limits.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

Summary

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

August 11, 2015

Merck Millipore Ltd. Chris Parr Regulatory Affairs Specialist III Tullagreen, Carrigtwohill Co. Cork, Ireland

Re: K143583

Trade/Device Name: Cathivex®-GV Filter Units Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPB Dated: June 29, 2015 Received: July 6, 2015

Dear Mr. Parr:

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.

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

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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 yours.

Erin I. Keith -S

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

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Indications for Use

510(k) Number (if known) K143583

Device Name Cathivex®-GV Filter Units

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Merck Millipore. The logo consists of a large, stylized letter 'M' in dark blue, with a smaller, light blue vertical rectangle to the left of the 'M'. To the right of the 'M', the words 'MERCK MILLIPORE' are written vertically in dark blue.

510(k) Summary K143583 Date Prepared August 11, 2015 Name, address and Merck Millipore Ltd. telephone number of Tullagreen, Carrigtwohill submitter Co. Cork, Ireland Phone: +353.21.4883666 / Fax: +353.21.4883048 Contact Person Chris Parr Merck Millipore | Global Regulatory Management

Device Trade Name	Cathivex®-GV Filter Units
Device Common Name	Filter Unit
Model Number	SLGV0250S
Device Class	II
Product Code	FPB
Regulation Number	880.5440
Regulation Name	Intravascular administration sets

Device Description

Merck Millipore Ltd., Ireland (A Subsidiary of Merck KGaA, Darmstadt, Germany) Tullagreen, Carrigtwohill Co. Cork Ireland

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Image /page/4/Picture/0 description: The image shows the logo for Merck Millipore. The logo consists of a large, stylized letter "M" in dark blue, with a light blue vertical rectangle to the left of the "M". To the right of the "M" is the text "MERCK MILLIPORE" in a vertical arrangement, with "MERCK" above "MILLIPORE".

Indications for Use

Predicate Device

Cathivex®-GV filter units are substantially equivalent to the following legally marketed predicate device, Pall Supor® AEF Filter.

Applicant	Pall Medical
Device Trade Name	Pall Supor® AEF Filter
Model Number	AEF1NTE
510(k) Number	K993379
Clearance date	12/16/1999
Device Class	II
Product Codes	FPB
Regulation Numbers	880.5440
Regulation Names	Intravascular administration sets
Indications for Use	Removal by in-line filtration of inadvertent contaminants(including bacteria, particles, and entrained air) from infusedintravenous fluids.

Predicate Device Description

The Pall Supor® AEF filter is an air eliminating filter with low protein binding 0.2um Supor membrane for up to 24 hours use, with any administration set, for the removal of inadvertent particulate debris, microbial contaminants and entrained air which may be found in solutions intended for intravenous use. The filter units are sterile, non-pyrogenic, single use filter units. Pall Supor® AEF filter is designed with a Female Luer Lok™ inlet and a Male Luer slip outlet with rotating locking collar. The filter membrane is Supor®

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Image /page/5/Picture/0 description: The image shows the logo for Merck Millipore. The logo features a large, stylized letter "M" in dark blue, with a smaller, light blue vertical bar to the left of the "M". To the right of the "M", the words "MERCK MILLIPORE" are written vertically in dark blue, with "MERCK" above "MILLIPORE".

polyethersulfone with a pore size of 0.2um (micron). The filter housing material is molded from acrylic polymer.

Summary of Technological Characteristics

The Intended Use for Cathivex®-GV filter units is the same as the predicate device in regards to in-line filtration of solutions administered intravenously.

Cathivex®-GV filter units and Pall Supor® AEF incorporate a common design feature of a vent membrane for venting air introduced upstream. The presence of a vent membrane in Cathivex®-GV filter units is considered a key technological similarity which is pivotal to the device achieving its intended use to prevent air locks caused by air introduced upstream and from preventing air emboli from entering the patient. Cathivex®-GV filter units and Pall Supor® AEF also include an application for low protein binding. This application is making use of the existential properties of the Durapore® PVDF filter membrane which is a low protein binding material.

From a design perspective there are similarities and differences between the predicate device and the subject device. The key similarity is the filter membrane pore size which is the same. The key difference is the introduction of the Durapore® PVDF filter membrane. Biocompatibility testing has been performed to address the difference between the filter membrane of the predicate and subject device. The material used in the molding of the filter housing of the predicate device (acrylic polymer) is different to that of the subject device (PVC). Biocompatibility testing has been performed to address the difference between the housing materials of the predicate and subject devices which offers suitable mechanical properties for the application.

At a high level, the subject and predicate devices are based on the following same technological elements:

. Filter unit for in-line filtration.
Intended to remove particles, microbial contaminants, and air. ●
0.22um filter membrane pore size. ●
Sterile, single use device. .
Hydrophobic vent membrane. .
Luer inlet and outlet connections.

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Image /page/6/Picture/0 description: The image contains the logo for Merck Millipore. The logo features a stylized letter 'M' in blue, with a light blue vertical bar on the left side of the 'M'. To the right of the 'M', the text 'MERCK MILLIPORE' is written in a vertical orientation, with 'MERCK' above 'MILLIPORE'.

The following technological differences exist between the subject and predicate devices:

Use of a different filter membrane type.
. Materials used in molding the filter housing.

The performance of the subject device has been verified through bench testing and the filter units have demonstrated to perform as intended.

Summary of Nonclinical Testing

The following performance data were provided in support of the substantial equivalence determination. All specified performance requirements were met.

Device Testing

Visual Inspection
Filter Integrity Test .
Burst Test ●
Gravity Flow Test
Bubble Point Test ●
. Water Intrusion Test
Endotoxin LAL Test
Particle Count Downstream Test ●
Gravimetric Test
. Luer Insertion Test
Bacterial Retention Test ●
Packaging Test ●
Hold Up Volume Test ●
USP Mouse Safety Test .
Physical Testing (ISO 8436-4) ●
. Chemical Testing (ISO 8536-4)

Packaging Testing

Peelability Test ●
Dye Test ●
Strength of Blister Seal and Burst Strength Test ●

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Image /page/7/Picture/0 description: The image contains the logo for Merck Millipore. The logo features a stylized letter "M" in dark blue, with a light blue vertical bar to the left of the "M". To the right of the "M", the words "MERCK MILLIPORE" are written in a vertical stack, with "MERCK" on top of "MILLIPORE".

Blister Seal Width ●
. Unit Packaging including Print Inspection

Biocompatibility

Biocompatibility testing was conducted in accordance with standard ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process, and the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The battery of testing included the following tests:

Cytotoxicity.
Sensitization. ●
Intracutaneous reactivity.
Systemic toxicity (acute). ●
Haemocompatibility. ●

Sterilization

Cathivex®-GV filter units are sterilized with ethylene oxide (EO) gas using a validated sterilization cycle. Sterilization validation was conducted in accordance with ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and FDA Guidance Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

Cathivex®-GV filter units are sterilized using Ethylene Oxide (EO) at 100% gas concentration in a 3 hour 30 min exposure cycle at the target parameters for temperature, relative humidity and gas concentration. The sterilization cycle has been validated to provide a Sterility Assurance Level (SAL) of 10-6.

Shelf Life

Cathivex®-GV filter units have a 3 year shelf life that is supported by accelerated and realtime stability studies.

The results demonstrate that the device maintains its performance and sterility throughout the duration of the study and supports a 3 year shelf life.

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Image /page/8/Picture/0 description: The image is the logo for Merck Millipore. The logo features a stylized letter "M" in dark blue, with a light blue vertical bar to the left of the "M". To the right of the "M", the words "MERCK MILLIPORE" are written vertically, with "MERCK" above "MILLIPORE".

Summary of Clinical Testing

This 510(k) premarket notification does not contain any clinical performance testing data obtained from clinical investigations or from literature sources with the predicate or subject device for the purposes of demonstrating substantial equivalence.

Summary and Conclusions from Non-Clinical and Clinical Testing

Cathivex®-GV filter units are substantially equivalent to the predicate device Pall Supor® AEF because they share the following similarities:

. Device Class (class II)
. Product Code (FPB)
. Intended Use (in-line filtration of solutions administered intravenously)
. Filter Membrane Pore Size (0.22µm)
Vent Membrane Type (hydrophobic membrane) .
High degree of similarity in design and principle of operation

Non-Clinical performance testing was conducted for Cathivex®-GV filter units in order to demonstrate that the filter units perform as intended and meet user needs and intended uses. All specified performance requirements were met for Device Testing and Packaging Testing. Biocompatibility testing was conducted in accordance with ISO 10993-1 and Blue Book Memorandum #G95-1, and demonstrated acceptable results. Sterilization Validation was completed in accordance with ISO 11135-1:2007 to achieve a Sterility Assurance Level (SAL) of 106. Shelf life testing demonstrated that the device maintains its performance throughout the proposed 3 year shelf life.

Based on the data presented in this 510(k), the subject device is sufficiently similar in design and intended use to the predicate device that they are considered to be substantially equivalent as supported by Non-Clinical performance testing.

Merck Millipore Ltd., Ireland (A Subsidiary of Merck KGaA, Darmstadt, Germany) Tullagreen, Carrigtwohill Co. Cork Ireland

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.