SwabTip™ is intended for use on ISO male luer connectors as a cover to protect the luer from potential contamination. The SwabTip™ acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabTip™ will disinfect the male luer (30) seconds after application and maintains a disinfected luer surface for up to four days (96 hours) if not removed.

Device Description

SwabTip™ Male Disinfectant Cap is an accessory to the terminal male luer of an intravenous administration set that is used to disinfect and maintain a physical barrier when the administration set is not in use. The SwabTip™ is a cap that when attached to an ISO compatible male luer slip, lock, or spin luer, delivers a small volume of 70% isopropyl alcohol to the external surfaces of the male luer including the internal threads. SwabTip™ is a single use sterile fluid path cap, provided in multi-unit delivery strip.

AI/ML Overview

The provided document describes the acceptance criteria and study that proves the SwabTip™ Male Disinfectant Cap meets these criteria, supporting its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Challenge Strain	Acceptance Criteria (≥ Log$_{10}$ Reduction)	Reported Device Performance (Number of Samples Passing)	Result
P. aeruginosa (ATCC #9027)	≥4.0 on 10/10 Samples	10/10 Samples	Pass
S. aureus (ATCC #6538)	≥4.0 on 10/10 Samples	10/10 Samples	Pass
E. coli (ATCC #11229)	≥4.0 on 10/10 Samples	10/10 Samples	Pass
S. epidermidis (ATCC #14990)	≥4.0 on 10/10 Samples	10/10 Samples	Pass
C. albicans (ATCC #10231)	≥4.0 on 10/10 Samples	10/10 Samples	Pass
C. glabrata (ATCC #2001)	≥4.0 on 10/10 Samples	10/10 Samples	Pass

Notes:

This table specifically refers to the "Efficacy Study" (time-kill study) for antimicrobial activity.
Other performance data mentioned includes: Microbial Barrier Performance Test, Male Luer Compatibility Testing, Visual Inspection, Foil Functional Test, Lid Peel Force, Integrity by Weight, Seal Leak Testing of Holder and Foil Lid, IPA Ingress/Alcohol Fluid Path Testing, Pyrogenicity Testing, and Particulates. The document states that the results of these tests "demonstrated that the subject device meets the performance requirements and ultimately supports a substantial equivalence determination," and that "Test results from the performance testing conducted demonstrate that SwabTip™ met all acceptance criteria requirements," but does not provide specific numerical outcomes or acceptance criteria for each of these additional tests in the provided text.

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

Sample Size for Efficacy Study: For the antimicrobial efficacy time-kill study, the sample size was 10 samples for each of the six challenge strains, totaling 60 samples evaluated for antimicrobial activity.
Data Provenance: The document states "A time kill study was conducted to determine how rapidly and effectively SwabTip™ kills a variety of microorganisms. SwabTip™ was tested for antimicrobial activity against six selected organisms using an industry standard protocol for time-kill assays." There is no specific information about the country of origin of the data or whether it was retrospective or prospective, but it implies a controlled laboratory study.

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

This document describes performance testing of a medical device (disinfectant cap) against specific microbial challenges and physical/chemical properties, not a diagnostic or AI-driven image analysis tool. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical interpretations (e.g., radiologists for imaging) is not applicable here. The ground truth (e.g., log reduction of bacteria) is established through standardized laboratory protocols and measurements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., medical images) is involved. For the laboratory performance tests described (antimicrobial efficacy, physical integrity, etc.), such adjudication methods are not relevant. The results are based on objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The SwabTip™ is a device with a direct physical and chemical function, not a diagnostic or AI-assisted system.

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

This question is also not applicable. The SwabTip™ is a physical device that performs disinfection, not a software algorithm. The "standalone performance" is the device's inherent ability to disinfect and maintain cleanliness, which was evaluated through the various performance tests listed.

7. The Type of Ground Truth Used

The ground truth for the efficacy study was based on quantitative microbiological measurements (Log$_{10}$ reduction) of specific microbial strains after exposure to the device, conducted under industry standard protocols for time-kill assays.
For other tests (e.g., Luer compatibility, physical integrity, biocompatibility), the ground truth was established by meeting specified engineering, material, and safety standards (e.g., ISO standards, USP requirements), against which the device's performance was measured.

8. The Sample Size for the Training Set

This document describes the validation of a physical medical device, not the development of an AI model. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation tests.

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

As there is no "training set" in the context of AI model development, this question is not applicable.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

ICU Medical Nichelle Cato Sr. Regulatory Affairs Associate 600 N. Field Drive Lake Forest, Illinois 60045

March 11, 2022

Re: K190918

Trade/Device Name: SwabTip Male Disinfectant Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP

Dear Nichelle Cato:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 6, 2020. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation 880.5440.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel(@fda.hhs.gov.

Sincerely,

Payal Patel Assistant Director for General Hospital Devices DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. Food & Drug Administration" in blue text.

March 6, 2020

ICU Medical Nichelle Cato Sr. Regulatory Affairs Associate 600 N. Field Drive Lake Forest, Illinois 60045

Re: K190918

Trade/Device Name: SwabTip Male Disinfectant Cap Regulatory Class: Unclassified Product Code: QBP Dated: February 4, 2020 Received: February 5, 2020

Dear Nichelle Cato:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sapana Patel -S

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K190918

Device Name

SwabTip™ Male Disinfectant Cap

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)

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."

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

Image /page/4/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is displayed in a sans-serif font, with "icu" in a bold, dark blue and "medical" in a lighter blue. Below the main text, in a smaller font, are the words "human connections".

K190918 - 510(k) Summary

Submitter Information
Name	ICU Medical
Address	600 North Field Drive
	Lake Forest, IL. 60046
Phone number	(224)-706-2852
Fax number	N/A
Establishment RegistrationNumber	3013319212
Name of contact person	Nichelle Cato, Manager, Global Regluatory Affairs
Date prepared	3/5/2020
Name of device
Trade or proprietary name	SwabTip™ Male Disinfectant Cap
Common or usual name	Cap, Device Disinfectant
Classification	Unclassified
Unclassification Reason	Pre-Amendment
Panel	General Hospital
Product Code(s)	QBP
Legally marketed device(s) towhich equivalence is claimed	SwabCap® - K130975
Reason for 510(k) submission	New SwabTip™ to be used on male luers.
Device description	SwabTip™ Male Disinfectant Cap is an accessory to the terminal male luerof an intravenous administration set that is used to disinfect and maintain aphysical barrier when the administration set is not in use. The SwabTip™ isa cap that when attached to an ISO compatible male luer slip, lock, or spinluer, delivers a small volume of 70% isopropyl alcohol to the externalsurfaces of the male luer including the internal threads. SwabTip™ is asingle use sterile fluid path cap, provided in multi-unit delivery strip.
Intended Use of Device/Indicationfor use	SwabTip™ is intended for use on ISO male luer connectors as a cover toprotect the luer from potential contamination. The SwabTip™ acts as aphysical barrier to contamination between line accesses and also serves asa disinfecting cleaner for use prior to line access. SwabTip™ will disinfectthe male luer (30) seconds after application and maintains a disinfected luersurface for up to four days (96 hours) if not removed.

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

wabTip™ Male Disinfectant Ca

Image /page/5/Picture/1 description: The image shows the logo for ICU Medical. The logo is vertically oriented, with the text "icumedical" in a blue sans-serif font. Below the main text, in a smaller font, are the words "human connections".

Characteristic	Summary of the technological characteristics of the device compared to the predicate device (K130975)		Comparison
Device Name	Subject Device	Predicate (K130975)
Common Name	SwabTip™	SwabCap®
Indications for Use	Cap, Device Disinfectant	Cap, Device Disinfectant	Same
	SwabTip™ is intended for use on ISO male luerconnectors as a cover to protect the luer frompotential contamination. The SwabTip™ acts asa physical barrier to contamination between lineaccesses and also serves as a disinfecting cleanerfor use prior to line access. SwabTip™ willdisinfect the male luer (30) seconds afterapplication and maintains a disinfected luersurface for up to four days (96 hours) if notremoved.	SwabCap® is intended for use on swab-able luer accessvalves as a cover to protect the luer access valves frompotential contamination. The SwabCap® acts as aphysical barrier to contamination between line accessesand also serves as a disinfecting cleaner for use prior toline access. SwabCaps®' will disinfect the valve five (5)minutes after application and maintains a disinfectedvalve surface for up to seven (7) days if not removed.	AntimicrobialEfficacy andMicrobial Barriertesting wereperformed on thesubject device fordifferences indisinfection timeand maintaining adisinfected luersurface.
Design	SwabTip™ is used on a male luer	The purpose of this 510(k) is to extend the indicationsfor use to include surface disinfection for up to 7 days.SwabCap® is used with a luer valve	Luer compatibilitytesting wasconducted onsubject device.Subject device isfor male luers, thepredicate is for aluer valve.
Materials ofConstruction	Outer Cap/Holder (packaging and cap) - High-Density Polyethylene	Outer Cap Holder (packaging) – Alathon M6580Cap – Medical Grade Santoprene	Subject devicewas testedaccording to ISO10993-1
	Sponge – Polyester Urethane foam	Sponge – SUGI absorbent material	Subject devicewas testedaccording to ISO10993-1
	Foil - Polyethylene Terephthalate & Low-DensityPolyethylene	Foil - Polyethylene Terephthalate & Low-DensityPolyethylene	Same
AntimicrobialAgent	Isopropyl Alcohol (70%)	Isopropyl Alcohol (70%)	Same
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Same
Shelf Life	2 years	2 years	Same
SterilizationMethod	Radiation (sterile fluid path)	Radiation	Same
SAL	$10^{-6}$	$10^{-6}$	Same

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

vabTip™ Male Disinfectant C

Image /page/6/Picture/1 description: The image shows the logo for ICU Medical. The logo is vertically oriented, with the text "icumedical" in a blue sans-serif font. Below the company name, in a smaller font, is the text "human connections."

Page 3 of 5

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

Image /page/7/Picture/1 description: The image shows the ICU Medical logo. The word "icu" is in bold blue letters, and the word "medical" is in light blue letters. Below the word "medical" are the words "human connections" in a smaller light blue font. The logo is simple and modern.

Discussion:

There are three major differences between the predicate and subject indications for use:

The predicate SwabCap® disinfects a valve and the subject device SwabTip™ disinfects a male luer
There is a decreased exposure time from the predicate to the subject which is, 5 minutes to 30 seconds disinfection time for male luer
There is a decrease in time, from which the disinfectant cap can be left in place, providing a physical barrier. The predicate disinfectant cap can be left on for 7 days and the subject disinfectant cap can be left on for 96 hours (4 days).

Summary of Technological Characteristics:

The subject device SwabTip™ has the same Indications for Use and is also technologically equivalent to the predicate device SwabCap®. They use similar functional specifications, materials and design (with minor modifications). They have the same sterilization method and shelf life. A comparison between the subject device – SwabTip™ and its predicate was performed to support a substantial equivalence determination. Apart from the above mentioned modifications, there are no technological differences between the subject and the predicate device. These modifications were assessed through antimicrobial efficacy testing, microbial barrier performance testing, and Luer compatibility testing. The conclusion of the comparison analysis is that the subject device – SwabTip™ is substantially equivalent to the currently marketed predicate device – SwabCap®

Summary of Non-Clinical Testing

Non-clinical verification of SwabTip™ has been conducted to evaluate the performance and functionality of the device. The results of these tests have demonstrated that the subject device meets the performance requirements and ultimately supports a substantial equivalence determination of SwabTip™ to the predicate device SwabCap®. A summary of the testing conducted is presented below.

Performance Data

The following performance data were provided in support of the substantial equivalence to internal test methods or standard:

. Antimicrobial (Disinfectant) Efficacy Testing
Microbial Barrier Performance Test .
Male Luer Compatibility Testing
Visual Inspection
Foil Functional Test ●
. Lid Peel Force
. Integrity by Weight
Seal Leak Testing of Holder and Foil Lid
IPA Ingress/Alcohol Fluid Path Testing ●
Pyrogenicity Testing

Particulates

Particulate contamination testing was performed by following USP <788> to demonstrate particulate levels on the SwabTip™ device meet USP <788> requirements.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in a sans-serif font. Below the word "icumedical" are the words "human connections" in a smaller, lighter font. The logo is simple and modern.

Efficacy Study

A time kill study was conducted to determine how rapidly and effectively SwabTip™ kills a variety of microorganisms. SwabTip™ was tested for antimicrobial activity against six selected organisms using an industry standard protocol for time-kill assays. The results demonstrated that SwabTip™ produces a 4 Log10 reduction are summarized below in Table 1.

Challenge Strain	Acceptance Criteria	Observed	Result
P. aeruginosa (ATCC#9027)	≥4.0 on 10/10 Samples	10/10	Pass
S. aureus (ATCC #6538)	≥4.0 on 10/10 Samples	10/10	Pass
E. coli (ATCC #11229)	≥4.0 on 10/10 Samples	10/10	Pass
S. epidermidis (ATCC#14990)	≥4.0 on 10/10 Samples	10/10	Pass
C. albicans (ATCC#10231)	≥4.0 on 10/10 Samples	10/10	Pass
C. glabrata (ATCC #2001)	≥4.0 on 10/10 Samples	10/10	Pass

		Table 1. Efficacy Test Results

Biocompatibility Testing

Biocompatibility testing for SwabTip™ was conducted in accordance with ISO 10993-1 and FDA's June, 2016 Guidance titled, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process," as recognized by FDA. Testing included:

ISO Elution Cytotoxicity per ISO 10993-5
Guinea Pig Maximization Sensitization per ISO 10993-10
Rabbit Intracutaneous Reactivity (Irritation) per ISO 10993-10
Acute Systemic Injection in Mice per ISO 10993-11
Hemolysis - Direct Contact and Extract Methods per ISO 10993-4
Rabbit Pyrogen Test per 10993-11
Subacute/Subchronic Study per ISO 10993-11

Conclusion

The SwabTip™ meets the functional claims and intended use as described in the product labeling. The functional specifications, components, design, sterilization, shelf-life and materials of construction of SwabTip™ are substantially equivalent to the predicate device. Test results from the performance testing conducted demonstrate that SwabTip™ met all acceptance criteria requirements. Therefore, the subject device – SwabTip™ is substantially equivalent to the currently marketed predicate device – SwabCap®. The changes outlined above, do not raise new or different questions of safety or effectiveness.

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.