(332 days)
Not Found
No
The device is a physical cap with disinfectant, and the summary describes standard performance and biocompatibility testing, with no mention of AI/ML.
No
The device is described as a disinfecting cap for medical luers, intended to prevent contamination and maintain a disinfected surface. It acts as a barrier and uses isopropyl alcohol to kill microorganisms, which is a preventative measure rather than a direct treatment for a disease or condition.
No
Explanation: The device is intended to disinfect and protect luer connectors from contamination, acting as a physical barrier and delivering an antimicrobial agent. Its purpose is preventative and maintenance-related, not to diagnose a condition or disease.
No
The device description and performance studies clearly indicate a physical device (cap) that delivers a liquid (isopropyl alcohol) and acts as a physical barrier. There is no mention of software components.
Based on the provided information, the SwabTip™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the SwabTip™ is for protecting and disinfecting the external surfaces of ISO male luer connectors. This is a physical and chemical action on a medical device component, not a test performed on a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces its function as a cap that delivers isopropyl alcohol to the luer surface.
- Performance Studies: The performance studies focus on the device's ability to disinfect, act as a barrier, and be compatible with luer connectors. These are not studies related to the diagnostic performance of a test on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the SwabTip™ is a medical device used for disinfection and protection of intravenous administration sets, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QBP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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®.
Summary of the testing conducted:
- 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
Particulate contamination testing was performed by following USP to demonstrate particulate levels on the SwabTip™ device meet USP requirements.
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Efficacy Test Results (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
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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,
P
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)
Device Name
SwabTip™ Male Disinfectant Cap
Indications for Use (Describe)
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.
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 Registration | |
| Number | 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) to | |
| which 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 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. | |
| Intended Use of Device/Indication | |
| for use | 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. |
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 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. | SwabCap® is intended for use on swab-able luer access | ||
| valves as a cover to protect the luer access valves from | |||
| potential contamination. The SwabCap® acts as a | |||
| physical barrier to contamination between line accesses | |||
| and also serves as a disinfecting cleaner for use prior to | |||
| line access. SwabCaps®' will disinfect the valve five (5) | |||
| minutes after application and maintains a disinfected | |||
| valve surface for up to seven (7) days if not removed. | Antimicrobial | ||
| Efficacy and | |||
| Microbial Barrier | |||
| testing were | |||
| performed on the | |||
| subject device for | |||
| differences in | |||
| disinfection time | |||
| and maintaining a | |||
| disinfected luer | |||
| surface. | |||
| Design | SwabTip™ is used on a male luer | The purpose of this 510(k) is to extend the indications | |
| for use to include surface disinfection for up to 7 days. | |||
| SwabCap® is used with a luer valve | Luer compatibility | ||
| testing was | |||
| conducted on | |||
| subject device. | |||
| Subject device is | |||
| for male luers, the | |||
| predicate is for a | |||
| luer valve. | |||
| Materials of | |||
| Construction | Outer Cap/Holder (packaging and cap) - High- | ||
| Density Polyethylene | Outer Cap Holder (packaging) – Alathon M6580 | ||
| Cap – Medical Grade Santoprene | Subject device | ||
| was tested | |||
| according to ISO | |||
| 10993-1 | |||
| Sponge – Polyester Urethane foam | Sponge – SUGI absorbent material | Subject device | |
| was tested | |||
| according to ISO | |||
| 10993-1 | |||
| Foil - Polyethylene Terephthalate & Low-Density | |||
| Polyethylene | Foil - Polyethylene Terephthalate & Low-Density | ||
| Polyethylene | Same | ||
| Antimicrobial | |||
| Agent | Isopropyl Alcohol (70%) | Isopropyl Alcohol (70%) | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Shelf Life | 2 years | 2 years | Same |
| Sterilization | |||
| Method | 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 to demonstrate particulate levels on the SwabTip™ device meet USP 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.