When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

Device Description

The DualCap Solo™ is designed to fit securely on luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for the Catheter Connections' DualCap Solo™. It does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. Instead, it makes a general claim of substantial equivalence to a predicate device (DualCap™ K093229) based on performance testing.

Therefore, I cannot fulfill most of your request directly from the provided text. I can, however, extract the claimed Indications For Use and the general statement about performance data.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided specifically. The document states, "The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing," but does not list these criteria or the numerical results from the performance testing.

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

Cannot be provided. The document states "Verification testing was performed according to protocols," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/Cannot be provided. This type of information is usually relevant for studies involving subjective assessments, such as imaging or diagnostic AI. The DualCap Solo is a physical device for disinfecting and acting as a barrier, so "ground truth" would be established through microbiology and engineering testing, not expert interpretation of outputs.

4. Adjudication method for the test set:

Not applicable/Cannot be provided. For the same reason as point 3, adjudication methods like 2+1 or 3+1 are not relevant for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Cannot be provided. This is an AI-specific study type, and the DualCap Solo is not an AI diagnostic or assistive device.

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

Not applicable/Cannot be provided. The device is not an algorithm.

7. The type of ground truth used:

Inferred based on device type: For a disinfectant and barrier cap, the "ground truth" would likely involve microbiological assays (to confirm disinfection efficacy) and physical barrier integrity tests (to confirm it prevents contamination). The document mentions "Biocompatibility requirements according to ISO-10993" and "Sterilization requirements of ISO 11137" which are examples of standards guiding such ground truth establishment.

8. The sample size for the training set:

Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

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

Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

Summary of available information:

Indications For Use (as per K113842):
"When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed."

General Statement on Performance:
"Performance data gathered demonstrated that the Catheter Connections' DualCap Solo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."
"The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing."

Type of Ground Truth (Inferred):
Microbiological efficacy (disinfection), physical barrier effectiveness, biocompatibility, and sterility testing, based on standards like ISO 11137 and ISO 10993.

The document is a regulatory submission for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as an already cleared predicate device, rather than providing a detailed scientific study report with all raw data and acceptance criteria specifics.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Catheter Connections, Inc. Donald D. Solomon President and COO 615 Arapeen Drive, Suite 302a Salt Lake City, Utah 84108

March 11, 2022

Re: K113842

Trade/Device Name: Catheter Connections' Dualcap Solo Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP

Dear Donald D. Solomon:

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 January 27, 2012 and the correction letter dated December 14, 2018. 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,

Pror R

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

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a staff entwined with a serpent, enclosed within a circle. The text is in bold, with "FDA" in a black square.

December 14, 2018

Catheter Connections. Inc. Donald Solomon President and CEO 2455 E Parleys Wav - Suite 150 Salt Lake City, Utah 84109

Re: K113842

Trade/Device Name: Catheter Connections' Dualcap Solo Regulatory Class: Unclassified Product Code: OBP Dated: December 22, 2011 Received: December 28, 2011

Dear Donald Solomon:

This letter corrects our substantially equivalent letter of January 27, 2012.

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 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. Iisting 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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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K113842 - Donald Solomon

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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catheter connections, Inc.

510(k) Premarket Notification Submission: Catheter Connections' DualCap Solo™

Indications For Use

510(k) Number (if known):

Device Name: Catheter Connections' DualCap Solo™

Indications For Use:

Prescription Use _ × AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Confidential

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-Oh)
Division of Anesthesiology. General Hospital Division Control, Dental Devices

510(k) Number: K113842

Page 18 of 98

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JAN 27 2012

CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: Catheter Connections' DualCap Solo™

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

(21 CFR 807.92)

for Catheter Connections' DualCap Solo™

SUBMITTER:

Catheter Connections, Inc. 615 Arapeen Drive, Suite 302a Salt Lake City, UT 84108

ESTABLISHMENT REGISTRATION NUMBER: 3009141010

CONTACT: Donald D. Solomon, Ph.D. President and COO Telephone: (801) 209-1269 Fax: {888) 862-2693 Email: dsolomon@cathconn.com

DATE PREPARED:

September 30, 2011

MODIFIED DEVICE (Submission Device):

DualCap Solo™ Trade Name: Regulation Number: Unclassified Pad, Alcohol, Device Disinfectant Regulation Classification Name: Regulatory Class: Unclassified Classification Product Code: гкв Classification Advisory Panel: General Hospital

SPONSOR'S CLEARED DEVICE - DualCap™ (K093229):

510(k) Holder of CLEARED DEVICE (K093229):	Catheter Connections, Inc.
Regulation Number:	Unclassified
Regulation Classification Name:	Pad, Alcohol, Device Disinfectant
Regulatory Class:	Unclassified
Classification Product Code:	LKB
Classification Advisory Panel:	General Hospital

Confidential

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DEVICE DESCRIPTION:

INTENDED USE:

DualCap Solo™ is intended for use on luer access valves. DualCap Solo™ will disinfect and decontaminate the valve and act as a barrier to contamination between IV administration line accesses.

DualCap Solo™ will disinfect the connections within five (5) minutes after application and act as a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

INDICATIONS FOR USE:

When left in place for five (5) minutes DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates (Sponsor's Cleared Device).

Does the new device have the same indication statements? Yes.

Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc. ? Yes. The Catheter Connections' DualCap Solo™ is substantially in equivalent design, materials, packaging, sterilization method of operation. The basic fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness? No.

Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.

Confidential

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CATHETER CONNECTIONS, INC.

510(k) Premarket Notification Submission: Catheter Connections' DualCap Solo™

Sterilization requirements of ISO 11137: 2006, Sterilization of health care products -Radiation.

Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

These and other standards were used to determine the appropriate methods for evaluating the device's performance.

Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.

Do performance data demonstrate equivalence? Yes. Performance data gathered demonstrated that the Catheter Connections' DualCap Solo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™).

CONCLUSION

The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing. This testing demonstrated that the Catheter Connections' DualCap Solo™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the above noted Sponsor's Cleared Device (DualCap™ - K093229).

Confidential .

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.