When left in place for five (5) minutes, DualCap Duo™ 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 Duo™ 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, latex free, non-pyrogenic, preservative free and DEHP free.

AI/ML Overview

The provided text describes a medical device called "Catheter Connections' DualCap Duo™" and its substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. Instead, it generally states that performance data demonstrate equivalence and that the device "will meet all established acceptance criteria for performance testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details since they are not present in the provided text.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:
* Not Available. The document states, "The Catheter Connections' DualCap Duo™ will meet all established acceptance criteria for performance testing," but does not list specific criteria or the quantitative performance results against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not Available. No details about sample size or data provenance (country of origin, retrospective/prospective) are mentioned for any testing.

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):
* Not Applicable / Not Available. This device is a disinfectant cap, not an AI/imaging device requiring expert ground truth for a test set in the same manner. No information about experts establishing ground truth is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable / Not Available.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not Applicable. This is not an algorithm. The device's performance is standalone in the sense that its disinfection capabilities are intrinsic to the product. The document states, "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols," and "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not Applicable / Not Available. For a device that disinfects, performance would likely be measured through microbiological testing against certain pathogen reductions or barrier efficacy, but the specific "ground truth" methodology is not detailed.

8. The sample size for the training set:
* Not Applicable / Not Available. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:
* Not Applicable / Not Available. This is not an AI/machine learning device.

Information that is available about the device and its testing:

Device Name: Catheter Connections' DualCap Duo™
Intended Use/Indications For Use: When left in place for five (5) minutes, it 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.
Key Technological Characteristic/Mechanism: Contains 70% isopropyl alcohol to disinfect. Provides a physical barrier.
Standards Used for Evaluation (referenced, not detailed):
- ISO 11137: 2006, Sterilization of health care products - Radiation.
- ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
- Other unspecified "additional standards and protocols."
Conclusion of Performance Data: "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)." This indicates that the new device's performance was found to be comparable to that of an already cleared device (K093229 - DualCap™) based on the testing performed according to the referenced standards. The device is deemed "safe and effective for its intended use."

To summarize, the document asserts that testing was performed and demonstrated substantial equivalence to a predicate device, and that the device meets acceptance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, or detailed study methodology that would be required to complete the requested table and answer many of the questions.

Summary

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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 is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

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

March 11, 2022

Re: K112985

Trade/Device Name: Catheter Connections' Dualcap Duo 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 November 9, 2011 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,

FDA

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 & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym along with the full name of the agency on the right. The symbol on the left is a stylized representation of a caduceus, a traditional symbol of medicine. To the right of the symbol is a black square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in bold, sans-serif font.

December 14, 2018

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

Re: K112985

Trade/Device Name: Catheter Connections' Dualcap Duo Regulatory Class: Unclassified Product Code: OBP Dated: September 30, 2011 Received: October 6, 2011

Dear Donald Solomon:

This letter corrects our substantially equivalent letter of November 9, 2011.

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, 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.

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K112985 - Donald Solomon

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 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 mediation-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,
FDA
Tina Kiang

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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Indications For Use

510(k) Number (if known):

Device Name: Catheter Connections' DualCap Duo™

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)

11/9/11
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K112985

Confidential

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NOV - 9 2011

CATHETER CONNECTIONS. INC. 510(k) Premarket Notification Submission: Catheter Connections' DualCap Duo™ Page 20 of 80

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

(21 CFR 807.92)

for Catheter Connections' DualCap Duo™

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):

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

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 Unclassified Regulatory Class: Classification Product Code: LKB Classification Advisory Panel: General Hospital

Confidential

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DEVICE DESCRIPTION:

INTENDED USE:

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

DualCap Duo™ 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 Duo™ disinfect 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 Duo™ 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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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 Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™).

CONCLUSION

The Catheter Connections' DualCap Duo™ will meet all established acceptance criteria for performance testing. This testing demonstrated that the Catheter Connections' DualCap Duo™ 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).

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.