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) Summary of Safety and Effectiveness for the Catheter Connections DualCap Solo™. It doesn't describe an AI/ML device, but rather a medical device with an administrative change related to its packaging. Therefore, the requested information about AI model performance, training data, ground truth establishment, and expert involvement is not applicable.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (the Sponsor's Cleared Device - K113842) by proving that a change in packaging configuration does not alter the device's safety or effectiveness.

Here's an analysis of the provided information within that context:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence based on the packaging change not affecting the core characteristics or performance. The "acceptance criteria" here are essentially "identical" or "substantially equivalent" when compared to the previously cleared device.

Characteristic	Acceptance Criteria (Compared to Cleared Device)	Reported Device Performance (Modified Device)	Result
Hermetic foil/polymer lid material	Identical	Identical	Met
Polymer sealing surface	Identical	Identical	Met
Process used to seal the hermetic foil/polymer lid	Identical	Identical	Met
Indications for Use Statements	Identical	Identical	Met
Design	Substantially Equivalent	Substantially Equivalent	Met
Materials	Substantially Equivalent	Substantially Equivalent	Met
Sterilization method	Identical	Identical	Met
Method of operation (Instructions for Use)	Substantially Equivalent	Substantially Equivalent	Met
Safety and Effectiveness	Equivalent (No new questions)	Equivalent (No new questions)	Met
Sterilization Validation	Substantially Equivalent	Substantially Equivalent	Met
Biocompatibility	Substantially Equivalent	Substantially Equivalent	Met
Seal Peel Force / Seal peel strength (performance data)	Identical	Identical	Met

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

The document does not specify a distinct "test set" in the context of an algorithm. Instead, it refers to various specifications and internal test methods.

For hermetic foil/polymer lid material, polymer sealing surface, and sealing process, "specifications" are compared. It does not mention a sample size for this comparison, suggesting a review of documentation rather than a physical test on a sample.
For indications for use, "label specifications" were compared, also implying documentation review.
For design, materials, sterilization method, and method of operation, "requirements (design input) and verification (design output)" were compared. Again, no specific test set sample size is mentioned.
For seal peel force/strength, an "Internal Test Method ATM 1208 based on ASTM F88" was used. The document mentions "performance data" but does not provide details on the sample size used for these tests.
The data provenance is internal to Catheter Connections, Inc., as indicated by references to internal document designations (e.g., "MSP 21-PX008", "ASC 1168", "ATM 1208"). The data is implicitly prospective in the sense that the testing was performed on the new modified device for this submission.

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

Not applicable. This device is not an AI/ML device requiring expert ground truth for a test set. Ground truth, in this context, would be established by the engineering and quality control standards applied during the manufacturing and testing of the device, referencing industry standards (e.g., ISO-10993, ASTM F88).

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for clinical or image-based studies. The assessment is based on comparing specifications and performance data to established standards and the predicate device.

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 device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" here is embodied by:

Identicality to predicate device specifications: For material, sealing process, indications for use, and sterilization method.
Substantial equivalence to predicate device characteristics: For design, materials (more broadly), and method of operation.
Compliance with recognized standards: Such as ISO-10993 (biocompatibility) and ASTM F88 (peel strength).
Risk Analysis: Performed according to internal methods to ensure no new safety or effectiveness questions are raised.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services, featuring a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text next to it. The text is stacked, with "Administration" on the bottom.

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

March 11, 2022

Re: K123065

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 December 14, 2012 and 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

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

December 14, 2018

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

Re: K123065

Trade/Device Name: Catheter Connections Dualcap Solo Regulatory Class: Unclassified Product Code: OBP Dated: September 28, 2012 Received: October 1, 2012

Dear Donald Solomon:

This letter corrects our substantially equivalent letter of December 14. 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, 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

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

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K123065 - 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.htm); 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/CDRHLeam). 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-S

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

4123665 510(k) Number (if known):

Device Name: Catheter Connections' DualCap Solo™

Indications For Use:

Prescription Use __ X

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)

Digitally signed by Richard C. Chapman Concurrence of CDRH, Office of Device Evaluation (ODE) Date: 2012.12.14 09:46:51 -05'00'

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

510(k) Number,

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K1230065

DEC 1 4 2012

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:

17 November 2012

MODIFIED DEVICE (Submission Device):

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

SPONSOR'S CLEARED DEVICE - DualCap Solo™ (K113842): 510(k) Holder of CLEARED DEVICE

(K113842): Catheter Connections, Inc.

Regulation Number: Unclassified Regulation Classification Pad, Alcohol, Device Disinfectant Name: Regulatory Class: Unclassified Classification Product Code: ГКВ Classification Advisory Panel: General Hospital

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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:

(Note: Document designations referenced below such as MSP, ASC, ATL, ATM, ARF, and numerical codes of the form xxxx-xx are internal Company proprietary and confidential document designations/identifiers)

1. New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates (Sponsor's Cleared Device).
- a. Change (new packaging configuration) to the Modified Device
  - i. Compared to the Marketed Device, the Modified Device of this submission contains a substantially equivalent package that retains the hermetic foil/polymer lid seal also found in the Sponsor's Cleared Device.
  - ii. Scientific methods used to assess the effects of the change in device packaging
    - 1. A comparison of the specifications was conducted to assess whether the hermetic foil/polymer lid material of the Modified Device was identical to the hermetic foil/polymer lid material of the Sponsor's Cleared Device.
    - 1. A comparison of the specifications was conducted to assess whether the polymer sealing surface of the Modified Device was identical to the polymer sealing surface of the Sponsor's Cleared Device.
    - 1. A comparison of the process specifications was conducted to assess whether the process used to seal the hermetic foil/polymer lid seal

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of the Modified Device was identical to the process used to seal the hermetic foil/polymer lid seal of the Sponsor's Cleared Device. Results that support substantial equivalence

	SpecificationCleared Device	SpecificationModified Device	Results
Hermeticfoil/polymerlid material	MSP 21-PX008See ASC 1168	MSP 21-PX008See ASC 1230	Identical
Polymersealing surface	PolypropyleneSee ASC 1018	PolypropyleneSee ASC 1243	Identical
Process usedto seal thehermeticfoil/polymerlid seal	Seal formed usingTool ATL 1174 andAMP 1170 withsame parameters	Seal formed usingTool ATL 1174 andAMP 1170 with sameparameters	Identical

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

iii.

a. Change (new packaging configuration) to the Modified Device
- i. The light blue disinfectant cap for both the Modified Device and the Sponsor's Cleared Device has the same Indications for use – to disinfect and protect luer access valves.
Scientific methods used to assess the effects of the change in device packaging ﻓ
- i. A comparison of the label specifications was conducted to assess whether the indication statements of the Modified Device was identical to the indication statements of the Sponsor's Cleared Device.
Results that support substantial equivalence C.

	SpecificationCleared Device	SpecificationModified Device	Results
Indications forUse Statements	1051-003-01	1222-005-01	Identical

1. 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.
- Change (new packaging configuration) to the Modified Device a.
  - The promotional material for the Modified Device is equivalent to that of i. the Sponsor's Cleared Device. Conceptually and by informational intent both the Modified Device and the Sponsor's Cleared Device refer to the light blue cap as the cap which disinfects and protects luer access valves.
  - ii. The Modified Device is used in the same way for the same intended use of disinfecting and protecting luer access valves. The Modified Device is used and applied to luer access valves in exactly the same way the Sponsor's Cleared Device is used.

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b. Scientific methods used to assess the effects of the change in device packaging
- A comparison of the label specifications was conducted to assess whether i.
- the changes alter the intended therapeutic/diagnostic/etc. Effect of the Modified Device compared to the intended therapeutic/diagnostic/etc. effect of the Sponsor's Cleared Device.
Results that support substantial equivalence C.

	SpecificationCleared Device	SpecificationModified Device	Results
Indications for UseStatements	1051-003-01	1222-005-01	Identical

1. Does the new device have the same technological characteristics, e.g. design, material, etc. ? Yes. The Modified Device is substantially equivalent in design, materials, sterilization method and method of operation. The basic fundamental scientific technology of the device has not changed.
- a. Change (new packaging configuration) to the Modified Device
  - The technological characteristics of the Modified Device are equivalent to 1. that of the Sponsor's Cleared Device. Both the Modified Device and the Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical structure and components to be used for the same indications in the same manner.
  - ii. Scientific methods used to assess the effects of the change in device packaging
    - 1. A comparison of the requirements (design input) and verification (design output) was conducted to assess whether the technological characteristics of the Modified Device are equivalent to the technological characteristics of the Sponsor's Cleared Device ..
  - iii. Results that support substantial equivalence

	SpecificationCleared Device	SpecificationModified Device	Results
Design	1024-003-01	1224-005-01	SubstantiallyEquivalent
Materials	See ASC 1024	See ASC 1224	SubstantiallyEquivalent
Sterilizationmethod	See AFM 1199VDMAX	See AFM 1199VDMAX	Identical
Method ofoperation	Instructions for Use1051-003-01	Instructions forUse 1222-005-01	SubstantiallyEquivalent

1. Could the new characteristics affect safety or effectiveness? No.
- Change (new packaging configuration) to the Modified Device a.
  - .. -The safety and effectiveness of the Modified Device are equivalent to that of the Sponsor's Cleared Device. Both the Modified Device and the

$\searrow$

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Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical structure and components to be used for the same indications in the same manner.

b. Scientific methods used to assess the effects of the change in device packaging
- i. See section 13.1 (p. 50 of the submission) Risk Analysis Method used to assess the impact of the modification
- Appendix 6 of the submission (p.81) ii.
Results that support substantial equivalence C.
- i. See section 13.1 (p. 50) Risk Analysis Method used to assess the impact of the modification
- ii. Appendix 6 of the submission (p.81)
1. Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
- Change (new packaging configuration) to the Modified Device a.
  - i. The safety and effectiveness of the Modified Device are equivalent to that of the Sponsor's Cleared Device. Both the Modified Device and the Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical structure and components to be used for the same indications in the same manner.

b. Scientific methods used to assess the effects of the change in device packaging

See section 13.1 Risk Analysis Method of the submission used to assess the i.. impact of the modification
See section 13.1 Risk Analysis Method used to assess the impact of the modification C.
1. Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
- a. Change (new packaging configuration) to the Modified Device
  - i. The effects of the new characteristics of the Modified Device can be assessed using accepted scientific methods. Both the Modified Device and the Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical structure and components to be used for the same indications in the same manner.
- b. Scientific methods used to assess the effects of the change in device packaging
  - .............................................................................................................................................................................. Sterilization of health care products - Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  - ii. Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testina.

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	SpecificationCleared Device	SpecificationModified Device	Results
SterilizationValidation	See ARF 1199	See ARF 1199	SubstantiallyEquivalent
Biocompatibility	ISO 10993 (seesubmission)	ISO 10993 (seesubmission)	SubstantiallyEquivalent
Seal Peel Force	See ASC 1024See Appendix 6 inthe submission	See ASC 1224See Appendix 6 inthe submission	Identical

Reports that support substantial equivalence 1.

8. 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. Change (new packaging configuration) to the Modified Device a.

i. The effects of the new characteristics of the Modified Device can be assessed using available performance data. Both the Modified Device and the Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical
- structure and components to be used for the same indications in the same manner.

Performance data used to assess the effects of the change in device packaging b.

i. Peel strength Internal Test Method ATM 1208 based on ASTM F88
- Specification Specification Results Cleared Device Modified Device Seal peel See ASC 1024 See ASC 1224 strength See Appendix 6 in See Appendix 6 in ldentical the submission the submission
C. Results that support substantial equivalence
ல் Do performance data demonstrate equivalence? Yes. Performance data gathered demonstrated that the Modified Device is substantially equivalent to the noted predicate (Sponsor's Cleared Device). .
- Change (new packaging configuration) to the Modified Device a.
  - i. The equivalence of the new characteristics of the Modified Device can be demonstrated using available performance data. Both the Modified Device and the Sponsor's Cleared Device retain the hermetic foil/polymer lid seal. Both the Modified Device and the Sponsor's Cleared Device retain the identical structure and components to be used for the same indications in the same manner.

Scientific methods used to assess the effects of the change in device packaging b.

Peel strength Internal Test Method ATM 1208 based on ASTM F88

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c. Results that support substantial equivalence

	SpecificationCleared Device	SpecificationModified Device	Results
Seal peel strength	See ASC 1024See Appendix 6 inthe submission	See ASC 1224See Appendix 6 inthe submission	Identical

CONCLUSION

The Modified Device will meet all established acceptance criteria for performance testing. This testing demonstrated that the Modified Device 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 Solo™ - K113842).

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.