K Number

Device Name

CATHETER CONNECTIONS DUALCAP SOLO

Manufacturer

CATHETER CONNECTIONS, INC.

Date Cleared

2012-12-14

(74 days)

Product Code

QBP LKB OBP

Regulation Number

880.5440

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113842

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical device containing isopropyl alcohol for disinfection and providing a physical barrier. There is no mention of AI, ML, image processing, or any data-driven algorithms.

Therapeutic

No
This device is intended for disinfecting luer access valves and providing a barrier against contamination, which are preventative measures rather than therapeutic treatments for a disease or condition.

Diagnostic

Explanation: The device disinfects and provides a physical barrier to contamination for luer access valves. Its function is to prevent infection and contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical cap containing isopropyl alcohol, designed to fit on luer access valves. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to disinfect and provide a physical barrier to contamination for needleless luer access valves. This is a direct action on a medical device to prevent infection, not a test performed on a biological sample to diagnose a condition.
Device Description: The device contains isopropyl alcohol and is designed to fit on luer access valves. This aligns with a disinfectant and barrier function, not an in vitro diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

QBP, LKB

Device Description

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)

Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols. 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 gathered demonstrated that the Modified Device is substantially equivalent to the noted predicate (Sponsor's Cleared Device).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K113842

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

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.

Summary

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

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

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

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,

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

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

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

| | Specification
Cleared Device | Specification
Modified Device | Results |
|---------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------|
| Hermetic
foil/polymer
lid material | MSP 21-PX008
See ASC 1168 | MSP 21-PX008
See ASC 1230 | Identical |
| Polymer
sealing surface | Polypropylene
See ASC 1018 | Polypropylene
See ASC 1243 | Identical |
| Process used
to seal the
hermetic
foil/polymer
lid seal | Seal formed using
Tool ATL 1174 and
AMP 1170 with
same parameters | Seal formed using
Tool ATL 1174 and
AMP 1170 with same
parameters | 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.

| | Specification
Cleared Device | Specification
Modified Device | Results |
|-----------------------------------|---------------------------------|----------------------------------|-----------|
| Indications for
Use 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.

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.

| | Specification
Cleared Device | Specification
Modified Device | Results |
|-----------------------------------|---------------------------------|----------------------------------|-----------|
| Indications for Use
Statements | 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

| | Specification
Cleared Device | Specification
Modified Device | Results |
|-------------------------|-------------------------------------|-------------------------------------|-----------------------------|
| Design | 1024-003-01 | 1224-005-01 | Substantially
Equivalent |
| Materials | See ASC 1024 | See ASC 1224 | Substantially
Equivalent |
| Sterilization
method | See AFM 1199
VDMAX | See AFM 1199
VDMAX | Identical |
| Method of
operation | Instructions for Use
1051-003-01 | Instructions for
Use 1222-005-01 | Substantially
Equivalent |

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

$\searrow$

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.

| | Specification
Cleared Device | Specification
Modified Device | Results |
|-----------------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------|
| Sterilization
Validation | See ARF 1199 | See ARF 1199 | Substantially
Equivalent |
| Biocompatibility | ISO 10993 (see
submission) | ISO 10993 (see
submission) | Substantially
Equivalent |
| Seal Peel Force | See ASC 1024
See Appendix 6 in
the submission | See ASC 1224
See Appendix 6 in
the 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

c. Results that support substantial equivalence

| | Specification
Cleared Device | Specification
Modified Device | Results |
|--------------------|-----------------------------------------------------|-----------------------------------------------------|-----------|
| Seal peel strength | See ASC 1024
See Appendix 6 in
the submission | See ASC 1224
See Appendix 6 in
the 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).