(27 days)
Not Found
No
The summary describes a physical device for disinfecting IV connectors and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended for disinfection of IV administration line male luer connectors and provides a physical barrier to contamination, which are functions related to infection control rather than treating a disease or condition.
No
The device disinfects and provides a physical barrier to contamination for IV administration line male luer connectors. It does not diagnose any condition or disease.
No
The device description clearly states it is a physical cap containing isopropyl alcohol, designed to fit on IV administration male luer connections. This indicates it is a hardware device with a chemical component, not software.
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 IV administration line male luer connectors. This is a direct action on a medical device (the luer connector) to prevent infection, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details a cap containing disinfectant and its physical properties. It does not describe a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the DualCap™ for male luer connectors falls under the category of a medical device used for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The dark blue DualCap™ intended for use on IV administration line male luer connectors, will disinfect and decontaminate the male luer connector and act as a barrier to contamination between IV administration line accesses.
The dark blue DualCap™ 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.
When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Product codes
QBP, LKB
Device Description
The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. 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.
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
Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.
Standard Peel strength tests were used and showed substantial equivalence. Performance data gathered demonstrated that the Modified Device is substantially equivalent to the noted predicate (Sponsor's Cleared Device).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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: K123967
Trade/Device Name: Catheter Connections' Dark Blue Dualcap For Male Luers 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 22, 2013 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,
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 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 depiction of a caduceus, a traditional symbol of medicine, enclosed in a circle. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
December 14, 2018
Catheter Connections. Inc. Donald Solomon President & Coo 2455 E Parleys Way - Suite 150 Salt Lake City, Utah 84109
Re: K123967
Trade/Device Name: Catheter Connections' Dark Blue Dualcap For Male Luers Regulatory Class: Unclassified Product Code: OBP Dated: December 19, 2012 Received: December 26, 2012
Dear Donald Solomon:
This letter corrects our substantially equivalent letter of January 22, 2013.
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
2
K123967 - 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 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. iang -
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
3
Page 18 of 147
CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
Indications For Use
K123967 510(k) Number (if known):
Device Name: Catheter Connections' Dark Blue DualCap™ for Male Luers
Indications For Use:
When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Digitally signed by Richard C.. |
|---|
| Chapman |
| Date: 2013.01.22 16:54:20 -05'00' |
Division Sian-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devic
510(k) Number: K123967
4
CATHETER CONNECTIONS, INC.
Page 20 of 147
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 2 2013
(21 CFR 807.92) for Catheter Connections' Dark Blue DualCap™ for Male Luers
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:
December 18, 2012
MODIFIED DEVICE (Submission Device):
Dark Blue DualCap™ for Male Luers Trade Name: Regulation Number: Unclassified Regulation Classification Name: Pad, Alcohol, Device Disinfectant 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 |
5
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
DEVICE DESCRIPTION:
The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. 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.
INTENDED USE:
The dark blue DualCap™ intended for use on IV administration line male luer connectors, will disinfect and decontaminate the male luer connector and act as a barrier to contamination between IV administration line accesses.
The dark blue DualCap™ 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, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; 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 1. predicates (Sponsor's Cleared Device).
- Change (new packaging configuration) to the Modified Device a.
- i. Compared to the Marketed Device, the Modified Device of this submission contains a substantially equivalent hermetic foil/polymer seal also found in the Sponsor's Cleared Device.
- ii. Scientific methods used to assess the effects of the change in device packaging
-
- A comparison of the specifications was conducted to assess whether the hermetic foil/polymer material of the Modified Device was substantially equivalent to the hermetic foil/polymer material of the Sponsor's Cleared Device.
-
- A comparison of the specifications was conducted to assess whether the polymer sealing seal surface of the Modified Device was substantially equivalent to the polymer sealing surface of the Sponsor's Cleared Device.
-
- Change (new packaging configuration) to the Modified Device a.
6
CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
- Does the new device have the same indication statements? Yes. 2.
- a. Change (new packaging configuration) to the Modified Device
- i. The dark blue disinfectant cap for both the Modified Device and the Sponsor's Cleared Device has the same Indications for use - to disinfect and protect male luer connectors.
- b. Scientific methods used to assess the effects of the change in device packaging
- 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. The indication statements were found to be substantially equivalent.
- Results that support substantial equivalence C.
- a. Change (new packaging configuration) to the Modified Device
| | Specification
Cleared Device | Specification
Modified Device | Results |
|----------------------------------|-------------------------------------------------------------|----------------------------------------------------------|-----------|
| Indication for Use
Statements | "...disinfect and
protect male
luer
connectors..." | "...disinfect and
protect male luer
connectors..." | Identical |
-
- 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.
- a. Change (new packaging configuration) to the Modified Device
- i. 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 male luer connectors in exactly the same way the Sponsor's Cleared Device is used.
- Scientific methods used to assess the effects of the change in device packaging ﻗ
- i. A comparison of the label specifications was conducted to assess whether the changes alter the intended therapeutic/diagnostic/etc. The change in packaging effect of the Modified Device does not alter the intended use compared to the intended therapeutic/diagnostic/etc. effect of the Sponsor's Cleared Device.
- Results that support substantial equivalence C.
| Intended Use | Specification
Cleared Device | Specification
Modified Device | Results |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | "...disinfect and
decontaminate the
male luer connector
and act as a barrier
to contamination
between IV
administration line
accesses." | "...disinfect and
decontaminate ... the
male luer and act as a
barrier to
contamination
between IV
administration line
accesses." | Dark Blue
disinfecting cap
has the same
intended use in
the Modified
Device and the
Sponsors
Cleared Device |
7
CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
-
- 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
- i. · The technological characteristics of the Modified Device are equivalent to that of the Sponsor's Cleared Device. Both the Modified Device and the Sponsor's Cleared Device retains the hermetic foil/polymer 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
-
- A comparison of the requirements (design input) and verification characteristics of the Modified Device are equivalent to the technological characteristics of the Sponsor's Cleared Device.
-
- Results that support substantial equivalence show that a specification comparison between the Cleared Device and the Modified Device comparing design, materials, sterilization method, and method of operation were all substantially equivalent.
-
5. Could the new characteristics affect safety or effectiveness? No.
a. Change (new packaging configuration) to the Modified Device
- The safety and effectiveness of the Modified Device are equivalent to that i. of the Sponsor's Cleared Device. Both the Modified Device and the Sponsor's Cleared Device have a hermetic foil/polymer 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
- Risk Analysis was used to assess the impact of the modification 1.
- ii. All tests were completed and showed substantial equivalence
-
- 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.
- The safety and effectiveness of the Modified Device are equivalent to that i. of the Sponsor's Cleared Device. Both the Modified Device and the Sponsor's Cleared Device have a hermetic foil/polymer 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 ﻘ i. Risk Analysis was used to assess the impact of the modification
- C. Risk Analysis Method identified the need to perform a standard Peel Test to assess the impact of the modification - results were substantially equivalent.
8
Do accepted scientific methods exist for assessing effects of the new characteristics? 7. Yes.
-
a. Change (new packaging configuration) to the Modified Device
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers -
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 have a hermetic foil/polymer 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 requirements of ISO 11137:2006, Sterilization of Health Care İ. 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 Testing.
-
- 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.
- a. Change (new packaging configuration) to the Modified Device
- 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 have a hermetic foil/polymer 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. Performance data used to assess the effects of the change in device packaging
- Standard Peel strength tests were used and showed substantial equivalence.
-
- 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 have a hermetic foil/polymer 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.
- ﻓ Scientific methods used to assess the effects of the change in device packaging
- i. Standard Peel strength tests were used and showed substantial equivalence.
9
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap™ for Male Luers
CONCLUSION
The Catheter Connections' Dark Blue DualCap® meets all established acceptance criteria for performance testing. This testing and comparison demonstrated that the Catheter Connections' Dark Blue DualCap® 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).