(84 days)
Not Found
No
The summary describes a physical device for disinfecting luer connectors and provides performance data based on biological and physical testing, with no mention of AI or ML.
No.
The device's intended use is to disinfect male luer connectors and provide a physical barrier to contamination, which are preventative or cleaning functions, not therapeutic actions on the body.
No
Explanation: The device is described as a cap that disinfects luer connectors and provides a physical barrier to contamination. Its function is to prevent infection, not to diagnose a condition or disease.
No
The device description clearly describes a physical cap designed to disinfect and provide a physical barrier to contamination for male luer connectors. It mentions materials, physical testing, and microbiological testing, all indicative of a hardware device. There is no mention of software functionality.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and provide a physical barrier for male luer connectors. This is a direct interaction with a medical device (luer connector) and not with a biological sample taken from the human body for the purpose of providing information about a physiological state, health, or disease.
- Device Description: The description focuses on the physical properties and function of the cap in disinfecting and protecting the luer connector.
- Performance Studies: The performance studies described are related to biocompatibility (interaction with the body), microbiological efficacy (killing microorganisms on the luer), and physical compatibility with luer devices. These are not studies typically associated with evaluating the performance of an IVD, which would involve evaluating the accuracy and reliability of measurements or detection in biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the Dark Blue DualCap is a medical device intended for disinfection and protection of medical equipment, not an IVD.
N/A
Intended Use / Indications for Use
When left in place for five (5) minutes, the Dark Blue DualCap disinfects 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, OBP, LKB
Device Description
The Date Blue DualCap" is designed to Internet on all ISO standard mater and man and newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP.
Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,
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)
Biocompatibility testing
The hiocompatibility evaluation for the dark blue can was condicted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1 Evaluation and Testing, "May 1, 1995. The submission device and predicate devices are identienl. The battery of tests included the following:
- Cylotoxicity
- Sensitization
- Iritation or Intracutaneous Reactivity
- Systemic Toxicity
- Hemocompatibility
- Pyrogen
Microbiological testing
Time Kill Studies were conducted for the evaluation of products for antimierobial activity against schected organisms using an industry standard protocol for unc-Kill assays (ASTM E 2315-03. 2008). The product is challenged with the test organism(s) and then assayed at selected time points to determine antimicrobial efficacy on a wide range of microorganisms such as Staphylococous aurens. Pseudomas aeruginasa, Sireptococcus pyogenes, intibiotic-resistant bacteria such as MRSA. VRF and veasts such as Candida albicans and Candida keusel. The study has shown a - 4 log reduction in all cases.
Additional in wiro antimierobial officacy studies were completed on the DualCape for Male iners under worst case conditions and show a 2 4 log reduction in each test organism (Staphylococcus aureus, Staphylococcus epidermichs; Pseudomonas aeruginosa, and Escherichie とのたず。
Other performance tests
Physical tests wore performed to ensure that Dark Blue DualCap® for Male Lucis was compatible with typical male luer dovices such as those found on IV administration sets and syninges. Applicable testing using JSO594-1 and ISC 594-2 was completed. The Dark Blue DualCap® for Male Lucrs passod all tests.
Testing was also completed to demonstrate that the Dark Blue DualCap® for Mals Luers did not allow disinfectant to enter into the fluid path of the male luers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Catheter Connections, Inc. Donald Soloman Sr.VP of Operations & Engineering/Chief Technology Officer 2455 E Parleys Way - Suite 150 Salt Lake City, Utah 84109
March 11, 2022
Re: K142399
Trade/Device Name: DualCap IV Pole Strips(Disinfectant Caps for Male Luers) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP
Dear Donald Soloman:
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 19, 2014 and the correction letter dated March 6, 2019. 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,
Pura Rao
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 contains 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 "U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol features a stylized image of an eagle, while the text is arranged in three lines, with "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
March 6, 2019
Catheter Connections, Inc. Donald Solomon Ph.D. Sr.VP of Operations & Engineering/Chief Technology Officer 2455 E Parleys Way - Suite 150 Salt Lake City, Utah 84109
Re: K142399
Trade/Device Name: Dark Blue DualCap® for Male Luers Regulatory Class: Unclassified Product Code: OBP Dated: August 19, 2014 Received: August 27, 2014
Dear Donald Solomon:
This letter corrects our substantially equivalent letter of November 19, 2014
We have reviewed vour 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 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 ww.fda.gov
2
K142399 - 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/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,
Image /page/2/Picture/6 description: The image shows the name "Geeta K. Pamidimukkala -S" in a simple, sans-serif font. The text is arranged vertically, with "Geeta K." on the top line, "Pamidimukkala" on the second line, and "-S" on the third line. The text is dark, contrasting with the lighter background.
for 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
2
3
CATHETER CONNECTIONS, INC.
Page 23 of 112
510(k) Premarket Notification Submission: Catheter Connections' Dark Blue DualCap® for Male Luers
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K142399 | |
| Device Name | Catheter Connections' Dark Blue DualCap for Male Luers | |
| Indications for Use (Describe) | When left in place for five (5) minutes, the Dark Blue DualCap disinfects male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. | |
| Type of Use (Select one or both, as applicable) | | |
| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
ﻟﻮ
4
K142399 510(R) SUMMARY OF SARETY AND EFFECTIVENESS (21 CFR 807 92)
for the Catheter Connections' Dark Blue DualCap® for Male Luers
SUBMISTOGR
Catheter Connections, Inc.
2455 East Parley's Way, Suite 150 Salt Lake City, UT 84109
CONTACTL
Donald D. Solomon, Ph.D.
Telephone: (801) 209-1269 Fas: (888) 862-2693 Enrail: asolomon@cathsomil.com Date Prepared: August 7, 2014
SUBMISSION DEVICE .
Trade Name: Dack Blue DualCap® for Male Luces Regulation Number: Unolassified Regulation Classification Name:
Regulatory Class: Pad, Alcohol, Device Disinfectant Unclassified Classification Product Code: IFB Classification Advisory Panel: General Hospital
PREDICATION DENICE
DualCop™ for Male Luers (K123967): (This predicate devices were used in this submission) Regulation Number: Unolassified Pad, Alcohol, Device Regulation Classification Name: Disinfectant Regulatory Class: Unclassified Classification Product Code: LKB Classification Advisory Panel: General Hospital
DEVICE DESCRIPTION:
The Date Blue DualCap" is designed to Internet on all ISO standard mater and man and
newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP,
Page 4 of 19
5
Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,
INTENDED USE:
The Durk Blue DualCap®, intended for use on male luer connectors, will disimlest and decomaminate male luer connectors and act as a barrier to vontamination between uses.
The Dark Blue DualCap will disintect the comections within five (5) minutes after application and act as a physical harrier To contamination up to minety - six (96) hours under normal conditions if not semoved.
INDICATIONS TOR USE:
When left in place for five (5) minutes the Dark Blue DualCap" disimiers male luer comectors. thereafter the caps provide a physical barrier to confamination up to ninety-six (96) hours under normal conditions if not removed
The difference in the Indications for Use for the submission device compared to the prodicate device is a clarification that the Dark Blue DualCape can be used on any male luce connector since male luers are dimensionally governed by an international standard (150) and are not. device specific.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Disinfection of surfaces by exposure to 70% isopropyl alcohol. (IFA) contained in a plastic caps while protecting the fluid pathway from disinfectant contamination is the general principle for both the submission and predicate devices. The submission and prodicate dovices are both based on the following technological elements:
- The devices are hermetically soaled and radiation sterifized g
- · They utilize an IPA reservoir
- They utilize an elastomeric tip to block the fluid pathway upon connection to a male fuer re
- There is an internal component which malifains the elastomeric tip noted abovedin 安 contact with the orifice of the fluid pathway
- 发 They have an-ISO compliant female luer 6% taper dimensional leature to mate with male Ther 6% taper feature
- They are mechanically secured via ISO compliant threads onto male luer connectors. ●
- · They disinfect and protect male fuer connectors
There are no technological differences between the submission and the prodicate devices
- · The submission device is physically identical to the predicates device. They have the same teclinological characteristics;
- e Same design
Page 5 of 19
S
6
- Same materials
- o Same components
- Same method of manufacture
- Same plastic injection molds used to make the polypropylene Dark Blue caps
- a Same method of operation
- Same sterrlization method
- · No change in the function/performance indication
- · No change in patient population
- · No change in clinical context
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination,
Biocompatibility testing
The hiocompatibility evaluation for the dark blue can was condicted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1 Evaluation and Testing, "May 1, 1995. The submission device and predicate devices are identienl. The battery of tests included the following:
- · Cylotoxicity
- · Sensitization
- · Iritation or Intracutaneous Reactivity
- Systemic Toxicity
- Hemocompatibility
- · Pyrogen
Microbiological testing
Time Kill Studies were conducted for the evaluation of products for antimierobial activity against schected organisms using an industry standard protocol for unc-Kill assays (ASTM E 2315-03. 2008). The product is challenged with the test organism(s) and then assayed at selected time points to determine antimicrobial efficacy on a wide range of microorganisms such as Staphylococous aurens. Pseudomas aeruginasa, Sireptococcus pyogenes, intibiotic-resistant bacteria such as MRSA. VRF and veasts such as Candida albicans and Candida keusel. The study has shown a - 4 log reduction in all cases,
Additional in wiro antimierobial officacy studies were completed on the DualCape for Male iners under worst case conditions and show a 2 4 log reduction in each test organism (Staphylococcus aureus, Staphylococcus epidermichs; Pseudomonas aeruginosa, and Escherichie とのたず。
Other performance tests
Physical tests wore performed to ensure that Dark Blue DualCap® for Male Lucis was compatible with typical male luer dovices such as those found on IV administration sets and
Page 6 of 19
p
7
syninges. Applicable testing using JSO594-1 and ISC 594-2 was completed. The Dark Blue DualCap® for Male Lucrs passod all tests.
Testing was also completed to demonstrate that the Dark Blue DualCap® for Mals Luers did not allow disinfectant to enter into the fluid path of the male luers.
CONCEESION
The Submission Device is physically identical to the predicate device in terms of intended use, design materials, operation, function, and sterifization method. All established acceptance criteria for performance testing for the predicate are identical to the Submission Device. This demonstrates that the Submission Device is safe and effective for its intended on FDA s: 510(k) Decision-Making Floweltart is substantially equivalentito The Dark Blue cap of the Prediente Device (K123967).
8
Image /page/8/Picture/0 description: This image shows a letter from the Department of Health & Human Services, specifically the Public Health Service and Food and Drug Administration. The letter was mailed from zip code 20993 on March 13, 2019, with a postage of $0.65. A yellow sticker indicates that the letter was undeliverable and is being returned to the sender, with a barcode and the number 20993.