CUROS RED PORT PROTECTOR

{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. Ivera Medical, Inc. Don Canal Vice President RA/QA 2731 Loker Avenue West Carlsbad, California 92010 March 11, 2022 Re: K140657 Trade/Device Name: Curos Red Port Protector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP Dear Don Canal: 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 4, 2014 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}------------------------------------------------ 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 representation of a caduceus, a traditional symbol of medicine, enclosed within a circle. The text is in a bold, sans-serif font, with "FDA" in a larger font size than the rest of the text. December 14, 2018 Ivera Medical. Inc. Don Canal Vice President RA/OA 2731 Loker Avenue West Carlsbad, California 92010 Re: K140657 Trade/Device Name: Curos Red Port Protector Regulatory Class: Unclassified Product Code: QBP Dated: March 14. 2014 Received: March 14, 2014 ## Dear Don Canal: This letter corrects our substantially equivalent letter of December 4, 2014. 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 www.fda.gov {2}------------------------------------------------ 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. Tina Kiang - Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K140657 Device Name Curos Red Port Protector ## Indications for Use (Describe) The Curos Red is intended for use on dialysis catheter fernale Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red in the home or healthcare facility. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ #### K140657 510(k) Summary ## General Company Information | Name: | |----------| | Contact: | Ivera Medical Corporation Don Canal Vice President Operations RAQA Address: Ivera Medical Corporation 3525 Del Mar Heights Road Suite #430 San Diego, CA 92130 972-955-7644 Telephone; 858-228-1770 Fax: don.canal@curos.com Email : ## Date Prepared: November 4, 2014 #### General Device Description The Curos Red Port Protector contains 70% Isopropyl alcohol and is intended for use on dialysis catheter open female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. The Curos Red has a highly visible red color that may allow improved compliance monitoring by easy visual verification to ensure that all open female luers are disinfected and covered. The Curos Red may be used in the home or healthcare facility. Common Name: Pad, Alcohol Curos Red Port Protector Trade Name: Unclassified Device, product Code LKB Classification: #### Predicate Devices K111992 Curos Port Protector, Ivera Medical, Inc. K101385 Dual Luer Lock Cap, Baxter Healthcare Corporation ## Intended Use (Indications) The Curos Red is intended for use on dialysis catheter female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, {5}------------------------------------------------ the Curos Red will disinfect the female luer and act as a cover until removed. The effectiveness of the Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red may be used in the home or healthcare facility. ## Comparison with Predicate Device | Characteristic | Subject Device | Curos Port Protector<br>K111992 | Predicate Device | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Curos Red Port Protector | Curos Port Protector | Dual Luer Lock Cap | | Common Name | Alcohol, disinfecting pad | Alcohol, disinfecting pad | IV Administration set | | Manufacturer | Ivera Medical | Ivera Medical | Baxter Healthcare<br>Company | | 510(k) number | Subject Device | K111992 | K101385 | | Regulation<br>number,<br>product code | Unclassified, Preamendment<br>device, product code: LKB | Unclassified, Preamendment<br>device, product code: LKB | IV Administration Set, 21<br>CFR 880.5440,<br>FPA, Class II | | Indications for<br>use | The Curos Red is intended for<br>use on dialysis catheter female<br>Luers and open female ports<br>on stopcocks as a<br>disinfecting cleaner prior to<br>line connection and to act as a<br>cover between line accesses. In<br>three (3) minutes after<br>application, the Curos Red will<br>disinfect the female Luer and<br>act as a cover until removed.<br>The effectiveness of the Curos<br>Red was tested in vitro against<br>Staphylococcus aureus,<br>Staphylococcus epidermidis,<br>Escherichia coli,<br>Pseudomonas aeruginosa,<br>Candida glabrata, and Candida<br>albicans. The Curos<br>Red may be used in the home<br>or healthcare facility. | The Curos is intended for use<br>on swab-able luer access<br>valves as a disinfecting<br>cleaner prior to line access<br>and to act as a physical<br>barrier to contamination<br>between line accesses. Curos<br>TM will disinfect the valve<br>three (3) minutes after<br>application and act as a<br>physical barrier to<br>contamination for up to<br>seven (7) days (168 hours) if<br>not removed. The<br>effectiveness of Curos<br>Protectors were tested in<br>vitro against Staphylococcus<br>aureus, Staphylococcus<br>epidermidis, Escherichia coli<br>and Pseudomonas<br>aeruginosa, Candida glabrata,<br>Candida albicans and was<br>found to have >4 log<br>reduction. The Curos Port<br>Protector may be used in the<br>home or healthcare facility. | The Dual Luer Lock Cap is<br>indicated for use as a cap<br>for male or female ports<br>on medical devices such<br>as manifolds, stopcocks<br>or sets. | | Disinfectant -<br>active ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | None | # Subject Device to Predicate Technological Comparison Table {6}------------------------------------------------ | Characteristic | Subject Device | Curos Port Protector<br>K111992 | Predicate Device | |----------------------------------------------------|------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------| | Male Luer<br>Connection | No | No | Yes | | Connection to<br>open female<br>luer connection | Yes | No | Yes | | Connection to<br>needleless IV<br>Valve | Yes | No | No | | Length | 0.47 inches | 0.40 inches | 0.365 | | Diameter | 0.50 inches | 0.54 inches | 0.205 | | User Population | Home and hospital use | Home and hospital use | Home and hospital use | | Colorants Used<br>(type, amount,<br>concentration) | Red, molded plastic, 3%<br>concentration | Translucent green, molded<br>plastic, 3% concentration | White Plastic. Exact<br>material formulation<br>and colorant is not<br>available | | Provided Sterile | Yes | Yes | Yes | | Single Use<br>Device | Yes | Yes | Yes | | Plastic Housing<br>to remain in<br>place | Yes | Yes | Yes | ## Substantial Equivalence Performance Testing Ivera Medical has provided non-clinical performance test data that demonstrates the predefined acceptance criteria for a disinfecting device has been met. This acceptance criteria is defined as a bacteria count reduction of ≥ 4 log reduction of 2 selected gram positive bacteria, 2 selected gram negative bacteria, and two selected fungus/yeast micro-organisms for a period of time from 3 minutes. The Efficacy testing methods and organisms are the same as those tested for the Curos Predicate device which was cleared under 510(k) K111992. The Curos Red device has been tested to meet the requirements of ISO 594-2 testing for sections: ease of assembly, rotational force to remove (un-torque evaluation) and leakage using water under pressure and leakage using vacuum with air. The testing was completed in accordance with Ivera test protocols. Ivera also completed Simulated Clinical Condition Evaluation testing to demonstrate that the Subject device seals and acts as a cover for the port. {7}------------------------------------------------ The efficacy test results are summarized in Table 1. | Organism | Acceptance Criteria<br>(bacterial count reduction<br>(ΔLog)) | 3 minute exposure<br>(bacterial count<br>reduction (ΔLog)) | |--------------------------|--------------------------------------------------------------|------------------------------------------------------------| | Staphylococcus aureus | ≥4 Log | 6.7 Log | | Staphylococcus epidermis | ≥4 Log | 6.9 Log | | Escherichia coli | ≥4 Log | 6.7 Log | | Pseudomonas aeruginosa | ≥4 Log | 6.9 Log | | Candida Albicans | ≥4 Log | 6.5 Log | | Candida Glabrata | ≥4 Log | 6.8 Log | Table 1 - Efficacy Test Results The Ivera Curos Red is sterilized using a validated Gamma sterilization process which complies with ISO11137-1:2006/(R) Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose. Recognition number 14-225. ISO11137-2:2006 Sterilization of health care products - Radiation - Part 1: requirements for development of validation and routine control of sterilization process for medical devices. Recognition number 14-297. 11137-3:2006/(R) 2010 10/04/2010 AAMI ANSI ISO 14-298 - Radiation - Part 3: Guidance on Dosimetric Aspects. Recognition number 14-298.FDA recognized standard ISO11137 Sterilization Standard. Ivera Medical has completed testing to demonstrate the materials of construction for the Subject Device meet FDA recognized standard ISO10993 for biocompatibility. #### Conclusion The analysis arguments and test results demonstrate the Curos Red device is safe for its intended use and is substantially equivalent to the predicate devices.