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, 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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Curos Red Port Protector, extracted from the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Organism	Acceptance Criteria (bacterial count reduction (ΔLog))	3 minute exposure (bacterial count reduction (ΔLog))
Staphylococcus aureus	≥4 Log	6.7 Log
Staphylococcus epidermidis	≥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

Beyond the bacterial count reduction, the device also met the following acceptance criteria (details on specific thresholds are not provided in the summary but are implied by meeting the requirements of the standards):

ISO 594-2 testing: for ease of assembly, rotational force to remove (un-torque evaluation), and leakage using water under pressure and leakage using vacuum with air.
Simulated Clinical Condition Evaluation testing: to demonstrate that the device seals and acts as a cover for the port.
Sterilization: Validated Gamma sterilization process complying with ISO11137-1:2006, ISO11137-2:2006, and ISO11137-3:2006/(R) 2010.
Biocompatibility: Materials of construction meet FDA recognized standard ISO10993.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for the efficacy studies. However, efficacy testing typically involves multiple replicates per organism and condition.
Data Provenance: The studies were conducted by Ivera Medical and are in vitro (laboratory-based) tests. The country of origin is not specified but is implicitly the location of Ivera Medical (Carlsbad, California, and San Diego, California, based on the contact information). The studies are prospective in the sense that they were conducted to specifically test the Curos Red device's performance against predefined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary. Efficacy testing (like pathogen reduction) relies on standardized laboratory protocols, and the "ground truth" is typically defined by the experimental results themselves against the known inoculation concentrations, rather than expert consensus on interpretation.

4. Adjudication method for the test set

This information is not applicable for the in vitro efficacy testing described. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations where human interpretation is involved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a MRMC comparative effectiveness study was not done. This device is a medical accessory for disinfection and port coverage, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Yes, the primary performance studies were standalone. The efficacy tests (bacterial count reduction) were performed directly on the device and its disinfectant properties, without human interpretation in the loop influencing the disinfection process or its outcome. The leakage and sealing tests were also evaluating the mechanical properties of the device independently.

7. The type of ground truth used

For the efficacy studies (bacterial count reduction), the ground truth was established through microbiological testing against known concentrations of target microorganisms. The reduction in viable organisms after exposure to the device's disinfectant determined the effectiveness.
For mechanical tests (ISO 594-2, Simulated Clinical Condition Evaluation), the ground truth would be based on engineering and performance specifications defined by the relevant standards and the manufacturer's internal protocols.

8. The sample size for the training set

This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI models. The device's performance is determined by its physical and chemical properties.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of medical device.

Summary

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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

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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

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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

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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)

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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

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,

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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 ProtectorK111992	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 HealthcareCompany
510(k) number	Subject Device	K111992	K101385
Regulationnumber,product code	Unclassified, Preamendmentdevice, product code: LKB	Unclassified, Preamendmentdevice, product code: LKB	IV Administration Set, 21CFR 880.5440,FPA, Class II
Indications foruse	The Curos Red is intended foruse on dialysis catheter femaleLuers and open female portson stopcocks as adisinfecting cleaner prior toline connection and to act as acover between line accesses. Inthree (3) minutes afterapplication, the Curos Red willdisinfect the female Luer andact as a cover until removed.The effectiveness of the CurosRed was tested in vitro againstStaphylococcus aureus,Staphylococcus epidermidis,Escherichia coli,Pseudomonas aeruginosa,Candida glabrata, and Candidaalbicans. The CurosRed may be used in the homeor healthcare facility.	The Curos is intended for useon swab-able luer accessvalves as a disinfectingcleaner prior to line accessand to act as a physicalbarrier to contaminationbetween line accesses. CurosTM will disinfect the valvethree (3) minutes afterapplication and act as aphysical barrier tocontamination for up toseven (7) days (168 hours) ifnot removed. Theeffectiveness of CurosProtectors were tested invitro against Staphylococcusaureus, Staphylococcusepidermidis, Escherichia coliand Pseudomonasaeruginosa, Candida glabrata,Candida albicans and wasfound to have >4 logreduction. The Curos PortProtector may be used in thehome or healthcare facility.	The Dual Luer Lock Cap isindicated for use as a capfor male or female portson medical devices suchas manifolds, stopcocksor sets.
Disinfectant -active ingredient	70% Isopropyl Alcohol	70% Isopropyl Alcohol	None

Subject Device to Predicate Technological Comparison Table

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Characteristic	Subject Device	Curos Port ProtectorK111992	Predicate Device
Male LuerConnection	No	No	Yes
Connection toopen femaleluer connection	Yes	No	Yes
Connection toneedleless IVValve	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(type, amount,concentration)	Red, molded plastic, 3%concentration	Translucent green, moldedplastic, 3% concentration	White Plastic. Exactmaterial formulationand colorant is notavailable
Provided Sterile	Yes	Yes	Yes
Single UseDevice	Yes	Yes	Yes
Plastic Housingto remain inplace	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.

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The efficacy test results are summarized in Table 1.

Organism	Acceptance Criteria(bacterial count reduction(ΔLog))	3 minute exposure(bacterial countreduction (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.

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.