The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.

Device Description

The Curos™ Port Protector device is a single use, non-sterile device that contains 70% Isopropyl Alcohol and is intended to be used to decontaminate needleless luer activated valves.

AI/ML Overview

This is a 510(k) premarket notification for the Curos™ Port Protector, a device containing 70% Isopropyl alcohol intended to decontaminate needleless luer activated valves. The submission aims to demonstrate substantial equivalence to a predicate device, the APLICARE Alcohol Prep Pad (K833182).

This document doesn't provide specific acceptance criteria or an explicit study that proves the device meets those criteria in the typical format of an AI/ML device study. Instead, it focuses on demonstrating substantial equivalence through performance test data for decontamination and comparison data to a predicate device.

Here's an attempt to extract and format the information based on the provided text, recognizing that it's not a direct fit for an AI/ML device study format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Reduction of bacterial count for selected gram-positive bacteria	"reducing the bacterial count two (2) selected gram positive bacteria"
Reduction of bacterial count for selected gram-negative bacteria	"reducing the bacterial count... 2 selected gram negative bacteria"
Equivalence to predicate device	"demonstrated equivalence to the predicate device with comparison test data."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). It only states "performance test data."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The "ground truth" here relates to microbial reduction, which would be measured in a lab setting, not through expert consensus on images or similar data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance tests for decontamination typically involve laboratory measurements and not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. The Curos™ Port Protector is a physical medical device for decontamination, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable in the context of an AI/ML algorithm. However, the performance tests on bacterial reduction and comparison to the predicate device can be considered a standalone evaluation of the device's efficacy without direct human interaction beyond its application.

7. Type of Ground Truth Used

The ground truth for the performance tests would be the measured bacterial counts before and after decontamination by the device, as determined by standard microbiological laboratory techniques. This is effectively a laboratory measurement/outcome data.

8. Sample Size for the Training Set

This information is not applicable and not provided, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as this is not an AI/ML device.

Summary of Device and Evidence:

The Curos™ Port Protector is a single-use, non-sterile device containing 70% Isopropyl Alcohol, designed to decontaminate needleless luer activated valves by reducing bacterial counts. It also provides a physical barrier.

The evidence for its effectiveness and substantial equivalence relies on:

Performance test data demonstrating the reduction of bacterial counts for two selected gram-positive and two selected gram-negative bacteria.
Comparison test data demonstrating equivalence to the predicate device, APLICARE Alcohol Prep Pad (K833182).

The details of these studies, such as specific bacterial strains, methodology, statistical analysis, and exact performance metrics (e.g., percentage reduction, log reduction), are not included in this summary document but would have been part of the full 510(k) submission.

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 Corporation Donald Canal Vice President 3525 Del Mar Heights Suite 430 San Diego, California 92130

March 11, 2022

Re: K080466 Trade/Device Name: Alcohol Pad Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP

Dear Donald 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 October 21, 2008 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,

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). On the left is the Department of Health and Human Services (HHS) logo, which features an abstract caduceus inside a circle. To the right of the HHS logo is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in a bold, sans-serif font. The word "FDA" is inside a black square.

December 14, 2018

122 Corporation Donald Canal Vice President 3525 Del Mar Heights Suite 430 San Diego, California 92130

Re: K080466

Trade/Device Name: Alcohol Pad Regulatory Class: Unclassified Product Code: QBP Dated: February 18, 2008 Received: February 21, 2008

Dear Donald Canal:

This letter corrects our substantially equivalent letter of October 21, 2008.

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 vou. 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 voor.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 (OS) 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, tiang

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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6. Indications for Use

K080466

Device Name: The CUROS™ Port Protector

Indications For Use:

Prescription Use

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 Deyice Evaluation (ODE)

A. A

(Division Sign<Off) Division of Anesthesiology, Gener Hos, nal Infection Control, Dental Devices

510(k) Number: K080466

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2. 510(k) SUMMARY OF SAFETV AND EFFECTIVENESS per 21 CFR 807.92

General Company Information

Name:	Ivera Medical Corporation
Contact:	Don CanalVice President RAQA
Address:	Ivera Medical Corporation3525 Del Mar Heights RoadSuite #430San Diego, Ca 92130
Telephone:	760-612-6090
Fax:	858-228-1770

Date Prepared: September 29, 2008

General Device Description

The Curos™ Port Protector device is a single use, non-sterile device that contains 70% Isopropyl Alcohol and is intended to be used to decontaminate needleless luer activated valves.

Curos™ Port Protector Product Name: Classification: Unclassified Device under product Code LKB

Predicate Devices

K833182 APLICARE Alcohol Prep Pad

Intended Use (Indications)

The Curos ™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.

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K080466
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Substantial Equivalence

lvera medical has provided performance test data to satisfy the requirements of a decontaminating device by reducing the bacterial count two (2) selected gram positive bacteria and 2 selected gram negative bacteria. Ivera Medical also demonstrated equivalence to the predicate device with comparison test data.

The data presented demonstrate that the device is substantially equivalent to the Predicate Device and is suitable for its indicated use.

Conclusions

The test results and analysis of data demonstrate the Curos™ Port Protector is substantially equivalent to the predicate devices with comparison data.

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.