The Curos Tips ™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips may be used in the home or healthcare facility.

Device Description

The Curos Tips™ are intended for use on IV administration lines Male luer as a disinfecting cleaner, which contains 70% IPA, prior to line connection and to act as a physical barrier to contamination between line accesses. The Curos Tips have a highly visible green color that may allow improved compliance by easy visual verification. The Curos Tips may be used in the home or healthcare facility.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Curos Tips™ (K121171)

1. Table of Acceptance Criteria and Reported Device Performance

Organism	Acceptance Criteria (bacterial count reduction (Δ Log))	Reported Device Performance (3-minute exposure (Δ Log))
Staphylococcus aureus	≥ 4 Log	6.61
Staphylococcus epidermidis	≥ 4 Log	6.48
Escherichia coli	≥ 4 Log	6.53
Pseudomonas aeruginosa	≥ 4 Log	6.49
Candida Albicans	≥ 4 Log	6.60
Candida Glabrata	≥ 4 Log	6.64

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

The document states "The efficacy testing was completed using a total of 6 bacteria." This refers to the six specific microorganisms listed in the table. The method described is in vitro testing.

Sample Size for Test Set: The sample size for each microorganism is not explicitly detailed beyond "a total of 6 bacteria" indicating six distinct species were tested. The actual number of replicates or individual tests per species is not provided.
Data Provenance: The study was an in vitro study. The country of origin is not explicitly stated, but the company (Ivera Medical Corporation) is based in San Diego, California, USA, suggesting the study was likely conducted in the USA. It is a prospective study in the sense that the testing was performed to evaluate the specific device for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described study is an in vitro microbiological efficacy test, not a study requiring human expert assessment of images or clinical outcomes. The "ground truth" is defined by the objective measurement of microbial reduction.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is an in vitro microbiological efficacy test. Adjudication typically applies to studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study detailed is an in vitro efficacy test, not a clinical study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) study was not done. This device is a physical disinfectant, not an algorithm or AI system. The study assessed the standalone efficacy of the physical device and its disinfectant properties.

7. The Type of Ground Truth Used

The ground truth used was microbiological reduction data. Specifically, it was the measured "bacterial count reduction (Δ Log)" after a 3-minute exposure to the Curos Tips™.

8. The Sample Size for the Training Set

This information is not applicable. The Curos Tips™ is a physical medical device, not a machine learning or AI model, and therefore does not have a "training set" in that context.

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

This information is not applicable as the device is not an AI/ML model and does not have a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Ivera Medical, Inc. Don Canal Vice President of Operations and Regulatory Affairs and Quality Assurance 3525 Del Mar Heights Road, Suite #430 San Diego, California 92130

March 11, 2022

Re: K121171 Trade/Device Name: Curos Tip 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 November 26, 2012 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). 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 circular emblem with abstract shapes, while the text is in bold, sans-serif font, with "FDA" in a black square.

December 14, 2018

Ivera Medical, Inc. Don Canal 2731 Loker Avenue West Carlsbad, California 92010

Re: K121171

Trade/Device Name: Curos Tip Regulatory Class: Unclassified Product Code: QBP Dated: April 17, 2012 Received: April 17, 2012

Dear Don Canal:

This letter corrects our substantially equivalent letter of November 26, 2012.

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 (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/MedicalDeviceRegulationandGuidance/) 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. liang

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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Indications for Use Statement 4.

Prescription Use

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(2) 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: 2012.11.21 11:26:03 -05'00'

(Division Sign-Off)

Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number:

K121171	Title: Ivera Medical Curos Tips 510(k) Notification
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510(k) Summary 5.

General Company Information

Name:Contact:	Ivera Medical CorporationDon CanalVice President of Operations and RAQA	NOV 26 2012
Address:	Ivera Medical Corporation3525 Del Mar Heights RoadSuite #430San Diego, CA 92130
Telephone:Fax:	972-955-7644858-228-1770

Date Prepared: October 23, 2012

General Device Description

Common Name:	Pad, Alcohol
Trade Name:	Curos Tips™
Classification:	Unclassified Device, product Code LKB

Predicate Devices

K111992 Curos Port Protector, Ivera Medical Corporation K093229 Catheter Connections Dual Cap

Intended Use (Indications)

The Curos Tips™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips may be used in the home or healthcare facility.

	Title:
K121171	Ivera Medical Curos Tips 510(k) Notification
Characteristic	Subject DeviceK121171	Curos Port ProtectorK111992	Predicate DeviceK093229
Device name	Curos Tips	Curos Port Protector	Dual Cap
Common Name	Alcohol, disinfecting pad	Alcohol, disinfecting pad	Alcohol, disinfecting pad
Manufacturer	Ivera Medical	Ivera Medical	Catheter Connections
510(k) number	Subject Device	K111992	K093992
Regulationnumber,product code	Unclassified, Preamendmentdevice, product code: LKB	Unclassified, Preamendmentdevice, product code: LKB	Unclassified,Preamendment device,product code: LKB
Indications foruse	The Curos Tips™ areintended for use as adisinfecting cleaner for maleluer connectors. Curos Tipswill disinfect the male luer(3) minutes after applicationand will cover the luer untilremoved. The effectivenessof the Curos Tips was testedin vitro againstStaphylococcus aureus,Staphylococcus epidermidis,Escherichia coli,Pseudomonas aeruginosa,Candida glabrata, andCandida albicans. TheCuros Tips may be used inthe home or healthcarefacility.	The Curos is intended foruse on swab-able lueraccess valves as adisinfecting cleaner prior toline access and to act as aphysical barrier tocontamination between lineaccesses. Curos ™ willdisinfect the valve three (3)minutes after applicationand act as a physical barrierto contamination for up toseven (7) days (168 hours)if not removed. Theeffectiveness of CurosProtectors were tested invitro againstStaphylococcus aureus,Staphylococcusepidermidis, Escherichiacoli and Pseudomonasaeruginosa, Candidaglabrata, Candida albicansand was found to have >4log reduction. The CurosPort Protector may be usedin the home or healthcarefacility.	DualCap™ is intendedfor use on Luer accessvalves and the IVadministration line maleLuer connections.DualCap™ will disinfectand decontaminate thevalve and male Luerand act as a barrier tocontamination betweenIV administration lineaccesses.DualCap™ will disinfectthe connections withinfive (5) minutes afterapplication and act as aphysical barrier tocontamination up toninety-six (96) hoursunder normal conditionsif not removed.
Disinfectant -activeingredient	70% Isopropyl Alcohol	70% Isopropyl Alcohol	70% Isopropyl Alcohol
Male LuerConnection	Yes	No	Yes
Female LuerConnection.	No	Yes	Yes
Length	0.76 inches	0.40 inches	1.82 inches
Diameter	0.272 inches	0.54 inches	0.47 inches
UserPopulation	Home and hospital use	Home and hospital use	Home and hospital use
Characteristic	Subject DeviceK121171	Curos Port ProtectorK111992	Predicate DeviceK093229
Colorants Used(type, amount, concentration)	Translucent green, molded plastic, 3% concentration	Translucent green, molded plastic, 3% concentration	Blue, white Plastic, unknown material and pigment(s)
Provided Sterile	Yes	Yes	Yes
Single Use Device	Yes	Yes	Yes
Plastic Housing to remain in place	Yes	Yes	Yes

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Comparison with Predicate Device

Subject Device to Predicate Technological Comparison Table

K121171

Ivera Medical Curos Tips 510(k) Notification

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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 3 minutes.

The efficacy testing was completed using a total of 6 bacteria. As recommended by the Draft Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents DRAFT GUIDANCE Ivera completed the 2-gram negative and 2 gram positive bacteria. This guidance document is being distributed for comment purposes only. Document issued on: July 19, 2007. Ivera has also completed testing on 2 fungus/yeast micro-organisms Candida Albicans and Candida Glabrata. The test results are summarized in Table 1.

Organism	Acceptance Criteria(bacterial countreduction ( $\Delta$ Log))	3 minute exposure(bacterial countreduction ( $\Delta$ Log))
Staphylococcus aureus	$\geq$ 4 Log	6.61
Staphylococcus epidermis	$\geq$ 4 Log	6.48
Escherichia coli	$\geq$ 4 Log	6.53
Pseudomonas aeruginosa	$\geq$ 4 Log	6.49
Candida Albicans	$\geq$ 4 Log	6.60
Candida Glabrata	$\geq$ 4 Log	6.64

Table 1 - Efficacy Test Results

The Ivera Curos Tips are 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.

K121171	Title:Ivera Medical Curos Tips 510(k) Notification
---------	--------------------------------------------------------

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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.

lvera 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 Tips™ device is safe for its intended use and is substantially equivalent to the predicate devices.

	itle:
VASAATAﺭ ﮐﮯ ﺍ	Ivera Medical Curos Tips 510(k) Notification
Company of the country of the country of the country of the county of	The first and the many of the interest and in the continues and

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.