(265 days)
Not Found
No
The device is a physical disinfecting cap containing isopropyl alcohol and does not describe any computational or data-driven processes indicative of AI/ML.
No.
The device is a disinfecting cleaner and cover for medical ports, not a device that treats or diagnoses a disease or condition.
No
The Curos Red is described as a disinfecting cleaner for medical device ports and a cover, not a device that diagnoses conditions. Its performance is measured by its ability to reduce bacteria counts, which is a funciton of disinfection, not diagnosis.
No
The device description clearly indicates it is a physical product containing 70% Isopropyl alcohol and is intended to be applied to physical ports. It is a disinfecting cleaner and cover, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to disinfect and cover female Luers and open female ports on stopcocks. This is a direct action on a medical device (catheter/stopcock) to prevent microbial contamination, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device contains isopropyl alcohol and is used as a disinfecting cleaner and cover. This aligns with a disinfectant/barrier function, not an in vitro diagnostic test.
- Performance Studies: The performance studies focus on the device's ability to reduce bacteria count on the port and its physical properties (sealing, leakage). These are relevant to its function as a disinfectant and cover, not to the accuracy of a diagnostic test.
- Key Metrics: The key metric is "bacteria count reduction (ΔLog)," which measures the effectiveness of the disinfection process, not the performance of a diagnostic test (like sensitivity, specificity, etc.).
- No mention of analyzing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample to provide diagnostic information.
In summary, the Curos Red Port Protector is a medical device intended for disinfection and protection of catheter ports, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QBP
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.
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
Home and hospital use
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)
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.
The efficacy test results are summarized in Table 1.
Table 1 - Efficacy Test Results:
| Organism | Acceptance Criteria (bacterial count reduction (ΔLog)) | 3 minute exposure (bacterial count 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 |
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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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
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
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
Company |
| 510(k) number | Subject Device | K111992 | K101385 |
| Regulation
number,
product code | Unclassified, Preamendment
device, product code: LKB | Unclassified, Preamendment
device, product code: LKB | IV Administration Set, 21
CFR 880.5440,
FPA, Class II |
| Indications for
use | 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 effectiveness of the 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. | The Curos is intended for use
on swab-able luer access
valves as a disinfecting
cleaner prior to line access
and to act as a physical
barrier to contamination
between line accesses. Curos
TM will disinfect the valve
three (3) minutes after
application and act as a
physical barrier to
contamination for up to
seven (7) days (168 hours) if
not removed. The
effectiveness of Curos
Protectors were tested in
vitro against Staphylococcus
aureus, Staphylococcus
epidermidis, Escherichia coli
and Pseudomonas
aeruginosa, Candida glabrata,
Candida albicans and was
found to have >4 log
reduction. The Curos Port
Protector may be used in the
home or healthcare facility. | The Dual Luer Lock Cap is
indicated for use as a cap
for male or female ports
on medical devices such
as manifolds, stopcocks
or sets. |
| Disinfectant -
active ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | None |
Subject Device to Predicate Technological Comparison Table
6
| Characteristic | Subject Device | Curos Port Protector
K111992 | Predicate Device |
|----------------------------------------------------|------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------|
| Male Luer
Connection | No | No | Yes |
| Connection to
open female
luer connection | Yes | No | Yes |
| Connection to
needleless IV
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
(type, amount,
concentration) | Red, molded plastic, 3%
concentration | Translucent green, molded
plastic, 3% concentration | White Plastic. Exact
material formulation
and colorant is not
available |
| Provided Sterile | Yes | Yes | Yes |
| Single Use
Device | Yes | Yes | Yes |
| Plastic Housing
to remain in
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
(bacterial count reduction
(ΔLog)) | 3 minute exposure
(bacterial count
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.