(183 days)
Not Found
No
The summary describes a physical device containing a disinfectant and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is a disinfecting cleaner and physical barrier, not intended for treating a disease or condition.
No
The device is described as a disinfecting cleaner and a physical barrier to contamination for luer access valves, not for diagnosing medical conditions.
No
The device description clearly states it is a "single use, sterile device that contains 70% lsopropyl Alcohol" and is a "Port Protector," indicating it is a physical device with a chemical component, not software.
Based on the provided text, the Curos device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and act as a physical barrier on luer access valves, which are part of medical lines used for patient access (e.g., IV lines). This is a direct interaction with a medical device used on a patient, not a test performed on a sample taken from a patient.
- Device Description: It's described as a "disinfectant for needleless luer activated valves," further reinforcing its role in disinfecting a medical device.
- Performance Studies: The performance studies focus on the disinfecting efficacy against specific microorganisms on the valve itself, not on analyzing a patient sample for diagnostic purposes. The metric is "Bacterial count reduction (Delta Log)," which measures the effectiveness of the disinfectant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Curos device falls under the category of a disinfectant for medical devices rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 ™ 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 glibrata, Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
QBP, LKE
Device Description
The Curos™ Port Protector device is a single use, sterile device that contains 70% lsopropyl Alcohol and is intended to be used as a disinfectant for needleless luer activated valves
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
The effectiveness of Curos Protectors were tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, Candida glibrata, Candida albicans. The efficacy testing was completed using a total of 4 bacteria, 2-gram negative and 2 gram positive, and two selected fungus/yeast micro-organisms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance test data was provided demonstrating the pre-defined acceptance criteria for a disinfecting device. 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 up to 168 hours (7 days). Key results:
- Staphylococcus aureus: 6.0 log reduction at 3 minutes, 6.9 log reduction at 7 days (168 hours)
- Staphylococcus epidermidis: 6.8 log reduction at 3 minutes, 7.3 log reduction at 7 days (168 hours)
- Escherichia coli: 5.2 log reduction at 3 minutes, 5.2 log reduction at 7 days (168 hours)
- Pseudomonas aeruginosa: 5.1 log reduction at 3 minutes, 5.1 log reduction at 7 days (168 hours)
- Candida Albicans: 5.6 log reduction at 3 minutes, >4.8* log reduction at 7 days (168 hours)
- Candida Glabrata: 5.4 log reduction at 3 minutes, >5.3* log reduction at 7 days (168 hours)
(* The entire population was killed, the reduction in bacteria count was limited to the population quantified by the positive controls used in the testing.)
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized eagle. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Ivera Medical, Inc. Don Canal Regulatory Affairs, Quality Manager 3525 Del Mar Heights Road, Suite #430 San Diego, California 92130
March 11, 2022
Re: K111992
Trade/Device Name: Curos 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 January 12, 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,
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 circular emblem with a stylized depiction of a caduceus, a symbol associated with medicine and healthcare. The text is arranged in three lines, with "FDA" in a bold, sans-serif font, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in a smaller, sans-serif font.
December 14, 2018
Ivera Medical, Inc. Don Canal RA/QA 2731 Loker Avenue West Carlsbad, California 92010
Re: K111992
Trade/Device Name: Curos Port Protector Regulatory Class: Unclassified Product Code: OBP Dated: July 13, 2011 Received: July 13, 2011
Dear Don Canal:
This letter corrects our substantially equivalent letter of January 12, 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
2
K111992 - Don Canal
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.htm); 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/ReportalProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
FDA 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
Indications for Use Statement 4.
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 ™ 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 glibrata, Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility.
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 UNE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Khel C. Chapa 1/9/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111992
Page 14 of 139
Title: 4 log reduction. The Curos Port Protector may be used in the home or healthcare facility.
5
Comparison with Predicate Device
There is no change to the device for this 510(k) notification, the only change is to the Intended Use (indications) to reflect the test data for disinfection which includes 3 minutes to 7 days (168 hours), as described below. The materials of construction and technological characteristics are equivalent to the predicate device.
| Characteristic | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| Device name | Curos Port Protector | Curos Port Protector | SwabCap |
| Common Name | Alcohol, disinfecting pad | Alcohol, disinfecting pad | Alcohol, disinfecting pad |
| Manufacturer | Ivera Medical | Ivera Medical | Excelsior Medical Corporation |
| 510(k) number | K110826 | K110826 | K083508 |
| Regulation | |||
| number, | |||
| product code | Unclassified, | ||
| Preamendment device, | |||
| product code: LKB | Unclassified, | ||
| Preamendment device, | |||
| product code: LKB | Unclassified, | ||
| Preamendment device, product code: | |||
| LKB | |||
| Indications for | |||
| use | 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 ™ 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 glibrata. Candida albicans | The Curos Port Protector is a device containing 70% Isopropyl Alcohol when left in place for 5 to15 minutes, the Curos Port Protector decontaminates the injection Port; thereafter the Curos Port Protector provides a physical barrier during the intended use. | SwabCap 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. SwabCap will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed. |
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| and was found to have >4 | |||
| log reduction. The Curos | |||
| Port Protector may be used | |||
| in the home or healthcare | |||
| facility. | |||
| Disinfectant - | |||
| active | |||
| ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | 70% Isopropyl |
| Alcohol | |||
| Length | 0.40 inches | 0.40 inches | 0.50 inches |
| Diameter | 0.54 inches | 0.54 inches | 0.60 inches |
| User Population | Home and hospital use | Home and hospital use | Home and hospital |
| use | |||
| Colorants Used | |||
| (type, amount, | |||
| concentration) | Translucent green, molded | ||
| plastic, 3% concentration | Translucent green, | ||
| molded plastic, 3% | |||
| concentration | Orange pigment, % | ||
| concentration | |||
| unknown | |||
| Provided Sterile | Yes | Yes | Yes |
| Single Use | |||
| Device | Yes | Yes | Yes |
| Plastic Housing | |||
| to remain in | |||
| place | Yes | Yes | Yes |
Subject Device to Predicate Technological Comparison Table
6
Substantial Equivalence Performance Testing
Ivera medical has provided non-clinical performance test data that demonstrates the pre-defined 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 up to 168 hours (7 days). The efficacy testing was completed using a total of 4 bacteria, 2-gram negative and 2 gram positive as recommended in Draft Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Document issued on: July 19, 2007. The test results are summarized in Table 1.
7
| Organism | Acceptance
Criteria
(bacterial count
reduction ( $\Delta$ Log)) | 3 minute exposure
(bacterial count
reduction ( $\Delta$ Log)) | 7 day (168 hours)
exposure
(bacterial count
reduction ( $\Delta$ Log)) |
|--------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Staphylococcus aureus | $\geq$ 4.0 | 6.0 | 6.9 |
| Staphylococcus epidermis | $\geq$ 4.0 | 6.8 | 7.3 |
| Escherichia coli | $\geq$ 4.0 | 5.2 | 5.2 |
| Pseudomonas aeruginosa | $\geq$ 4.0 | 5.1 | 5.1 |
| Candida Albicans | $\geq$ 4.0 | 5.6 | >4.8* |
| Candida Glabrata | $\geq$ 4.0 | 5.4 | >5.3* |
Table 1 - Efficacy Test Results
- The entire population was killed, the reduction in bacteria count was limited to the population quantified by the positive controls used in the testing.
The Ivera Curos Port Protector 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 Curos Port Protector materials of construction meet FDA recognized standard ISO10993 for biocompatibility.
Conclusion
The analysis arguments and test results demonstrate the Curos™ device is safe for its intended use and is substantially equivalent to the predicate devices.