(91 days)
Not Found
No
The device description and performance studies focus on the chemical disinfection properties of the device, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is described as a "Port Protector" that decontaminates an injection port and provides a physical barrier, acting as a disinfectant. Its purpose is to prevent infection, not to treat a pre-existing medical condition or disease within the body.
No
The device is a disinfectant and physical barrier for injection ports, not a diagnostic tool used to identify diseases or conditions.
No
The device description clearly states it is a physical device containing 70% Isopropyl Alcohol, intended for disinfection and providing a physical barrier. It is not software.
Based on the provided information, the Curos™ Port Protector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to decontaminate and provide a physical barrier for injection ports on medical devices. This is a direct action on a medical device used for patient care, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is described as a disinfectant for needleless luer activated valves. This aligns with its intended use as a medical device accessory for infection control.
- Performance Studies: The performance studies focus on the device's ability to reduce bacterial counts on the injection port. This is a measure of its effectiveness as a disinfectant, not its ability to detect or measure substances in a biological sample.
- Key Metrics: The key metrics are bacterial count reduction, which is relevant to disinfection efficacy, not diagnostic performance (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Curos™ Port Protector does not perform this function.
N/A
Intended Use / Indications for Use
The CurosTM Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the CurosTM Port Protector decontaminates the injection port; thereafter the CurosTM Port Protector provides a physical barrier during the intended use.
Product codes
QBP
Device Description
The CurosTM Port Protector device is a single use, sterile device that contains 70% Isopropyl 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
Not Found
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
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 and 2 selected gram negative bacteria 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 bacteria tested and the test results are included in Table 1.
Key Metrics
- Staphylococcus aureus: 6.0 (3 min exposure), 6.9 (7 day (168 hours) exposure)
- Staphylococcus epidermis: 6.8 (3 min exposure), 7.3 (7 day (168 hours) exposure)
- Escherichia coli: 5.2 (3 min exposure), 5.2 (7 day (168 hours) exposure)
- Pseudomonas aeruginosa: 5.1 (3 min exposure), 5.1 (7 day (168 hours) exposure)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Ivera Medical Corporation Don Canal Consultant RA / Qa 2731 Loker Avenue West Carlsbad, California 92010
March 11, 2022
Re: K110826
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 June 23, 2011 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
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 in a circle. The text is arranged in three lines, with "FDA" in a black square, followed by "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
December 14, 2018
Ivera Medical Don Canal RA / OA 2731 Loker Avenue West Carlsbad, California 92010
Re: K110826
Trade/Device Name: Curos Port Protector Regulatory Class: Unclassified Product Code: OBP Dated: March 18, 2011 Received: March 24, 2011
Dear Don Canal:
This letter corrects our substantially equivalent letter of June 23, 2011.
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.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/ReportaProblem/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.
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.
Device Name: The CUROS™ Port Protector
Indications For Use:
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.
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 Device Evaluation (ODE)
Al C. Ch
(Division Sign-Üff) Division of Anesthesiology, General Hospital infection Control, Dental Devices
:10(k) Number: K110826
| Page 13 of 127 | Title:
Ivera Medical Curos 510(k) Notification | Confidential |
| ---------------- | --------------------------------------------------- | -------------- |
|---|
4
KII0806
5. 510(k) Summary
General Company Information
Name: Ivera Medical Corporation Contact: Don Canal Consultant RAQA
Ivera Medical Corporation Address: 3525 Del Mar Heights Road Suite #430 San Diego, CA 92130
760-612-6090 Telephone: 858-228-1770 Fax:
Date Prepared: May 19, 2011
General Device Description
The Curos™ Port Protector device is a single use, sterile device that contains 70% Isopropy! Alcohol and is inlended to be used as a disinfectant for needleless luer activated valves.
Common Name: Pad, Alcohol Curos™ Port Protector Trade Name: Unclassified Device, product Code LKB Classification:
Predicate Devices
K080466 Curos Port Protector
Intended Use (Indications)
The Ivera Medical 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.
Comparison with Predicate Device
The only change from the predicate device is that the Subject device is provided sterile with the revised labeling to add the sterile symbol. The materials of construction and technological characteristics are the same as the predicate device.
Substantial Equivalence Performance Testing
Ivera medical has provided non-clinical performance test data that demonstrates the pre-dafined 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
5
positive bacteria and 2 selected gram negative bacteria 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 bacteria tested and the test results are included in Table 1.
| Organism | Acceptance
Criteria
(bacterial count
reduction (ΔLog)) | 3 minute exposure
(bacterial count
reduction (ΔLog)) | 7 day (168 hours)
exposure
(bacterial count
reduction (ΔLog)) |
|--------------------------|-----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------|
| Staphylococcus aureus | > 4.0 | 6.0 | 6.9 |
| Staphylococcus epidermis | > 4.0 | 6.8 | 7.3 |
| Escherichia coli | > 4.0 | 5.2 | 5.2 |
| Pseudomonas aeruginosa | > 4.0 | 5.1 | 5.1 |
Table 1 - Efficacy Test Results
The data presented demonstrates demonstrate the Subject Device is safe and effective. and the performance test results meet the requirements of its pre-defined acceptance criteria and intended uses.
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.
Conclusions
The analysis arguments and test results demonstrate the Curos™ device is substantially equivalent to the predicate devices.