(223 days)
Not Found
No
The device is a physical disinfecting cleaner and barrier, and the summary focuses on its chemical efficacy against microorganisms. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
The device is a disinfecting cleaner and physical barrier to contamination, rather than a device for treating a disease or condition.
No
The device is described as a disinfecting cleaner and a physical barrier to contamination, rather than a tool for diagnosis. Its purpose is to kill microorganisms and prevent contamination, not to identify or assess a medical condition.
No
The device description clearly states it is a physical product ("Curos Tips") containing 70% IPA and acting as a physical barrier, indicating it is a hardware device, not software.
Based on the provided text, the Curos Tips™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is to disinfect and protect male luer connectors on IV administration lines. This is a direct action on a medical device used in patient care, not a test performed on a biological sample from a patient to diagnose a condition.
- Mechanism of Action: The device works by applying a disinfectant (70% IPA) and acting as a physical barrier. This is a cleaning and protective function, not a diagnostic test.
- Performance Testing: While the effectiveness was tested in vitro against various microorganisms, this testing was to demonstrate the device's ability to kill microbes on the luer connector, not to diagnose an infection in a patient. The "in vitro" here refers to testing outside of a living organism, which is common for disinfectant efficacy testing, not necessarily indicative of an IVD.
- Lack of Diagnostic Claims: There are no claims about using the device to detect, measure, or analyze substances in a biological sample for diagnostic purposes.
In summary, the Curos Tips™ is a disinfecting and protective device for medical equipment, not a device used to perform diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QBP
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.
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 or healthcare facility.
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 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. Ivera has also completed testing on 2 fungus/yeast micro-organisms Candida Albicans and Candida Glabrata. The test results are summarized in Table 1.
Table 1 - Efficacy Test Results:
- Staphylococcus aureus: 6.61 (bacterial count reduction (delta Log))
- Staphylococcus epidermidis: 6.48 (bacterial count reduction (delta Log))
- Escherichia coli: 6.53 (bacterial count reduction (delta Log))
- Pseudomonas aeruginosa: 6.49 (bacterial count reduction (delta Log))
- Candida Albicans: 6.60 (bacterial count reduction (delta Log))
- Candida Glabrata: 6.64 (bacterial count reduction (delta Log))
All organisms met the acceptance criteria of greater than or equal to 4 Log reduction at 3 minutes exposure.
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. 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.)
Bacteria count reduction: greater than or equal to 4 Log reduction.
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 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
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 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
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 (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
3
Indications for Use Statement 4.
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.
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 |
|---|---|
| --------- | ----------------------------------------------------- |
4
510(k) Summary 5.
General Company Information
| Name:
Contact: | Ivera Medical Corporation
Don Canal
Vice President of Operations and RAQA | NOV 26 2012 |
|--------------------|---------------------------------------------------------------------------------------------|-------------|
| Address: | Ivera Medical Corporation
3525 Del Mar Heights Road
Suite #430
San Diego, CA 92130 | |
| Telephone:
Fax: | 972-955-7644
858-228-1770 | |
Date Prepared: October 23, 2012
General 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.
| 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 Device | ||
| K121171 | Curos Port Protector | ||
| K111992 | Predicate Device | ||
| K093229 | |||
| 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 |
| 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 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. | 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 | |||
| glabrata, Candida albicans | |||
| and was found to have >4 | |||
| log reduction. The Curos | |||
| Port Protector may be used | |||
| in the home or healthcare | |||
| facility. | DualCap™ is intended | ||
| for use on Luer access | |||
| valves and the IV | |||
| administration line male | |||
| Luer connections. | |||
| DualCap™ will disinfect | |||
| and decontaminate the | |||
| valve and male Luer | |||
| and act as a barrier to | |||
| contamination between | |||
| IV administration line | |||
| accesses. | |||
| DualCap™ will disinfect | |||
| the connections within | |||
| five (5) minutes after | |||
| application and act as a | |||
| physical barrier to | |||
| contamination up to | |||
| ninety-six (96) hours | |||
| under normal conditions | |||
| if not removed. | |||
| Disinfectant - | |||
| active | |||
| ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol |
| Male Luer | |||
| Connection | Yes | No | Yes |
| Female Luer | |||
| Connection. | No | Yes | Yes |
| Length | 0.76 inches | 0.40 inches | 1.82 inches |
| Diameter | 0.272 inches | 0.54 inches | 0.47 inches |
| User | |||
| Population | Home and hospital use | Home and hospital use | Home and hospital use |
| Characteristic | Subject Device | ||
| K121171 | Curos Port Protector | ||
| K111992 | Predicate Device | ||
| K093229 | |||
| 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 |
5
Comparison with Predicate Device
:
Subject Device to Predicate Technological Comparison Table
Ivera Medical Curos Tips 510(k) Notification
6
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 count
reduction ( $\Delta$ Log)) | 3 minute exposure
(bacterial count
reduction ( $\Delta$ 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 |
| --------- | -------------------------------------------------------- |
|---|
7
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: | ||
|---|---|---|
| VASAATA | ||
| ﺭ 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 |