(266 days)
No
The device is a physical cap containing disinfectant and does not involve any computational or data processing elements that would utilize AI or ML.
No.
The device is intended to disinfect needleless connectors to prevent contamination, which is a preventive measure rather than a treatment for a disease or condition.
No
Justification: The device's intended use is to disinfect needleless connectors using isopropyl alcohol and act as a cover. It does not perform any diagnostic function such as identifying diseases, conditions, or determining the presence of a medical condition. Its function is preventative and disinfecive, not diagnostic.
No
The device description clearly outlines a physical cap containing isopropyl alcohol and a plunger mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, the Curos Jet™ Disinfecting Cap is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and protect needleless connectors on IV lines. This is a direct action on a medical device used in patient care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a cap containing disinfectant, designed to be applied to a medical device (needleless connector). It doesn't involve analyzing biological samples.
- Performance Studies: While the effectiveness was tested in vitro against microorganisms, this testing was to demonstrate the disinfectant's efficacy on the needleless connector, not to diagnose a condition in a patient. The key metrics are log reduction of microorganisms, not diagnostic performance metrics like sensitivity or specificity.
- Lack of IVD Characteristics: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a disinfectant medical device intended for use on other medical devices (needleless connectors) to prevent infection.
N/A
Intended Use / Indications for Use
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
QBP
Device Description
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
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)
3M Company has provided non-clinical performance test data for the Curos Jet™ Disinfecting Cap Subject Device that demonstrates the pre-defined acceptance criteria for a disinfecting device have been met. This acceptance criterion is defined as a ≥ 4 Log count reduction of two gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa), two gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis), and two fungi (Candida albicans), for one minute. The efficacy testing methodologies and microbes are the same as those tested for the Curos™ Disinfecting Cap Predicate Device cleared under 510(k) K111992 and the Curos Tips™ Disinfecting Cap Reference Device cleared under 510(k) K121171. The efficacy test results for the Subject Device over the three-year shelf life of the product are summarized below.
The Curos Jet™ Disinfecting Cap Subject Device cap and packaging performance has been tested to meet pre-specified requirements related to foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing.
The Curos Jet™ Disinfecting Cap Subject Device is sterilized via gamma irradiation using a validated sterilization process which ISO 11137-1:2006 (Sterilization Of Health Care Products -Radiation - Part 1: Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices, FDA Recognition Number 14-528) and the VDma25 method described in ISO 11137-2:2013 (Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose: FDA Recognition Number 14-409). Bioburden testing is in compliance with ISO 11737-1:2018 (Sterilization of health care products – Microbiological methods – Part 1: Determination of the population of microorganisms on product; FDA Recognition Number 14-514) while suitability of the sterility test methodology is in compliance with ISO 11737-2:2009 (Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; FDA Recognition Number 14-327).
The Curos Jet™ Disinfecting Cap Subject Device sterile barrier foil lid complies with ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems; FDA Recognition Number 14-454). Packaging validation activities comply with ISO 11607-2:2006 (Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes; FDA Recognition Number 14-455). The packaging validation activities demonstrated the foil lid maintains product sterility, form, and function over the 3-year shelf life.
Biocompatibility testing has been completed according to ISO 10993-1:2009 (Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing: FDA Recognition Number 2-220) to demonstrate the materials of construction for the Curos Jet™ Disinfecting Cap Subject Device are safe for their intended use and is substantially equivalent to the Predicate Device plus Reference Device. Test results included cytotoxicity, sensitization, and irritation.
A review of commercial experience data is provided, comprised of publicly available literature plus product complaints data from the MAUDE database. The dataset supports the proven safety and effectiveness of the Curos Jet™ Disinfecting Cap Subject Device, when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microorganism, Mean Log Reduction (1-Minute), Mean Log Reduction (7-Day)
Candida albicans, 5.25, 5.25
Candida glabrata, 4.53, 5.46
Escherichia coli, 4.57, 4.94
Pseudomonas aeruginosa, 5.03, 5.55
Staphylococcus aureus, 5.36, 5.15
Staphylococcus epidermis, 4.70, 5.22
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.
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 for 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
3M Company Dianne Gibbs Regulatory Affairs Manager 2510 Conway Ave. St. Paul, Minnesota 55144-1000
March 11, 2022
Re: K200299
Trade/Device Name: Curos Jet Disinfecting Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP
Dear Dianne Gibbs:
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 October 29, 2020. 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,
Signature
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. To the left of the FDA logo is the Department of Health & Human Services logo, which is a stylized image of a human figure.
October 29, 2020
3M Company Dianne Gibbs Regulatory Affairs Manager 2510 Conway Ave., Bldg. 275-5NW-06 St. Paul. Minnesota 55144-1000
Re: K200299
Trade/Device Name: Curos Jet Disinfecting Cap Regulatory Class: Unclassified Product Code: QBP Dated: September 28, 2020 Received: September 29, 2020
Dear Dianne Gibbs:
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 (for the indications for use stated in the enclosure) 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 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
2
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sapana Patel -S
Payal Patel for Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Expiration Date
See PRA State
K200299
Device Name
Curos Jet™ Disinfecting Cap for Needleless Connectors - Single (CFJ1-270); Curos Jet™ Disinfecting Cap for Needleless Connectors - Strip (CFJ5-250)
Indications for Use (Describe)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/2 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
510(k) Summary 3M™ Curos Jet™ Disinfecting Cap
General Company Information
| Name: | 3M Company |
|---|---|
| Contact: | Cory J. Hitzman, Ph.D. |
| Regulatory Affairs Specialist | |
| Address: | 3M Company, 3M Health Care |
| 2510 Conway Ave., Bldg. 275-5NW-06 | |
| St. Paul, MN 55144-1000 | |
| Telephone: | (651) 733-9304 |
| Fax: | (651) 737-5320 |
Date Prepared
February 5, 2020
Subject Device
| Trade Name: | Curos Jet™ Disinfecting Cap |
|---|---|
| Regulation Number: | Unclassified |
| Regulatory Class: | Unclassified |
| Classification Name: | Cap, Device Disinfectant |
| Classification Code: | QBP |
| Classification Panel: | General Hospital |
Predicate/Reference Devices
Same regulatory classifications for Predicate/Reference Devices as the Subject Device above: K111992 - 3M™ Curos™ Disinfecting Cap Predicate Device: Reference Device: K121171 - 3M™ Curos Tips™ Disinfecting Cap
Device Description
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
Intended Use (Indications)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus. Staphylococus epidermidis. Escherichia coli. Pseudomonas aeruqinosa. Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
5
Comparison with Predicate/Reference Devices
| Characteristic | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Device Name | Curos Jet™ Disinfecting Cap | Curos™ Disinfecting Cap | Curos Tips™ Disinfecting Cap |
| Common Name | Cap, Device Disinfectant | Cap, Device Disinfectant | Cap, Device Disinfectant |
| 510(k) # | Not Assigned | K111992 | K121171 |
| Manufacturer | 3M Company | 3M Company | 3M Company |
| Regulation | |||
| Number, | |||
| Product Code | Unclassified, Pre-amendment device, product code: QBP | Unclassified, Pre-amendment device, product code: QBP | Unclassified, Pre-amendment device, product code: QBP |
| Indications | |||
| for Use | The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility. | The Curos ™ Disinfecting Cap is intended for use on swabbable 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, Pseudomonas aeruginosa, Candida glabrata and Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility. | The Curos Tips ™ disinfecting cap is intended for use as a disinfecting cleaner on male luer connections only and to act as a cover between line accesses. The Curos Tips disinfecting cap will disinfect the male luer one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of Curos Tips disinfecting cap was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have > 4 log reduction. The Curos Tip disinfecting cap may be used in the home or healthcare facility. |
| Connection | |||
| Site | Needleless Luer Connectors | Needleless Luer Connectors | Male Luer Connections |
| Cap Materials | Molded Cap: HDPE | ||
| Molded Plunger: HDPE | Molded Cap: HDPE | ||
| Molded Insert: HDPE | |||
| Foam: Polyurethane | Molded Cap: HDPE | ||
| Molded Plunger: HDPE | |||
| Characteristic | Subject Device | Predicate Device | Reference Device |
| Disinfectant - | |||
| Active | |||
| Ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol |
| Minimum | |||
| Disinfectant | |||
| Time | One (1) Minute | Three (3) Minutes | |
| (Data on File Supports | |||
| One (1) Minute) | One (1) Minute | ||
| Maximum | |||
| Disinfectant | |||
| Time | Seven (7) Days | Seven (7) Days | Seven (7) Days |
| Disinfectant | |||
| Delivery | IPA Reservoir (via | ||
| HDPE plunger | |||
| compression) | IPA Reservoir (via foam | ||
| sponge compression) | IPA Reservoir (via | ||
| HDPE plunger | |||
| compression) | |||
| Cap Length | 0.46 inches | 0.36 inches | 0.78 inches |
| Cap Diameter | 0.54 inches | 0.54 inches | 0.31 inches |
| Colorants Used | Translucent Green in | ||
| molded HDPE, 3% | |||
| concentration | Translucent Green in | ||
| molded HDPE, 3% | |||
| concentration | Translucent Green in | ||
| molded HDPE, 3% | |||
| concentration | |||
| Provided | |||
| Sterile | Yes | Yes | Yes |
| Single Use | |||
| Device | Yes | Yes | Yes |
| Plastic | |||
| Housing to | |||
| remain in place | Yes | Yes | Yes |
| User | |||
| Population | Home and Hospital Use | Home and Hospital Use | Home and Hospital Use |
6
Comparison of Technological Characteristics with the Predicate Device
The Subject Device and Predicate Device are both based on the same technological elements:
- Both are disinfectant caps for use with needleless connectors ●
- Both utilize IPA as the disinfectant
- . Both are mechanically secured to the needleless connector
- Both are sterilized via gamma irradiation ●
- Both are indicated for home and hospital use
There are two functional characteristics that do differ when comparing the Subject Device to the Predicate Device (these characteristics do not differ when comparing to the Reference Device, demonstrating these changes are not novel):
- Minimum time required for disinfection:
- Subject Device: 1 minute O
- Predicate Device = 3 minutes (data on file at 3M Company to support 1 minute) o
- Reference Device: 1 minute O
- . IPA disinfectant delivery:
- Subject Device: HDPE Plunger compression o
- Predicate Device: Sponge compression O
- Reference Device: HDPE Plunger compression O
7
These differences in minimum time for disinfection and IPA disinfectant delivery do not affect the performance of the Subject Device, demonstrated through acceptable device functional, efficacy, biocompatibility, sterility, and packaging test results as described below.
Substantial Equivalence Performance Testing
3M Company has provided non-clinical performance test data for the Curos Jet™ Disinfecting Cap Subject Device that demonstrates the pre-defined acceptance criteria for a disinfecting device have been met. This acceptance criterion is defined as a ≥ 4 Log count reduction of two gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa), two gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis), and two fungi (Candida albicans), for one minute. The efficacy testing methodologies and microbes are the same as those tested for the Curos™ Disinfecting Cap Predicate Device cleared under 510(k) K111992 and the Curos Tips™ Disinfecting Cap Reference Device cleared under 510(k) K121171. The efficacy test results for the Subject Device over the three-year shelf life of the product are summarized below.
| Microorganism | Mean Log Reduction
(1-Minute) | Mean Log Reduction
(7-Day) |
|--------------------------|----------------------------------|-------------------------------|
| Candida albicans | 5.25 | 5.25 |
| Candida glabrata | 4.53 | 5.46 |
| Escherichia coli | 4.57 | 4.94 |
| Pseudomonas aeruginosa | 5.03 | 5.55 |
| Staphylococcus aureus | 5.36 | 5.15 |
| Staphylococcus epidermis | 4.70 | 5.22 |
Subiect Device Efficacy Test Results
The Curos Jet™ Disinfecting Cap Subject Device cap and packaging performance has been tested to meet pre-specified requirements related to foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing. All testing was completed in accordance with approved company protocols and was completed to demonstrate that the Subject Device seals and acts as a cover for needleless connectors.
The Curos Jet™ Disinfecting Cap Subject Device is sterilized via gamma irradiation using a validated sterilization process which ISO 11137-1:2006 (Sterilization Of Health Care Products -Radiation - Part 1: Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices, FDA Recognition Number 14-528) and the VDma25 method described in ISO 11137-2:2013 (Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose: FDA Recognition Number 14-409). Bioburden testing is in compliance with ISO 11737-1:2018 (Sterilization of health care products – Microbiological methods – Part 1: Determination of the population of microorganisms on product; FDA Recognition Number 14-514) while suitability of the sterility test methodology is in compliance with ISO 11737-2:2009 (Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; FDA Recognition Number 14-327).
The Curos Jet™ Disinfecting Cap Subject Device sterile barrier foil lid complies with ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems; FDA Recognition Number 14-454). Packaging validation activities comply with ISO 11607-2:2006 (Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes; FDA Recognition Number 14-455). The packaging validation activities demonstrated the foil lid maintains product sterility, form, and function over the 3-vear shelf life.
8
Biocompatibility testing has been completed according to ISO 10993-1:2009 (Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing: FDA Recognition Number 2-220) to demonstrate the materials of construction for the Curos Jet™ Disinfecting Cap Subject Device are safe for their intended use and is substantially equivalent to the Predicate Device plus Reference Device. Due to the intended use of the product, the biocompatibility evaluation was completed as a surface device, skin contact, prolonged (