(90 days)
Not Found
No
The device is a physical tamper-evident cover with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device's explicit purpose is to serve as a "tamper-evident cover" for vascular access devices, providing "visual indication to suspect tampering." It does not directly treat or prevent any medical condition or disease.
No
This device is a tamper-evident cover for vascular access devices. Its purpose is to provide a visual indication of tampering, not to diagnose a medical condition or disease.
No
The device description clearly indicates it is a physical, tamper-evident cover made of transparent material with a green strap, intended to be applied to vascular access devices. It is not software.
Based on the provided information, the 3M™ Curos™ Tamper-Evident Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a tamper-evident cover for vascular access devices. This is a physical device used externally on medical equipment.
- Device Description: The description details a physical cover with a transparent material and a tamper-evident strap. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting diseases, conditions, or states of health, or providing information for diagnosis, monitoring, or treatment decisions based on such analysis.
- Performance Studies: The performance studies focus on the physical properties of the device (tamper-evidence, removal, biocompatibility) and its function as a cover, not on diagnostic accuracy or analytical performance related to biological samples.
In summary, the 3M™ Curos™ Tamper-Evident Device is a medical device used to indicate potential tampering with IV access points, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
3MTM Curos™ Tamper-Evident Device:
The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
3MTM Curos™ Tamper-Evident Device, Large:
The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device provides visual indication to suspect tampering. This is not a tamper-proof device.
Product codes
PZW, FPA, LJS
Device Description
The 3M™ Curos™ Tamper-Evident Device provides visual indication to suspect tampering with or attempted removal of the device for reasons other than delivering prescribed medical treatment. The Tamper-Evident Device can be used on any type of vascular access device to cover needleless connectors and the Y-sites on IV tubing [with or without disinfecting caps]. The device material is transparent allowing for visualization of the connector(s) inside, and the tamper-evident strap is green allowing for easy visualization and assessment. The 3M™ Curos™ Tamper-Evident Device is also provided in a larger size to accommodate larger needleless connector combinations including the Y-sites on IV tubing [with or without disinfecting caps] and infusing connections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing.
Indicated Patient Age Range
Patients requiring a vascular access device
Intended User / Care Setting
Hospitals and Clinics
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)
Bench testing and biocompatibility testing were completed to demonstrate substantial equivalence of the submission device, the 3MTM Curos™ Tamper-Evident Device, to the predicate device, PICCGuard.
The device performance was verified through the following tests:
- Confirmation of Tamper-Evidence: Device exhibits signs of tampering - Passed
- Repeated Application and Removal of Device from IV lines: Catheter shows no sign of leakage after removal - Passed
- Removable by Design: Device can be removed from IV Line by single-use tear strip - Passed
Biocompatibility tests performed:
- Cytotoxicity
- Sensitization
- Irritation ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services 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.
May 23, 2022
3M Company Hilary Hovde Regulatory Affairs Specialist 2510 Conway Ave. Building 275-5W-06 St. Paul, Minnesota 55144
Re: K220507
Trade/Device Name: 3MTM Curos™ Tamper-Evident Device, 3M™ Curos™ Tamper-Evident Device, Large Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous. Implanted. Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: PZW, FPA, LJS Dated: February 17, 2022 Received: February 22, 2022
Dear Hilary Hovde:
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
1
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/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 medical devices and radiation-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,
David Wolloscheck For Payal Patel 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220507
Device Name
3MTM Curos™ Tamper-Evident Device 3M™ Curos™ Tamper-Evident Device, Large
Indications for Use (Describe)
3MTM Curos™ Tamper-Evident Device:
The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
3MTM Curos™ Tamper-Evident Device, Large:
The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device provides visual indication to suspect tampering. This is not a tamper-proof device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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."
3
K220507 - 510(k) Summary for 3MTM Curos™ Tamper-Evident Device
3M Company 2510 Conway Ave. 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
- Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364
Preparation Date: May 20, 2022
Device Name and Classification
| Trade Name: | 3M™ Curos™ Tamper-Evident Device
3M™ Curos™ Tamper-Evident Device, Large |
|--------------------------|---------------------------------------------------------------------------------------|
| Common/Usual Name: | Tamper-Resistant Catheter Access Cover |
| Device Classification: | Class II |
| Regulation Name/Number: | Percutaneous, implanted, long-term intravascular catheter
[21 CFR § 880.5970, PZW] |
| Secondary Product Codes: | FPA, LJS |
Predicate Device
PICCGuard, K191195, 21 CFR § 880.5970, PZW, Secondary Product Codes (LJS, FPA)
Indications for Use
3MTM Curos™ Tamper-Evident Device:
The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
3MTM Curos™ Tamper-Evident Device, Large:
4
The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
Description of Device
The 3M™ Curos™ Tamper-Evident Device provides visual indication to suspect tampering with or attempted removal of the device for reasons other than delivering prescribed medical treatment. The Tamper-Evident Device can be used on any type of vascular access device to cover needleless connectors and the Y-sites on IV tubing [with or without disinfecting caps]. The device material is transparent allowing for visualization of the connector(s) inside, and the tamper-evident strap is green allowing for easy visualization and assessment. The 3M™ Curos™ Tamper-Evident Device is also provided in a larger size to accommodate larger needleless connector combinations including the Y-sites on IV tubing [with or without disinfecting caps] and infusing connections.
Comparison of Technological Characteristics with the Predicate Device
The 3M™ Curos™ Tamper-Evident Device was shown to be substantially equivalent to PICCGuard cleared per K191195. Any differences in technological characteristics such as materials and design differences were addressed through biocompatibility and performance testing. The biocompatibility and performance data demonstrated substantial equivalence. There were no new questions of safety and efficacy.
| Feature | Submission Device:
3M™ Curos™
Tamper-Evident Device | Predicate Device
(K191195):
PICCGuard | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The 3M™ Curos™ Tamper-
Evident Device is intended to
be used as a tamper-evident
cover for vascular access
devices for IV access points
including needleless
connectors and Y-sites on IV
tubing. This device provides
visual indication to suspect
tampering. This is not a
tamper-proof device.
3M™ Curos™ Tamper-
Evident Device, Large: | The PICCGuard
device is indicated
for use as a tamper
evident enclosure for
the shaft of the
catheter and Luer hub
with needleless
connector attached on
medical devices such
as PICC lines and
other central line
catheter ports. | Both the
submission and
predicate devices
are intended to
provide tamper
evidence of IV
access points. |
| Feature | Submission Device:
3MTM Curos TM
Tamper-Evident Device | Predicate Device
(K191195):
PICCGuard | Comparison |
| | The 3M™ CurosT™ Tamper-
Evident Device, Large is
intended to be used as a
tamper-evident cover on
vascular access device
needleless connectors
including Y-sites on IV
tubing, and infusing
connections, providing visual
indication of attempts to
tamper with or remove the
device. This device provides
visual indication to suspect
tampering. This is not a
tamper-proof device. | | |
| Use Environment | Hospitals and Clinics | Hospitals and Clinics | Identical |
| Patient Population | Patients requiring a vascular
access device | Patients requiring a
long-term central line
catheter | Both the
submission and
predicate device
are used with
patients requiring
vascular access
devices. |
| Technological
Characteristics | One-piece plastic housing
with enclosing lid and green
tamper-evident strap which is
folded over lid of the device
securing the latch inside the
receiver to close. | Two-piece plastic
housing with locking
barb. | |
| | Available in two sizes to
accommodate different size
vascular access device
combinations. | Available in one size. | Differences in the
design were
evaluated through
performance
testing. |
| | Side door accommodates Y-
site tubing. | Entire PICC line fits
inside of box for use. | |
| | Designed with a tear strip that | Medical scissors are | |
| Feature | Submission Device:
3MTM CurosTM
Tamper-Evident Device | Predicate Device
(K191195):
PICCGuard | Comparison |
| | breaking through the green
tamper-evident strap when IV
access is needed by the
Health Care Professional. | the lid from the
locked portion when
IV access is needed
by the Health Care
Professional. | |
| | Tampering is indicated if the
green tamper-evident strap
has become separated, the
tear strip is broken, or the
device is missing. | Tampering is
indicated if the
PICCGuard is
damaged or is
missing from the IV
line. | |
| Sterility | Non-sterile | Non-sterile | same |
5
K220507
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Curos™ Tamper-Evident Device
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Curos™ Tamper-Evident Device
Discussion of Nonclinical testing
Bench testing and biocompatibility testing were completed to demonstrate substantial equivalence of the submission device, the 3MTM Curos™ Tamper-Evident Device, to the predicate device, PICCGuard.
The device performance was verified through the following tests:
| Test | Results |
|---|---|
| Confirmation of Tamper-Evidence | |
| Device exhibits signs of tampering | Passed |
| Repeated Application and Removal of Device from IV lines | |
| Catheter shows no sign of leakage after removal | Passed |
| Removable by Design | |
| Device can be removed from IV Line by single-use tear strip | Passed |
Biocompatibility
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process as recognized by FDA. The 3M™ Curos™ Tamper-Evident Device is categorized as a surface contacting device, with intact skin contact of permanent duration (> 30 days) in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. " The battery of tests included the following:
7
- Cytotoxicity
- Sensitization
- Irritation ●
Clinical Tests
Not Applicable
Conclusion
Based on the intended use, technological characteristics, and performance data, the submission device is substantially equivalent to PICCGuard (cleared under K191195), Class II, product code PZW (subsequent product codes FPA, LJS) and does not raise new questions of safety and effectiveness.