3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large

K220507 · 3M Company · PZW · May 23, 2022 · General Hospital

Device Facts

• Record ID: K220507
• Device Name: 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
• Applicant: 3M Company
• Product Code: PZW · General Hospital
• Decision Date: May 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

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.

Device Story

Device is a non-sterile, one-piece plastic housing with an enclosing lid and a green tamper-evident strap. Used in hospitals and clinics to cover vascular access device needleless connectors and Y-sites on IV tubing. Healthcare professionals apply the device over the connector; the strap is folded over the lid to secure the latch. The transparent material allows visualization of the connector; the green strap provides visual indication of tampering or attempted removal. If the strap is separated, the tear strip is broken, or the device is missing, tampering is suspected. Designed for removal via a single-use tear strip when IV access is required. Benefits include providing visual evidence of unauthorized access to IV lines, helping maintain the integrity of the vascular access site.

Clinical Evidence

No clinical data. Bench testing performed to verify tamper-evidence, repeated application/removal, and functionality of the tear strip. Biocompatibility testing conducted per ISO 10993-1 for surface-contacting devices with permanent duration (>30 days), including cytotoxicity, sensitization, and irritation.

Technological Characteristics

One-piece plastic housing with enclosing lid and green tamper-evident strap. Available in two sizes. Features a side door for Y-site tubing and a tear strip for removal. Non-sterile. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring vascular access devices; used as a tamper-evident cover for IV access points, including needleless connectors and Y-sites on IV tubing.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• PICCGuard (K191195)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

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## 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: [phone]
## Preparation Date: May 20, 2022

## Device Name and Classification

| Trade Name: | 3M™ Curos™ Tamper-Evident Device<br>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<br>[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:

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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:<br>3M™ Curos™<br>Tamper-Evident Device | Predicate Device<br>(K191195):<br>PICCGuard | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The 3M™ Curos™ Tamper-<br>Evident Device is intended to<br>be used as a tamper-evident<br>cover for vascular access<br>devices for IV access points<br>including needleless<br>connectors and Y-sites on IV<br>tubing. This device provides<br>visual indication to suspect<br>tampering. This is not a<br>tamper-proof device.<br>3M™ Curos™ Tamper-<br>Evident Device, Large: | The PICCGuard<br>device is indicated<br>for use as a tamper<br>evident enclosure for<br>the shaft of the<br>catheter and Luer hub<br>with needleless<br>connector attached on<br>medical devices such<br>as PICC lines and<br>other central line<br>catheter ports. | Both the<br>submission and<br>predicate devices<br>are intended to<br>provide tamper<br>evidence of IV<br>access points. |
| Feature | Submission Device:<br>3MTM Curos TM<br>Tamper-Evident Device | Predicate Device<br>(K191195):<br>PICCGuard | Comparison |
| | The 3M™ CurosT™ Tamper-<br>Evident Device, Large is<br>intended to be used as a<br>tamper-evident cover on<br>vascular access device<br>needleless connectors<br>including Y-sites on IV<br>tubing, and infusing<br>connections, providing visual<br>indication of attempts to<br>tamper with or remove the<br>device. This device provides<br>visual indication to suspect<br>tampering. This is not a<br>tamper-proof device. | | |
| Use Environment | Hospitals and Clinics | Hospitals and Clinics | Identical |
| Patient Population | Patients requiring a vascular<br>access device | Patients requiring a<br>long-term central line<br>catheter | Both the<br>submission and<br>predicate device<br>are used with<br>patients requiring<br>vascular access<br>devices. |
| Technological<br>Characteristics | One-piece plastic housing<br>with enclosing lid and green<br>tamper-evident strap which is<br>folded over lid of the device<br>securing the latch inside the<br>receiver to close. | Two-piece plastic<br>housing with locking<br>barb. | |
| | Available in two sizes to<br>accommodate different size<br>vascular access device<br>combinations. | Available in one size. | Differences in the<br>design were<br>evaluated through<br>performance<br>testing. |
| | Side door accommodates Y-<br>site tubing. | Entire PICC line fits<br>inside of box for use. | |
| | Designed with a tear strip that | Medical scissors are | |
| Feature | Submission Device:<br>3MTM CurosTM<br>Tamper-Evident Device | Predicate Device<br>(K191195):<br>PICCGuard | Comparison |
| | breaking through the green<br>tamper-evident strap when IV<br>access is needed by the<br>Health Care Professional. | the lid from the<br>locked portion when<br>IV access is needed<br>by the Health Care<br>Professional. | |
| | Tampering is indicated if the<br>green tamper-evident strap<br>has become separated, the<br>tear strip is broken, or the<br>device is missing. | Tampering is<br>indicated if the<br>PICCGuard is<br>damaged or is<br>missing from the IV<br>line. | |
| Sterility | Non-sterile | Non-sterile | same |

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## K220507

# TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Curos™ Tamper-Evident Device

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#### 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 |
|--------------------------------------------------------------------------------------------------------------------|---------|
| <b>Confirmation of Tamper-Evidence</b><br>Device exhibits signs of tampering | Passed |
| <b>Repeated Application and Removal of Device from IV lines</b><br>Catheter shows no sign of leakage after removal | Passed |
| <b>Removable by Design</b><br>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:

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- 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.