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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the 3M™ Curos™ Tamper-Evident Device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria for AI/ML performance.

The provided document describes a physical medical device designed to indicate tampering with vascular access devices, not an AI/ML-driven diagnostic or treatment device. Therefore, the concepts and questions related to AI/ML performance metrics (such as sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, ground truth establishment by experts, etc.) are not applicable to this submission.

The document outlines bench testing and biocompatibility testing for the physical device. I will extract the information that is relevant to the physical device's performance acceptance criteria as described in the provided text.

Here's a breakdown of the information that is available, reframed to address the spirit of the request where possible, but emphasizing that this is not an AI/ML device:

Device Description and Purpose:

The 3M™ Curos™ Tamper-Evident Device is a physical cover intended to provide a visual indication of attempts to tamper with or remove vascular access devices (like needleless connectors and Y-sites on IV tubing). It is not a tamper-proof device. Its primary function is to show if it has been disturbed.

Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The document details the bench testing performed to demonstrate that the device functions as intended. These tests serve as the "acceptance criteria" for the mechanical and visual integrity of the tamper-evident feature.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test)	Purpose	Reported Device Performance (Results)
Confirmation of Tamper-Evidence	Device exhibits signs of tampering when disturbed.	Passed
Repeated Application and Removal of Device	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 Testing:
The device also passed biocompatibility tests (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993-1, categorized as a surface-contacting device with intact skin contact of permanent duration. This is another set of "acceptance criteria" for the materials used.

Information Not Applicable to This Device (as it's not an AI/ML system):

The following points from your request are not relevant to this 510(k) submission because it pertains to a physical medical device, not an AI/ML system:

2. Sample size used for the test set and the data provenance: Not an AI/ML test set. Bench tests are likely performed on a representative sample of manufactured devices.
3. Number of experts used to establish the ground truth... and qualifications: Ground truth for a physical tamper-evident device is visual observation of tampering, not expert interpretation of AI predictions.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device doesn't "improve human readers" in an interpretive sense.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the tamper-evident feature is the physical state of the device (intact vs. torn/missing strap).
8. The sample size for the training set: Not applicable; there is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the 3M™ Curos™ Tamper-Evident Device is a physical product whose acceptance criteria are based on its mechanical performance (visual indication of tampering, safe removal, and no leakage on the catheter after removal) and material biocompatibility. The provided document does not involve or describe an AI/ML study.

Summary

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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 (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

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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:

3MTM Curos™ Tamper-Evident Device, Large:

Type of Use (Select one or both, as applicable)
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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: (651) 736-0364

Preparation Date: May 20, 2022

Device Name and Classification

Trade Name:	3M™ Curos™ Tamper-Evident Device3M™ 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:

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

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 tobe used as a tamper-evidentcover for vascular accessdevices for IV access pointsincluding needlelessconnectors and Y-sites on IVtubing. This device providesvisual indication to suspecttampering. This is not atamper-proof device.3M™ Curos™ Tamper-Evident Device, Large:	The PICCGuarddevice is indicatedfor use as a tamperevident enclosure forthe shaft of thecatheter and Luer hubwith needlelessconnector attached onmedical devices suchas PICC lines andother central linecatheter ports.	Both thesubmission andpredicate devicesare intended toprovide tamperevidence of IVaccess points.
Feature	Submission Device:3MTM Curos TMTamper-Evident Device	Predicate Device(K191195):PICCGuard	Comparison
	The 3M™ CurosT™ Tamper-Evident Device, Large isintended to be used as atamper-evident cover onvascular access deviceneedleless connectorsincluding Y-sites on IVtubing, and infusingconnections, providing visualindication of attempts totamper with or remove thedevice. This device providesvisual indication to suspecttampering. This is not atamper-proof device.
Use Environment	Hospitals and Clinics	Hospitals and Clinics	Identical
Patient Population	Patients requiring a vascularaccess device	Patients requiring along-term central linecatheter	Both thesubmission andpredicate deviceare used withpatients requiringvascular accessdevices.
TechnologicalCharacteristics	One-piece plastic housingwith enclosing lid and greentamper-evident strap which isfolded over lid of the devicesecuring the latch inside thereceiver to close.	Two-piece plastichousing with lockingbarb.
	Available in two sizes toaccommodate different sizevascular access devicecombinations.	Available in one size.	Differences in thedesign wereevaluated throughperformancetesting.
	Side door accommodates Y-site tubing.	Entire PICC line fitsinside of box for use.
	Designed with a tear strip that	Medical scissors are
Feature	Submission Device:3MTM CurosTMTamper-Evident Device	Predicate Device(K191195):PICCGuard	Comparison
	breaking through the greentamper-evident strap when IVaccess is needed by theHealth Care Professional.	the lid from thelocked portion whenIV access is neededby the Health CareProfessional.
	Tampering is indicated if thegreen tamper-evident straphas become separated, thetear strip is broken, or thedevice is missing.	Tampering isindicated if thePICCGuard isdamaged or ismissing from the IVline.
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
Confirmation of Tamper-EvidenceDevice exhibits signs of tampering	Passed
Repeated Application and Removal of Device from IV linesCatheter shows no sign of leakage after removal	Passed
Removable by DesignDevice 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.

Regulation Number and Section

§ 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.”