The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

Device Description

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The provided document is a 510(k) summary for the SecurAcath medical device, specifically for an update to include new sizes (10F and 12F) and updated product specification testing. It's important to note that this document does not describe a study involving an AI algorithm or human readers analyzing medical images. Instead, it details the performance testing for a physical medical device.

Therefore, many of the requested points related to AI/algorithm performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for adjudication, are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text, structured according to your request where applicable, with an explanation of why other points are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device meets product specifications and functions as intended. Specific numerical acceptance criteria are not explicitly listed in this summary, nor are the precise quantitative results ("reported device performance"). The summary states "Test results demonstrate that the device functions as intended" and "In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device."

Acceptance Criteria (General Description)	Reported Device Performance (Summary)
Meets product specifications	Functions as intended
Secures catheters to access sites	Able to secure catheters to access sites
Functions as intended	Functions as intended
Equivalent performance to predicate device	Demonstrated equivalent performance to predicate device
Risk analysis in accordance with ISO 14971:2012	Completed and supported by modifications

Specific tests performed to demonstrate meeting criteria:

Dimensional verification
Joint Tensile Strength
Base & Cover Interaction
Hinge performance
Catheter Securement Performance
Catheter Interaction

The document doesn't provide the numeric pass/fail criteria for these tests or the quantitative results obtained.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for dimensional verification, tensile strength, etc.).
The data provenance is from laboratory testing performed by the manufacturer, Interrad Medical Inc. It is not patient data (retrospective or prospective), and thus no country of origin for patient data is applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The ground truth for a physical device's performance tests (e.g., tensile strength, dimensions) is established by engineering specifications and measurement standards, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. As the tests are for physical device performance against specifications, an adjudication method for conflicting expert opinions is not relevant. The tests likely yield objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This document describes performance testing for a physical medical device (catheter securement system), not an AI algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This document describes performance testing for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests are the engineering specifications and design requirements for the device. For example, a "Joint Tensile Strength" test would have an engineering specification for the minimum required tensile strength, which serves as the ground truth for that particular test. "Dimensional" tests would compare measured dimensions to specified tolerances.

8. The Sample Size for the Training Set

This is not applicable. There is no AI algorithm being trained, so no training set is relevant.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2018

Interrad Medical Inc % Denise Lenz Regulatory Consultant Libra Medical, Inc 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55428

Re: K180769

Trade/Device Name: SecurAcath Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: OKC, KMK Dated: May 21, 2018 Received: May 29, 2018

Dear Denise Lenz:

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) 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.

Geeta K. Pamidimukkala -S

for 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

Enclosure

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Indications for Use

510(k) Number (if known) K180769

Device Name SecurAcath

Indications for Use (Describe)

The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

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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K180769 510(K) SUMMARY

Manufacturer's Name:	Interrad, Inc181 Cheshire Lane, Suite 100Plymouth, MN 55441
Corresponding Official:	Denise LenzRegulatory Consultant, Libra Medical, Inc.8401 73rd Ave North, Suite 63Brooklyn Park, MN 55428
Telephone Number:	612-965-3445
Email:	dlenz@libramed.com
Preparation Date:	June 25, 2018
Device Trade Name:	SecurAcath
Device Common or Usual Name:	Implanted subcutaneous securement catheter
Regulation Name:	Percutaneous, implanted, long-term intravascular catheter.
Regulation Number:	21 CFR 880.5970
Product Code:	OKC, KMK
Device Class:	Class II
Classification Panel:	General Hospital
Primary Predicate Device:	K120935; SecurAcath

Purpose of 510(k)

The purpose of this 510(k) is to add the 10F and 12F sized SecurAcath devices to the SecurAcath family to secure 10F and 12F catheters and to update the product specification testing requirements for device fatigue and reliability testing.

Indications for Use

The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.

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Device Description

The intended use of the SecurAcath device is to secure catheters by means of a subcutaneous anchor.

Technological Characteristics Comparison

The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters. The securement to the catheter access site is achieved by means of a blunt nitinol Anchor deployed into the subcutaneous space at the catheter access site. The securement of the catheved by the clamping of the catheter shaft between the Base Assembly and Cover of the device. This reduces catheter migration and accidental pull-out while not significantly affecting fluid flow.

The changes between the subject device and predicate device is the addition of the 10F and 12F sized SecurAcath devices to the SecurAcath family to secure 10F and 12F catheters. Design changes for the 10F and 12F includes the removal of alignment fingers and the shaft lock shape change to oval.

Characteristic	Predicate Device:SecurAcath (K120935)	Subject Device:SecurAcath (K180769)	Comparison
Indications forUse	The SecurAcath Device isindicated for short or longterm securement ofpercutaneous indwellingcatheters for intravenoususe to the access site bymeans of a subcutaneousanchor.	The SecurAcath Device isindicated for short or longterm securement ofpercutaneous indwellingcatheters for intravenoususe to the access site bymeans of a subcutaneousanchor.	Same
RegulationNumber	21 CFR 880.5970	21 CFR 880.5970	Same
Product Code	OKC, KMK	OKC, KMK	Same
DeviceConfiguration	Single use, sterile device	Single use, sterile device	Same
Cathetercompatibility	3F, 4F, 5F, 6F, 7F, 8F	3F, 4F, 5F, 6F, 7F,8F, 10F, 12F	Different
Biocompatibility	Materials testing inaccordance with ISO10993-1	Identical materials used innew device configurations	Same
Sterility	EtO and SAL of 10-6In accordance with ISO11135	EtO and SAL of 10-6In accordance with ISO11135	Same

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Substantial Equivalence Discussion

The indications for use and intended use of the predicate 510(k) K120935, are equivalent to the subject 510(k) device.

The differences between the subject device and predicate device are the following:

The additional sizes of 10F and 12F compatibility to the device ●
Update the product specification testing requirements to the device fatigue and reliability . testing.

The additional sizes (10F, 12F) for SecurAcath have the same principles of operation, same technological characteristics, incorporate the same basic design, incorporate the same materials, have the same shelf life, and are packaged and sterilized using the same materials and processes as the previously cleared predicate device. The changes have been verified/validated through performance testing and risk management activities.

Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

Performance Testing Summary

Based on a risk analysis of the changes, the following testing was conducted to demonstrate substantial equivalence to the predicate device:

Performance testing, includes dimensional verification, functional tests and securement reliability. Testing was performed to demonstrate that the device meets product specifications and is able to secure catheters to access sites. The device uses the same material as its predicate device and meets the same specifications as its predicate devices. Test results demonstrate that the device functions as intended. The following tests were performed:

. Dimensional
Joint Tensile Strength ●
. Base & Cover Interaction
Hinge performance ●
. Catheter Securement Performance
Catheter Interaction ●

A risk analysis was completed in accordance with ISO 14971:2012, Medical Devices -Applications of Risk Management to Medical Devices.

In all instances. the subject device functioned as intended and demonstrated equivalent performance to the predicate device.

CONCLUSION

The modifications to the device do not raise different questions of safety and effectiveness and are supported by risk management activities. The SecurAcath is substantially equivalent to the Interrad Medical SecurAcath device, cleared under K120935.

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.”