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 is a single use, sterile device for securing indwelling catheters. The device is a standalone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SecurAcath device:

Based on the provided text, the device is a catheter securement device, and the submission is a Special 510(k) for a device that is substantially equivalent to a previously cleared predicate device (K092306). Special 510(k)s typically involve modifications to a company's own legally marketed device for which design control activities have been completed. This means the focus of the submission is often on demonstrating that the changes do not raise new questions of safety or efficacy and that the device still meets its established performance specifications.

Due to the nature of a Special 510(k) and the content provided, the level of detail regarding acceptance criteria and a deep statistical study may be less extensive than for a novel device or a Traditional 510(k) where new clinical data might be required.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Dimensional Verification	Device "meets all product specifications"
Securement Reliability	Device "is able to secure catheters to insertion sites"
Material Equivalence	Device "uses the same material as its predicate device"
Specification Equivalence	Device "meets similar specification as its predicate devices"
Functional Performance	"Test results demonstrate that the device functions as intended."

Note: The provided text does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, specific pull-out force resistance values). Instead, it makes general statements about meeting specifications and demonstrating intended function. This is common for Special 510(k) submissions where the changes are often minor and the primary goal is to ensure the modified device performs comparably to the predicate.

Study Details

Based on the provided text, a comprehensive clinical study with human subjects, a test set, and ground truth established by experts, as typically seen for AI/ML devices or novel therapies, was not performed or reported in this 510(k) summary. The evaluation primarily relied on non-clinical performance testing to demonstrate substantial equivalence to the predicate device.

Here's why some requested sections cannot be filled:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The text refers to "Performance tests" including "dimensional verification" and "securement reliability." These are laboratory-based engineering tests, not clinical studies with a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. Ground truth, in the context of expert consensus on patient data, is not relevant for the type of engineering performance tests described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are used in clinical studies when multiple human readers interpret data, which is not described here.
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:
- No. This is not an AI/ML device, nor is it a device that directly assists human readers in interpreting clinical data. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (catheter securement), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications. The "ground truth" for the performance tests would be the established engineering specifications and design requirements that the device was tested against (e.g., a specific pull-out force standard).
The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/ML device, a "training set" in that context does not exist. The development and testing would follow standard engineering design and verification principles.
How the ground truth for the training set was established:
- Not applicable / Not provided. See above.

Summary

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SecurAcath Special 510(k) Notification

K120935

510(k) Page 24

APR 2 7 2012

SECTION 8. 510(K) SUMMARY

8.1 ADMINISTRATIVE INFORMATION

8.1.1 Name and address

Sponsor:

181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: (763) 225-6699 Fax: (763) 225-6694

Contact Person Sew-Wah Tay, PhD Regulatory Consultant 18555 37th Ave N, Plymouth, MN 55446

Tel: 612-801-6782 Fax: 763-208-4465 Email: swtav@libramed.com

March 27, 2012 Date Prepared:

8.1.2 Device Name

Trade Name	SecurAcath
Common Name	Catheter securement device
Classification Name	Implanted subcutaneous securementcatheter
Classification	21 CFR 880.5970/880.5210Class II

8.1.3 Applicant

Applicant"s Name:

Interrad Medical Inc. 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: (763) 225-6699 Fax: (763) 225-6694

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8.2 PREDICATE DEVICE

Interrad Medical Inc. SecurAcath Device, K092306

8.3 Intended/indication 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.

8.4 TECHNOLOGICAL CHARACTERISTICS

8.5 SUBSTANTIAL EQUIVALENCE

The SecurAcath device covered by this submission is substantially equivalent to the original Interrad Medical SecurAcath device K092306.

The SecurAcath™ has the same indication for use, same principles of operation, and similar technological characteristics as the previously cleared predicate device. The minor differences between this device and its predicate devices do not raise new questions of safety or efficacy.

8.6 PERFORMANCE DATA

Performance tests included dimensional verification; securement reliability. The company performed testing to demonstrate that the device meets all product specifications and is able to secure catheters to insertion sites. The device uses the same material as its predicate device and meets similar specification as its predicate devices. Test results demonstrate that the device functions as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Interrad Medical. Incorporated C/O Dr. Sew-Wah Tay Regulatory Consultant Libra Medical, Incorporated 8401 73rd Avenue North Suite 63 Minneapolis, Minnesota 55428

APR 2 7 2012

Re: `K120935

Trade/Device Name: SecurAcath Divice Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter. Regulatory Class: II Product Code: OKC, KMK Dated: March 27, 2012 Received: March 28, 2012

Dear Dr. Wah Tay:

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.

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Page 2- Dr. Wah Tay

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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March 27, 2012

SECTION 7. INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name: SecurAcath Device

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.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhi C. Ch

(Division Sign-Off) (Division Sign-Um)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, Devices Division of Anosthoontal Devices

510(k) Number: _

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.”