The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

Device Description

The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 60 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics. The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SecurAcath Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing devices rather than a detailed clinical study proving performance against specific acceptance criteria with statistical rigor in the way a clinical trial for a new drug or complex diagnostic device might.

Here's an analysis based on the provided text, addressing the requested information where applicable:

Acceptance Criteria and Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format with specific thresholds and corresponding reported device performance. Instead, it makes a general statement about performance.

Acceptance Criteria (Implied)	Reported Device Performance
Product Specifications are met	"The performance data demonstrates that the device meets all the product specifications."
Device is safe and effective for intended use	"Test results demonstrate that the device is safe and effective for its intended use."
Securement reliability	Performance testing included, and results demonstrate safety and effectiveness.
Catheter tensile strength	Performance testing included, and results demonstrate safety and effectiveness.
Dimensional verification	Performance testing included, and results demonstrate safety and effectiveness.
Substantially equivalent to predicate devices	"The SecurAcath™ has the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy."

Note: The acceptance criteria here are inferred from the types of performance testing mentioned and the overall goal of a 510(k) submission, which is to show safety and effectiveness, often by demonstrating substantial equivalence to a legally marketed device. Specific numerical targets for these criteria are not provided in this excerpt.

Study Information:

Sample size used for the test set and the data provenance:
- The document mentions "performance test data is provided in the 510(k) submission," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective). The tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are typically bench or engineering tests, not clinical studies involving human patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The performance tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are engineering/bench tests and would not typically involve experts establishing "ground truth" in the clinical sense (like radiologists marking images). The "ground truth" for these tests would be derived from physical measurements and engineering standards.
Adjudication method for the test set:
- Not applicable. As the tests are engineering/bench tests, there wouldn't be an adjudication method in the context of clinical expert review.
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:
- Not applicable. This device is a catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mentioned performance tests, the "ground truth" would be based on engineering specifications and measurements conforming to industry standards or internal design requirements. For example, tensile strength would be measured against a predefined breaking point, and dimensions would be verified against blueprint specifications.
The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for a physical medical device.

In summary: The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating that the device meets its own product specifications through various performance tests (dimensional, securement, tensile strength) and is substantially equivalent to predicate devices. It does not contain information related to clinical studies, AI performance, or ground truth establishment by experts in the context of diagnostic performance, as these are not relevant to this type of device and submission.

Summary

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K082047

SEP 3 0 2008

510(K) SUMMARY 1.

1.1 ADMINISTRATIVE INFORMATION

1.1.1 Name and address

Sponsor: Interrad Medical, Inc. 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: 763-225-6699 Fax: 763-225-6695

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

Tel: 612-801-6782 Fax: 763-208-4465 Email: swtay(@)libramed.com

Date Prepared: July 15 2008

1.1.2 Device Name

Trade Name	SecurAcath Catheter
Common Name	Periphery Inserted Central Catheter(PICC)
Classification Name	Implanted subcutaneous securementcatheter
Product Code	OKC
Classification	21 CFR 880.5970Class II
Model	SPK01
1.1.3 Applicant

Applicant's Name: Interrad Mcdical, Inc. 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: 763-225-6699 Fax: 763-225-6695

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K082047

1.2 Indication for use

1.3 DEVICE DESCRIPTION

The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body.

1.4 SUBSTANTIAL EQUIVALENCE

The SccurAcath Catheter device covered by this submission is substantially equivalent to other legally marketed devices namely, the Poly-Per-Q (K0001901) Angio Dynamic Morpheus PICC (K060887), Cook Tubo0Flo (K041849), Bard Power PICC (K053501) and the Statlock CV (K943147).

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

1.5 Performance Data

The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets all the product specifications. Performance testing included dimensional verification; securement reliability, catheter tensile strength. Test results demonstrate that the device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three curved lines representing the snakes intertwined around a staff, which is a common representation of the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2008

Interrad Medical, Incorporated C/O Dr. Sew-Wah Tay Regulatory Consultant Libra Medical, LLC 18555 37th Avenue North Plymouth, Minnesota 55446

Re: K082047

Trade/Device Name: SecurAcath 5F Dual Lumen PICC 65cm with Subcutancous Securement System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: OKC Dated: July 17, 2008 Reccived: July 18, 2008

Dear Dr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D. 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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SECTION 4.

INDICATION FOR USE STATEMENT

510(k) Number (if known): *082047

Device Name: SecurAcath Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinton Q. Rose

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K482047 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.”