The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

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

The provided text is a 510(k) summary for a medical device called SecurAcath. It focuses on demonstrating substantial equivalence to a previously cleared device, not on proving the device meets general acceptance criteria through a specific clinical study with detailed performance metrics like sensitivity, specificity, or accuracy, which is typical for AI/ML-based medical devices or diagnostics.

The changes described are primarily related to manufacturing processes and materials (e.g., laser marking instead of pad printing, slight material formulation change in polypropylene, different anti-block additive in packaging, and an extended shelf life). The "performance data" section mentions engineering tests to confirm the device still meets product specifications after these changes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth types, training set details) are not applicable (N/A) for this type of submission because the device is a physical medical device (catheter securement system), not an AI/ML diagnostic or imaging device. The "acceptance criteria" here refer to ensuring the manufacturing changes do not negatively impact the device's original functionality and safety.

Here's an attempt to answer the questions based on the provided text, indicating N/A where information is not present or relevant to this type of device:

Description of Acceptance Criteria and Proving Device Meets Criteria (SecurAcath Device)

The device in question, SecurAcath, is a physical medical device (a catheter securement system), not a software or AI/ML-based diagnostic device. The acceptance criteria and "study" described in the provided document revolve around demonstrating that manufacturing/material changes to the device do not negatively impact its performance, safety, or effectiveness compared to its predicate device. The study performed is a series of engineering performance tests and material characterizations, not a clinical trial or AI model validation study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with specific thresholds (e.g., tensile strength > X N) alongside numerical reported performance values. Instead, it states that tests were performed to demonstrate the device "meets product specifications" and "is not negatively impacted by the material change or marking process change." The acceptance is qualitative in the sense that the new device performs "as intended" and "continues to meet the same specifications as its predicate devices."

Acceptance Criteria Category	Reported Device Performance
Material/Process Changes don't negatively impact performance/safety/effectiveness	The device continued to meet the same specifications as its predicate devices. Tests demonstrated that the device functions as intended.
Dimensional Integrity	Testing performed. (No specific numerical data provided)
Functional Performance	Testing performed for: - Joint Tensile Strength - Base & Cover Interaction - Hinge performance (No specific numerical data provided, but it states results demonstrate "device functions as intended.")
Marking Durability	Testing performed per IEC 60601-1 for durability of markings. The laser marking does not impact safety and effectiveness.
Biocompatibility	Meets ISO 10993-1. (Same as predicate)
Sterilization & Sterility	EtO and SAL of 10-6. (Same as predicate, new packaging configuration passed testing)
Shelf Life	Extended to 4 years. Shelf life product was 2X sterilized, passed design verification testing including pouch seal peel and bubble leak tests. The extension does not impact safety and effectiveness.
Packaging Integrity	New packaging configuration passed ISTA 2A, ASTM D4169, sterile barrier performance testing and ISO 10993-7 testing. The new configuration does not impact safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML model. The "tests" mentioned are engineering and material verification tests (e.g., dimensional, functional, durability). The number of samples used for these engineering tests is not specified in this summary.
Data Provenance: N/A for this type of device; no patient data or clinical data is mentioned for performance evaluation in this premarket notification. The tests are lab-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This is an engineering/manufacturing change submission for a physical device. There is no "ground truth" derived from expert interpretation (e.g., radiologists, pathologists) in the context of a diagnostic or imaging study. The "truth" is established through engineering specifications and industry standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. No expert adjudication of data is mentioned or relevant.

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:

N/A. This is a physical medical device, not an AI/ML-assisted diagnostic device. No MRMC study was performed.

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

N/A. Not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

N/A. The "ground truth" for this device's "performance" is its adherence to engineering specifications, material compatibility standards (e.g., ISO 10993), and functional requirements that ensure continuous safe and effective operation after manufacturing changes.

8. The sample size for the training set:

N/A. This is a physical device, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established:

N/A. Not applicable as no training set exists for this type of device submission.

Summary

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

Re: K210629

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: February 19, 2021 Received: March 2, 2021

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 Mav 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.

James M. Simpson Jr -S7

for Paval Patel Acting 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210629

Device Name SecurAcath

Indications for Use (Describe)

The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:

a) Short or long-term securement of percutaneous indwelling catheters for intravenous use

b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY 8

8.1 ADMINISTRATIVE INFORMATION

February 19, 2021 Date of Summary Preparation:

Contact Information 8.1.1

Submitter/Manufacturer Interrad, Inc 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: 763-225-6699 Fax: 763-225-6695

Primary Submission Contact

Primary Contact

Denise Lenz

Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Cell: 612-965-3445 Email: dlenz@libramed.com

Secondary Submission Contact

Secondary Contact

Sew-Wah Tay Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Cell: 612-801-6782 Email: swtay@libramed.com

8.1.2 Device Information

Trade Name	SecurAcath
Common Name	Subcutaneous securement device or SubcutaneousEngineered Stabilization Device
Classification Name	Implanted Subcutaneous Securement Catheter
Classification Regulation	21 CFR 880.5970/880.5210/878.4200
Class	Class II
Panel	General Hospital
Product Code	OKC / KMK

8.2 PREDICATE DEVICE

The modified device is substantially equivalent to the Interrad Medical SecurAcath (K180994).

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8.3 DEVICE DESCRIPTION

8.4 INTENDED USE

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

INDICATIONS FOR USE 8.5

The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:

a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

TECHNOLOGICAL CHARACTERISTICS 8.6

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 SecurAcath has the same technological characteristics as the predicate device beside the predicate device is pad printed and does not contain the laser marking additive in the polypropylene portion to optimize the laser marking of the device (K180994).

Table 8-1: Comparison of Device Characteristics to Marketed Predicate Device
Items	Predicate SecurAcath (K180994)	SecurAcath (Current Device)
Product Name	Interrad Medical SecurAcath	Same-No change
Intended Use	The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.	Same - No change
Indication for Use	The SecurAcath Device is indicated for catheter securement to the access site by means ofsubcutaneous anchors in:a) Short or long-term securement of percutaneous indwelling catheters for intravenous useb) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage	Same - No change
RegulationNumber andProduct Code	21 CFR 880.597021 CFR 880.521021 CFR 878.4200OKC/KMK	Same - No change
Classification	Class II	Same - No change
RegulatoryClassificationName	Device, Vascular and Non-Vascular CatheterSecurement	Same - No change
TechnologicalCharacteristics	Single use, sterile device for securingindwelling catheters. The device is a stand-alone accessory to percutaneous indwellingcatheters and consists of a subcutaneousnitinol anchor that is deployed in thesubcutaneous space at the catheter access siteto reduce catheter migration and pull-out.	Same - No change
Technology-Materials	PP Mevopur/Compound 100% SG702Poppy V2 (first shot material) TPE Mevopur/Counpound 100%G2706SLRBL V2 (second shot material) Nitinol (anchor) Marabu TPR 980 (Black ink)	PP Mevopur-Orange/Compound 100%SG702 (first shot material) with lasermarking additive. Material passed ISO10993, design verification and shelf lifetesting and does not impact safety andeffectiveness. TPE Mevopur/Compound 100%G2706SLRBL V2 (second shot material)-Same, no change. Nitinol with/without premium surfacefinish (anchor). Material passed ISO10993 and design verification testing andthe change does not impact safety andeffectiveness.
DressingCompatibility	Compatible with standard adhesive dressingincluding Biopatch and Tegaderm.	Same - No change
Cleaning solutioncompatibility	Compatible with standard skin cleaningsolution including Chlorhexidine, alcohol,and iodine solution.	Same - No change
Principles ofOperation	Catheter shaft held between the Base and Capof the SecurAcath with nitinol anchorsextending into the subcutaneous space fromthe base.	Same - No change
Use duration	For the life of the catheter secured unlessanchors get accidently pulled out.	Same - No change
MRICompatibility	MR Conditional	Same - No change
DeviceConfiguration	Single use, sterile device	Same - No change
PackagingConfiguration	1) Device on a backercard and an ExtensionTube Tag inside a Tyvek pouch. Tendevices in Tyvek Pouch and ten PatientGuide Cards inside the 10-up shelf box.	1) Device in a Tyvek pouch. 10 devices inTyvek Pouch inside the 10-up shelf box.Patient Guide Cards available uponrequest. New packaging configuration
	2) Tyvek pouch contains anti-block additive(CAS number 7631-86-9) in the nylon.	passed ISTA 2A, ASTM D4169, sterilebarrier performance testing and ISO10993-7 testing and the new packagingconfiguration does not impact safety andeffectiveness.
	2) Tyvek pouch contains anti-blockadditive (CAS number 1344-01-0) in thenylon. Tyvek pouch supplier data forsterilization validation and shelf lifewere evaluated and pouch sealingprocess validation testing passed. Theanti-block additive in the nylon layerdoes not impact safety and effectiveness.
LabelingConfiguration	1) Extension Tube Tag included in Tyvekpouch.2) Label content on device applied as anink.3) Labeling on Pouch and Shelf Box.	1) Extension Tube Tag available uponrequest. New packaging configurationpassed ISTA 2A, ASTM D4169, sterilebarrier performance testing and ISO10993-7 testing. The new packagingconfiguration does not impact safety andeffectiveness.2) Label content on device applied as alaser marking. Laser marking passedtesting per IEC 60601-1 for durability ofmarkings and the laser marking does notimpact safety and effectiveness.3) Labeling on Pouch and Shelf Box-Same,no change.
Shelf Life	Shelf life of 2 years.	Shelf life of 4 years. Shelf life product was2X sterilized, passed design verificationtesting including pouch seal peel and bubbleleak tests. The extension of the shelf life doesnot impact safety and effectiveness.
Size	3F, 4F, 5F, 6F, 7F, 8F, 10F, 12F	Same - No change
Biocompatibility	Meets ISO 10993-1	Same - No change
Sterilizationmethod andsterility	EtO and SAL of 10-6	Same - No change

8.7 DEVICE COMPARISON

Table 8-1; Comparison of Dovice Charactoristics to Marketed Prodicate Device

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PERFORMANCE DATA 8.8

Performance tests include dimensional verification, functional tests and marking durability. The company performed testing to demonstrate that the device meets product specifications and is not negatively impacted by the material change or marking process change. The device uses a modified Polypropylene material formulation to optimize the device markings using a laser instead of pad printing the device markings. All other materials are the same as its predicate device. The device continues to meet the same specifications as its predicate devices. Test results demonstrate that the device functions as intended. The following tests were performed:

Dimensional

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Joint Tensile Strength Base & Cover Interaction Hinge performance Device Marking Durability

SUBSTANTIAL EQUIVALENCE 8.9

The SecurAcath device covered by this submission is substantially equivalent to the predicate Interrad Medical SecurAcath device K180994.

The Polypropylene material formulation change and change from pad printing to laser marking to the SecurAcath device results in the same indication for use, same principles of operation, same technological characteristics, incorporates the same design, and are packaged and sterilized using the same materials and processes as the previously cleared predicate device. The changes do not raise new questions of safety or efficacy.

8.10 CONCLUSION

Based on the test data, the same intended use, and same indications for use, the modified SecurAcath device is found to be substantially equivalent to its predicate.

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.”