SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

Device Description

SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

AI/ML Overview

The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Catheter Adhesion to Skin	Hold BD Autoguard Catheter 1, 3, and 7 days; Hold Nexiva catheter 1 to 7 days	Pass, same as predicate device
Sealant of the Cannulation Site	Prevent dye penetration at 1, 4, and 7 days	Pass, same as predicate device
Immobilization of Surface Bacteria	Prevent bacteria from penetrating cannulation site	Pass, same as predicate device
Removal Time	Same removal time as predicate device	Pass, same as predicate device
Clinical (Securement Time)	Securement time obtained	Pass (14 seconds, compared to predicate's 143 seconds)
Cytotoxicity	ISO 10993-5: Tests for in vitro cytotoxicity	Pass
Sensitization	ISO 10993-10: Tests for irritation and skin sensitization	Pass
Irritation	ISO 10993-10: Tests for irritation and skin sensitization	Pass
Pyrogenicity	LAL Limit Screen; Current USP <85>	Pass
Acute Systemic Toxicity	ISO 10993-10: Tests for irritation and skin sensitization	Pass
Subacute Systemic Toxicity	ISO 10993-11: Tests for systemic toxicity	Pass
Implantation	ISO 10993-6: Tests for local effects after implantation	Pass
Intracutaneous	ISO 10993-10: Tests for irritation and skin sensitization	Pass
Hydrolytic Degradation	<10µg/mL	Pass
Heat of Polymerization	No greater than predicate device	Pass

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

The document does not explicitly state the specific sample sizes for each individual test related to catheter adhesion, sealant effectiveness, or bacterial immobilization. The tests are described generally, indicating they were qualitative "Pass" results compared to the predicate device.

For the Clinical (Securement Time), the result for the subject device is 14 seconds compared to the predicate's 143 seconds. However, the sample size or methodology for obtaining these times is not detailed in the provided text.

The data provenance is internal to Adhezion Biomedical, LLC, and appears to be from non-clinical (laboratory/bench) studies. There is no mention of specific country of origin or whether these studies were retrospective or prospective, but given they are performance tests against acceptance criteria, they are inherently prospective for this device.

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

This information is not provided in the given document. The document describes non-clinical performance and biocompatibility testing, which typically rely on standardized methods and laboratory assessments rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies when multiple reviewers assess subjective data (e.g., medical images). Since the provided data focuses on non-clinical performance and biocompatibility parameters, an adjudication method is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study being conducted or its results in the provided document. The study focuses on direct performance comparisons and biocompatibility rather than human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This device is not an AI algorithm; it's a physical medical device (an adhesive). Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The performance criteria are for the device itself.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

Established laboratory performance standards: For adhesion, sealant penetration, and bacterial immobilization, the device's performance was compared to that of the legally marketed predicate device.
Standardized ISO and USP guidelines: For biocompatibility testing (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, systemic toxicity, implantation; USP <85> for pyrogenicity).
Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.

8. Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.

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

This question is not applicable as the device is a physical medical product, not an AI algorithm.

Summary

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June 12, 2023

Adhezion Biomedical, LLC. Richard Jones Consultant - RA/QA One Meridian Boulevard Suite 1B02 Wyomissing, PA 19610

Re: K223669

Trade/Device Name: SecurePortIV Advanced Catheter Securement Adhesive Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: NZP Dated: May 12, 2023 Received: May 12, 2023

Dear Richard Jones:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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, Christopher K. Duqard -S

for Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K223669

Device Name

SecurePortIV Advanced catheter securement adhesive

Indications for Use (Describe)

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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510(k) Summary - K223669

As required by 21 CFR 807.92

Submitter Information: I.

Adhezion Biomedical, LLC One Meridian Boulevard Suite 1B02 Wyomissing, PA 19610

Phone:	(484) 334-2929
Fax:	(610) 373-2081
Establishment Registration:	3006385287
Contact Person:	Pete Molinaro, Chairman and CEO
Date prepared	May 12, 2023

II. Device

Trade or proprietary name:	SecurePortIV Advanced Catheter Securement Adhesive
Common or usual name:	Catheter Securement Adhesive
Classification name:	Microbial Sealant
Classification Panel:	General and Plastic Surgery
Regulation:	Class II, under 21 CFR 878.4370
Product Code(s):	NZP

III. Predicate Device

SecurePortIV Catheter Securement Adhesive; K170505

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IV. Device Description

The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

V. Indications for Use

SECUREPORTIV™ ADVANCED catheter securement adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SECUREPORTIV™ ADVANCED is intended to be used with a transparent film dressing for short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

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Characteristic	SecurePortIV[predicate device]	SecurePortIVAdvanced	Result
	2-octyl cyanoacrylate	2-octyl cyanoacrylate	same

Comparison of Technical Characteristics with Predicate Device VI.

	2-octyl cyanoacrylate	2-octyl cyanoacrylate	same
Formulation	n-butyl cyanoacrylate	18-6-crown ether	different
	BHA	BHA	same
	D&C Violet #2	D&C Violet #2	same
Applicator	filled ampoule housedin tapered plastic tube	filled ampoule housedin tapered plastic tube	same
Sterilization	terminally sterilized byethylene oxide; liquid-filled ampoulecomponent terminallysterilized by irradiation	terminally sterilized byethylene oxide; liquid-filled ampoulecomponent terminallysterilized by irradiation	same
Adhesion Strength	≥.5 lbf	≥.5 lbf	same
Securement Time	143 seconds	14 seconds	different, fastersecurement time thanpredicate device.

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VII. Performance Data

A. Efficacy Performance

Test	Acceptance Criteria	Result
Catheter Adhesion to Skin	Hold BD Autoguard Catheter 1,3, and 7 daysHold Nexiva catheter 1 to 7 days	Pass, same as predicatedevice
Sealant of the CannulationSite	Prevent dye penetration at1, 4, and 7 days	Pass, same as predicatedevice
Immobilization of SurfaceBacteria	Prevent bacteria frompenetrating cannulation site	Pass, same as predicatedevice
Removal Time	Same removal time aspredicate device	Pass, same as predicatedevice
Clinical	Securement time obtained	PassPredicate: 143 secondsSubject: 14 seconds

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B. Biocompatibility Testing

Test	Acceptance Criteria	Result	Comparison toPredicate
Cytotoxicity	ISO 10993-5: Tests forin vitro cytoxocity	Pass	Same
Sensitization	ISO 10993-10: Testsfor irritation and skinsensitization	Pass	Same
Irritation	ISO 10993-10: Testsfor irritation and skinsensitization	Pass	Same
Pyrogenicity	LAL Limit Screen;Current USP <85>	Pass	Same
Acute SystemicToxicity	ISO 10993-10: Testsfor irritation and skinsensitization	Pass	Same
Subacute SystemicToxicity	ISO 10993-11: Testsfor systemic toxicity	Pass	N/A
Implantation	ISO 10993-6: Testsfor local effects afterimplantation	Pass	N/A
Intracutaneous	ISO 10993-10: Testsfor irritation and skinsensitization	Pass	N/A
HydrolyticDegradation	<10µg/mL	Pass	Same
Heat of Polymerization	No greater thanpredicate device	Pass	Same

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The biocompatibility testing for the SecurePortIV Advanced catheter securement adhesive was conducted according to the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO - 10933, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995; and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process,' as recognized by FDA.

VIII. Conclusions

The conclusion drawn from the non-clinical tests demonstrates that the subject device, SecurePortIV Advanced is as safe, as effective and performs as well or better than the legally marketed predicate device, K170505

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.