SecurePortIV Advanced Catheter Securement Adhesive

K223669 · Adhezion Biomedical, LLC · NZP · Jun 12, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223669
• Device Name: SecurePortIV Advanced Catheter Securement Adhesive
• Applicant: Adhezion Biomedical, LLC
• Product Code: NZP · General, Plastic Surgery
• Decision Date: Jun 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended 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 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 Story

SecurePortIV Advanced is a sterile, liquid cyanoacrylate-based adhesive (2-octyl cyanoacrylate) used to secure vascular access catheters. Supplied in an applicator with an internal ampoule, the liquid is applied to the catheter skin entry site, where it polymerizes into a film within 14 seconds. This film acts as a mechanical securement to reduce catheter movement/dislodgment and as a sealant to immobilize surface bacteria and provide a moisture barrier. Used in conjunction with a transparent film dressing, the device is intended for clinical settings where peripheral IVs, PICCs, or CVCs are managed. By immobilizing the catheter and sealing the entry site, the device aims to reduce catheter-related complications. Healthcare providers apply the adhesive during catheter placement.

Clinical Evidence

Bench testing only. Performance data demonstrated the device meets acceptance criteria for catheter adhesion (1-7 days), sealant efficacy, bacterial immobilization, and removal time. Biocompatibility testing (ISO 10993-5, -6, -10, -11) and pyrogenicity (USP <85>) passed. Securement time was measured at 14 seconds compared to 143 seconds for the predicate.

Technological Characteristics

Materials: 2-octyl cyanoacrylate, 18-6-crown ether, BHA, D&C Violet #2. Form factor: Liquid-filled ampoule in tapered plastic tube. Sterilization: Ethylene oxide (applicator) and irradiation (ampoule). Adhesion strength: ≥0.5 lbf. Securement time: 14 seconds.

Indications for Use

Indicated for patients requiring short-term or long-term vascular access catheters (peripheral IVs, PICCs, CVCs) to secure the catheter to the skin and protect the entry site from bacterial ingress and moisture.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SecurePortIV Catheter Securement Adhesive (K170505)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: | [phone] |
|-----------------------------|---------------------------------|
| Fax: | [phone] |
| 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

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.

#### 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<br>[predicate device] | SecurePortIV<br>Advanced | 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 housed<br>in tapered plastic tube | filled ampoule housed<br>in tapered plastic tube | same |
| Sterilization | terminally sterilized by<br>ethylene oxide; liquid-<br>filled ampoule<br>component terminally<br>sterilized by irradiation | terminally sterilized by<br>ethylene oxide; liquid-<br>filled ampoule<br>component terminally<br>sterilized by irradiation | same |
| Adhesion Strength | ≥.5 lbf | ≥.5 lbf | same |
| Securement Time | 143 seconds | 14 seconds | different, faster<br>securement time than<br>predicate device. |

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# VII. Performance Data

# A. Efficacy Performance

| Test | Acceptance Criteria | Result |
|---------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------|
| Catheter Adhesion to Skin | Hold BD Autoguard Catheter 1,<br>3, and 7 days<br><br>Hold Nexiva catheter 1 to 7 days | Pass, same as predicate<br>device |
| Sealant of the Cannulation<br>Site | Prevent dye penetration at<br>1, 4, and 7 days | Pass, same as predicate<br>device |
| Immobilization of Surface<br>Bacteria | Prevent bacteria from<br>penetrating cannulation site | Pass, same as predicate<br>device |
| Removal Time | Same removal time as<br>predicate device | Pass, same as predicate<br>device |
| Clinical | Securement time obtained | Pass<br>Predicate: 143 seconds<br>Subject: 14 seconds |

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# B. Biocompatibility Testing

| Test | Acceptance Criteria | Result | Comparison to<br>Predicate |
|-------------------------------|-----------------------------------------------------------------|--------|----------------------------|
| Cytotoxicity | ISO 10993-5: Tests for<br>in vitro cytoxocity | Pass | Same |
| Sensitization | ISO 10993-10: Tests<br>for irritation and skin<br>sensitization | Pass | Same |
| Irritation | ISO 10993-10: Tests<br>for irritation and skin<br>sensitization | Pass | Same |
| Pyrogenicity | LAL Limit Screen;<br>Current USP <85> | Pass | Same |
| Acute Systemic<br>Toxicity | ISO 10993-10: Tests<br>for irritation and skin<br>sensitization | Pass | Same |
| Subacute Systemic<br>Toxicity | ISO 10993-11: Tests<br>for systemic toxicity | Pass | N/A |
| Implantation | ISO 10993-6: Tests<br>for local effects after<br>implantation | Pass | N/A |
| Intracutaneous | ISO 10993-10: Tests<br>for irritation and skin<br>sensitization | Pass | N/A |
| Hydrolytic<br>Degradation | <10µg/mL | Pass | Same |
| Heat of Polymerization | No greater than<br>predicate 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