SecurePortIV Catheter Securement Adhesive

K170505 · Adhezion Biomedical, LLC · NZP · Sep 29, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170505
• Device Name: SecurePortIV Catheter Securement Adhesive
• Applicant: Adhezion Biomedical, LLC
• Product Code: NZP · General, Plastic Surgery
• Decision Date: Sep 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

SecurePortIV™ 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. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

Device Story

SecurePortIV is a sterile, liquid cyanoacrylate-based adhesive (2-octyl cyanoacrylate and butyl cyanoacrylate) with D&C Violet #2 colorant. Supplied in a single-use applicator with an ampoule in a tapered plastic tube. Applied at the vascular access catheter skin entry point; polymerizes in minutes to form a film. Used in conjunction with a transparent film dressing. The film immobilizes surface bacteria and provides a moisture barrier while securing the catheter to the skin to reduce movement, migration, or dislodgment. Used by clinicians in clinical settings for short-term and long-term vascular access catheters. Benefits include improved catheter securement and protection of the entry site from microbial contamination and moisture.

Clinical Evidence

Bench testing only. In vitro studies demonstrated adhesion strength values statistically equal or superior to commercially available dressings from 3 minutes to 7 days. In vivo animal (dog) study showed no pullout failures over 6 hours under 100g shear force challenge, demonstrating equivalency to transparent film dressing alone. Biocompatibility testing conducted per ISO 10993-1:2009, including cytotoxicity, sensitization, irritation, and genotoxicity studies.

Technological Characteristics

Liquid cyanoacrylate-based adhesive (2-octyl cyanoacrylate and butyl cyanoacrylate). Low viscosity. Packaged in a single-use applicator with ampoule. Terminally sterilized by ethylene oxide (applicator) and irradiation (ampoule) per ISO 11135 and ISO 11137. Primary packaging material is Barex.

Indications for Use

Indicated for use as a film-forming securement and sealant at the skin entry site of short-term and long-term vascular access catheters (peripheral IVs, PICCs, CVCs) to reduce catheter movement/migration, immobilize surface bacteria, and provide a moisture barrier. Intended for use with a transparent film dressing.

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

• FloraSeal Microbial Sealant (K083354)

Reference Devices

• IV Clear Antimicrobial Clear Silicone Adhesive Securement Dressing with Chlorohexidine and Silver (K112549)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the perimeter of the circle.

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

September 29, 2017

Adhezion Biomedical, LLC Richard Jones Regulatory And Ouality Assurance Consultant One Meridian Blvd - Suite 1b02 Wyomissing, Pennsylvania 19610

Re: K170505

Trade/Device Name: SecureportIV Catheter Securement Adhesive Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: NZP Dated: August 30, 2017 Received: August 30, 2017

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. 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 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

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170505

Device Name

SecurePortIV Catheter Securement Adhesive

#### Indications for Use (Describe)

SecurePortIV™ 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. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

| 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

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 is below:

| Submitter Information: 510(k) # K170505 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Adhezion Biomedical, LLC |
| Address | One Meridian Boulevard<br>Suite 1B02<br>Wyomissing, PA 19610 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment<br>Registration | 3006385287 |
| Name of contact<br>person | Richard G. Jones, Regulatory and Quality Assurance Consultant |
| Date prepared | 09/26/17 |
| Name of Device: | |
| Trade or<br>proprietary name | SecurePortIV Catheter Securement Adhesive |
| Common or usual<br>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 |
| Legally Marketed<br>Predicate Device | FloraSeal Microbial Sealant, 510(k) K083354 |
| Reference Device | IV Clear Antimicrobial Clear Silicone Adhesive Securement Dressing<br>with Chlorohexidine and Silver, 510(k) K112549 |
| Reason for 510(k) submission | Premarket Notification |
| Device Description | SecurePortIV Catheter Adhesive is a sterile, professional liquid<br>cyanoacrylate-based adhesive containing a two monomeric<br>formulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and the<br>colorant D&C Violet #2. The device is an applicator with the<br>formulation incorporated in an ampoule housed in a tapered plastic<br>tube.<br><br>The SecurePortIV liquid is applied as a film forming securement and<br>sealant at the point of catheter skin entry, polymerizing in minutes. It<br>is intended to be used in conjunction with a transparent film dressing. |
| Indications for use | SecurePortIV Catheter Securement Adhesive is to be applied as a film<br>forming securement and sealant at the point of vascular catheter<br>access skin entry. The film holds the catheter to the skin to reduce<br>catheter movement, migration, and /or dislodgment. It is used to<br>protect the skin entry site by creating a sealant that immobilizes<br>surface bacteria, preventing them from entering into the catheter skin<br>entry site while also providing a moisture barrier. SecurePortIV is<br>intended to be used with a transparent film dressing on short- term<br>and long-term vascular access catheters including peripheral IVs,<br>PICCs, and CVCs. |
| Technological Characteristics | SecurePortIV is a liquid applied at the point of vascular catheter and<br>skin entry forming a film securement and sealant. This liquid is a<br>combination of two monomeric cyanoacrylates, 2-octyl cyanoacrylate<br>and butyl cyanoacrylate formulation packaged in a single-use<br>applicator. This formulation is a low viscosity to facilitate flow around<br>the catheter for sealing to the skin and creating a barrier to moisture.<br><br>In vitro studies demonstrate the film holds the catheter to skin to<br>reduce movement as well as create a sealant that immobilizes bacteria<br>from entering the catheter skin entry site and preventing moisture<br>penetration as long as the film remains intact. It is to be used in<br>conjunction with a transparent film dressing that increased the<br>securement measured holding strength values greater than either<br>product used alone. A live securement animal dog study showed under |
| Biocompatibility | The following tests were conducted in accordance with ISO 10993-<br>1:2009:<br>Bacterial Reverse Mutation Study<br>Intracutaneous Study<br>Muscle Implantation Study<br>In Vitro Cytotoxicity<br>Mouse Peripheral Blood Micronucleus Study<br>Skin Irritation Study<br>Genotoxicity (In Vitro Chromosomal Aberration Study)<br>Maximization Sensitization Study |
| Performance Testing<br>Securement: | <i>In vitro</i> studies show the adhesion strength values for<br>SecurePortIV compared to several different commercially<br>available transparent adhesive dressings for catheter<br>securement of widely marketed vascular access catheter<br>devices. Values were statistically equal or significantly<br>greater than these devices from 3 minutes to 7 days.<br><br>An <i>in vivo</i> animal dog study presented significant shear pull<br>out force challenge (100 g) to SecurePortIV alone and in<br>combination with a transparent film dressing. There were<br>no pullout failures in any test point for 6 hours showing<br>equivalency securement strength with the transparent film<br>dressing. The SecurePortIV is to be used in conjunction<br>with a transparent film dressing. |
| Physical/Other: | Performance for SecurePortIV compared to the predicate<br>devise for packaging material, viscosity, set time, shelf life,<br>flexibility and moisture barrier are identical being the<br>identical formula.<br>Moisture barrier studies performed demonstrate the device<br>to provide a film barrier to moisture penetration. This<br>activity is shared with the reference product providing a<br>seal repellant. |
| Sterilization and Shelf life: | SecurePortIV is terminally sterilized by ethylene oxide<br>following ISO 11135-1:2008 and ISO 11135-2:2008.<br>The liquid formula filed ampoule component is<br>terminally sterilized by irradiation following ISO 11137- |
| The shelf life is a 24 month expiration date. The stability<br>studies have both accelerated aging and real-time evaluations<br>supporting this shelf life. See Table 1 for side by side<br>comparisons below. | |
| | |

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1:2013 and ISO 11137-2:2013.

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# Table 1. SecurePortIV Technological Comparison to Predicate Devices and Reference Device

| [Subject Device] | [Predicate<br>(K083354)] | [Reference<br>Device<br>(K112549)] | Comparison | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for Use<br>Statement | SecurePortIV<br>Catheter<br>Securement<br>Adhesive is to be<br>applied as a film<br>forming<br>securement and<br>sealant at the<br>point of vascular<br>catheter access<br>skin entry. The<br>film holds the<br>catheter to the<br>skin to reduce<br>catheter<br>movement,<br>migration, and/or<br>dislodgment. It is<br>used to protect the<br>skin entry site by<br>creating a sealant<br>that immobilizes<br>surface bacteria,<br>preventing them<br>from entering into<br>the catheter skin<br>entry site while<br>also providing a<br>moisture barrier.<br>SecurePortIV is<br>intended to be<br>used with a<br>transparent film<br>dressing short-<br>term and long-<br>term vascular<br>access catheters<br>including<br>peripheral IVs,<br>PICCs, and<br>CVCs. | Flora SealTM<br>Microbial<br>Sealant is<br>intended for<br>use after<br>topical<br>operative skin<br>preparations,<br>with standard<br>surgical<br>draping, and<br>prior to a<br>surgical<br>incision. The<br>product is<br>used to reduce<br>the risk of the<br>skin flora<br>contamination<br>throughout a<br>surgical.<br>procedure. | IV Clear® is<br>intended to cover<br>and protect<br>insertion sites,<br>and secure<br>devices to skin.<br>Common<br>applications<br>include IV<br>catheters, central<br>venous lines,<br>PICCs, suction<br>catheters, epidural<br>catheters,<br>hemodialysis<br>catheters,<br>orthopedic pins,<br>other<br>intravascular<br>catheters and<br>percutaneous<br>devices. IV<br>Clear® inhibits<br>microbial growth<br>within the<br>dressing and<br>prevents external<br>contamination. | Page 5 of 7 |
| IFU Comparison | Indication a.<br>holds catheter to<br>skin / adhesive<br>claim | Holds a<br>drapeduring a<br>surigical<br>procedure | Holds catheter<br>to skin | adhesive<br>effectiveness =<br>adhesive claim;<br>difference -<br>holds<br>catheter/skin |
| | | | NA | Page 6 of 7 |
| | b. seal<br>immobilizes<br>bacteria,<br>prevents from<br>entering<br>compromised<br>skin | | NA | |
| | | identical | | same claim |
| | c. moisture<br>barrier | identical | Provides a barrier to<br>external<br>contamination | identical |
| Packaging Material | Primary - Barex | identical | NA | identical<br>ampoule<br>material<br>reservoir |
| Viscosity | < 200 cps | identical | NA | same values for<br>each<br>component<br>separately |
| Set Time | identical | identical | NA | same values for<br>identical<br>formula |
| Shelf-life | 24 month | identical | NA | Identical shelf-<br>life for each<br>predicate<br>component |
| Biocompatibility | original studies<br>applied and<br>verification -<br>cytotoxicity | identical | NA | identical |
| Flexibility | No ripples, no<br>cracks, no chips | identical | | predicate<br>identical |

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510(k) K170505
Page 6 of 7

| Flexibility | cracks, no chips | identical | |
|------------------|------------------|-----------|------------------------|
| | | | predicate<br>identical |
| Moisture barrier | identical | identical | |

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| | | | 510(k) K170505<br>Page 7 of 7 |
|----------------------------|-------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anti-bacterial<br>activity | immobilization of<br>bacteria | identical | identical to<br>primary;<br>different anti-<br>bacterial to<br>secondary<br>predicate. All<br>equivalently<br>effenctive<br>against gram<br>positive and<br>gram<br>negativebacte<br>ria |
| Protection duration | 5 days to skin<br>sloughing | 5 days to skin<br>sloughing | identical |

Summary Conclusion: The conclusions drawn from the non- clinical, in vitro and in vivo tests that demonstrated that the device is as safe, as effective, and performed as well or better than the legally marketed device.