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 Description

SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl 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 liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.

AI/ML Overview

This document describes the premarket notification for the "SecurePortIV Catheter Securement Adhesive" (K170505). However, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets specific acceptance criteria. The information provided is descriptive of the device and comparative to predicates.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly present in the provided text. I will extract what I can and note where information is missing.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of defined metrics and thresholds that the SecurePortIV device must pass. Instead, it presents a comparison table (Table 1) against predicate and reference devices, aiming to show comparable or superior performance to establish substantial equivalence. The "Acceptance Criteria" here are implicitly that the SecurePortIV performs "as well or better than" the legally marketed predicate/reference devices across various characteristics.

Characteristic	Implicit Acceptance Criteria (based on comparison)	Reported Device Performance (SecurePortIV)
Indications for Use (IFU)	Comparable functionality to predicate/reference device, with specific claims.	Film forming securement and sealant at vascular access catheter skin entry. Holds catheter to skin to reduce movement/migration/dislodgement. Protects skin entry site by creating sealant that immobilizes surface bacteria, prevents entry, and provides moisture barrier. Intended for use with transparent film dressing on short-term and long-term vascular access catheters (peripheral IVs, PICCs, CVCs).
Adhesion Strength/Securement	Statistically equal or significantly greater than commercial transparent adhesive dressings; no pullout failures under challenge.	In vitro: Adhesion strength values statistically equal or significantly greater than several commercially available transparent adhesive dressings from 3 minutes to 7 days. In vivo (dog study): Presented significant shear pull out force challenge (100g) with no pullout failures in any test point for 6 hours (SecurePortIV alone and in combination with transparent film dressing).
Moisture Barrier	Provides a film barrier to moisture penetration, comparable to predicate.	Provides a film barrier to moisture penetration. Activity shared with reference product (seal repellant).
Anti-bacterial Activity	Immobilization of bacteria, equivalently effective against gram positive and gram negative bacteria (compared to predicates).	Immobilization of bacteria. Identical to primary predicate; different anti-bacterial to secondary predicate, but all equivalently effective against gram positive and gram negative bacteria.
Protection Duration	5 days to skin sloughing, comparable to predicate.	5 days to skin sloughing. (Identical to predicate).
Packaging Material	Identical to predicate.	Primary - Barex. Identical ampoule material reservoir to predicate.
Viscosity	< 200 cps, identical values for each component.	< 200 cps. Same values for each component separately (identical to predicate).
Set Time	Identical to predicate.	Identical to predicate and same values for identical formula.
Shelf-life	24 months, identical to predicate component.	24 months. Supported by accelerated aging and real-time evaluations. Identical shelf-life for each predicate component.
Biocompatibility	Pass standard biocompatibility tests, identical results to predicate.	Passed tests per ISO 10993-1:2009 (Bacterial Reverse Mutation, Intracutaneous, Muscle Implantation, In Vitro Cytotoxicity, Mouse Peripheral Blood Micronucleus, Skin Irritation, Genotoxicity (In Vitro Chromosomal Aberration), Maximization Sensitization Study). Results identical to predicate.
Flexibility	No ripples, no cracks, no chips. Identical to predicate.	No ripples, no cracks, no chips. Identical to predicate.

2. Sample sizes used for the test set and the data provenance

Securement (In vitro): "several different commercially available transparent adhesive dressings" were used for comparison, but the number of tests or samples per test is not specified.
Securement (In vivo): One "animal dog study" was conducted. The number of dogs or test sites on the dogs is not specified.
Biocompatibility: Standard ISO tests were conducted. The sample sizes for these specific tests are not detailed.
Provenance: All studies described appear to be pre-market, in-house, or contract lab studies conducted to support the 510(k) submission. The country of origin for the animals or human data (as there is none specified) is not provided. The studies are most likely prospective as they were conducted specifically for this submission.

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

This information is not provided in the document as it pertains to expert independent review of the device's performance against a "ground truth." The studies described are primarily performance and comparison tests, not AI model validation studies requiring expert ground truth labeling.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved. The studies described are laboratory and animal performance tests.

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

This information is not applicable and not provided. The device is a physical medical device (catheter securement adhesive), not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable and not provided. The device is a physical medical device, not an algorithm.

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

The "ground truth" for this medical device is established through physical performance measurements (e.g., adhesion strength, flexibility, moisture barrier) and biological testing (biocompatibility, anti-bacterial activity) against established industry standards and comparison to legally marketed predicate devices. For the in vivo securement study, the ground truth was the objective observation of "no pullout failures" under a specified force.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical product, not an AI model requiring a training set.

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

This information is not applicable and not provided. As above, no training set for an AI model is involved.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 BoulevardSuite 1B02Wyomissing, PA 19610
Phone Number	(610) 241-7191
Fax Number	(610) 373-2081
EstablishmentRegistration	3006385287
Name of contactperson	Richard G. Jones, Regulatory and Quality Assurance Consultant
Date prepared	09/26/17
Name of Device:
Trade orproprietary name	SecurePortIV Catheter Securement Adhesive
Common or usualname	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 MarketedPredicate Device	FloraSeal Microbial Sealant, 510(k) K083354
Reference Device	IV Clear Antimicrobial Clear Silicone Adhesive Securement Dressingwith Chlorohexidine and Silver, 510(k) K112549
Reason for 510(k) submission	Premarket Notification
Device Description	SecurePortIV Catheter Adhesive is a sterile, professional liquidcyanoacrylate-based adhesive containing a two monomericformulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and thecolorant D&C Violet #2. The device is an applicator with theformulation incorporated in an ampoule housed in a tapered plastictube.The SecurePortIV liquid is applied as a film forming securement andsealant at the point of catheter skin entry, polymerizing in minutes. Itis intended to be used in conjunction with a transparent film dressing.
Indications for use	SecurePortIV Catheter Securement Adhesive is to be applied as a filmforming securement and sealant at the point of vascular catheteraccess skin entry. The film holds the catheter to the skin to reducecatheter movement, migration, and /or dislodgment. It is used toprotect the skin entry site by creating a sealant that immobilizessurface bacteria, preventing them from entering into the catheter skinentry site while also providing a moisture barrier. SecurePortIV isintended to be used with a transparent film dressing on short- termand long-term vascular access catheters including peripheral IVs,PICCs, and CVCs.
Technological Characteristics	SecurePortIV is a liquid applied at the point of vascular catheter andskin entry forming a film securement and sealant. This liquid is acombination of two monomeric cyanoacrylates, 2-octyl cyanoacrylateand butyl cyanoacrylate formulation packaged in a single-useapplicator. This formulation is a low viscosity to facilitate flow aroundthe catheter for sealing to the skin and creating a barrier to moisture.In vitro studies demonstrate the film holds the catheter to skin toreduce movement as well as create a sealant that immobilizes bacteriafrom entering the catheter skin entry site and preventing moisturepenetration as long as the film remains intact. It is to be used inconjunction with a transparent film dressing that increased thesecurement measured holding strength values greater than eitherproduct used alone. A live securement animal dog study showed under
Biocompatibility	The following tests were conducted in accordance with ISO 10993-1:2009:Bacterial Reverse Mutation StudyIntracutaneous StudyMuscle Implantation StudyIn Vitro CytotoxicityMouse Peripheral Blood Micronucleus StudySkin Irritation StudyGenotoxicity (In Vitro Chromosomal Aberration Study)Maximization Sensitization Study
Performance TestingSecurement:	In vitro studies show the adhesion strength values forSecurePortIV compared to several different commerciallyavailable transparent adhesive dressings for cathetersecurement of widely marketed vascular access catheterdevices. Values were statistically equal or significantlygreater than these devices from 3 minutes to 7 days.An in vivo animal dog study presented significant shear pullout force challenge (100 g) to SecurePortIV alone and incombination with a transparent film dressing. There wereno pullout failures in any test point for 6 hours showingequivalency securement strength with the transparent filmdressing. The SecurePortIV is to be used in conjunctionwith a transparent film dressing.
Physical/Other:	Performance for SecurePortIV compared to the predicatedevise for packaging material, viscosity, set time, shelf life,flexibility and moisture barrier are identical being theidentical formula.Moisture barrier studies performed demonstrate the deviceto provide a film barrier to moisture penetration. Thisactivity is shared with the reference product providing aseal repellant.
Sterilization and Shelf life:	SecurePortIV is terminally sterilized by ethylene oxidefollowing ISO 11135-1:2008 and ISO 11135-2:2008.The liquid formula filed ampoule component isterminally sterilized by irradiation following ISO 11137-
The shelf life is a 24 month expiration date. The stabilitystudies have both accelerated aging and real-time evaluationssupporting this shelf life. See Table 1 for side by sidecomparisons 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(K083354)]	[ReferenceDevice(K112549)]	Comparison
Indications for UseStatement	SecurePortIVCatheterSecurementAdhesive is to beapplied as a filmformingsecurement andsealant at thepoint of vascularcatheter accessskin entry. Thefilm holds thecatheter to theskin to reducecathetermovement,migration, and/ordislodgment. It isused to protect theskin entry site bycreating a sealantthat immobilizessurface bacteria,preventing themfrom entering intothe catheter skinentry site whilealso providing amoisture barrier.SecurePortIV isintended to beused with atransparent filmdressing short-term and long-term vascularaccess cathetersincludingperipheral IVs,PICCs, andCVCs.	Flora SealTMMicrobialSealant isintended foruse aftertopicaloperative skinpreparations,with standardsurgicaldraping, andprior to asurgicalincision. Theproduct isused to reducethe risk of theskin floracontaminationthroughout asurgical.procedure.	IV Clear® isintended to coverand protectinsertion sites,and securedevices to skin.Commonapplicationsinclude IVcatheters, centralvenous lines,PICCs, suctioncatheters, epiduralcatheters,hemodialysiscatheters,orthopedic pins,otherintravascularcatheters andpercutaneousdevices. IVClear® inhibitsmicrobial growthwithin thedressing andprevents externalcontamination.	Page 5 of 7
IFU Comparison	Indication a.holds catheter toskin / adhesiveclaim	Holds adrapeduring asurigicalprocedure	Holds catheterto skin	adhesiveeffectiveness =adhesive claim;difference -holdscatheter/skin
			NA	Page 6 of 7
	b. sealimmobilizesbacteria,prevents fromenteringcompromisedskin		NA
		identical		same claim
	c. moisturebarrier	identical	Provides a barrier toexternalcontamination	identical
Packaging Material	Primary - Barex	identical	NA	identicalampoulematerialreservoir
Viscosity	< 200 cps	identical	NA	same values foreachcomponentseparately
Set Time	identical	identical	NA	same values foridenticalformula
Shelf-life	24 month	identical	NA	Identical shelf-life for eachpredicatecomponent
Biocompatibility	original studiesapplied andverification -cytotoxicity	identical	NA	identical
Flexibility	No ripples, nocracks, no chips	identical		predicateidentical

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510(k) K170505
Page 6 of 7

Flexibility	cracks, no chips	identical
			predicateidentical
Moisture barrier	identical	identical

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			510(k) K170505Page 7 of 7
Anti-bacterialactivity	immobilization ofbacteria	identical	identical toprimary;different anti-bacterial tosecondarypredicate. Allequivalentlyeffenctiveagainst grampositive andgramnegativebacteria
Protection duration	5 days to skinsloughing	5 days to skinsloughing	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.

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.