(220 days)
FloraSeal Microbial Sealant, 510(k) K083354
No
The device description and performance studies focus on the physical and chemical properties of an adhesive for catheter securement. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as an adhesive for catheter securement and site protection, not for treating or diagnosing a disease or condition.
No
The device is a securement and sealant for catheters, used for physical securement and infection prevention, not for diagnosing a condition or disease.
No
The device description clearly states it is a liquid adhesive applied with an applicator, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure and seal a vascular access catheter at the skin entry site. This is a physical action performed on the patient's skin to manage a medical device (the catheter).
- Device Description: The device is a liquid adhesive applied externally to the skin.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are used to provide information about a patient's health status through the analysis of biological samples.
The device's function is purely for securement and protection at the catheter insertion site, which falls under the category of a medical device used for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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. SecurePortIV™ 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.
Product codes (comma separated list FDA assigned to the subject device)
NZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
at the point of vascular access catheter skin entry
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The following tests were conducted in accordance with ISO 10993-1:2009: Bacterial Reverse Mutation Study, Intracutaneous Study, Muscle Implantation Study, In Vitro Cytotoxicity, Mouse Peripheral Blood Micronucleus Study, Skin Irritation Study, Genotoxicity (In Vitro Chromosomal Aberration Study), Maximization Sensitization Study.
Performance Testing Securement: In vitro studies show the adhesion strength values for SecurePortIV compared to several different commercially available transparent adhesive dressings for catheter securement of widely marketed vascular access catheter devices. Values were statistically equal or significantly greater than these devices from 3 minutes to 7 days.
An in vivo animal dog study presented significant shear pull out force challenge (100 g) to SecurePortIV alone and in combination with a transparent film dressing. There were no pullout failures in any test point for 6 hours showing equivalency securement strength with the transparent film dressing. The SecurePortIV is to be used in conjunction with a transparent film dressing.
Physical/Other: Performance for SecurePortIV compared to the predicate devise for packaging material, viscosity, set time, shelf life, flexibility and moisture barrier are identical being the identical formula. Moisture barrier studies performed demonstrate the device to provide a film barrier to moisture penetration. This activity is shared with the reference product providing a seal repellant.
Sterilization and Shelf life: SecurePortIV is terminally sterilized by ethylene oxide following ISO 11135-1:2008 and ISO 11135-2:2008. The liquid formula filed ampoule component is terminally sterilized by irradiation following ISO 11137-1:2013 and ISO 11137-2:2013. The shelf life is a 24 month expiration date. The stability studies have both accelerated aging and real-time evaluations supporting this shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FloraSeal Microbial Sealant, 510(k) K083354
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
IV Clear Antimicrobial Clear Silicone Adhesive Securement Dressing with Chlorohexidine and Silver, 510(k) K112549
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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 |
| Suite 1B02 | |
| Wyomissing, PA 19610 | |
| Phone Number | (610) 241-7191 |
| Fax Number | (610) 373-2081 |
| Establishment | |
| Registration | 3006385287 |
| Name of contact | |
| person | Richard G. Jones, Regulatory and Quality Assurance Consultant |
| Date prepared | 09/26/17 |
| Name of Device: | |
| Trade or | |
| proprietary name | SecurePortIV 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 |
| Legally Marketed | |
| Predicate Device | FloraSeal Microbial Sealant, 510(k) K083354 |
| Reference Device | IV Clear Antimicrobial Clear Silicone Adhesive Securement Dressing |
| with Chlorohexidine and Silver, 510(k) K112549 | |
| Reason for 510(k) submission | Premarket Notification |
| 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. |
| Indications for use | SecurePortIV Catheter Securement Adhesive is to be applied as a film
forming securement and sealant at the point of vascular catheter
access skin entry. The film holds the catheter to the skin to reduce
catheter movement, migration, and /or dislodgment. It is used to
protect the 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 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. |
| Technological Characteristics | SecurePortIV is a liquid applied at the point of vascular catheter and
skin entry forming a film securement and sealant. This liquid is a
combination of two monomeric cyanoacrylates, 2-octyl cyanoacrylate
and butyl cyanoacrylate formulation packaged in a single-use
applicator. This formulation is a low viscosity to facilitate flow around
the catheter for sealing to the skin and creating a barrier to moisture.
In vitro studies demonstrate the film holds the catheter to skin to
reduce movement as well as create a sealant that immobilizes bacteria
from entering the catheter skin entry site and preventing moisture
penetration as long as the film remains intact. It is to be used in
conjunction with a transparent film dressing that increased the
securement measured holding strength values greater than either
product 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 Study
Intracutaneous Study
Muscle Implantation Study
In Vitro Cytotoxicity
Mouse Peripheral Blood Micronucleus Study
Skin Irritation Study
Genotoxicity (In Vitro Chromosomal Aberration Study)
Maximization Sensitization Study |
| Performance Testing
Securement: | In vitro studies show the adhesion strength values for
SecurePortIV compared to several different commercially
available transparent adhesive dressings for catheter
securement of widely marketed vascular access catheter
devices. Values were statistically equal or significantly
greater than these devices from 3 minutes to 7 days.
An in vivo animal dog study presented significant shear pull
out force challenge (100 g) to SecurePortIV alone and in
combination with a transparent film dressing. There were
no pullout failures in any test point for 6 hours showing
equivalency securement strength with the transparent film
dressing. The SecurePortIV is to be used in conjunction
with a transparent film dressing. |
| Physical/Other: | Performance for SecurePortIV compared to the predicate
devise for packaging material, viscosity, set time, shelf life,
flexibility and moisture barrier are identical being the
identical formula.
Moisture barrier studies performed demonstrate the device
to provide a film barrier to moisture penetration. This
activity is shared with the reference product providing a
seal repellant. |
| Sterilization and Shelf life: | SecurePortIV is terminally sterilized by ethylene oxide
following ISO 11135-1:2008 and ISO 11135-2:2008.
The liquid formula filed ampoule component is
terminally sterilized by irradiation following ISO 11137- |
| The shelf life is a 24 month expiration date. The stability
studies have both accelerated aging and real-time evaluations
supporting this shelf life. See Table 1 for side by side
comparisons below. | |
| | |
4
5
1:2013 and ISO 11137-2:2013.
6
Table 1. SecurePortIV Technological Comparison to Predicate Devices and Reference Device
| [Subject Device] | [Predicate
(K083354)] | [Reference
Device
(K112549)] | Comparison | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for Use
Statement | SecurePortIV
Catheter
Securement
Adhesive is to be
applied as a film
forming
securement and
sealant at the
point of vascular
catheter access
skin entry. The
film holds the
catheter to the
skin to reduce
catheter
movement,
migration, and/or
dislodgment. It is
used to protect the
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 is
intended to be
used with a
transparent film
dressing short-
term and long-
term vascular
access catheters
including
peripheral IVs,
PICCs, and
CVCs. | Flora SealTM
Microbial
Sealant is
intended for
use after
topical
operative skin
preparations,
with standard
surgical
draping, and
prior to a
surgical
incision. The
product is
used to reduce
the risk of the
skin flora
contamination
throughout a
surgical.
procedure. | IV Clear® is
intended to cover
and protect
insertion sites,
and secure
devices to skin.
Common
applications
include IV
catheters, central
venous lines,
PICCs, suction
catheters, epidural
catheters,
hemodialysis
catheters,
orthopedic pins,
other
intravascular
catheters and
percutaneous
devices. IV
Clear® inhibits
microbial growth
within the
dressing and
prevents external
contamination. | Page 5 of 7 |
| IFU Comparison | Indication a.
holds catheter to
skin / adhesive
claim | Holds a
drapeduring a
surigical
procedure | Holds catheter
to skin | adhesive
effectiveness =
adhesive claim;
difference -
holds
catheter/skin |
| | | | NA | Page 6 of 7 |
| | b. seal
immobilizes
bacteria,
prevents from
entering
compromised
skin | | NA | |
| | | identical | | same claim |
| | c. moisture
barrier | identical | Provides a barrier to
external
contamination | identical |
| Packaging Material | Primary - Barex | identical | NA | identical
ampoule
material
reservoir |
| Viscosity |