(187 days)
Not Found
No
The summary describes a liquid adhesive for catheter securement and does not mention any AI or ML components or functionalities.
No.
The device is described as a film-forming securement and sealant for vascular access catheters, acting as an adhesive to reduce catheter movement and protect the skin entry site. It does not treat or diagnose a disease or condition.
No
The device is described as an adhesive for securing catheters and protecting the skin entry site, not for diagnosing conditions.
No
The device description clearly states it is a liquid adhesive 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 clearly states that the device is applied to the skin at the point of vascular access catheter entry. Its purpose is to secure the catheter, seal the site, and immobilize surface bacteria. This is a physical action on the body surface, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a liquid adhesive applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
A. Efficacy Performance
- Test: Catheter Adhesion to Skin
- Acceptance Criteria: Hold BD Autoguard Catheter 1, 3, and 7 days; Hold Nexiva catheter 1 to 7 days
- Result: Pass, same as predicate device
- Test: Sealant of the Cannulation Site
- Acceptance Criteria: Prevent dye penetration at 1, 4, and 7 days
- Result: Pass, same as predicate device
- Test: Immobilization of Surface Bacteria
- Acceptance Criteria: Prevent bacteria from penetrating cannulation site
- Result: Pass, same as predicate device
- Test: Removal Time
- Acceptance Criteria: Same removal time as predicate device
- Result: Pass, same as predicate device
- Test: Clinical
- Acceptance Criteria: Securement time obtained
- Result: Pass (Predicate: 143 seconds, Subject: 14 seconds)
B. Biocompatibility Testing
- Test: Cytotoxicity
- Acceptance Criteria: ISO 10993-5: Tests for in vitro cytoxocity
- Result: Pass, Comparison to Predicate: Same
- Test: Sensitization
- Acceptance Criteria: ISO 10993-10: Tests for irritation and skin sensitization
- Result: Pass, Comparison to Predicate: Same
- Test: Irritation
- Acceptance Criteria: ISO 10993-10: Tests for irritation and skin sensitization
- Result: Pass, Comparison to Predicate: Same
- Test: Pyrogenicity
- Acceptance Criteria: LAL Limit Screen; Current USP
- Result: Pass, Comparison to Predicate: Same
- Test: Acute Systemic Toxicity
- Acceptance Criteria: ISO 10993-10: Tests for irritation and skin sensitization
- Result: Pass, Comparison to Predicate: Same
- Test: Subacute Systemic Toxicity
- Acceptance Criteria: ISO 10993-11: Tests for systemic toxicity
- Result: Pass, Comparison to Predicate: N/A
- Test: Implantation
- Acceptance Criteria: ISO 10993-6: Tests for local effects after implantation
- Result: Pass, Comparison to Predicate: N/A
- Test: Intracutaneous
- Acceptance Criteria: ISO 10993-10: Tests for irritation and skin sensitization
- Result: Pass, Comparison to Predicate: N/A
- Test: Hydrolytic Degradation
- Acceptance Criteria:
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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) | |
|---|---|
| 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
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.
5
| Characteristic | SecurePortIV
[predicate device] | SecurePortIV
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 | ||
| in tapered plastic tube | filled ampoule housed | ||
| in tapered plastic tube | same | ||
| Sterilization | terminally sterilized by | ||
| ethylene oxide; liquid- | |||
| filled ampoule | |||
| component terminally | |||
| sterilized by irradiation | terminally sterilized by | ||
| ethylene oxide; liquid- | |||
| filled ampoule | |||
| component terminally | |||
| sterilized by irradiation | same | ||
| Adhesion Strength | ≥.5 lbf | ≥.5 lbf | same |
| Securement Time | 143 seconds | 14 seconds | different, faster |
| securement time than | |||
| 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, | |
| 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 obtained | Pass
Predicate: 143 seconds
Subject: 14 seconds |
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B. Biocompatibility Testing
| Test | Acceptance Criteria | Result | Comparison to
Predicate |
|-------------------------------|-----------------------------------------------------------------|--------|----------------------------|
| Cytotoxicity | ISO 10993-5: Tests for
in vitro cytoxocity | Pass | Same |
| Sensitization | ISO 10993-10: Tests
for irritation and skin
sensitization | Pass | Same |
| Irritation | ISO 10993-10: Tests
for irritation and skin
sensitization | Pass | Same |
| Pyrogenicity | LAL Limit Screen;
Current USP | Pass | Same |
| Acute Systemic
Toxicity | ISO 10993-10: Tests
for irritation and skin
sensitization | Pass | Same |
| Subacute Systemic
Toxicity | ISO 10993-11: Tests
for systemic toxicity | Pass | N/A |
| Implantation | ISO 10993-6: Tests
for local effects after
implantation | Pass | N/A |
| Intracutaneous | ISO 10993-10: Tests
for irritation and skin
sensitization | Pass | N/A |
| Hydrolytic
Degradation |