(187 days)
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.
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.
The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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) | Securement time obtained | Pass (14 seconds, compared to predicate's 143 seconds) |
| Cytotoxicity | ISO 10993-5: Tests for in vitro cytotoxicity | Pass |
| Sensitization | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Irritation | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Pyrogenicity | LAL Limit Screen; Current USP | Pass |
| Acute Systemic Toxicity | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Subacute Systemic Toxicity | ISO 10993-11: Tests for systemic toxicity | Pass |
| Implantation | ISO 10993-6: Tests for local effects after implantation | Pass |
| Intracutaneous | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Hydrolytic Degradation | for pyrogenicity). |
- Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.
8. Sample Size for the Training Set
This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical product, not an AI algorithm.
§ 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.