(220 days)
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.
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.
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 |
§ 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.