(266 days)
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.
The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.
The provided text describes the acceptance criteria and the results from non-clinical testing performed for the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Barrier Performance | Level 4 | PASS |
| Force at 25% Elongation | 400 g/m²/24 hours | PASS |
| in vitro Direct Time Kill and Minimum Effective Concentration | > 4 log reduction at 90 minutes | PASS |
| CHG Release Kinetics | > 0.0% after 90 minute extraction | PASS |
| Ethylene Oxide Residuals | Per ISO 10993-7: 2008; Amd 1: 2019 | PASS |
| Biocompatibility (Chemical Characterization, Hemolysis, Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity) | Not cytotoxic, slight irritant, not a potential skin sensitizer, not pyrogenic, not acutely systemically toxic, non-hemolytic (for predicate, but additional endpoints tested for submission device) | All tests PASS (e.g., Not cytotoxic, slight irritant, not a potential skin sensitizer, not pyrogenic, not acutely systemically toxic, non-hemolytic) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily details non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for each individual test. The data provenance is not explicitly stated beyond being "bench testing" and "biocompatibility testing," implying laboratory-based data rather than patient data from a specific geographical location. The nature of these tests suggests they are prospective, as they were conducted specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. These types of tests typically rely on standardized methods and laboratory analysis rather than expert human interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation of outputs, which is not the case here.
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. The device is an incise drape with antibacterial properties, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device (incise drape), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is established by objective measurements against predefined scientific and regulatory standards/methods. For example:
- Barrier Performance: Measured against AAMI PB70:2012 using ASTM F1670.
- Antibacterial Activity: Measured by in vitro direct time kill based on ASTM E2315, aiming for a >4 log reduction.
- Biocompatibility: Evaluated against ISO 10993-1 and FDA Guidance for biological evaluation.
8. The sample size for the training set
This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.