(269 days)
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.
MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.
MediClear™ PreOp is intended to be used on intact skin and for external use only.
MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.
MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.
MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.
The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Antimicrobial Activity (In Vitro) | ISO 22196:2010 - Measurement of Antimicrobial Activity on Plastic Surface (for 7-day and Minimum Effective Concentration) | "In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear." |
| Cytotoxicity | ISO 10993-5:2009 - Tests for in vitro Cytotoxicity | "Under the conditions of the studies employed, the device is non-cytotoxic..." |
| Skin Irritation | ISO 10993-10:2010 - Tests for irritation and skin sensitization | "...non-irritating..." |
| Sensitization (Guinea Pig Maximization) | ISO 10993-10:2010 - Tests for irritation and skin sensitization | "...not a potential skin sensitizer" (implied, per predicate comparison which explicitly states this) |
| Acute Systemic Toxicity | ISO 10993-11:2006 - Tests for systemic toxicity | "...does not induce acute...toxicity..." |
| Subacute Toxicity (4-week Subcutaneous implantation) | ISO 10993-6:2007 - Tests for local effects after implantation & ISO 10993-11:2006 - Tests for systemic toxicity (for subcutaneous implantation) | "...does not induce...subacute toxicity..." |
| Material-mediated Pyrogenicity | ISO 10993-11:2006 - Tests for systemic toxicity & USP 30 Pyrogenicity Test | "...is non-pyrogenic as per the rabbit pyrogen test." |
| Liquid Barrier Performance | AAMI PB-70-2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities & ASTM F1670/F1670M-08(Reapproved 2014) Standard test method for resistance of material used in protective clothing to penetration by synthetic blood | "Level 4" |
| Moisture Vapor Transmission Rate (MVTR) | E96/E96M-05 Standard Test Methods for Moisture Transmission of Materials & EN 13726-2-2002 Test methods for primary wound dressings. Part 2: Moisture Vapour Transmission Rate of Permeable Film Dressings | Not explicitly stated as a pass/fail, but the device is described as "breathable" and the test method is listed as performed. |
| Real-time Aging/Stability | ICH Q1A Stability Testing of New Drug Substances and Products | Tested (implies satisfactory performance for shelf-life claims). |
| EO Sterilization | ANSI/AAMI/ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide – Part 1: Requirements for development, validation, and routine control & ANSI/AAMI/ISO 10993-7:2008 - Biological Evaluation of Medical Devices Part 7: Ethylene oxide sterilization residuals | "Ethylene Oxide (ETO) sterilized, 10-6 SAL per ISO 11135" |
| Distribution Simulation (Journey Hazards) | ISTA Project 2A (2008); Performance Test for Individual Packaged- Products 150 lb. or Less. & ASTM D 4169-09; Performance Testing of Shipping Containers and Systems | Tested (implies satisfactory performance). |
| Microbial Strikethrough | Not explicitly stated, but listed under "Performance Testing". | Tested (implies satisfactory performance). |
| Operational Qualification | Not explicitly stated, but listed under "Performance Testing" including visual, functional, and additional criteria. | Tested (implies satisfactory performance). |
*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.
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 studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.
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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
§ 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.