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510(k) Data Aggregation
(175 days)
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre-operatively to skin. The film 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 CHG contained in the adhesive provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound.
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressure-sensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application.
Here's a breakdown of the acceptance criteria and the studies conducted to prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K801550) | Reported Device Performance (3M™ Steri-Drape™ CHG) | Comparison |
|---|---|---|---|
| Intended Use | Antimicrobial incise drape with continuous antimicrobial activity for external use only. | Antimicrobial incise drape with continuous antimicrobial activity for external use only. | Same |
| Design/Materials | Antimicrobial impregnated adhesive coated on breathable film with silicone-coated release liner. | Antimicrobial impregnated adhesive coated on breathable film with silicone-coated release liner. | Same |
| Antimicrobial Agent | Iodine | Chlorhexidine Gluconate (CHG) | Both are well-characterized, broad-spectrum antimicrobials. Safety and efficacy testing demonstrates substantial equivalence. |
| Sold Sterile | Yes | Yes | Same |
| Sterilization Method | Gamma Sterilized, 10⁻⁶ SAL per ISO 11137 | Ethylene Oxide sterilized, 10⁻⁶ SAL per ISO 11135 | Different sterilization method, but same sterility assurance level (SAL). Iodine not compatible with EO, CHG not compatible with gamma. Both sterilized to 10⁻⁶ SAL. |
| Packaging | Foil Pouch | Film/Tyvek Pouch | Foil laminate for Ioban (protects from EO if in kit). Film/Tyvek for CHG (enables EO sterilization). |
| Sterility Assurance Level | SAL 10⁻⁶ | SAL 10⁻⁶ | Same |
| Principles of Operation | Sterile adhesive film applied pre-operatively, incised through by surgeon, provides sterile barrier, antimicrobial agent reduces microbial contamination. | Sterile adhesive film applied pre-operatively, incised through by surgeon, provides sterile barrier, antimicrobial agent reduces microbial contamination. | Same |
| Biocompatibility | Not cytotoxic, slight irritant, not a potential skin sensitizer | Not cytotoxic, slight irritant, not a potential skin sensitizer | Same |
| Tensile and Elongation | Tensile > 1365 g/25mm and Elongation > 500% | Tensile > 1365 g/25mm and Elongation > 500% | Same |
| Moisture Vapor Transmission Rate (MVTR) | > 400 g/m²/24 hrs | > 400 g/m²/24 hrs | Same |
| Flammability | Class I (Normal) | Class I (Normal) | Same |
| Barrier Performance | Level 4 (according to AAMI PB70:2012) | Level 4 (according to AAMI PB70:2012) | Same |
| In vitro Antimicrobial Performance | Broad Spectrum, > 4 log reduction at 90 min | Broad Spectrum, > 4 log reduction at 90 min | Same |
| In vivo Porcine Model (Wound Contamination) | Significant reduction in microbial contamination compared to placebo drape | T0: CHG drape lower than placebo (0.35 log₁₀ difference, P=0.026) | |
| T4: CHG drape lower than placebo (0.68 log₁₀ difference, P=0.001) | |||
| Log₁₀ CFU/cm² under drape lower than placebo (0.70 log₁₀ difference, Exact P-value not provided in text, but indicated as highly significant and lower than 0.0001 based on table format and values) | Test article reduces microbial contamination of surgical wound compared to the placebo | ||
| Adhesion to Skin (Wet Challenge) | No statistical difference in skin adhesion when compared to predicate over specific prep solutions. | No statistical difference in skin adhesion over either DuraPrep Solution or PVP-I prep solutions. | Same performance as predicate |
| Adhesion to Skin (Dry Challenge) | Similar removal force and skin reactions when compared to predicate. | Removal force of test article is higher than predicate, no difference in skin reactions. | Similar performance to predicate |
| Adhesion to Skin (Fragile Skin) | No adverse events and acceptable removal force. | No adverse events associated with test article post-wear; removal force slightly higher for test article. | Similar performance to predicate |
2. Sample Size Used for the Test Set and the Data Provenance
- Bench Testing (In vitro): The exact sample sizes for each specific bench test (Tensile, MVTR, Flammability, Barrier, Antimicrobial Activity) are not explicitly stated. The document mentions "sample cut to size" for the device components tested. The data provenance is internal, as "Bench testing was performed to demonstrate substantial equivalence for this submission."
- In vivo Animal Efficacy Data: The sample size for the porcine model is not explicitly stated. The study involved a comparison of "test versus placebo drape." The data provenance is internal, as "In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape."
- Clinical Performance Data (Adhesion to Skin):
- In-house clinical panels (wet and dry challenge): The exact number of subjects or samples is not specified, only "Finished Drape Samples, cut to size." Data provenance is internal.
- External clinical study: The exact number of subjects is not specified, but it involved "subjects with very dry and potentially fragile skin types." Data provenance is external ("Outside clinical adhesion studies were conducted").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies are primarily focused on physical and microbiological performance, and clinical adhesion, rather than interpretation of diagnostic images or outcomes that would typically require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the studies described do not involve human interpretation or subjective assessments that would require an adjudication method. The studies are quantitative measurements of device performance.
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
An MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic devices, which is not the case for this antimicrobial incise drape.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (incise drape), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench tests is based on objective, quantifiable physical and microbiological properties and established standards (e.g., AAMI PB70:2012, ASTM F1670, 16 CFR 1610, ASTM E2315).
- In vivo Animal Efficacy: The ground truth for antimicrobial efficacy in the porcine model was established by measuring microbial contamination (CFU/sample, CFU/cm²) under the test drape versus a placebo drape. This is essentially direct measurement of biological outcome.
- Clinical Performance (Adhesion): The ground truth for adhesion studies was based on objective measurements of adhesion properties and visual assessment of skin reactions by unspecified clinical personnel.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable.
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