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510(k) Data Aggregation
(387 days)
The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact.
The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical setting, as well as other clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants. Equipment drapes are supplied non-sterile. The non-sterile version is supplied primarily for repackers and re-labelers. Sterile, disposable, single use applications are supplied to a distributor or directly to the end-user. These devices are specifically designed for a variety of surgical and general hospital equipment, such as microscopes, cameras, monitors, tables, robotics, c-arms and various other x-ray and/or similar equipment. The DAS Medical Equipment Drapes are manufactured with polyethylene cut to form to a specific shape for the equipment they are intended to cover. Adhesive tape, bands; elastic, and hook and loop attachments are applied to the products in specific areas to aid in positioning and securing the product to the equipment. All of these devices are non-patient contacting. These equipment drapes are substantially equivalent to other drapes currently being marketed for the same purpose.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DAS Medical Equipment Drapes:
Summary of Device and Regulatory Context:
The submission K121436 describes DAS Medical, LLC equipment drapes used to cover various surgical and clinical equipment to prevent contamination. The drapes are made of polyethylene, supplied sterile or non-sterile, and are non-patient contacting. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (Medline K032065 and Volcano Corporation K052395).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Method/Standard | Reported Device Performance |
|---|---|---|
| Tensile Strength | ASTM D882 | "DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... tensile strength..." (Comparison chart states "Similarities: Equivalent; Differences: Raw material manufacturer/proprietary blend and weight" but this refers to the material itself, not the performance test outcome.) |
| Water Resistance/Impact Penetration | AATCC 42/INDA IST Method 80.3 | "DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including impact penetration..." (Comparison chart states "Similarities: Equivalent; Differences: None" for Physical Testing.) |
| Flammability | 16 CFR, Part 10 - Class I | "DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... flammability..." (Comparison chart states "Class I" under Flammability and "Equivalent" when compared to predicates.) |
| Tear Resistance | ASTM D1004 | "DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... tear strength..." (Comparison chart states "Similarities: Equivalent; Differences: None" for Physical Testing.) |
| Functionality, Safety, and Effectiveness | (Implied by intended use) | "DAS Medical, LLC has determined these products... meet the pre-determined characteristics of the material properties for functionality, safety, and effectiveness for the intended use of the products." (The substantial equivalence chart heavily relies on "Similarities: Equivalent" across various characteristics like design, functionality, intended use, sterile/non-sterile, sterilization, and technological characteristics, implying that the predicates have established appropriate levels for these.) |
| Substantial Equivalence to Predicate Devices | (Overall comparison of characteristics) | "All information supplied in this Premarket Notification support the determination that this device is substantially equivalent to the predicate devices listed." The detailed comparison chart (Table 1) provides line-by-line justification for this claim across design, functionality, intended use, sterile/NS, sterilization, material, flammability, technological characteristics, physical testing, labeling, and instructions for use, mainly identifying "Similarities: Equivalent" or minor "Differences" that do not affect safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size used for the performance tests (Tensile, Water Resistance/Impact, Flammability, Tear Resistance).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions that DAS Medical, LLC performed the comparison and determined the products met acceptance criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a medical drape that relies on physical performance characteristics. It does not involve interpretation of data or images by experts to establish a "ground truth" in the way an AI diagnostic tool would. The ground truth for the physical performance tests would be the measured values from the tests themselves, compared against established standards.
4. Adjudication Method for the Test Set:
Not applicable. As this is not a study requiring human interpretation or consensus for ground truth, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is not applicable. The device is equipment drapes, not a diagnostic AI system intended to assist human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, in essence, the performance testing described is a standalone evaluation of the device's physical properties. The tests for tensile strength, water resistance, flammability, and tear resistance are conducted on the material or product itself, without human intervention in its function (beyond conducting the test). The device itself (the drape) does not have an "algorithm" as typically understood in AI-based systems.
7. Type of Ground Truth Used:
The ground truth used for this device's performance is established industry standards and physical material properties. For example:
- Tensile strength is compared against the specific requirements of ASTM D882.
- Water resistance/impact penetration is compared against AATCC 42/INDA IST Method 80.3.
- Flammability is compared against 16 CFR, Part 10 - Class I.
- Tear resistance is compared against ASTM D1004.
The "ground truth" for demonstrating substantial equivalence against predicate devices is based on an assessment that the new device shares fundamental scientific technology characteristics and performs at least as safely and effectively as a legally marketed device.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
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