(76 days)
Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Here's an analysis of the acceptance criteria and study information for the Whitney Medical Solutions eShield, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 10993-1 Biological evaluation of medical devices - Part 1: general requirements | Under the conditions of the study, the device is not a sensitizer, an irritant, is non-toxic and Non-cytotoxic. | Device is not an irritant, not a sensitizer, non-cytotoxic, non-toxic (stated under "Biocompatible" in the substantial equivalence table, implying it meets the criteria). |
| ASTM F1886 Standard test method for determining integrity of seals for flexible packaging (sterility) | Product meets inspection requirements of standard for visual defects found. | "Product meets inspection requirements of standard for visual defects found." (Implied Pass) |
| AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices - part 1 | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6 | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6" (Implied Pass) |
| ASTM F88/F88M Standard test method for seal strength of flexible barrier materials | Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTM F1980 and ASTM D4169. | "Meets or exceeds minimum internal acceptance criteria of 1 PLI after ASTM F1980 and ASTM D4169." (Implied Pass) |
| ASTM F 2096 Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test) | Meets performance criteria set by standard for maintaining pressure for 5 seconds under 1" of water after ASTM F1980 and ASTM D4169. | "Meets performance criteria set by standard for maintaining pressure for 5 seconds under 1" of water after ASTM F1980 and ASTM D4169" (Implied Pass) |
| AAMI/ANSI/ISO 11137-2 Sterilization of healthcare products - radiation - part 2 establishing the sterilization dose | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-0 (Note: Typo in document, likely 10^-6) | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-0" (Implied Pass, assuming 10^-6 intended) |
| AAMI/ANSI/ISO 11737-1,2 Sterilization of medical devices - microbial methods part 1: determination of the population of microorganisms on product; part 2: tests of sterility performed in the definition, validation and maintenance of a sterile process | Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6 | "Used as guideline for sterilization process. Adhered to specified requirements and test methods. Device sterilization dose will maintain a SAL 10-6" (Implied Pass) |
| ASTM F1671/F1671M Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using phi-x174 bacteriophage penetration as a test system. | Under the conditions of the study, the device does not allow viral penetration nor plaque formation. | "Pass" (Under "Viral Penetration ASTM F1671" in the substantial equivalence table, indicating it met the criteria). |
| ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities | The device meets the acceptance criteria set by the standard (AQL 4% and RQL of 20%) and up to one plaque growth per 13 samples. | "The device meets the acceptance criteria set by the standard (AQL 4% and RQL of 20%) and up to one plaque growth per 13 samples." (Implied Pass) |
| ASTM D882 Standard test methods for tensile properties of thin plastic sheeting. (Ophthalmic) | The device meets the tensile acceptance criteria set by the standard for equivalence when the films are within 400 psi of each other. | "Pass" (Under "Tensile Test ASTM D882" in the substantial equivalence table, indicating it met the criteria). |
| ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting | The device meets the tear acceptance criteria set by the standard for equivalence when the films are within 89.53 grams in machine direction and 42.6 grams in transverse direction | "Pass" (Under "Tear ASTM D1004" in the substantial equivalence table, indicating it met the criteria). |
| ASTM D3420 Standard Test Method for Pendulum Impact Resistance of Plastic Film1 | The device meets the puncture acceptance criteria set by the standard for equivalence when the films within 9.4%. | "Pass" (Under "Puncture Test ASTM D3420" in the substantial equivalence table, indicating it met the criteria). |
| 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles | The device meets the flammability acceptance criteria set by the standard for a Class 1 rating with a burn time of >3.5 seconds. | "Class 1" (Under "Flammability 16 CFR Part 1610" in the substantial equivalence table, indicating it met the criteria for a Class 1 rating). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of drapes tested for tensile strength, number of samples for biocompatibility). The document describes studies that were performed, but not the specific sample sizes required by those standards.
Regarding data provenance, the document does not specify the country of origin. The studies appear to be laboratory-based standardized tests (e.g., ASTM, ISO standards), which are typically performed in a controlled environment. The studies are retrospective in the sense that they were completed to demonstrate conformity for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "Whitney Medical Solutions eShield" is a surgical drape, and its performance is evaluated against engineering and biological standards (e.g., material strength, sterility, biocompatibility). These properties are determined through standardized laboratory tests, not typically by expert consensus of human interpretation, as would be the case for an imaging diagnostic device. Therefore, there is no "ground truth" in the sense of expert human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are objective, laboratory-based measurements against established standards, not subjective interpretations requiring adjudication.
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
Not applicable. This is not an AI-powered diagnostic device or a device involving human readers for interpretation. It is a physical medical device (surgical drape).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is defined by the objective pass/fail criteria established within the referenced national and international standards (e.g., ISO, ASTM, AAMI, CFR). For example:
- Biocompatibility: Absence of sensitization, irritation, toxicity, and cytotoxicity.
- Seal Integrity: Meeting visual inspection requirements or maintaining pressure for a specified time.
- Sterility Assurance: Achieving a Sterility Assurance Level (SAL) of 10^-6.
- Material Strength (Tensile, Tear, Puncture): Meeting specified force/resistance values or equivalence to a reference.
- Flammability: Achieving a Class 1 rating with a burn time >3.5 seconds.
- Viral Penetration: No viral penetration or plaque formation.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set. The performance is based on physical and biological testing of the product itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.