(75 days)
As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination.
The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surqical site.
Volmed Operations Drapes are supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation.
The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Volmed™ Operation Drape:
Based on the provided text, the Volmed™ Operation Drape is a sterile surgical incise drape. The document focuses on demonstrating its equivalence to a predicate device (Steri-Drape® Surgical Incise Drapes) and its safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Material Composition | Polyurethane film coated on one side with acrylic medical grade adhesive. | Meets- composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive. |
| Support Layer | Supported by peelable white, silicon coated, double-sided polyethylene protected release paper. | Meets- supported by peelable white, silicon coated, double sided polyethylene protected release paper. |
| Protective Layer | Other side of polyurethane film protected by polyethylene film for post-application removal. | Meets- The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surgical site. |
| Sizes Available | Multiple standard sizes. | Meets- supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes. |
| Sterilization Method | Sterilized by gamma irradiation. | Meets- sterilized by gamma irradiation. |
| Biocompatibility - Cytotoxicity | In vitro cytotoxicity test. | Established by in vitro cytotoxicity. |
| Biocompatibility - Implantation | Subcutaneous implantation (guinea pig) test. | Established by subcutaneous implantation (guinea pig). |
| Biocompatibility - Dermal Irritation | Dermal irritation (rabbit) test. | Established by dermal irritation (rabbit) tests. |
| Biocompatibility - Sensitization | Repeat insult patch test in human volunteers to assess irritation or allergic contact dermatitis. | Showed that the material does not induce irritation or allergic contact dermatitis. |
| Microbial Barrier Performance | Microbial permeability study with S. aureus to demonstrate effective performance as a bacterial barrier. | Demonstrated effective performance of the drape as a bacterial barrier. |
| Intended Use | Protective patient covering during surgical procedures, to isolate a site of surgical incision from microbial and other contamination. | "Technological characteristics... are the same as those of predicate devices... Biocompatibility and performance testing... have demonstrated topical safety as well as effective microbial barrier performance." -> Implies criteria for intended use are met. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- In vitro Cytotoxicity: Sample size not specified.
- Subcutaneous Implantation (guinea pig): Sample size not specified.
- Dermal Irritation (rabbit): Sample size not specified.
- Repeat Insult Patch Test (human volunteers): Sample size not specified.
- Microbial Permeability Study (S. aureus): Sample size not specified.
The data provenance (country of origin, retrospective/prospective) is not specified for any of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device submission does not involve a diagnostic imaging AI algorithm and therefore, the concept of "experts used to establish ground truth" in the way it's typically applied to AI in medicine (e.g., radiologists, pathologists) is not applicable. The "ground truth" for this device revolves around established biological and physical performance standards (e.g., absence of cytotoxicity, effective microbial barrier).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the studies described pertain to material science, biocompatibility, and microbiological performance, not expert consensus on medical images or clinical diagnoses.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a sterile surgical drape.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (a surgical drape), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Volmed™ Operation Drape was established through:
- Established laboratory protocols and standards for in vitro cytotoxicity, subcutaneous implantation, and dermal irritation tests.
- Direct observation/measurement of irritation/allergic reactions in human volunteers.
- Microbiological testing against S. aureus to demonstrate barrier effectiveness.
Essentially, the ground truth is based on scientific, empirical evidence from standardized biological and microbiological testing, rather than human expert interpretation of complex data (like pathology or imaging).
8. The sample size for the training set
Not Applicable. This document describes a physical medical device, not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.
§ 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.