(143 days)
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).
The International Medsurg Connection Fluid Collection Under Buttocks Drape.
The International Medsurg Connection Fluid Collection Under Buttocks Drape was tested for biocompatibility to demonstrate its safety. The acceptance criteria and the device performance are shown in the table below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-Part 5 | Non-cytotoxic | Passed |
| Skin Sensitivity | ISO 10993 - Part 10 | Non-sensitizing | Passed |
| Skin Irritation | ISO 10993 - Part 10 | Non-irritating | Passed |
| Systemic Toxicity | ISO 10993 - Part 11 | Non-toxic | Passed |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each biocompatibility test. It indicates that "International Medsurg Connection Fluid Collection Under Buttocks Drape were tested," implying a sufficient number of samples were used to meet the requirements of the standards. The data provenance is not specified, but these are standard in-vitro and in-vivo biocompatibility tests, typically performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For biocompatibility testing according to ISO 10993 standards, "ground truth" is established by adherence to standardized protocols and interpretation by trained laboratory technicians and toxicologists. The document does not specify the number or specific qualifications of these experts, but it is implied they are qualified to conduct and interpret tests according to international standards.
4. Adjudication method for the test set:
Not applicable in the context of standard biocompatibility testing. The results are typically objectively measured and interpreted according to the specific criteria of each ISO standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret results, and it is not relevant for a fluid collection drape.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a fluid collection drape, not an algorithm or a diagnostic tool. The performance evaluated here is related to its material safety.
7. The type of ground truth used:
The ground truth used for these tests is based on established biological safety endpoints and objective measurements defined by the ISO 10993 series of standards for biological evaluation of medical devices. For example:
- Cytotoxicity: Cell viability and morphology compared to controls.
- Skin Sensitivity: Presence or absence of delayed hypersensitivity reactions.
- Skin Irritation: Erythema and edema scores compared to controls.
- Systemic Toxicity: Clinical observations, body weight, organ weights, and histopathology.
8. The sample size for the training set:
Not applicable. Biocompatibility testing does not involve training sets in the same way machine learning algorithms do. The tests are designed to assess the intrinsic biological properties of the material.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set in the context of these biocompatibility tests. The "ground truth" for evaluating the safety of the device's materials is established by the well-defined methodologies and criteria specified in the ISO 10993 standards.
§ 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.