(246 days)
The AVD Left and Right Radial Drapes are single use sterile devices intended for use by medical professionals as a protective patient covering, such as to isolate a site of surgical incision or vascular puncture from microbial and other contamination. The drapes are attached to the patient in proximity to a vascular puncture site to isolate vascular access punctures from microbial and other contamination during procedures including angiographies and percutaneous interventions.
The AVD Radial Drapes are composed of a fluid-resistant film layer, an absorbent barrier layer, and an adhesive material that bonds the two layers. The surgical site is accessed through an oval opening in the drape that is surrounded by an adhesive tape to keep the drape in position over the surgical or vascular puncture site. The AVD Drapes are supplied sterile and for single use only. The Drapes are available in both a Left Radial and a Right Radial configuration. They may be sold singly or as part of a procedure pack.
Here's an analysis of the provided 510(k) summary regarding the AVD Radial Drapes, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance for AVD Radial Drapes (K131571)
The AVD Radial Drapes are a Class II surgical drape indicated for isolating surgical incision or vascular puncture sites from microbial contamination. The submission primarily relies on demonstrating substantial equivalence to a predicate device (HVO Various Disposable Non-Sterile Drapes, K050508) and performing non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests conducted on the AVD Radial Drapes. The "acceptance criteria" for many of these appear to be "Pass" or "Acceptable" based on adherence to specific standards.
| Parameter | Acceptance Criteria (Implicit from Standards) | Reported Device Performance | Comments / Supporting Standard |
|---|---|---|---|
| Barrier Protection | Barrier Level 4 (ANSI/AAMI PB70) | Barrier Level 4 | ANSI/AAMI PB70 |
| Resistance to Tears | Pass (ASTM D5587-08, WSP 100.2) | Pass | ASTM D5587-08, WSP 100.2 |
| Tensile Strength | Pass (ASTM 5034-09) | Pass | ASTM 5034-09 |
| Flammability | Class I (16 CFR 1610) | Class I | 16 CFR 1610 |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5:2009) | Non-cytotoxic | ISO 10993-5:2009 |
| Skin Sensitization | Non-sensitizing (ISO 10993-10:2002) | Non-sensitizing | ISO 10993-10:2002 |
| Skin Irritation | Non-irritating (ISO 10993-10:2002) | Non-irritating | ISO 10993-10:2002 |
| EO Residuals | Acceptable (ISO 10993-10:2008) | Acceptable | ISO 10993-10:2008 |
| Sterilization Validation | Acceptable (not explicitly stated, but implied by "Sterile (EO)" and "sterilization validation" under non-clinical testing) | Performed and accepted | Implied by non-clinical testing section |
Note: For parameters where the predicate device's performance was "Not stated" or "Not available," the AVD Drapes demonstrated performance against recognized standards, contributing to the claim of substantial equivalence. The predicate device was non-sterile, so sterilization validation and EO residuals were not applicable to it.
2. Sample Size and Data Provenance
The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many drapes were tested for tensile strength or tear resistance). However, these are typically laboratory tests performed on a representative sample of manufactured products.
- Test Set Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: The non-clinical tests were conducted specifically for this submission (prospective testing) and are laboratory-based, without reference to human or animal data for these specific performance metrics. The country of origin of the data is not stated, but the submission is to the US FDA, and the submitter is based in Milwaukie, OR, USA.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth Establishment: Not applicable in the traditional sense for this submission. The "ground truth" for the non-clinical tests is established by the specified international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR). These standards define the methodology and acceptance criteria for measuring material properties and performance. There isn't a panel of clinical experts establishing a ground truth for device performance in this context, as it's a materials and functional performance evaluation.
4. Adjudication Method
- Adjudication Method: Not applicable. Non-clinical tests follow established, standardized protocols with objective measurements, rather than requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The AVD Radial Drape is a physical medical device (surgical drape), not a diagnostic imaging AI.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in essence, the non-clinical testing described in Section G constitutes standalone performance evaluations for the AVD Radial Drapes against specified standards. The results for parameters like Barrier Protection, Tensile Strength, Tear Resistance, Flammability, and Biocompatibility (cytotoxicity, sensitization, irritation, EO residuals) were obtained directly from testing the AVD Drapes themselves, without human intervention as part of the performance metric. This is "algorithm only" in the sense that the device's inherent physical and biological properties were evaluated.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the ground truth is established by objective technical standards and regulatory requirements. For example, "Barrier Level 4" is an objective classification defined by ANSI/AAMI PB70, not by expert consensus or clinical outcomes. Similarly, "Non-cytotoxic" is determined by a specific laboratory assay described in ISO 10993-5.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance is based on the physical and chemical properties of the materials and design, evaluated through standard non-clinical tests.
9. How Ground Truth for Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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.