(104 days)
The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries.
The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) :
- l Access the abdominal cavity during surgery through an atraumatically retracted incision.
- 피 Delivery maximum exposure of the abdominal cavity with minimum incision size.
- 트 Protect against wound contamination during laparoscopic and open surgery.
- . Seal off the incision opening to permit insufflating the peritoneum.
- 트 Convert the incision wound to an additional trocar port site.
- 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.
The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings.
To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material The Wound Retractor package also includes an incision template.
The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure.
The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.
The provided text is a 510(k) summary for the Alexis® Wound Retractor, a device used for surgical retraction and wound protection. It does not contain a study demonstrating that the device meets specific acceptance criteria in the way typically found for diagnostic algorithms or devices with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the submission focuses on substantial equivalence to a predicate device, and the "acceptance criteria" are related to biocompatibility, material properties, and sterility, which are standard for a medical device of this type.
Here's an analysis based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-irritant status (ISO 10993, Part I) | Found "non-irritant" when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices. |
| Material Properties | Tensile Strength (ASTM D 412) | Determined to "pass" tensile strength testing. |
| Elongation (ASTM D 412) | Determined to "pass" elongation testing. | |
| Tear Strength (ASTM D 624) | Determined to "pass" tear strength testing. | |
| Functional Performance | Device function for surgical retraction and protection | "Functional performance testing has been completed and has passed the required testing." (Specific metrics not detailed, but imply it functions as intended for its stated use.) |
| Sterility | Sterility Assurance Level (SAL) | 10⁻⁶ SAL provided by 100% EO sterilization cycle. |
| Sterilant Residue Levels | In compliance with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices (20 mg ethylene oxide, 12 mg ethylene chlorohydrin). | |
| Substantial Equivalence | Equivalence to predicate device | "The Alexis Wound Retractor is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed." |
2. Sample size used for the test set and the data provenance
- For the material and biocompatibility testing, specific sample sizes are not mentioned in the document. These tests are typically performed on a statistically relevant number of samples to demonstrate compliance with standards.
- Data provenance is not explicitly stated, but it can be inferred that these tests were conducted internally by Applied Medical Resources Corporation or by a qualified third-party testing facility under their direction, as part of the device development and regulatory submission process. These are laboratory-based tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of this device and submission. The "ground truth" here is compliance with established physical, chemical, and biological safety standards (e.g., ISO, ASTM). These standards define the test methods and acceptance criteria, rather than requiring expert consensus on a diagnostic outcome. Experts involved would be those qualified to execute and interpret these standard tests (e.g., toxicologists for biocompatibility, materials scientists for mechanical properties, microbiologists for sterility validation).
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies comparing diagnostic interpretations, not for physical device property testing. Compliance is determined by whether the test results meet the predefined numerical or qualitative criteria of the respective standards.
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. This is a physical surgical device, not a diagnostic AI or imaging interpretation tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical surgical device. The concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable here. Its function is to be used by a human surgeon.
7. The type of ground truth used
- The "ground truth" for this device's acceptance is based on compliance with recognized international and national standards for:
- Biocompatibility: ISO 10993 (biological safety).
- Material Properties: ASTM D 412 (tensile strength, elongation) and ASTM D 624 (tear strength).
- Sterility Validation: ANSI/AAMI/ISO 10993-7 (sterilant residues) and principles for achieving a 10⁻⁶ SAL (e.g., "three half-cycle validation runs").
- Functional Adequacy: Demonstrated by "functional performance testing" (details not provided, but implies it mechanically performs its intended role).
- Ultimately, the overarching "ground truth" for regulatory clearance is substantial equivalence to an already legally marketed predicate device, demonstrating that it is as safe and effective.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
§ 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.