(61 days)
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.
Wound retraction device providing abdominal access and Protection from wound contamination
Here's an analysis of the provided information regarding the Surgisleeve™ Wound Protector XS, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Assessment Method) |
|---|---|
| Film Penetration Resistance | In-vitro testing |
| Strength of Attachment Between Film and Proximal Ring | In-vitro testing |
| Strength of Attachment Between Film and Distal Ring | In-vitro testing |
| Film Weld Seam Strength | In-vitro testing |
| In-Vivo Use: Ring Insertion and Rolling | In-vivo testing |
| In-Vivo Use: Instrument Insertion and Removal | In-vivo testing |
| In-Vivo Use: Specimen removal | In-vivo testing |
| In-Vivo Use: Thoracic use | In-vivo testing |
| In-Vivo Use: Thoracic use specimen removal | In-vivo testing |
| In-Vivo Use: Digital ring removal | In-vivo testing |
| Biocompatibility (Materials) | Evaluated in accordance with ISO 10993-1:2009 |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for the in-vitro or in-vivo testing. The data provenance (e.g., country of origin, retrospective/prospective) is also not explicitly stated. However, given the context of a 510(k) submission, the testing would typically be conducted by or for the manufacturer (Covidien) and would be considered prospective for the purpose of demonstrating device performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. For a medical device like a wound protector, "ground truth" often relates to objective physical properties and functional performance rather than expert interpretation of images or clinical data. The "in-vivo use" testing would likely involve animal models or human cadavers/simulators, and the assessment would be based on direct observation of the device's function, potentially by engineers, surgeons, or trained personnel.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For the mechanical and functional tests described, it's unlikely that an adjudication process similar to clinical image interpretation (e.g., 2+1, 3+1) would be used. Performance would be assessed against predefined criteria and specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. The device is a physical wound protector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Surgisleeve™ Wound Protector is a physical medical device, not an algorithm. Its performance is inherent in its design and materials, and it functions independent of any algorithm.
7. Type of Ground Truth Used
The ground truth used for this device would be primarily objective physical measurements and functional performance observations during in-vitro and in-vivo testing. For example:
- Film Penetration Resistance: Measured force required to penetrate the film.
- Strength of Attachment: Measured force required to detach components.
- Weld Seam Strength: Measured strength of the welded seams.
- In-Vivo Use: Direct observation and assessment of the device's ability to be inserted, retracted, allow instrument passage, and facilitate specimen removal without failure or adverse events in a simulated or actual surgical environment.
- Biocompatibility: Established by adherence to ISO 10993-1:2009, which involves various biological and chemical tests.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth establishment process in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering standards, material specifications, and pre-clinical testing protocols.
§ 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.