(78 days)
The 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.
Wound retraction device providing access and protection from wound contamination. The Wound Protector Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The Interior and Exterior rings are flexible to aid insertion, film retraction, and removal.
The provided text describes a 510(k) summary for the Covidien Wound Protector, a sterile surgical drape. This document focuses on the device's technical characteristics and performance data related to its physical properties and usability, rather than clinical performance against specific metrics like accuracy or diagnostic efficacy that would require a study with human subjects, ground truth, and statistical analysis.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and the information provided. The "performance data" section in the document refers to a series of in-vitro and in-vivo tests designed to confirm the device's mechanical integrity and functionality, not a clinical study to prove efficacy or diagnostic capability.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test/Characteristic) | Reported Device Performance (Implied "Meets" for 510k Clearance) |
|---|---|
| Film Penetration (Tear) Resistance (ASTM D3787) | Passed (Implied by 510k clearance) |
| Strength of Attachment between Film and Exterior Ring (Tensile/Elongation) | Passed (Implied by 510k clearance) |
| Strength of Attachment between Film and Interior Ring (Tensile/Elongation) | Passed (Implied by 510k clearance) |
| Film Weld Seam Strength (ASTM D412) | Passed (Implied by 510k clearance) |
| Ease of Digital Insertion | Passed (Implied by 510k clearance) |
| Incision Retraction / Rolling | Passed (Implied by 510k clearance) |
| Ease of Use | Passed (Implied by 510k clearance) |
| Instrument Access / Specimen Removal | Passed (Implied by 510k clearance) |
| Specimen Manipulation | Passed (Implied by 510k clearance) |
| Ease of Removal | Passed (Implied by 510k clearance) |
| Film Tear Resistance In-Vivo | Passed (Implied by 510k clearance) |
| Tissue Trauma | Passed (Implied by 510k clearance) |
| Biocompatibility (ISO 10993-1: 2009) | Passed (Evaluated as per standard) |
Note: The document lists the tests performed, and the 510(k) clearance implies that the device met the acceptance criteria for all these tests. Specific numerical values for the performance are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. The performance data refers to in-vitro and in-vivo testing. For in-vivo tests, the sample size would typically refer to the number of animals or human subjects, but this is not provided. For in-vitro tests, the sample size would be the number of units tested.
- Data Provenance: The document does not specify the country of origin of the data. It mentions both in-vitro (laboratory) and in-vivo testing, but does not indicate if it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests are typically prospective tests conducted specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical surgical drape, not an AI or diagnostic device that relies on interpretation of data to establish ground truth with experts. The "tests" are about physical properties and usability, not diagnostic accuracy.
4. Adjudication method for the test set
- Not Applicable. As there's no diagnostic component requiring expert judgment or consensus, no adjudication method like 2+1 or 3+1 is relevant.
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 not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used
- For physical/mechanical tests (in-vitro): Ground truth is established by objective measurements against industry standards (e.g., ASTM D3787, ASTM D412) or established engineering specifications for strength, tear resistance, etc.
- For usability/in-vivo tests: Ground truth for "Ease of Use," "Incision Retraction," "Tissue Trauma," etc., would be established through observation, subjective assessment by trained personnel (possibly surgeons or medical professionals simulating use), and potentially histological examination for tissue trauma. However, the specific methodology for establishing this "ground truth" (or assessment criteria) is not detailed.
- For biocompatibility: Ground truth is established by adherence to the ISO 10993-1:2009 standard, which involves specific biological evaluation tests to ensure the materials are safe for patient contact.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI 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 for an AI algorithm, this question is not relevant.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.