(47 days)
THE GENICON SIMPLE SPECIMEN RETRIEVAL IS INDICATED FOR USE IN LAPAROSCOPIC PROCEDURES TO CAPTURE ORGANS OR TISSUE TO BE REMOVED FROM THE BODY CAVITY.
The Genicon Simple Specimen Retrieval Bags are comprised of a flexible plastic bag with and without a deployment mechanism. The deployment mechanism consists of a push rod and handle. The deployment mechanism allows for easy insertion through the cannula to deploy the bag within the body cavity. Bags without a deployment mechanism may be introduced using a standard atraumatic grasper or dissector. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
This is a medical device submission for the GENICON Simple Specimen Retrieval Bag (SimplyStrong and SimplyEZee) and therefore does not include information about AI/ML algorithm performance. The document describes the substantial equivalence of the device to a predicate device based on non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test/Characteristic | Acceptance Criteria (Bench Test Outcome) | Reported Device Performance (GENICON Simple Specimen Retrieval Bag) |
|---|---|---|
| Introduction Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for introduction forces. |
| Seam Strengths | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for seam strengths. |
| Puncture Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for puncture forces. |
| Fluid Permeability | Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely non-permeable for fluid containment) and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for fluid permeability. |
| Transparency | Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely transparent enough for visualization) and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for transparency. |
| Open/Closure Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" for ease of use and secure closure, and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for open/closure forces. |
| Packaging Validation | Not explicitly stated, but implies meeting established standards for medical device packaging integrity. | Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Visual Inspection | Not explicitly stated, but implies conforming to manufacturing specifications and absence of defects. | Inspection was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Biocompatibility | Conforms to ISO 10993. | Conforms to ISO 10993. |
| Sterilization Validation | Not explicitly stated, but implies meeting established standards for medical device sterilization. | Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Radiopaque Markers | The predicate device (Espiner Tissue Retrieval System) is X-ray opaque, implying the ability for detection. For the GENICON device, it's the incorporation of radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure. | Bags incorporate radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure. (This isn't a direct performance-based "acceptance criterion" in the same way as forces, but a design feature that meets a safety requirement). |
| Intended Use | Endoscope and Accessories (GCJ) for capturing organs or tissue to be removed from the body cavity during laparoscopic surgery. | SAME – Indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity. |
| Volume | 50 to 6000 mL (Predicate) | 50 to 3000 mL (GENICON) - Note: Reduced volume range compared to predicate, but still deemed substantially equivalent for its intended use. |
| Cannula Diameter | 5 to 15 mm (Predicate) | SAME – 5 to 15 mm. |
| Sterilization | Sterile/Single-Use. | SAME – Sterile/Single-Use. |
| Prescription Only | Yes. | SAME – Yes. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily discusses "bench testing" and "performance studies" for non-clinical evaluation. It does not specify sample sizes for these tests, nor does it explicitly mention data provenance (country of origin, retrospective/prospective). These are typically internal corporate tests supporting substantial equivalence claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the submission is for a physical medical device (specimen retrieval bag) and relies on technical bench testing and comparison to a predicate, not clinical "ground truth" established by experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the predicate device's established performance and the generally accepted engineering and material standards for medical devices (e.g., ISO 10993 for biocompatibility, sterility standards). The new device's performance is compared against these established benchmarks through non-clinical bench testing.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm requiring a training set.
§ 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.