(90 days)
The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.
The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures. The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.
Here's a breakdown of the acceptance criteria and the study information for the DeRoyal Laprador Specimen Retrieval System, based on the provided text:
Acceptance Criteria and Device Performance
A table of acceptance criteria and reported device performance is not explicitly detailed with quantitative outcomes in the provided document. The document states that "All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively."
However, we can infer the types of performance criteria that were assessed:
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Device pressure leak rate (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device (Anchor K091930 or Applied Medical K100959). |
| Bag leakage and volume (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Bag puncture resistance (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Bag burst resistance (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Retraction functionality (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Deployment functionality (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Cinch string strength (Pass/Fail) | Passed design verification tests; performed comparably to at least one competitor device. |
| Sterilization (Ethylene Oxide per ISO 11135-1: 2014) | Confirmed to be sterilized by ethylene oxide per ISO 11135-1:2014 (Same as predicate). |
| Biocompatibility (According to ISO 10993-1: 2009) | Confirmed to be biocompatible according to ISO 10993-1:2009 (Same as predicate). |
Note: The document does not provide specific numerical thresholds for "passing" or detailed comparative metrics (e.g., "bag burst resistance was X Newtons, which exceeded the predicate's Y Newtons"). It only states that the device "passed all design verification tests" and "performed comparable to at least one competitor device."
Study Information
Due to the nature of this document (a 510(k) summary for a specimen retrieval system), the type of study described is a bench testing study for device performance and comparison. It is not a clinical study involving human subjects or AI algorithms. As such, many of the requested fields are not applicable in this context.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated how many units of each device (DeRoyal, Anchor, Applied Medical) were tested for each criterion. The document refers to "bench testing" without detailing the number of units.
- Data Provenance: The testing was conducted internally or by a contracted lab for DeRoyal Industries, Inc. This is a prospective test in the sense that the new device was built and then tested, but not a prospective clinical trial. The country of origin of the testing itself is not explicitly stated but can be inferred to be associated with DeRoyal's operations (USA or Dominican Republic based on company locations listed).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a bench test of physical device performance, not a diagnostic or interpretive task requiring expert medical opinion to establish ground truth.
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Adjudication method for the test set:
- Not applicable. This was a direct measurement/performance test, not a subjective assessment requiring adjudication.
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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 a physical medical device; there is no AI component or human reader interpretation involved in its direct function.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device without an algorithm component.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the pre-defined performance specifications for each characteristic (e.g., a specific pressure leak rate limit, a minimum puncture resistance). The device either met these objective physical parameters or it did not.
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The sample size for the training set:
- Not applicable. There is no AI model or training set involved.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.