(105 days)
The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
The FDA 510(k) summary for the LapBox Tissue Containment Removal System does not contain the level of detail typically found in reports of diagnostic device performance, such as sensitivity, specificity, or accuracy. This is a surgical device designed for tissue containment and removal, rather than a diagnostic AI-powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing specific numerical acceptance criteria and performance data for a diagnostic algorithm. The acceptance criteria described are often a "pass" or "same as predicate" for various engineering and biocompatibility tests.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance (LapBox) | Comparison to Predicate (K142427) |
|---|---|---|---|
| Regulatory & Classification | Regulation Number | 876.1500 | Same |
| Product Code | GCJ | Same | |
| Indications for Use | To contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. Contraindicated for laparoscopic power morcellation during gynecologic procedures and with powered cutting devices. | Same | |
| Biocompatibility | Cytotoxicity | Successfully passed | Same (predicate also tested) |
| Sensitization | Successfully passed | Same (predicate also tested) | |
| Irritation | Successfully passed | Same (predicate also tested) | |
| Acute Systemic Toxicity | Successfully passed | Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility | |
| Pyrogenicity | Successfully passed | Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility | |
| Infrared Spectroscopy | Successfully passed | Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility | |
| Material/Design Properties | Chamber/bag & Port/Guard Materials | TPU (Polyurethane) film, Nylon reinforced fabric and polyurethane port | Similar (Predicate: TPU and coiled HDPE port) |
| Single use | Yes | Same | |
| Sterility | EtO | Same | |
| Puncture Force (chamber/Bag) | Tested against predicate, yielded superior results | Superior results for LapBox | |
| Puncture Force (Port/Guard) | Tested against predicate, yielded superior results | Superior results for LapBox | |
| Viral Penetration per ASTM F 1671 | Pass | Same | |
| Functionality (Non-Clinical Performance Testing) | Performance Characterization In-Vivo Study | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. |
| Corrosion Resistance | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Pressure Relief Valve Testing | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Burst Pressure Evaluation | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Bond Strength Test | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Dimensional Verification Test | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Closure Integrity Test: Bubble Test | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Design and Performance Validation Test | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Clinical Simulation Study | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Training Validation Study | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. | |
| Maximum organ size testing | Performed and successfully passed | Not explicitly in comparison table, but overall supports substantial equivalence. |
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 lists "Performance Characterization In-Vivo Study" and "Clinical Simulation Study" as non-clinical performance testing, but does not specify the sample size, type of data (e.g., animal, cadaveric, human), or provenance for these studies. These are likely bench or animal studies rather than human clinical trials based on the context of a 510(k) for this type of device.
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 provided in the document. Given the nature of the device (surgical tissue containment), "ground truth" in the diagnostic sense is not directly applicable. For performance testing, experts might have been involved in assessing the functionality or usability, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of device and testing described in this 510(k) summary. Adjudication methods are typically relevant for human clinical reads in diagnostic studies.
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 MRMC study was conducted or is applicable as this is not an AI-powered diagnostic device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a surgical device, ground truth usually relates to the successful and safe performance of its intended function. The document mentions an "In-Vivo Study" and "Clinical Simulation Study," which would generate data on performance. However, the specific type of "ground truth" or endpoints (e.g., successful tissue containment, absence of leakage, ease of use) and how it was established are not detailed for these studies. For biocompatibility, the ground truth is typically laboratory assay results.
8. The sample size for the training set
Not applicable, as this is a physical surgical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical surgical device, not an AI model.
§ 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.