(46 days)
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.
The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope. The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is inflated until it contacts the intestinal wall near the proximal end of the articulating section of an endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled using an Inflation Handle with a squeeze bulb to manually inflate and deflate them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.
Here's an analysis of the provided text regarding the DiLumen Endolumenal Interventional Platform, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device (DiLumen Endolumenal Interventional Platform). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting entirely new, rigorous clinical trials for effectiveness. Therefore, the information related to studies proving new performance claims is limited, and much of the "proof" is based on the substantial equivalence argument, relying on prior clearances and bench testing. Questions related to AI algorithm performance (e.g., MRMC studies, training set details) are not applicable as this is a mechanical accessory, not an AI device.
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., "Device must maintain position for X minutes" or "Force required to reposition must be Y"). Instead, the performance is demonstrated through its substantial equivalence to predicate devices and confirmation of its mechanical and functional specifications via bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for patient contact. | Relied upon testing from prior 510(k) (K162428). |
| Functional Performance: |
- Ability to securely fit over a standard endoscope (12.5 - 14.3 mm distal tip OD).
- Balloons can be inflated and deflated independently.
- Capable of positioning and stabilizing the endoscope within the large intestine.
- Creates an isolated diagnostic/therapeutic zone.
- Permits usage of standard endoscopic tools through the endoscope working channel.
- Endoscope flexibility, maneuverability, and functionalities (visualization, suction, insufflation) are unaffected.
- Facilitates tissue manipulation. | Relied upon testing from prior 510(k) (K162428).
Confirmed through bench testing (for suture loops and overall functionality).
"Performs to its pre-defined specifications." Note: No specific numerical performance metrics are provided in this summary. |
| Mechanical Performance: - Structural integrity of components (sleeve, balloons, push rods, inflation handle, suture loops).
- Durability for single-use. | Relied upon testing from prior 510(k) (K162428).
Confirmed through bench testing (for suture loops and overall functionality). |
| Safety: Device presents no new safety concerns compared to predicates. | Demonstrated through substantial equivalence argument and performance data (bench testing, biocompatibility). |
2. Sample Size Used for the Test Set and the Data Provenance
- The document states: "The testing submitted in that 510(k) notice [K162428] is relied upon to establish the device's biocompatibility and functional and mechanical performance."
- "In addition, the company has conducted bench testing to assess the performance and impact of the suture loops added to the Fore Balloon."
- Sample Size: Not explicitly stated for any of the bench tests. 510(k) summaries often do not detail the exact number of units tested.
- Data Provenance: The testing was conducted by or for Lumendi LLC. The location (country) of the testing is not specified. All testing described is retrospective (i.e., conducted before the 510(k) submission). No mention of prospective clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This device is a mechanical accessory, not an AI or diagnostic device that requires expert adjudication of images or outputs.
- "Ground truth" in this context would relate to the mechanical and functional performance specifications. These are established through engineering design, regulatory standards, and bench testing, not expert consensus on diagnostic interpretations.
- Therefore, this question is not applicable.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- Not applicable, as this is not a diagnostic device requiring adjudication of human readings or algorithm outputs.
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 a mechanical accessory, not an AI-powered device or a diagnostic aid that would involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. For the new features (suture loops), the "ground truth" would be the successful demonstration via bench testing that they perform as intended and do not compromise safety or functionality. This is primarily engineering specifications and bench test results.
8. The sample size for the training set
- Not applicable. This is a mechanical accessory, not an AI device that requires a training set.
9. 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.