(15 days)
Intended for the application of two non-homogenous liquids.
The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar.
The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts:
- . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately)
- Stainless steel shaft connecting hub to Pebax ●
- Flexible Pebax portion connecting stainless steel shaft to distal tip
- Fixed-position distal tip. ●
Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media.
The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.
This document describes the Laparoscopic Spray Applicator with Spinning Luers and its substantial equivalence to a predicate device. It explicitly states that no clinical performance data was provided as a basis for substantial equivalence. Therefore, the device relies on non-clinical performance data to demonstrate its safety and effectiveness.
Here's an analysis of the provided information based on your requested criteria:
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed and states that the "test articles met the pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test nor the quantitative results of the device's performance. It only states that the device "met the pre-defined acceptance criteria."
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Particulate Matter | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Dimensional Verification Test | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Leak Test | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Spray Test | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Pebax/Tip Bond Strength | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Pebax/Shaft Bond Strength | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Hub/Shaft Pull Strength | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Hub/Shaft Torque Strength | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Spinning Luer Actuation Torque | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Spinning Luer Side Load | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Spinning Luer Pull Strength | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| ISO 594-1 and -2 (Luer Gauge, Luer Leak, | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Luer Separation, Luer Ease of Assembly, | ||
| Luer Override, and Luer Stress Cracking) | ||
| Sterilization | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Shelf life | Not specified (pre-defined criteria met) | Met pre-defined acceptance criteria |
| Biocompatibility (ISO 10993 Part 1) | Considered safe for intended biocontact (ISO 10993-1) | Device is considered safe for use for its intended biocontact |
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 does not specify the sample size used for any of the non-clinical tests. The data provenance is also not explicitly stated, but since it's an FDA submission for a device manufactured by Micromedics Inc. (d/b/a Nordson Medical) in St. Paul, Minnesota, it can be inferred that the testing likely occurred in the US and was prospective for the purpose of this submission.
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 question is not applicable as the study did not involve human interpretation or subjective assessment that would require external experts to establish a "ground truth" in the traditional sense (e.g., for image analysis). The ground truth was established through adherence to engineering specifications and international standards for device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the non-clinical testing for this device did not involve subjective human assessment requiring adjudication. The results were based on objective measurements against pre-defined engineering and performance criteria.
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 comparative effectiveness study was done. This device is a laparoscopic spray applicator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" was based on pre-defined engineering specifications, design requirements, and adherence to relevant international standards (e.g., ISO 10993 for biocompatibility, ISO 594-1 and -2 for luer connections). It was not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies or diagnostic evaluations.
8. The sample size for the training set
This question is not applicable. There was no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable. There was no 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.