(269 days)
EzVu Visual Vasopressor Injector (EV-19) is intended to inject vasopressor solution into the uterine musculature during laparoscopic surgery.
EzVu Visual Vasopressor Injector (EV-19) is a 330 mm long and 5 mm diameter hollow bore laparoscopic instrument, used to enable laparoscopic flashback visualization before injecting Vasopressor drug into the uterine musculature during laparoscopic surgery. It consists of a stainless steel needle at the distal end, securely connected to a hub, an elongated shaft with transparent window at the distal end and stopcock with luer connection at the proximal end onto which a syringe can be attached. The shaft is made of transparent plastic tube, surrounded by a stainless steel tube along the proximal portion of the injector to provide stability. The stainless steel tube around the transparent plastic tube is wrapped in a heat shrink. The injector is available in one needle size (19 gauge).
Here's a breakdown of the acceptance criteria and the study details for the EzVu Visual Vasopressor Injector (EV-19), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance |
|---|---|
| Blood Stain should be clearly visible in the transparent window when aspirated. | Blood aspirate was detected in 4 out of 25 cases (16% of aspirations). The document states "Blood Stain should be clearly visible... when aspirated," but doesn't explicitly state the percentage of times it was clearly visible when present, only how often aspiration occurred and blood was observed. |
| No leakage or breakage should be observed in any samples of the EzVu device. | The device maintained structural integrity throughout the study. No leakage or breakage was reported. |
Secondary Endpoint:
| Acceptance Criteria (Secondary Endpoint) | Reported Device Performance |
|---|---|
| The performance of EzVu and other laparoscopic instruments should not be affected when used together in the procedure. | Compatibility with laparoscopic instruments was confirmed. All surgeons provided usability ratings of 4.6 or greater (on a 1-5 Likert scale) for 19 usability questions, indicating favorable device usability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Study (Patients): 13 women
- Injections: 24 injections across the 13 patients.
- Blood Aspiration Cases: 25 cases (Note: this number is slightly different from the 24 injections mentioned earlier in the text for detection of blood aspirate).
- Data Provenance: The study was a "multi-center, prospective observational study." The country of origin is not explicitly stated, but the sponsor is located in Navi Mumbai, Maharashtra, India.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 5
- Qualifications: "trained laparoscopic gynecological surgeons"
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the clinical study's primary and secondary endpoints. It appears that the observations (visibility of blood aspirate, leakage/breakage, compatibility, and usability ratings) were collected directly from the surgical procedures and surgeon feedback.
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
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there any mention of AI assistance or its effect size on human readers. This device is a physical injector, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The EzVu Visual Vasopressor Injector is a physical medical device, not an algorithm, and does not operate without human interaction. Its performance is intrinsically linked to its use by a surgeon.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through direct observation during surgical procedures by trained laparoscopic gynecological surgeons and their subjective feedback via Likert scales for usability. For the primary endpoint, it was the actual presence/absence of blood aspirate and device integrity as observed by the surgeon, and for the secondary endpoint, it was the surgeons' qualitative assessment of performance and compatibility.
8. The Sample Size for the Training Set
The document does not mention a training set, as this is a physical medical device and not an AI/machine learning algorithm that requires a training phase. The described studies are for validation of the fully developed device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no mention of a training set for this device.
§ 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.