(73 days)
EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.
The Virtual Ports EndoClear™ system is a sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer. The EndoClear Lens Cleaner is an internally anchored hands-free, laparoscope lens cleaning device which is attached to the internal abdominal cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity. The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.
The Virtual Ports EndoClear™ system is a sterile, single-patient use system designed to clean the lens of a laparoscope internally during surgery without removing it from the abdominal cavity. This allows for uninterrupted visualization of internal structures during diagnostic and therapeutic laparoscopic procedures.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device performs safely. Materials in contact with the human body are biocompatible. | The animal study demonstrated that "no safety and effectiveness questions were raised." All materials in contact with the human body are biocompatible in accordance with ISO 10993-1. |
| Effectiveness: Device effectively cleans the laparoscope lens of blood, fat, fog, and secretions without removal from the cavity, enabling uninterrupted visualization. | Bench tests and an animal study were performed. The document states: "All testing results demonstrated satisfactory performance." The animal study showed that "the EndoClear™ system performs as intended." The overall conclusion is that "the device performs safely and efficiently in accordance with its intended use." |
| Substantial Equivalence: Device is substantially equivalent to predicate devices. | Preclinical and bench performance data were supplied to demonstrate that the EndoClear™ meets its labeled performance claims and to establish substantial equivalence to the predicate devices (Laparoscope and Monopolar laparoscopic instruments; Instrumed International, Inc. K040855 and g-Lix™ Tissue Grasper; USGI Medical K061268). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Bench Tests: The document does not specify a numerical sample size for the bench tests. It states "Series of bench tests were performed."
- Animal Study: The document does not specify a numerical sample size (e.g., number of animals) for the animal study. It just states "An animal study was performed."
- Data Provenance: The document does not explicitly state the country of origin for the studies. Given the applicant's address (Israel), it's highly probable the studies were conducted in Israel or a location collaborating with the applicant. The studies described are prospective in nature, as they involve testing the device to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information regarding the number of experts, their qualifications, or the method used to establish ground truth for the test set in either the bench tests or the animal study. The evaluation of performance in the animal study would typically involve veterinary surgeons or researchers, but this is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or conducted, as this device is a physical tool for cleaning a laparoscope lens, not an imaging or diagnostic algorithm used by multiple human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted. The EndoClear™ system is a physical medical device, not an algorithm, and it is intended for human-in-the-loop use by a surgeon during laparoscopic procedures.
7. Type of Ground Truth Used
- Bench Tests: The ground truth for bench tests would be defined by pre-established engineering specifications or performance metrics for lens cleaning effectiveness (e.g., clarity measurements after cleaning, removal of specific contaminants).
- Animal Study: The ground truth for the animal study would likely be a combination of direct observation by the surgical team/researchers on the safety (e.g., lack of device-related injury) and effectiveness (e.g., visual clarity through the endoscope, ability to complete the intended surgical task). The document implies a qualitative assessment ("performs as intended," "no safety and effectiveness questions were raised").
8. Sample Size for the Training Set
This information is not applicable as the EndoClear™ system is a physical device and does not involve a "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.