(51 days)
The Encision Disposable Handle Assemblies are used for minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.
The DH0100 series and DH0500 series Disposable Handle Assemblies are fully disposable surgical instruments which are packaged for use without additional setup. The instruments fit standard 5.5mm cannulas. The Disposable Handle Assemblies are available in various operative lengths and styles. Tip styles include scissors, and double action and single action forceps and jaws for dissection or grasping. The handle and trigger open and close the working tip of the instrument. The rotation knob turns to allow 360°orientation of the tip as the surgeon prefers. This device does not transmit electrosurgical energy. There is no connection for monopolar or bipolar output from a generator. However, the shaft is insulated, in the event the instrument comes into contact with an active instrument, to prevent stray energy burns. The assembly is supplied sterile and is not intended for more than one use.
The Encision Disposable Handle Assemblies are surgical instruments designed for minimally invasive, laparoscopic, and endoscopic procedures. The device's safety and effectiveness were primarily demonstrated through a declaration of substantial equivalence to predicate devices, supported by non-clinical performance testing.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Articulating Functions (Bench Testing) | Performance verified |
| Shaft Insulation Dielectric Withstand | Performance verified |
| Biocompatibility ISO 10993 series | Materials selected and verified to meet requirements |
| Equivalence to Predicate Device - Cutting | Performs in an equivalent manner to predicate devices |
| Equivalence to Predicate Device - Tissue Manipulation | Performs in an equivalent manner to predicate devices |
| Equivalence to Predicate Device - Handle Articulation | Transmitted to the tips in the same way as predicate devices |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified. The performance verification was conducted through "bench testing."
- Data Provenance: Not specified, but generally, bench testing for medical devices is performed in a laboratory setting, likely within the manufacturer's facilities or a contracted testing lab. The data is retrospective in the sense that it's gathered specifically for regulatory submission.
3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth
This information is not applicable as the study described is a non-clinical, bench testing program for device functionality and material properties, not a study involving human subjects or expert assessment of clinical images/data. The "ground truth" was based on established engineering specifications, safety standards, and performance metrics for surgical instruments.
4. Adjudication Method
Not applicable, as no expert consensus or adjudication process was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. The device's performance was evaluated through bench testing and comparison to predicate devices, not through a study involving human readers or AI assistance. Therefore, there is no effect size of human readers improving with or without AI.
6. Standalone Performance Study
A standalone performance evaluation was conducted in the form of "non-clinical performance testing" and "bench testing." This evaluated the device's articulating functions, shaft insulation, and material biocompatibility against defined engineering and safety standards. This study did not involve human operators in a clinical setting to assess performance, but rather technical performance attributes.
7. Type of Ground Truth Used for Test Set
The ground truth for the test set (bench testing) was based on:
- Established engineering specifications for articulating functions.
- Industry standards for dielectric withstand (for insulation).
- ISO 10993 series of standards for biocompatibility.
- Performance characteristics of the predicate devices for cutting, tissue manipulation, and handle articulation.
Essentially, the "ground truth" was defined by a combination of engineering requirements and the performance of already-approved, substantially equivalent devices.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How Ground Truth for Training Set was Established
Not applicable, as there is no 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.