(225 days)
The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.
The PENTAX Medical Video Duodenoscope ED32-i10 has a smaller insertion portion width (32 French size) compared to the predicate device, ED34-i10T2, (34 French size) and is expected to provide better access to patients for whom that the ED34-i10T2 may have had difficulties accessing, for example in patients with narrowed lumens and in pediatric patients.
The ED32-i10 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion is inserted into the body cavity of patient. The insertion portion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connector is connected to the video processor via electrical contacts.
The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control the position of the cannula which is inserted through the Instrument Channel.
The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A65). The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned.
The remote button is used to operate the functions of the video processor and any external device from the control body, as necessary.
The single use, Distal End Cap with elevator (OE-A65) is provided as a sterile product. OE-A65 is attached to the elevator link of the distal end of ED32-i10. It is discarded after use.
Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.
The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guides the light from light guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the monitor.
The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED32-i10.
The PENTAX Medical ED32-i10 Video Imaging System is provided with the following accessories:
- Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
- Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
- Suction Control Valve - intended to control suction.
- Air/Water Valve - intended to control air and water feeding.
- Distal End Cap with Elevator - intended to guide the endoscopic device.
Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O-Rings.
The provided text describes a 510(k) premarket notification for the PENTAX Medical Video Duodenoscope ED32-i10, asserting its substantial equivalence to a predicate device, the PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245). This is a medical device clearance, not an AI/ML device, so many of the requested sections related to AI/ML studies are not applicable.
Here's an analysis based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a single table directly comparing acceptance criteria with reported performance in a quantitative manner for most tests. Instead, it states that "All acceptance criteria were satisfied" for most tests.
| Test Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Effectiveness of reprocessing procedures for cleaning, high-level disinfection, and rinsing in accordance with FDA's 2015 Reprocessing Guidance. Acceptance criteria established per AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency. | Validation studies confirmed the effectiveness of reprocessing procedures at the distal end, instrument/suction channel, and air/water channel. "All acceptance criteria were satisfied." |
| Sterilization & Shelf Life | For Distal End Cap with Elevator (OE-A65): Sterilization using electron beam and a shelf-life of 2 years after sterilization. | The Distal End Cap with Elevator (OE-A65) is provided as a single-use, sterile product. Electron beam sterilization was conducted and a shelf-life of 2 years after sterilization was verified. (The main device is not sterile, so shelf-life is not applicable for it). |
| O-ring Sealing Performance | Same dimensions and sealing performance as the predicate device's O-ring. | The O-ring on the elevator link has "the same dimensions and sealing performance as the predicate device." |
| Software | Equivalent to predicate device software. | The subject device "utilizes the same software as the predicate device." |
| EMC and Electrical Safety | Acceptable levels per IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. | Conformed to the specified standards. |
| System Performance | Equivalence to the predicate device. A service life of six years. | Demonstrated equivalence to the predicate device. Test results also demonstrated "six years of the service life for the ED32i10." |
| Optical Performance | Equivalence in optical characteristics (signal to noise, color, limiting spatial resolution (LSR), modulation transfer function (MTF), distortion, image intensity uniformity (IIU), and photobiological safety) to the predicate device when used with EPK-i7010 and EPK-i5010 Video Processors. | "All results show that the optical characteristics of the subject device is equivalent to those of the predicate device." |
| Distal End Cap (OE-A65) Performance Testing | OE-A65 attachment performance. | Verification studies for attachment performance tests were conducted on the Distal End Cap with Elevator, OE-A65, and "all test items satisfied the acceptance criteria and were determined to be acceptable." |
| Human Factors Testing | Acceptable user performance for reprocessing procedures and critical tasks. | Human Factors validation testing from the ED34-i10T2 (predicate) was leveraged for the ED32-i10 because the proposed manual reprocessing procedures and all critical tasks are identical, and the user-interface is the same. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each individual test in the non-clinical performance data section. It generally refers to "validation studies," "verification studies," and "test results" without numerical detail for the number of devices or data points used.
- Provenance: The studies were conducted by PENTAX Medical and STERIS Corporation. The document doesn't explicitly state the country of origin for the data, but it's part of a submission to the U.S. FDA by PENTAX Medical HOYA Corporation located in Montvale, New Jersey, USA. All studies mentioned appear to be prospective testing for device verification and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given this is a non-AI/ML device, the concept of "ground truth" established by experts as typically understood in AI/ML performance evaluation doesn't directly apply in the same way. The performance is assessed against engineering specifications, recognized standards, and equivalence to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device clearance. Adjudication methods are typically used in clinical studies or AI/ML studies where multiple human readers' interpretations of data need to be resolved to establish ground truth or evaluate diagnostic performance. This document focuses on engineering and performance testing.
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
This is not applicable. This document describes a medical device (endoscope) and not an AI/ML software device. No MRMC study or AI assistance evaluation is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is a hardware medical device; it does not have a standalone algorithm for performance evaluation in the context of AI/ML. Its performance is assessed as an integrated system with compatible video processors.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications, performance standards (e.g., AAMI TIR 30:2011, IEC 60601 series), and the performance of the legally marketed predicate device (PENTAX Medical Video Duodenoscope ED34-i10T2). For reprocessing, laboratory tests were used to measure residual soil and extraction efficiency against pre-defined limits.
8. The Sample Size for the Training Set
This is not applicable. This is a hardware medical device, not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As it's not an AI/ML device, there is no "training set" or ground truth established for one.
§ 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.