(30 days)
The PENTAX Medical Video Duodenoscope ED34-110T2 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, Billary 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 ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device 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 ED34-i10T2 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion 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 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-A63). 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-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 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 ED34-i10T2.
The primary components of the system include the following:
The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:
- Keyboard input device for the video processor.
- White Balance Adjuster – controls the white balance feature.
- Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
- 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 waterfeeding.
- Distal End Cap with Elevator intended to guide the endoscopicdevice.
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 FDA 510(k) summary for the PENTAX Medical Video Duodenoscope ED34-i10T2 does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The submission is a Special 510(k), which typically addresses minor modifications to an already cleared device. In this specific case, the primary purpose of the submission is to obtain clearance for "updated instructions that enhance awareness of Distal End Cap attachment process" and a minor software change due to component obsolescence.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for clinical performance evaluation are not present in this document, as they would have been assessed during the original clearance of the predicate device (K192245).
Here's a breakdown of what can be extracted from the document regarding "performance data," which in this context refers to engineering and software validation rather than clinical efficacy:
Acceptance Criteria and Study for PENTAX Medical Video Duodenoscope ED34-i10T2 (Special 510(k) Submission K210710)
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for minor changes (updated instructions and software component change), the "acceptance criteria" and "reported device performance" referenced relate to software and cybersecurity testing, rather than clinical performance metrics like sensitivity, specificity, or reader agreement. The document explicitly states: "Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed."
| Acceptance Criteria Category | Specific Criteria (Implicit for Special 510(k)) | Reported Device Performance (Summary) |
|---|---|---|
| Software Functional Equivalence | Software update does not alter device functions. | Functions of two software versions are identical. |
| Software Safety & Effectiveness | Software update does not affect device safety or effectiveness. | No effect on safety or effectiveness. |
| Software Hardware Performance | Software update does not affect hardware performance. | No effect on hardware performance (e.g., CPU processing speed). |
| Software Verification & Validation | Compliance with relevant standards and guidances. | Conducted according to IEC 62304: 2006 + A1: 2015. |
| Cybersecurity Assessments | Compliance with relevant FDA cybersecruity guidances. | Conducted according to FDA guidances for cybersecurity management. |
2. Sample Size Used for the Test Set and Data Provenance
- Test set for software changes: Not explicitly stated as a number of cases or patients. The "test set" would refer to the software verification and validation protocols and test cases derived from software requirements. These are internal engineering tests, not a clinical study.
- Data provenance: Not applicable in the context of clinical study data for this submission. The software changes are internal to the device and its manufacturing process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable as this is a software/engineering verification and validation, not a clinical study requiring expert diagnosis for ground truth. Software testing typically involves software engineers and quality assurance personnel.
4. Adjudication Method for the Test Set
- Not applicable for this type of software verification and validation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done as part of this Special 510(k) submission. This type of study would evaluate human reader performance with and without AI assistance, which is not relevant to the minor software and instruction changes addressed here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of clinical diagnostic accuracy or image analysis was not done for this submission. The "algorithm" here refers to the device's operational software, not an AI for interpretation. Software verification and validation address the algorithm's functional correctness.
7. The Type of Ground Truth Used
- For the software verification and validation mentioned, the "ground truth" would be the expected behavior or specified requirements of the software and hardware, as defined by engineering specifications and design documents. It is not clinical ground truth (e.g., pathology, expert consensus).
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the typical sense for clinical applications. The software changes are due to component obsolescence, not model retraining.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for a clinical algorithm in this submission.
Summary of the K210710 Submission:
This 510(k) is a Special 510(k) for the PENTAX Medical Video Duodenoscope ED34-i10T2. It concerns two minor modifications:
- Updated Instructions: Enhancing awareness of the Distal End Cap attachment process.
- Minor Software Change: Due to obsolescence of electronic components. The submission asserts that the new software versions are functionally identical to the previous one and do not affect the device's safety, effectiveness, or hardware performance.
The "performance data" provided relates specifically to the software and cybersecurity aspects of these minor changes. The submission confirms that software verification and validation, including cybersecurity assessments, were conducted according to relevant standards (IEC 62304) and FDA guidances. The conclusion is that the updated device remains substantially equivalent to its predicate.
§ 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.