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The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy with Mode of Operation B, M, PWD, Color Doppler, Amplitude Doppler.

PENTAX EG-3670URK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a radial array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

The provided document is a 510(k) summary for a medical device modification. It states that the submission is a "Special 510(k)" for a system configuration change, specifically replacing an older ultrasound scanner (Hitachi HI VISION 900) with a newer one (Hitachi HI VISION PREIRUS) while keeping the same PENTAX EG-3670URK Ultrasound Video Gastroscope.

Since this is a Special 510(k) for a modification that does not impact intended use, safety, and/or effectiveness, a detailed clinical study proving device performance against acceptance criteria is generally not required in the same way as a new device submission. Instead, the document focuses on demonstrating substantial equivalence to the predicate device and verification and validation of compatibility.

Therefore, the document does not contain the information requested in your numbered points about acceptance criteria and detailed study results. It primarily focuses on regulatory compliance and the demonstration that the modified system is equivalent to the predicate device.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

• Missing. The document does not provide a table of acceptance criteria or specific performance metrics for the device. As a Special 510(k) for a system configuration change, the focus is on maintaining existing performance, not establishing new performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Missing. No information on a test set sample size or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Missing. No information on experts or ground truth for a test set is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Missing. No information on an adjudication method is provided.

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:

• Missing. This device is an Endoscopic Ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Missing. This is not an AI algorithm, but a medical imaging system. Standalone performance as described is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Missing. No information on ground truth type is provided for a performance study.

8. The sample size for the training set:

• Missing. No information on a training set sample size is provided. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Missing. No information on how ground truth was established for a training set is provided.

Summary from the document regarding the study and acceptance:

The central 'study' mentioned in this Special 510(k) is the verification and validation (V&V) activities performed to ensure compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner.

• Acceptance Criteria (Implied): The implied acceptance criterion for this submission is that the modified system configuration (Gastroscope + HI VISION PREIRUS) performs "as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system" (Gastroscope + HI VISION 900). This is a regulatory acceptance criterion for a Special 510(k), not a clinical performance metric.
• Study/Proof: "The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3670URK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner."

In essence, for this specific type of submission, the "proof" is the successful execution of design control activities, including verification and validation, demonstrating that the new component (HI VISION PREIRUS) is compatible with the existing device (EG-3670URK) and that the overall system maintains its previous safety and effectiveness. No new clinical performance data is presented because the fundamental performance characteristics are not expected to change, and the change is limited to swapping one compatible component for another.

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The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, suction selection control, balloon insufflation/ evacuation, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

The provided 510(k) summary for the PENTAX EG-3670URK Ultrasound Video Gastroscope does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The submission explicitly states: "The submission for substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical drawings, material lists, labeling, standard components, optional accessories, and system performance testing (which likely refers to technical specifications rather than diagnostic performance in a clinical context) and acoustic power data.

No clinical study, performance metrics, or ground truth establishment is described in this 510(k) summary.

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The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories as described in the Endoscope operator Manual cleaning instructions).

This is an interesting case where the provided document is a 510(k) summary for a medical device, but it explicitly states that the submission for substantial equivalence was not based on an assessment of clinical performance data. Instead, it relied on a comparison of specifications and standard components to predicate devices. Therefore, the device was cleared without a study demonstrating that it meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

As a result, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, because such a study was not performed or submitted for this particular 510(k) clearance.

Here's a breakdown of what can be extracted from the document in relation to your request, and why other parts cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The 510(k) summary explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical, performance, data." Therefore, there are no reported device performance metrics against acceptance criteria related to clinical efficacy or diagnostic accuracy. The substantial equivalence was based on a comparison to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it is considered safe and effective for its intended use without new performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No test set data was used because no study assessing clinical or performance data was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. As no test set was used, no ground truth was established by experts for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No test set, no adjudication method.

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

• Cannot be provided. This device is an ultrasound video gastroscope, not an AI-powered diagnostic tool. No MRMC study or AI-related comparative effectiveness study was performed or is relevant to this traditional medical device clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Cannot be provided. Not applicable. This is a physical medical device (endoscope with ultrasound capability), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth was established for performance evaluation.

8. The sample size for the training set

• Cannot be provided. No training set was used as no performance study was conducted.

9. How the ground truth for the training set was established

• Cannot be provided. No training set, no ground truth establishment for it.

Summary of Device and 510(k) Clearance:

The EG-3670URK Ultrasound Video Gastroscope was cleared based on substantial equivalence to existing predicate devices (Pentax EG-3630UR Video Ultrasound Gastroscope and Hitachi EUB-5500 Ultrasound Diagnostic Scanner). The manufacturer provided specifications, standard components, and accessories, along with comparison tables to illustrate similarity to the predicates. This type of clearance, common for many medical devices, does not require new clinical performance data if the device is deemed sufficiently similar to a legally marketed predicate device.

The FDA's clearance letter (K061068) confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The only specific post-clearance requirement mentioned is a "special report" containing acoustic output measurements based on production line devices, which relates to safety rather than clinical efficacy or diagnostic performance in a clinical study context.

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