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510(k) Data Aggregation
(261 days)
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(290 days)
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(122 days)
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(30 days)
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(261 days)
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(262 days)
Niti-S Biliary Stent:
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
Niti-S Biliary Slim M Stent:
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667.
The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.
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(264 days)
The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.
The BT-PD1-SERIES-G / BT-PD1-SERIES(MN)-G / BT-PD1-SERIES-G(+FSC) / BT-PDS-SERIES-G / BT-PDS-SERIES(MN)-G / BT-PDS-SERIES(B)-RB-G Percutaneous Drainage Catheter with hydrophilic coating is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or mini-pigtail close loop and drainage holes.
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(32 days)
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the gastroenterologist in identifying suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.
The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT® system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT® system by observing the software display, including the polyp detection box and device status indicator signal.
The provided FDA 510(k) clearance letter describes the SKOUT system, a software device designed to detect potential colorectal polyps in real-time during colonoscopy examinations. The document outlines acceptance criteria and summarizes performance testing.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, it refers to performance objectives implicitly through comparisons to the predicate device and mentions passing results in applicable testing. Based on the "Performance Testing" section, the following can be inferred as the general performance areas that were assessed:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification and Validation | SKOUT® system software meets design requirements for its intended use, in line with recommendations outlined in "General Principles of Software Validation, Guidance for Industry and FDA Staff." |
| Algorithm Performance (True Positives, False Positives, Polyp Detection Time) | Standalone and on-device algorithm performance testing was conducted, with passing results. Optimized performance with Endocuff, multiple polyps, and/or sessile serrated lesions, and reduced false positive rate. |
| Pixel Degradation | No pixel level degradation is introduced by SKOUT® to the Endoscopic System. |
| Video Delay (due to marker annotation) | Video delay due to marker annotation = 0ms (no standard error; all results were 0, minimum resolution 1.1ms). |
| Video Delay (due to device) | Video delay due to device = 0ms (no standard error; all results were 0, minimum resolution 1.1ms). |
| Endocuff Compatibility | Optimized performance in videos with Endocuff. |
| Multiple Polyps and Sessile Serrated Lesions | Optimized performance for multiple polyps and/or sessile serrated lesions. |
| Reduced False Positive Rate | Reduced false positive rate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "an expanded dataset for the added Endocuff compatibility" for standalone and on-device algorithm performance testing. However, it does not specify the exact numerical sample size (e.g., number of videos, number of polyps, or number of patients) of this expanded dataset.
- Data Provenance: The document does not specify the country of origin of the data used for testing, nor whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication method for the test set:
The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none).
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:
The document explicitly states that the "clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that a new MRMC comparative effectiveness study was not conducted for this submission (K253664). The existing clinical performance from K213686 was relied upon. Therefore, no new effect size for human reader improvement with AI vs. without AI assistance is reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone algorithm performance study was done. The "Performance Testing" section states: "Standalone and on-device algorithm performance testing was conducted for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added Endocuff compatibility."
7. The type of ground truth used:
The type of ground truth used is not explicitly specified in this document. Given it's a device for detecting polyps, it would typically be based on expert consensus (e.g., gastroenterologists reviewing videos and annotating polyps) or pathology (histopathological confirmation of removed lesions). However, the document does not confirm this.
8. The sample size for the training set:
The document does not specify the sample size used for the training set. It mentions "Retraining and refinement of inference algorithms... optimized performance," which indicates that a training process occurred, but details on the training set size are absent.
9. How the ground truth for the training set was established:
The document does not provide information on how the ground truth for the training set was established.
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(220 days)
The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.
The subject devices are coated ureteral stent that are supplied as a standalone product (including a pigtail straightener) or as part of a set, available in two configurations:
- Basic Set: Includes a ureteral stent, pigtail straightener, and positioner.
- Full Set: Includes a ureteral stent, pigtail straightener, positioner, and J-tip guide wire.
The coated stents are flexible tubular devices made of radiopaque polyurethane, featuring self-retaining coiled pigtail structures at both ends. The stent body incorporates multiple drainage holes to ensure smooth urine flow from the renal pelvis to the bladder. The dual-pigtail design positions the proximal end in the renal pelvis and the distal end in the bladder. Additionally, the stent surface is marked with graduated scales for precise intraoperative positioning.
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(134 days)
The disposable CE Deliver is a 2.5mm single-sheathed device indicated for transendoscopic delivery to the stomach or duodenum of CapsoCam Plus capsule endoscope (CE) devices. This device is intended for patients who are either unable to swallow the capsule or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
The CapsoVision CE Deliver device is a single use, disposable, non-sterile catheter-based medical device designed to facilitate the transendoscopic delivery of the CapsoCam Plus Capsule Endoscope to the stomach or duodenum. CE Deliver is an accessory to the CapsoCam Plus, and is intended for use in patients who are unable to swallow a capsule endoscope or cannot pass it beyond the pylorus in a timely manner.
The CE Deliver is comprised of a thin, flexible catheter with a Capsule Holder at its distal end and a Handle at its proximal end. The Capsule Holder is detachable from the Handle and Catheter by means of a threaded connector. CE Deliver is designed to be used in conjunction with a standard upper endoscope, through which the flexible catheter is inserted into the endoscope's instrument channel, upon which the Capsule Holder may be threaded onto the distal end. The device enables a user to securely load a capsule endoscope onto the distal Capsule Holder, guide it under direct endoscopic visualization to the desired location within the upper gastrointestinal tract, and then precisely release the capsule. After capsule release, the CE Deliver is retracted along with the endoscope, allowing the capsule to proceed naturally through the GI tract.
The CE Deliver is compatible with upper endoscopes with an instrument channel diameter of 2.8mm or larger.
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