Search Results

The BARE Wireguided Balloon Dilation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.

The BARE Wireguided Balloon Dilation Catheter is an over-the-wire, through the scope, dual lumen balloon catheter compatible with 0.035" guidewires with a distally mounted semicompliant inflatable balloon and an atraumatic tapered tip. The multistage balloon provides three distinct diameters at three corresponding pressures. The device has two radiopaque marker bands, visible under fluoroscopy, to aid in balloon positioning.

The BARE Wireguided Balloon Dilation Catheter is available in multiple balloon diameters and balloon lengths with a catheter shaft length of 180 cm or 240 cm. A balloon compliance chart with inflation pressures and balloon diameters is located on the foil pouch label and on the information tag attached to the catheter shaft.

N/A

Ask a specific question about this device

The Retrieval Balloon is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. The device is for adult use only.

The proposed device Single use stone retrieval balloons includes Stone Retrieval Balloon, inflation pump and two-way valve. Stone Retrieval Balloon is commonly used in traditional ERCP surgery with a long guidewire.

The proposed Single use stone retrieval balloons is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.

Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire. Another separate lumen is designed for contrast agent.

The balloon can be inflated to 8.5 mm, 12 mm, 15 mm and 18 mm diameters using the inflation pump and be kept in an inflated state by two-way valve. Balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.

There are two developing rings placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

N/A

Ask a specific question about this device

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.

N/A

Ask a specific question about this device

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.

N/A

Ask a specific question about this device

The DISPOSABLE BALLOON CATHETER B5-2Q, B7-2Q/2LA have been designed to be used with Olympus endoscopes to inject contrast medium into the biliary or pancreatic track. They can also be used for retrieval of biliary or pancreatic stones.

The Balloon Catheters are constructed of an inflatable balloon, tube, branch, injection port, air feeding port, and stopcock.

Prior to use, a sterile syringe is attached to the air feeding port and injects air into the tube to inflate the balloon to the specified volume to confirm that the balloon inflates properly. The balloon is then deflated completely, and the tube is inserted into the instrument channel of the endoscope and advanced to the target area, where the balloon is inflated to allow for biliary or pancreatic stone removal or contrast medium injection through the injection port. When the procedure is completed, the balloon is deflated and the tube is removed from the patient.

N/A

Ask a specific question about this device

The EndoFix™Tissue Fixation System is an endoscopic tissue approximation system intended for anchoring the gallbladder to the stomach or duodenum to aid placement of a luminal apposing metal stent (LAMS) for EUS-guided gallbladder drainage.

The EndoFix™ Tissue Fixation System (TFS) is an endoscopic (through the scope) tissue approximation device consisting of two main components:

1. EndoFix Tissue Fixation Device – Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based implant delivered through an 18 gauge echogenic needle.
2. Secure Suture Locking Device – Secures the implant assembly with an implant grade suture lock and cuts the suture once approximation is complete.

The EndoFix TFS is designed to place an implant for endoscopic tissue approximation to anchor the gallbladder to the stomach or duodenum to aid placement of a luminal metal apposing stent (LAMS). During use, the EndoFix Tissue Fixation Device is advanced through a ≥3.2 mm working channel of a commercially available echoendoscope (EUS). Under ultrasound guidance, the EndoFix TFS needle is advanced through the target tissues and the implant subassembly is deployed to approximate the luminal tissues (either transgastric or transduodenal based on clinical requirements). With applied suture tension, a Suture Lock is deployed to secure the tissues using the Secure Suture Locking Device. The implant subassembly and Suture Lock are considered permanent implants.

Each of the respective delivery systems used to deliver the implant assembly/Suture Lock are short term contact devices.

This FDA 510(k) clearance letter for the EndoFix™ Tissue Fixation System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Specifically, it does not include:

• A table of acceptance criteria with reported device performance metrics (e.g., success rates, tensile strength, specific measurements).
• Details about a "test set" for a performance study (sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods).
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human reader improvement.
• Distinction between standalone algorithm performance and human-in-the-loop performance, as this is a medical device, not an AI/software-only device in the context of typical AI performance criteria.
• Training set sample size or how its ground truth was established.

However, based on the provided text, I can infer and extract some relevant information regarding performance testing.

Inferable Acceptance Criteria and Reported Device Performance

The document lists categories of performance testing that were conducted with "acceptable results." While specific numerical acceptance criteria and reported performance values are not given, the implication is that the device met internal, pre-defined criteria for these aspects.

A table of acceptance criteria and reported performance cannot be fully constructed from the provided text because specific numerical values for criteria and performance are absent. However, based on the categories mentioned under "Performance Data," we can infer the types of criteria and the general statement of performance:

Study Details (as far as extractable):

1. Sample size used for the test set and the data provenance:

   • The document mentions "bench testing" and a "preclinical animal study." For bench testing, sample sizes are not specified.
   • For the animal study, the model used was a "porcine model," indicating an animal test subject. The number of animals or specific cases within that study is not provided.
   • Data provenance: Porcine model (animal study), laboratory/bench for other tests. Retrospective/prospective is not specified, but animal studies are typically prospective experimental designs.

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

   • The document does not specify the number or qualifications of experts for establishing ground truth, as this device's performance assessment relies on physical and functional tests, and an animal study, rather than expert interpretation of medical images or data.

3. Adjudication method for the test set:

   • Not applicable/Not specified. The performance testing described (bench, animal study) does not involve adjudication processes typically used in clinical imaging or diagnostic studies.

4. 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:

   • No. This is a medical device, not an AI-assisted diagnostic tool subject to MRMC studies. The clearance is for the physical device itself.

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

   • Not applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the context of AI software is not relevant here.

6. The type of ground truth used:

   • For bench testing: Engineering specifications, physical measurements, functional demonstrations.
   • For the animal study: Observation of safety and performance (e.g., successful tissue approximation, LAMS deployment, absence of adverse events) within the porcine model. This could be considered "outcomes data" in an experimental animal model context.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning algorithms. Its design would be informed by engineering principles and possibly prior animal/cadaver studies, but not a formal 'training set'.

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

   • Not applicable, as there is no training set mentioned for this type of device.

Ask a specific question about this device

The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.

The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.

The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.

The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.

The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.

The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within <95 days.

The provided FDA 510(k) clearance letter and summary for the ARCHIMEDES™ Biodegradable Pancreatic Stent do not contain the specific acceptance criteria and detailed performance results for the device. While it states that "All tests met required acceptance criteria," the actual criteria and reported numerical performance are not explicitly listed.

Furthermore, the document alludes to "eight clinical studies" but provides no details whatsoever about their methodology, sample sizes, data provenance, expert qualifications, adjudication methods, or specific outcomes. It's a high-level statement without any actionable data.

Therefore, many of your requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the input:

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

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

• Sample Size: Not specified for any of the eight clinical studies mentioned.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective is only generally mentioned as "various settings, including single-center and multicenter, prospective and retrospective, randomized and non-randomized designs" for the collection of 8 studies, but not for any specific study or a "test set").

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)

• Not specified. The document only mentions "eight clinical studies" but no details on expert involvement for ground truth establishment.

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

• Not specified.

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

• Not applicable. This device is a physical medical stent, not an AI or imaging diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers and AI assistance is irrelevant to this submission.

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

• Not applicable, as this is not an algorithm-based device.

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

• For the non-clinical tests, the ground truth is based on the specified acceptance criteria for each test (e.g., ISO standards, FDA guidance documents).
• For the clinical studies, the document vaguely states they evaluated "safety, efficacy, clinical performance, degradation profile, and technical success," implying outcomes data would be the primary ground truth. However, no specifics are provided.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set. If the question implicitly refers to pre-clinical testing or animal studies that might inform design, no specific "training set" size is provided in the document.

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

• Not applicable, as there is no "training set" in the context of this device.

Ask a specific question about this device

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):
• Used to drain pancreatic ducts

The Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and Pushers is a plastic pancreatic stent designed for the delivery of the stent to the pancreatic duct and used to drain pancreatic ducts.

The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, in rounded or tapered leading end tip to facilitate access through papilla, and a rounded trailing end or about the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic or fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

I regret to inform you that the provided text is a U.S. FDA 510(k) clearance letter and summary for a medical device (Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers).

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance bench testing and biocompatibility.

Crucially, this document does not contain information about clinical studies with human patients, nor does it establish device performance against specific acceptance criteria in a clinical setting.

Therefore, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and the reported device performance: These are not defined in the context of clinical outcomes within this document. The "performance" mentioned refers to bench testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical medical device (a stent and delivery system), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the clinical performance criteria you are asking about. The "ground truth" for the bench tests would be the established engineering specifications and standards.
8. The sample size for the training set: Not applicable, as there is no training set for a clinical algorithm.
9. How the ground truth for the training set was established: Not applicable.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that the submission includes Performance Bench Testing and Biocompatibility Testing. These are standard tests for physical devices to ensure their safety and physical functionality, not their clinical effectiveness in terms of patient outcomes or diagnostic accuracy.

In summary, the provided document is not a study report that demonstrates clinical performance against acceptance criteria for patient outcomes or diagnostic accuracy.

Ask a specific question about this device

The EGIS Biliary Double Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.

EGIS Biliary Double Bare Stent has straight and round cylinder form made of nitinol wire. The double bare type is composed of two structures, an inner stent and an outer stent, and has a double-layer form. Each stent has the same structure as the single bare type of the product. A double layer is formed by overlapping a separately manufactured inner stent and an outer stent, and both ends are physically fixed using medical sutures. No additional bonding material in this process. This manufacturing method also allows the product to have more conformability and a smaller cell size.

The provided FDA 510(k) clearance letter for the EGIS Biliary Double Bare Stent does not contain any information about a study involving acceptance criteria for device performance with respect to AI or human reader assistance.

The document primarily focuses on demonstrating the substantial equivalence of the EGIS Biliary Double Bare Stent to a predicate device (EGIS Biliary Single Bare Stent) through non-clinical bench testing and biocompatibility evaluation. The letter explicitly states: "Clinical testing was not required for this submission." This means no human-in-the-loop or standalone AI performance studies were conducted or reported in this clearance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input. The information requested regarding AI performance, human reader studies, ground truth establishment, expert adjudication, and training/test set details is entirely absent from this 510(k) clearance letter, as it's not relevant to the type of device (a biliary stent) or the regulatory pathway chosen (510(k) based on substantial equivalence through non-clinical data).

If you have a document pertaining to an AI device or a study involving human reader performance, please provide that document, and I would be happy to analyze it according to your requested criteria.

Ask a specific question about this device

The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.

The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.

Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.

The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.

Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.

This document, a 510(k) Premarket Notification for the Olympus Single Use Retrieval Basket V (K243807), details the device's substantial equivalence to a predicate device. However, it does not contain the specific information required to address your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human comparative effectiveness study.

The provided text focuses on the device's mechanical, material, and operational equivalence to a previously cleared device. It outlines:

• Device Description: Single-use retrieval baskets for stones in the biliary tract.
• Performance Data: Biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135), packaging validation (ISO 11607-1, ASTM F1980-21), and mechanical testing (Insertion/Withdrawal, Open/Close Basket, Dimensional verification, Grasping Basket Effective Test, Attachment/Detachment of Hook, Injecting Fluid, Strength of Junction).
• Conclusion: The device is substantially equivalent to the predicate based on these non-clinical tests.

Crucially, the document explicitly states:

• "Animal study data and clinical study data were not required to demonstrate substantial equivalence."

This indicates that a study involving human subjects or AI-assisted performance, which would typically contain the data you're requesting, was not part of this 510(k) submission. The acceptance criteria described are for the physical and material properties of the basket, not for diagnostic performance or human-AI interaction.

Therefore, I cannot provide the requested information from this document. The device in question is a medical instrument (a retrieval basket), not an AI/software as a medical device (SaMD) that would have diagnostic performance metrics, ground truth establishment, or multi-reader studies.

Ask a specific question about this device