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The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

Pilling® Esophageal Bougies are weighted, cylindrical instruments used for the dilation of the larynx and esophagus. They are designed to be reusable and resterilized by the user. Made from silicone elastomer and filled with tungsten, the bougies are marketed in French sizes 20 to 60. Pilling® Bougies have two tip styles; the Maloney bougie has a long tapered tip and the Hurst has a rounded tip. Both tips are impregnated with radio-opaque material (barium sulfate) and contain calibration marks along the tubing. By inserting the bougie through the patient's mouth and down the patient's esophagus, a clinician can mechanically push a blockage out of the esophagus or can mechanically dilate a stricture in the esophagus.

This document describes the performance testing for the Pilling® Esophageal Bougies, focusing on demonstrating substantial equivalence to a predicate device rather than a standalone AI device study.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly applicable to an AI device:

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

2. Sample size used for the test set and the data provenance

• Sample size: 30 samples of the Pilling® Esophageal Bougies and 30 samples of the predicate Medovations® M-Flex™ Esophageal Bougies were tested.
• Data provenance: Not explicitly stated, but based on the context of 'bench testing' and 'Teleflex has performed', it is implied to be prospective data generated by the manufacturer for the purpose of this submission. The "country of origin of the data" is not specified but would typically be the location of the manufacturing and testing facility.

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

This information is not applicable. The study described is a bench test evaluating the physical properties (tensile strength) of mechanical devices, not a study involving medical images or clinical data requiring expert human interpretation for ground truth. The "ground truth" here is a predefined engineering specification (10 lbs tensile strength).

4. Adjudication method for the test set

This information is not applicable. As a bench test with objective physical measurements, there is no need for expert adjudication. The results are quantitative and directly measured against the acceptance criteria.

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 information is not applicable. This submission concerns a physical medical device (esophageal bougies) and is not an AI-powered diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This information is not applicable. The device is a mechanical tool, not an algorithm or AI system.

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

The "ground truth" for this study is a predefined engineering specification/acceptance criterion: a minimum tensile strength of 10 lbs. This is a technical standard rather than a medical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI device or a machine learning model.

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

This information is not applicable. As there is no AI or machine learning involved, there is no training set or ground truth establishment method for it.

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The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter. It is intended to transilluminate the esophagus during the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures on the esophagus. The Stryker InfraVision™ Esophageal Kit is intended to help the surgeon identify organs and placement of medical tissue.

The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter.

The provided documentation for K983220, the Stryker InfraVision™ Esophageal Kit, does not contain information on acceptance criteria or a study proving that the device meets specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.

Here's a breakdown of why the requested information is absent and what the document does provide:

• Acceptance Criteria & Device Performance: These are not mentioned. The submission's core argument is that the device is "equivalent in safety and effectiveness to currently marketed devices." It does not present novel performance data or specific thresholds it aims to achieve.
• Study Details: No study is described that would involve sample sizes, data provenance, expert ground truth, adjudication methods, MRMC analysis, or standalone algorithm performance. This type of detailed study is typically associated with devices that introduce new mechanisms of action, novel clinical claims, or AI/software components that require empirical validation of performance.
• Ground Truth: Since no performance study is detailed, the concept of ground truth for a test set or training set is not applicable in this submission.
• Training Set Size & Ground Truth (for AI): The device described is an "esophageal transillumination dilation device," a physical medical instrument with a light source and dilator. It is not an AI or software-as-a-medical-device (SaMD) product, therefore, training sets and AI-specific ground truth are irrelevant to this submission.

Summary of Information from the Provided Document:

The 510(k) submission for the Stryker InfraVision™ Esophageal Kit (K983220) focuses on demonstrating substantial equivalence to predicate devices. The arguments presented are:

• Compliance with Standards: The illumination source will comply with 21 CFR 1040.10 Performance Standard for Medical and Dental Equipment.
• Material Equivalence: Constructed of materials with the same manufacturing process, chemical composition, body contact, and sterilization methods as currently marketed and approved medical devices, and are safe, effective, and durable.
• Intended Use: The device is intended to help the surgeon identify organs and placement of medical devices and help illuminate the esophagus during thoracoscopic, laparoscopic, or open surgical procedures (e.g., fundoplication).
• Predicate Devices: Gabriel InfraVision™ Esophageal Kit (K960173), Bard Balloon Dilatation System (K86343), Sherwood Argyle Salem Sump Tube (K810156), BioEnterics EndoLumina Illuminated (K960173, K86343, K810156, 11-12-20148 - this last one seems like a typo/fragment). The submission explicitly states, "this device does not raise new issues when compared to its predicate devices or uses."

Conclusion:

Based on the provided text, the submission for K983220 relies on demonstrating substantial equivalence to existing, legally marketed devices rather than presenting specific acceptance criteria and performance study data for novel claims. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, and expert adjudication is not present in this regulatory document.

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The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Tungsten Filled Maloney and Hurst Bougies." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The letter primarily states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

The "Indications For Use" section lists the medical conditions the device is intended to treat, but this is distinct from acceptance criteria or performance study results.

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The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below:
a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures;
b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and
C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.

The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.

This document describes the K960173 InfraVision™ Bougie, a medical device designed to aid in the identification of internal structures using infrared transillumination.

Based on the provided text, there is no detailed information about acceptance criteria or a specific study proving the device meets them in the format typically seen for modern AI/ML medical devices. The document is from 1996 and pertains to a physical medical device (an illuminated bougie), not an AI/ML diagnostic or predictive tool, hence the requested metrics like sample size for test/training sets, ground truth establishment methods, expert qualifications, and MRMC studies are not applicable or detailed in the provided text.

However, I can extract the information related to the "testing" section provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies "less tissue heating" is a desirable outcome and thus serves as an implicit acceptance criterion. No specific numerical thresholds are provided.

2. Sample Size Used for the Test Set and Data Provenance

The testing was performed using "simulated test tissue."

• Sample Size (Test Set): Not specified.
• Data Provenance: Simulated tissue.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The testing described focuses on a physical characteristic (tissue heating) using simulated tissue, not on diagnostic accuracy requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the testing was on a physical characteristic using simulated tissue.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for evaluating the performance of diagnostic tools (often AI-assisted) where human interpretation is involved. The InfraVision™ Bougie is a physical device used for illumination.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable, as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" implicitly used was the actual temperature measurements or observation of tissue heating in simulated tissue. The comparison was against a predicate device's heating profile.

8. Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant to the described testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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