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This device is intended for aspiration biopsy in the biliary system.

The Howell Biliary Aspiration Needle is a sterile, single use device that consists of a luer slip handle with adjustment wheel, outer catheter sheath, needle catheter with needle, stylet and winged hub. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Howell Biliary Aspiration Needle is 200 cm long. The catheter is comprised of PTFE while the needle is stainless steel and the stylet is nitinol.

The provided text describes a medical device submission (K153763) for the "Howell Biliary Aspiration Needle". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the safety and effectiveness of a novel device through extensive clinical trials for a new intended use.

Therefore, the document does not contain the information necessary to describe acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML or diagnostic imaging device, as implied by the structure of the prompt.

Specifically, the document states:

• "Performance testing consisting of non-clinical bench testing demonstrates that the Howell Biliary Aspiration Needle met the performance requirements to fulfill the intended use of the device."
• "The device is substantially equivalent to the cleared predicate device."

This indicates that the performance evaluation was based on bench testing for equivalence, not a clinical study designed to establish diagnostic performance against a ground truth.

Because the prompt asks for details typically found in submissions for AI/ML or diagnostic devices (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), and this document describes a physical medical instrument (a biopsy needle), most of the requested information is not applicable or present.

Therefore, I cannot populate the table or answer the specific questions as requested, because the provided text is about a physical medical device (a needle) and its substantial equivalence application, not a diagnostic or AI device with performance metrics like accuracy, sensitivity, or specificity against a ground truth from patient data.

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The Multiple Biopsy System is intended to be used with a suction source to collect biopsy samples from the upper and lower gastrointestinal tract for microscopic examination.

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This is a letter for a 510(k) premarket notification for a "Multiple Biopsy System". This document does not contain information about acceptance criteria or a study proving device performance, as it is a regulatory clearance letter rather than a scientific study or performance report.

Therefore, I cannot extract the requested information from the provided text.

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The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

The RB12 consists of a gamma sterilized single use polystyrene closed end cylinder shaped capsule with a small hole at the closed end which contains a stainless steel cutting blade and a polyethylene seal. The capsule connects to a re-useable handpiece (HP1000) via a quick twist and lock system and suits both left and right handed operators. The HP1000 has an inner piston which automatically locates in the internal seal when the capsule is connected. This creates an airtight loop to the attached syringe via the suction tube/syringe adaptor. The inner piston is pushed forward when the thumb trigger is activated pushing the blade forward past the capsule hole cutting the specimen. The RBI2 design uses a combination of a re-useable handpiece and a disposable (single use) capsule. The capsule is supplied to the end users in a sterile state completely assembled with an internal blade and seal. A syringe is connected to the rear end of the internal trigger tube via a piece of suction tube and a syringe/tube adaptor (supplied sterile with capsules). The disposable is placed onto the outer tubing that is housed within the handle. While placing the capsule the internal trigger tube automatically locates and passes through the seal. When capsule is placed onto the handpiece it creates an air loop from the syringe to the front section of the capsule. The capsule is placed against the mucosal wall of the rectum of the patient covering the capsule port. When the syringe is withdrawn this causes negative pressure in the capsule sucking the mucosal and sub mucosal into the capsule. The thumb trigger is pushed forward which pushes the blade forward cutting the tissue that has been sucked into the port. The front of the capsule remains airtight as the trigger/inner tube slides through the internal seal.

The provided text describes a medical device, the RB12 Suction Rectal Biopsy System, and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on:

• Device description and indications for use.
• Substantial equivalence comparison with a predicate device.
• Voluntary standards applied (related to quality systems, sterilization, biocompatibility, etc.).
• Performance data mentioning "bench testing" including a "seal test, a chisel blade test, and an assembled capsule test."
• A "critical evaluation" performed by a pediatric surgeon.
• The FDA's 510(k) clearance letter.

Therefore, I cannot provide the requested information from the given text.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details of a specific study proving performance.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This is a non-AI medical device).
6. Information about a standalone (algorithm only) performance study. (This is a non-AI medical device).
7. The type of ground truth used (e.g., pathology, outcomes data) in a performance study.
8. Sample size for a training set. (This is a non-AI medical device).
9. How ground truth for a training set was established. (This is a non-AI medical device).

The "Performance Data" section briefly mentions "bench testing," but it does not elaborate on the specific criteria, results, or the study design in enough detail to answer the prompt. The "Critical Evaluation" by a pediatric surgeon is an expert assessment, but it is not presented as a structured study with quantifiable acceptance criteria and performance metrics.

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The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature indicated for transendoscopic polypectomy and suction retrieval of lesions between 3mm and 7mm in size.

The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature.

This document is a marketing authorization letter (510(k) clearance) from the FDA for a medical device called the "dSnare™ Diminutive Polypectomy and Suction System."

Crucially, this document does not contain any information regarding acceptance criteria, study details, or device performance metrics. It merely states that the device has been found substantially equivalent to a legally marketed predicate device.

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 text. The document is strictly a regulatory clearance and does not include the technical details of device validation.

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Ask a specific question about this device