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The Aquarius™ Nasal Feeding Tubes, /Nasogastric & Nasojejunal / provide nutritional support for patients who require liquid feedings as a substitution for solid food. Intended for enteral administration of nutrients. fluids and/or medications into alimentary tract via natural nasoenteric route.

The Aquarius™ Nasogastric Tubes are for the administration of nutrition. fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continued feeding/and or medication into the stomach.

The Aquarius™ Nasojejunal Feeding Tubes are for the administration of . nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Designated for patients who are critically ill and require early enteral feeding/and or medication into the small intestine; may be with a dual tube allowing simultaneous gastric drainage.

The Aquarius™ Nasal Tube / Nasoqastric Tube (NG-Tube) & Nasojejunal Tube (NJ Tube) / are enteral feeding tubes comprised of flexible tubes and ENFit enteral specific connection access. The tubing part of the devices is constructed with radiopaque polyurethane material and with a hydrophilic coating at the distal end to assist the easy insertion of the tube. The Nasogastric Tube may be with metal stylet and/ or with weighted tip to assist the tube insertion and to maintain the tube in the place. The Nasoieiunal Tube is with stylet and with radiopaque polyurethane antenna tip at the distal end of the tubing to assist to advance the tube into the jejuna. There is an external marking on both NG & NJ-Tubes for measuring of the tube length inserted into the alimentary tract.

This document describes the Aquarius™ Nasal Feeding Tubes (Nasogastric & Nasojejunal) and their substantial equivalence to predicate devices, based on nonclinical testing. It does not contain information about studies proving the device meets acceptance criteria or details regarding human reader performance, AI-assistance, or ground truth establishment for AI/ML-based devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, implying these tests serve as acceptance criteria. However, explicit numerical acceptance criteria and the quantitative reported performance for each are not provided in this document. Instead, it states that the device was "found to be in compliance with the design and performance requirements."

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

This document summarizes nonclinical testing. It does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the tests conducted. These tests are typically performed on physical samples of the device, not patient data in the context of an AI/ML device.

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

This information is not applicable as the document describes nonclinical, physical device testing, not an AI/ML study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the document describes nonclinical, physical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This document describes the 510(k) premarket notification for a physical medical device (feeding tubes), not an AI/ML-driven diagnostic or assistive system that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used:

The "ground truth" for the nonclinical tests would be the established engineering specifications and international standards (e.g., ISO 80369-1:2010, EN1615:2000, ISO 10993 series, ISO 14971:2012). The device's physical properties and performance during these tests are compared against these predetermined specifications.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/ML device and therefore does not have a training set in that context.

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

This information is not applicable as this is not an AI/ML device.

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AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.

The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.

This document describes a Special 510(k) submission for the AQUARIUS™ Extension Feeding Set, focusing on its non-clinical summary. The submission asserts that the device is substantially equivalent to a predicate device (K132686).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for each test mentioned (e.g., number of devices tested for tensile strength, flow rate, leakage, or biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The non-clinical summary suggests these were laboratory-based tests conducted on the proposed device.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This study involves non-clinical (laboratory) testing, not assessments that require human expert interpretation of results to establish ground truth in the way medical imaging or diagnostic tests do. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is established by the objective measurements and observations against pre-defined engineering and safety standards.

4. Adjudication Method for Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., when multiple readers assess images and their opinions need reconciliation). As this is a non-clinical, laboratory-based study focusing on device performance and safety, an adjudication method is not applicable. The results are based on direct measurements and adherence to specified standards.

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

No MRMC comparative effectiveness study was conducted. This device is an extension feeding set, and the evaluation is based on its physical properties, biocompatibility, and functional performance, not on diagnostic accuracy requiring human interpretation or comparison with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was conducted. This is a medical device (hardware), not an algorithm or AI software. Therefore, this section is not applicable.

7. Type of Ground Truth Used

The ground truth used in these non-clinical studies is based on:

• Standardized Test Methods and Criteria: These are established by international and national standards such as ISO 10993-5, ISO 10993-10, ISO 80369-1 Annex B, and AAMI/ANSI ID54.
• Objective Measurements: Results are derived from quantitative and qualitative measurements (e.g., tensile strength values, flow rates, visual inspection for leakage, assays for cytotoxicity, irritation, sensitization, and physical connection tests for compatibility).
• Compliance with Specifications: The device's performance is compared directly against pre-defined engineering and safety specifications derived from the predicate device and relevant standards.

8. Sample Size for the Training Set

This product is a physical medical device. The concept of a "training set" is typically associated with machine learning algorithms. Therefore, a training set as understood in that context is not applicable. The device's design and manufacturing processes are likely informed by prior engineering knowledge and predicate device characteristics, but there isn't a "training set" in the AI sense.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI algorithm, the method for establishing its ground truth is not applicable. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, regulatory requirements, and the performance characteristics of the predicate device.

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AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system.

Not Found

This FDA 510(k) clearance document for the AQUARIUS™ Enternal Extension Set is a premarket notification, indicating substantial equivalence to a predicate device. It does not include detailed information on acceptance criteria or the specific studies performed to demonstrate performance.

Therefore, the requested information cannot be fully extracted from the provided text. The document primarily focuses on regulatory approval based on equivalence and administrative details.

Here's what can be stated based on the provided text, and what cannot:

What can be extracted:

• Device Name: AQUARIUS™ Enternal Extension Set
• Regulatory Class: II
• Product Code: KNT
• Indication for Use: "AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system."
• Type of Use: Prescription Use

What cannot be extracted from this document:

• A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a detailed study report. It states that the device is "substantially equivalent" to a legally marketed predicate device, but does not provide specific performance metrics or acceptance criteria for that equivalence.
• Sample sized used for the test set and the data provenance: Not available.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• Adjudication method: Not available.
• 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 is not an AI device or an imaging device requiring reader studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• The type of ground truth used: Not available. The clearance is based on substantial equivalence, implying performance similar to a predicate device, but the specific "ground truth" for the current device's testing is not detailed here.
• The sample size for the training set: Not applicable. This is not an AI algorithm.
• How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Conclusion:

The provided document is a 510(k) clearance letter from the FDA. It confirms that the AQUARIUS™ Enternal Extension Set is substantially equivalent to a predicate device for its stated indications for use. However, it does not contain the detailed technical or clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert qualifications, that would typically be found in a study report. This kind of detailed information is part of the 510(k) submission, but not part of the publicly released clearance letter.

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SILICONE FOLEY CATHETER WITH TS, 6FR, intended for urological use only. TSC indicated for drainage of the urinary bladder and simultaneous monitoring of temperature.

Not Found

This document is a 510(k) premarket notification FDA approval letter for a SILICONE FOLEY CATHETER WITH TS, 6FR, (TSC). It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.

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

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Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Degania Silicone Gastrostomy Button. It is not a study report and therefore does not contain the information requested in your prompt regarding acceptance criteria and performance data for a device.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device but does not provide any details about performance criteria, study design, or results.

To answer your questions, I would need access to the actual 510(k) submission (K122030) or a separate study report for the Degania Silicone Gastrostomy Button.

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Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.

Maximum recommended indwelling time is not more than 30 days.

Prescription Use ONLY (Part 21 CFR 801 Subpart D)

Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.

This document is a 510(k) summary for a medical device (Coude Foley catheter / or Tiemann Foley catheter). It primarily focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

Therefore, the provided text does not contain information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies as requested in the prompt.

The document states the "Indications for Use" for the device, which is "for routine drainage of the urinary bladder" with a "Maximum recommended indwelling time is not more than 30 days." However, these are indications, not performance metrics or acceptance criteria.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a detailed technical specification for the device.

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Gastrostomy Replacement Tube of Degania Silicone Ltd is indicated for use in a well established Gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Gastrostomy Replacement Tube and does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information.

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All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Urinary Foley catheter

This document is a 510(k) premarket notification approval letter for a Foley Catheter. It discusses the regulatory approval, but it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

Therefore, I cannot fulfill your request based on the provided text. The document is about a traditional medical device (a catheter), not a device that relies on AI/ML.

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The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. The Identi Loops is not designed nor indicated for implantation.

The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction,, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation. The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber. The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi. The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Degania Silicone Identi Loops:

The provided documents are a 510(k) Summary and an FDA-issued clearance letter for the Degania Silicone Identi Loops. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific performance data from a clinical or technical study in the format typically used for AI/ML device evaluations.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from these documents. The "study" in this context is the submission for 510(k) clearance based on substantial equivalence to a predicate device, not a performance study as would be conducted for a novel device or AI/ML product.

Here's a breakdown of the available information:

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

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

• Not applicable / Not provided. The submission is based on substantial equivalence, not a clinical "test set" with performance data in the typical sense. It relies on the existing safety and effectiveness of the legally marketed predicate device.

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

• Not applicable / Not provided. No such "ground truth" establishment process for a test set is described, as the submission focuses on comparing the new device's characteristics to a predicate, not evaluating its performance against a new dataset. The "experts" involved would be the regulatory affairs personnel and potentially internal engineers at Degania Silicone, as well as the FDA reviewers.

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

• Not applicable / Not provided. No adjudication method is described for a test set. The determination of substantial equivalence is made by the FDA based on the information provided in the 510(k) submission.

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

• No. This is not an AI/ML device, and no MRMC study was performed or is relevant to this type of medical device clearance.

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

• No. This is not an AI/ML device.

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

• Not applicable / Not provided in the context of device performance. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (which in this unique case, is an earlier version of the same manufacturer's device). The argument is that the new device is sufficiently similar to the predicate that it raises no new concerns about safety or effectiveness.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device, so there is no "training set."

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

• Not applicable / Not provided. As there is no training set, this question is not relevant.

In summary: The provided documents represent a 510(k) substantial equivalence submission, which operates on the principle that if a new device is sufficiently similar to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness profile), it does not require a new premarket approval. Therefore, the "study" is the comparison against the predicate, and the "acceptance criteria" are compliance with FDA's substantial equivalence requirements, rather than performance metrics from a traditional clinical study.

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The Sil-K is designed and indicated for treating thick painful, itchy, red and raised hypertrophic or keloid scars.

Sil-K is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars. Sil-K is designed to be used only after the skin has completely healed and is non invasive.

This document is a 510(k) summary for Degania Silicone Sil-K, a silicone elastomer sheet used to treat hypertrophic or keloid scars. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested elements for a study proving device meets acceptance criteria cannot be extracted because such a study is not detailed in the provided text.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text, as this is a 510(k) for substantial equivalence, not a performance study against specific criteria. The core acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
• Reported Device Performance: Not detailed in terms of measurable outcomes (e.g., scar height reduction, pain relief) from a clinical study. The document states the device "is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars," implying its intended function, but no performance metrics are provided.

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

• Sample Size: Not applicable. No test set or clinical study is described.
• Data Provenance: Not applicable. No study data is presented.

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

• Not applicable. No test set or ground truth establishment by experts is described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication process is described.

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 silicone sheet, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used:

• Not applicable. No ground truth is established as no performance study is detailed.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable. (See #8)

Key Information from the Document Regarding "Acceptance Criteria" for a 510(k):

The primary "acceptance criteria" for a 510(k) submission is to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device.

• Predicate Device: "We are Substantially Equivalent to ourselves." This statement indicates that Degania Silicone is submitting for a new Premarket Notification for a device (Sil-K) that is deemed substantially equivalent to a previous version of their own device that was already cleared (510(k) number K914701).
• Basis for SE: The document states: "The Sil-K is manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k)." This is the justification for claiming substantial equivalence.

In essence, the "study" proving the device meets 510(k) acceptance criteria (i.e., substantial equivalence) is the comparison of the manufacturing process, raw materials, and intended use of the new Sil-K device to its previously cleared predicate device, and finding them identical or sufficiently similar. There is no performance study against specific clinical outcomes detailed in this document.

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