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510(k) Data Aggregation
(287 days)
The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.
Only intended for adult patients, not for pediatric use.
The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.
The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.
The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food
The provided text does not contain information about an AI/ML-driven medical device, an acceptance criteria table with reported device performance for such a device, or a study that proves a device meets specific acceptance criteria using AI/ML technology.
The document is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically an AMSure® Enteral Feeding Pump and Feeding Set. It details the device's indications for use, technological characteristics, and compares it to a predicate device (SENTINEL Enteral Feeding pump K011587) to demonstrate substantial equivalence.
While the document mentions "custom software designed to allow the user to set feed rates and volumes as well as other feeding options" and "2 separate MCUs, and each MCU embeds a specific software in order to secure the pump's running," this refers to basic embedded software for controlling the pump's mechanical functions and not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies.
Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance for an AI/ML device, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details, or ground truth establishment) because the document describes a traditional medical device without AI/ML components.
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(259 days)
The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.
The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.
The provided text is a 510(k) summary for the PUGGLE® Enteral Feeding Pump and Feeding Set. It outlines the device's technical characteristics and how it compares to a predicate device (Kangaroo™ Connect Enteral Feeding Pump and Set K143263). The document primarily focuses on demonstrating substantial equivalence to the predicate, rather than detailing a specific clinical study with acceptance criteria and device performance in the way a traditional clinical trial report would.
However, based on the Performance Testing section, we can extract information regarding acceptance criteria in the form of standards and general performance attributes, and the "reported device performance" is indicated by the statement that the device was verified and validated to meet these requirements.
Here's an attempt to structure the information based on your request, acknowledging that some fields may not be directly available in the provided document:
1. Table of Acceptance Criteria (based on standards and essential performance) and an indication of Device Performance
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance (as stated in the document) |
|---|---|
| Software Verification & Validation per FDA Guidances | Software verification and validation were successfully performed for a Major Level of Concern, in accordance with FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices" and "Infusion Pump Total Product Life Cycle." |
| Cybersecurity Evaluation per FDA Guidances | Cybersecurity was evaluated, and the risk associated with cybersecurity-related hazards was determined to be low, following FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Electrical Safety per IEC 60601-1 | Electrical Safety testing was successfully completed in accordance with IEC 60601-1:2005 AAMI ES 60601-1:2005. |
| EMC per IEC 60601-1-2:2014 | Electromagnetic compatibility evaluation was successfully performed against IEC 60601-1-2:2014. |
| Administration Set Compatibility | Verification of essential pump performance was completed with the indicated administration sets. |
| Essential Performance Requirements (e.g., Flow Rate Accuracy, Occlusion Detection, Alarms) | The essential performance requirements (including feeding sets) were verified through performance testing in accordance with the intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle." This included: System V&V, Performance testing of essential attributes, Stability testing of feeding set, Flow Rate Accuracy testing across all operating conditions, Downstream Occlusion Detection, Pump Alarms (Air presence, upstream/downstream occlusions, set dislodged, rotor stuck, cassette error). |
| The device's flow rate accuracy is +/- 5%. (Compared to predicate's +/-5% or 0.5 mL/h according to IEC standard 60601-2-24, where the subject device confirmed +/-5% for "all flow rates" not just those in the standard). | |
| The maximum occlusion pressure is 16 psi (110 kPa), and the device has a more sensitive detection of occlusions and raises an alarm in a shorter period compared to the predicate's 20 psi (138 kPa). | |
| Battery Safety per IEC 62133 | NiMH battery safety was successfully tested per IEC 62133. |
| Human Factors per FDA Guidance | Human factors studies were conducted with the intended user population, use environment, and scenarios to simulate clinical conditions. The results demonstrate validation of the device per its intended use, in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Reprocessing/Cleaning per AAMI TIR30 | Compliance with AAMI TIR30:2011/R 2016 for cleaning reusable medical devices. (Implies successful verification). |
| Biocompatibility per ISO-10993 (FDA Guidance) | Biocompatibility testing demonstrated the biological safety of parts of the medical device that may indirectly contact the patient, as outlined in FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
The study that proves the device meets the acceptance criteria is detailed under the "Performance Testing" section within the 510(k) summary. It describes a "safety assurance case" approach.
Detailed Information about the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a numerical sample size for individual performance tests (e.g., how many pumps or feeding sets were tested). It refers to "performance testing of essential performance attributes" and "stability testing of feeding set" but doesn't give a number of units tested.
- Data Provenance: Not specified in the document. It does not mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for bench performance testing of this nature.
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)
- This question is Not Applicable (N/A) in this context. The testing described is primarily bench and engineering validation (e.g., electrical safety, EMC, flow rate accuracy). "Ground truth" established by experts, as in clinical image interpretation, is not relevant here. The "ground truth" for these tests would be the measured physical parameters against defined engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of medical images. For engineering performance testing, the results are typically objectively measured against pre-defined specifications.
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
- N/A. This is an enteral feeding pump, not an AI-assisted diagnostic device. Therefore, MRMC studies or human reader improvement with AI are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is partially applicable in the sense that the device's technical functions (e.g., pump mechanism, sensors, alarms) were tested in isolation (standalone performance) against technical specifications. The "Performance Testing" section confirms that the "essential performance requirements of the device (including feeding sets) were verified through performance testing". This implies testing the device's inherent functionality. However, this is not "algorithm only" in the context of AI but rather the entire device's automated functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests is based on established engineering specifications, national and international standards (e.g., IEC standards), and regulatory guidance documents (e.g., FDA guidance for Infusion Pumps). For example, flow rate accuracy is measured against a defined percentage deviation. Occlusion detection is measured against specified pressure thresholds and response times.
8. The sample size for the training set
- N/A. As an enteral feeding pump, there is no "training set" in the context of machine learning or AI that would require a data sample for training. The device operates based on programmed logic and hardware, not a learned model from a dataset.
9. How the ground truth for the training set was established
- N/A. Since there is no training set, this question is not applicable.
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(122 days)
INTENDED USE:
The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic lowfriction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.
The provided document is a 510(k) summary for the AMSure® Hydrophilic Intermittent Catheter. This document details the regulatory pathway for a medical device and typically does not include the specifics of a standalone algorithm study, MRMC comparative effectiveness study, or details like the number and qualifications of experts for ground truth establishment, which are more common for AI/ML-based device submissions.
Based on the provided text, here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Test items" under "Performance Testing" which serve as the acceptance criteria for the device. The reported performance is that these tests were conducted and demonstrate the device's substantial equivalence. Specific quantitative performance metrics (e.g., specific friction values, flow rates, or strength measurements) that would constitute "acceptance criteria" are not reported in this summary, only the tests performed.
| SN | Test items (Acceptance Criteria) | Reported Device Performance (Summary) |
|---|---|---|
| 1 | Packaging inspection | Conducted |
| 2 | Appearance inspection | Conducted |
| 3 | Leakage | Conducted |
| 4 | Kink resistance | Conducted |
| 5 | Strength test | Conducted |
| 6 | Connector security | Conducted |
| 7 | Flow test | Conducted |
| 8 | Friction value | Conducted |
| 9 | Chemical performance: Reducing matter | Conducted |
| 10 | Chemical performance: pH value | Conducted |
| 11 | Chemical performance: Metal ions | Conducted |
| 12 | Chemical performance: EO residue | Conducted |
| 13 | Biological performance: Sterility | Conducted |
| 14 | Physical performance: Water sachet | Conducted |
| 15 | Chemical performance: sterile water | Conducted |
| 16 | Aging (shelf life/stability testing) | Conducted |
| 17 | Human factor testing | Conducted |
| Biocompatibility | Cytotoxicity, Sensitization, and Irritation | Demonstrated biological safety per ISO 10993-5 and ISO 10993-10 for direct contact with patients. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for performance testing (test set) for any of the listed items (e.g., number of catheters tested for leakage, kink resistance, etc.). The data provenance (country of origin, retrospective/prospective) is also not mentioned.
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)
This information is not applicable and is not provided in the document. The device is a physical urological catheter, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided in the document, as it relates to expert review for diagnostic devices, not performance testing of a physical medical device.
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 MRMC comparative effectiveness study was performed or mentioned. This type of study is relevant for AI-powered diagnostic devices, which this catheter is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not performed. The device is a physical medical device (catheter) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests would be based on the established standards for each physical and chemical test (e.g., passing a specific leakage pressure, meeting a defined friction value, demonstrating sterility). For biocompatibility, the ground truth is generally adherence to ISO 10993 standards and the absence of adverse biological reactions. It's not a diagnostic "ground truth" in the AI/ML sense.
8. The sample size for the training set
This information is not applicable. The device is a physical catheter, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical catheter and does not involve a training set.
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(99 days)
AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush
- For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
- For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications.
The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.
The provided text is an FDA 510(k) summary for a medical device: "AMSure Sterile Water, and Sterile Normal Saline for Wound Flush." This document outlines the manufacturer's claim that their device is substantially equivalent to legally marketed predicate devices.
However, the document does NOT contain information about an AI/algorithm-driven device, nor does it present data from a "study that proves the device meets the acceptance criteria" in the way one would for an AI-powered diagnostic tool.
The acceptance criteria mentioned are related to:
- Biocompatibility: Ensuring the materials are safe for patient contact.
- Performance: Meeting USP standards for sterile saline and sterile water.
- Stability: Maintaining properties after accelerated aging.
The "studies" are described as "Nonclinical Testing (Bench)" and include:
- Biocompatibility testing: Demonstrated biological safety.
- Performance testing: Demonstrated meeting USP standards.
- Stability testing: Evaluated properties after accelerated aging.
The conclusion is that the device "passed all acceptance criteria."
Given this, I cannot provide the detailed information requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided text. The device in question is a simple medical product (sterile water/saline for wound flush), not a complex AI diagnostic system.
Therefore, the table and other detailed points will reflect the lack of this information from the provided document.
Acceptance Criteria and Device Performance (Based on provided document)
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Biological safety for direct/indirect patient contact (ISO10993 standard) | Demonstrated as non-cytotoxic, non-irritating, and non-sensitizing. |
| Performance | Meet USP<40> requirements for sterile saline and sterile water. | Demonstrated that proposed devices meet the standard on USP Sterile Saline and USP Sterile Water. |
| Stability | Maintain properties after accelerated aging. | Evaluated properties after accelerated aging in support of the labeling; results shown to pass acceptance criteria. |
Study Details (Information Not Available or Applicable for this type of device)
- Sample size used for the test set and the data provenance: Not applicable. The "tests" were benchtop performance, biocompatibility, and stability testing on the product itself, not a clinical study on patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound flush solution is based on chemical composition and sterility standards (USP<40>), not expert clinical review of images or data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of clinical findings.
- 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 sterile water/saline, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component to this device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was based on established industry standards and regulations for medical devices, specifically USP<40> for chemical composition and sterility, and ISO10993 for biocompatibility.
- The sample size for the training set: Not applicable. There is no training set as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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