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510(k) Data Aggregation
(90 days)
PUMA-G System
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed using the guidewire and Seldinger technique.
The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.
| Acceptance Criteria Category (Derived) | Desired Outcome (Derived) | Reported Device Performance |
|---|---|---|
| Effectiveness (Affixture) | Adequately bring together the stomach and anterior abdominal wall. | "Performance test results demonstrate reasonable assurance that the PUMA-G System can effectively bring together the stomach and anterior abdominal wall..." |
| Safety (Tissue Harm) | Maintain healthy tissue (no harm during affixture). | "...while maintaining healthy tissue." |
| Effectiveness (Guidewire) | Reliably capture and retain the guidewire for gastrostomy tube placement. | "The PUMA-G System also reliably captures and retains the guidewire for eventual completion of the gastrostomy tube placement." |
| Magnetic Force Characterization | Adequate magnetic force for temporary tissue affixture without causing harm. | "The magnetic force was characterized in performance testing to ensure it can adequately create temporary affixture of the tissue (effectiveness) without harming the tissue (safety)." (This is a statement about the purpose of the test rather than the quantitative result, but implies the characteristic was met.) The "Performance Data" section also mentions "magnetic force characterization and coupling strength information," suggesting these were measured and found acceptable. |
| Biocompatibility | Materials are safe for medical use. | "ISO 10993 Compatible" (Table 1) |
| Sterilization | Device can be reliably sterilized. | "Ethylene Oxide ISO 11135 Validated" (Table 1) |
| Time (Procedural) | Procedure time is within acceptable limits. | " |
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(159 days)
PUMA-G System
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.
The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.
The provided text describes the CoapTech PUMA-G System and its substantial equivalence determination, but it does not contain the detailed information requested for acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states that "Bench and animal performance data were collected to support a substantial equivalence determination" and lists the types of testing performed (balloon performance, magnetic force characterization, coupling strength, capture reliability, biocompatibility, and sterilization). However, it does not provide:
- A table of specific acceptance criteria and reported device performance values. It only gives a high-level summary that the "PUMA-G System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue" and "reliably captures and retains the guidewire."
- Sample sizes, data provenance, or details of the test sets.
- Information about experts used for ground truth, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance if it were an AI device (which it is not).
- The type of ground truth used (beyond implying animal and bench testing results).
- Training set information, as this is a medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
Therefore, I cannot fulfill the request with the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on functional and safety performance, but not on detailed performance metrics against predefined acceptance criteria in the format requested.
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(131 days)
G+ SYSTEM
The Glucommander System is a glycemic management tool intended to evaluate current and cumulative patient blood glucose values and coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable clinician determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The Glucommander System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
The Glytec, LLC Glucommander System is a software device used to evaluate current and cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, recommend an IV dosage of insulin, glucose or saline to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2 - 17 years) and adult patients.
Acceptance Criteria and Study for Glytec LLC, Glucommander™ System (K113853)
This 510(k) submission (K113853) is for a modification to an existing device, the GlyTec, LLC G+ System (K101344). The modification is the addition of a pediatric protocol that considers the weight of the patient. As such, the submission focuses on the performance of the modified software and its substantial equivalence to the predicate device, rather than establishing new acceptance criteria or conducting a comprehensive clinical study to prove general device performance.
Based on the provided document, the following can be inferred regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or performance metrics for the modified Glucommander™ System (K113853) in a table format.
Instead, the submission relies on demonstrating substantial equivalence to the predicate device (K101344) and emphasizes that the modifications introduced (pediatric protocol) do not raise new safety or effectiveness concerns.
The reported "performance" is qualitative, focusing on functional aspects:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate device (K101344) for adult patients | "Other user screen labeling such as the function of screen buttons, the ability to add additional patient data and user information, the ability to password protect information and other similar security features, data handling performance, user controlled automatic system shutdown and software update notifications are unchanged." |
| Correct Calculation of Initial Multiplier for pediatric patients based on weight | "An additional input validation on the date of birth field identifies pediatric patients and calculates the patient's initial multiplier based on the patient's weight..." |
| Appropriate User Interface Design for adult/pediatric identification | "Initial starting parameters and the user interface design were modified to allow for the easy identification and calculation of initial multiplier based on a pediatric patient's weight that clearly indicate the order set as either adult or pediatric." |
| Software Functionality as intended | "The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended." |
| No New Safety or Effectiveness Concerns compared to predicate device | "Glytec, Inc. believes no differences exist between this system and the predicate system that raise any new safety.or effectiveness concerns." |
2. Sample Size for the Test Set and Data Provenance
The document mentions "usability testing of representative users of the device, software testing and performance testing of the device." However, it does not specify the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature of data).
Given the nature of the submission (modification to an existing device for substantial equivalence), it's likely these tests were focused on verifying the correct implementation of the new pediatric protocol and ensuring no regressions in existing functionalities, rather than a large-scale clinical validation study.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" for a test set. The evaluation appears to be based on internal testing (usability, software, performance) to confirm the new features work as designed and that overall functionality remains equivalent to the predicate.
4. Adjudication Method for the Test Set
Since there is no mention of external experts establishing ground truth for a test set, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The submission focuses on substantial equivalence based on technical modifications rather than a comparative study of human reader performance with and without AI assistance.
6. Standalone Performance Study
A standalone performance study focused on the algorithm only (without human-in-the-loop performance) was implicitly done through "software testing and performance testing of the device." These tests would assess the internal logic and calculations of the Glucommander™ System, including the new pediatric protocol's ability to correctly calculate the initial multiplier. However, the specific metrics and results of such a standalone study are not detailed.
7. Type of Ground Truth Used
For the "software testing and performance testing," the ground truth would likely be based on:
- Engineering specifications and design documents: Verifying that the software calculations and logic conform to the intended design, especially for the new pediatric weight-based multiplier.
- Predetermined correct outputs: For specific test cases, the expected correct IV dosage recommendations or multiplier calculations would be known and used to validate the device's output.
- Clinical rationale: The pediatric protocol's design would be based on clinical understanding of pediatric glycemic management.
The document does not explicitly state that pathology, outcomes data, or expert consensus (external to the development process) were used as "ground truth" in a formal sense for this specific submission.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. As this is a software device for recommending insulin dosages based on blood glucose values and patient parameters, it's likely built on established algorithms and clinical guidelines, rather than relying on a large "training set" in the context of machine learning for image classification, for example. If any machine learning elements were involved, details are not provided.
9. How the Ground Truth for the Training Set Was Established
Given the lack of information on a training set, the method for establishing its ground truth is also not described.
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(46 days)
G+ SYSTEM
The G+ System is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, regulate the infusion of I.V. fluids, through and I.V. infusion pump, and drive the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The G+ System logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
The Glytec, LLC G+ System is a software device intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, regulate the infusion of I.V. fluids, through an I.V. infusion pump, and direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The device is available in a Standard Edition or server based Enterprise Edition.
This 510(k) summary does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a study proving those criteria are met. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a new, comprehensive performance study that establishes and validates new acceptance criteria.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance:
This document does not provide explicit acceptance criteria or detailed performance metrics. The core of this 510(k) is a declaration of substantial equivalence to a predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110). Studies demonstrating new performance would have been required for a device that wasn't substantially equivalent to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No information is provided regarding a test set sample size or data provenance for a performance study. Since this is a Special 510(k) and focuses on substantial equivalence, it's likely they are relying on the predicate device's established performance without conducting new, extensive performance trials.
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):
No information is provided regarding experts or ground truth establishment for a test set. This would be relevant if a new performance study were conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No information is provided on an adjudication method, as there's no mention of a performance study with a test set.
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 information is provided about an MRMC study or the effect size of human improvement with AI assistance. This document describes a software device for dose calculation, not an AI for image interpretation or diagnosis where MRMC studies are common.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device description explicitly states: "The G+ System logic is not a substitute for, but rather an assist to clinical reasoning... No medical decision should be based solely on the recommended guidance provided by this software program." This indicates it's designed for use with human-in-the-loop. Therefore, a standalone performance study in the sense of a fully autonomous algorithm acting without human oversight would contradict its intended use. However, no specific standalone performance study results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No information is provided regarding the type of ground truth used, as there's no mention of a new performance study requiring ground truth establishment.
8. The sample size for the training set:
No information is provided regarding a training set sample size. This document focuses on a "Special 510(k)" for modifications to an existing predicate device, implying that the core algorithms and their validation likely happened with the original device and are not being re-evaluated with a new training set.
9. How the ground truth for the training set was established:
No information is provided on how ground truth was established for a training set.
In summary:
This document is a Special 510(k), which is typically used for modifications to an existing device where the changes do not significantly affect the safety or effectiveness. The primary claim for regulatory clearance is substantial equivalence to the predicate device (CollaborativeMed, LLC, Glucommander Plus #K061110) based on an analysis of "overall performance characteristics." This type of submission generally does not require a new, comprehensive clinical or performance study with new acceptance criteria and detailed data as would be found in a Traditional 510(k) for a novel device or a device with significant changes in technology or indications. The assumption is that the predicate device already demonstrated adequate performance.
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