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510(k) Data Aggregation
(177 days)
Disposable Enteral Feeding Sets
The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents, and adults.
The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults. The proposed device is provided sterile or non-sterile and single use.
The provided text is a 510(k) Pre-market Notification for a medical device called "Disposable Enteral Feeding Sets". The document largely focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in a study description for evaluation of AI/algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria in an AI/algorithm context. The document describes standard performance testing for a physical medical device, not a software or AI device.
Here's why and what information can be extracted regarding general acceptance criteria and testing:
Why the requested information cannot be fully provided from this document:
- No AI/Algorithm Focus: The device is a "Disposable Enteral Feeding Set," which is a physical medical device for enteral nutrition. There is no indication that it incorporates any AI, machine learning, or complex algorithms that would require the kind of performance studies (e.g., standalone performance, MRMC studies, ground truth establishment by experts) typically associated with AI/ML-driven medical devices.
- "Acceptance Criteria" for Physical Device: The term "acceptance criteria" here refers to the performance specifications and safety standards for a physical product (e.g., leak integrity, flow rate, material biocompatibility, sterility), not diagnostic accuracy or clinical utility of an AI.
- "Study" for Physical Device: The "study" mentioned refers to non-clinical performance tests (chemical, physical, sterility, ENfit physical performance) conducted on the physical device to ensure it meets established safety and performance standards relevant to its physical function. It is not a clinical efficacy study or an AI performance study.
Information that can be extracted relevant to general performance and acceptance (for a non-AI physical device):
-
A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria paired with reported device performance values. It states that "the test result showed that the aged proposed device met the acceptance criteria" for various tests. The specific acceptance criteria are implicitly those defined by the referenced international standards and internal procedures.Acceptance Criteria (Implied) Reported Device Performance Compliance with ISO 20695:2020 Annex C & D Met Compliance with ISO 8536-4:2022 Annex B Met Compliance with ISO 8536-4:2020 Annex B.4 Met Compliance with ISO 80369-20:2015 Met Compliance with USP Sterility Tests Met Final product inspection procedure specifications Met Performance of bag part (e.g., integrity, capacity) Met Performance of spike part (e.g., connection integrity) Met Biocompatibility (for patient-contact material) Met (no adverse effects) -
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 sizes for the non-clinical performance tests. The data provenance is implied to be from the manufacturer's testing in China, as the applicant is "Beijing L&Z Medical Technology Development Co., Ltd." These are non-clinical lab tests, not human data. -
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):
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or prognostic devices. For a physical device like an enteral feeding set, performance is evaluated against engineering specifications and international standards, not against expert human interpretations of data. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a physical device's non-clinical performance testing. -
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. The device is a physical feeding set, not an AI or imaging device that would involve human readers or AI assistance. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. Performance is measured against physical and chemical standards and specifications (e.g., sterility, dimensional accuracy, material integrity, flow rates), not a ground truth derived from expert consensus, pathology, or outcomes data. -
The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML model that requires training data. -
How the ground truth for the training set was established:
Not applicable.
In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device and therefore do not contain the information requested regarding AI/algorithm performance studies.
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(103 days)
Enteral Feeding Sets
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
The provided document is a 510(k) Premarket Notification from the FDA for "Enteral Feeding Sets." It describes the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.
However, the document does not contain any information about a study that proves the device meets the acceptance criteria for an AI/ML powered medical device. The acceptance criteria and testing detailed in the document are for traditional medical device performance, such as dimensions, material properties, leakage, tensile strength, and biocompatibility. There is no mention of AI models, test sets for AI performance, expert ground truth establishment, or MRMC studies.
Therefore, I cannot fulfill your request for information regarding AI/ML acceptance criteria and study details based on the provided text.
If you are looking for an example of how such a request would be answered for an AI/ML device, please provide a document that discusses an AI/ML powered medical device and its validation.
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(108 days)
U Deliver Bolink ENFit Enteral Feeding Sets
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:
- U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
- U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
The provided document is an FDA 510(k) clearance letter for a medical device: "U Deliver Bolink ENFit Enteral Feeding Sets." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.
However, the document does not contain any information about an AI/ML-driven medical device. Specifically, it does not describe:
- An AI algorithm or its performance.
- Acceptance criteria for an AI model.
- A study that proves an AI device meets acceptance criteria, including details on sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details.
The "Performance Data" section explicitly states: "No new device testing was necessary as no changes have been been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use." This confirms that the critical study mentioned was a usability test for a physical device, not an AI performance study.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI device based on this document.
The document pertains to the clearance of a physical medical device (enteral feeding sets) and its change in indications for use from prescription-only to over-the-counter, based on usability testing and substantial equivalence to a cleared predicate device.
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(59 days)
CONOD Enteral Feeding Sets
CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
The CONOD Enteral Feeding Sets have three models, CONOD safety spike plus pump set, CONOD gravity feeding set and CONOD feeding pump set. The CONOD Feeding Pump Set (1200ml) and gravity feeding set both have a structure of a 1200ml formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. CONOD Safety spike plus Pump Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification for "CONOD Enteral Feeding Sets," which is a medical device for dispensing liquid nutrition. The provided sections detail:
- Submission Information: Company, contact, device name, regulation, product code.
- Device Description: Models (pump set, gravity set, safety spike plus pump set), single-use, non-sterile.
- Indications for Use: Dispensing liquid nutrition at a user-controlled rate, interfacing with a feeding tube, for infants, children, adolescents, and adults.
- Comparison to Predicate Device (K150286, Medline Enteral Feeding Sets): Highlights similarities in intended use, product code, classification, design features (non-DEHP material, ISO 80369-3:2016 connector), materials, prescription use, disposability, intended use time (no longer than 24 hours), non-sterility, shelf-life, and available tube lengths.
- Performance Data: This section describes biocompatibility testing (cytotoxicity, sensitization, skin irritation, 10993-1, 10993-5, 10993-10 standards) and performance testing (fluid leakage, stress cracking, resistance to separation (axial load, unscrewing), resistance to overriding, disconnection by unscrewing, tensile properties, liquid leakage, flow rate, bioburden, usability), all conducted according to various ISO/EN/IEC standards.
- Animal Study/Clinical Study: States that neither was required.
- Conclusion: The device is substantially equivalent to the predicate based on non-clinical data and performance testing.
The "performance data" discussed refers to engineering and material safety tests for the medical equipment itself, not the performance of an AI/ML algorithm. Therefore, I cannot extract the information requested about AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth for an AI/ML device.
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(174 days)
U Deliver Bolink ENFit Enteral Feeding Sets
The U Deliver Bolink ENFit Enteral Feeding Sets are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:
- U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. . BK-1085)
- U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) .
The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO/DIS 18250-3. 'Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
This document is a 510(k) premarket notification for the U Deliver Bolink ENFit Enteral Feeding Sets, establishing substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with human subjects or medical imaging analysis.
Instead, the document focuses on bench testing to demonstrate physical and functional equivalence of the U Deliver Bolink ENFit Enteral Feeding Sets to the predicate device and compliance with recognized standards.
Here's an analysis of the information provided, addressing the requested points where applicable, and noting where the information is not present in this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it lists the types of bench tests conducted, implying that the acceptance criteria for these tests are met by conforming to recognized standards (ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, ISO 10993) or by demonstrating equivalence to the predicate device.
Bench Tests Performed (Implied performance met as per standards/equivalence):
| Test Type | Basis for Acceptance (Implied) |
|---|---|
| Fluid leakage | Compliance with ISO 80369-3 and ISO 80369-20 |
| Stress cracking | Compliance with ISO 80369-3 and ISO 80369-20 |
| Resistance to separation from axial load | Compliance with ISO 80369-3 and ISO 80369-20 |
| Resistance to separation from unscrewing | Compliance with ISO 80369-3 and ISO 80369-20 |
| Resistance to overriding | Compliance with ISO 80369-3 and ISO 80369-20 |
| Disconnection by unscrewing | Compliance with ISO 80369-3 and ISO 80369-20 |
| Dimensional analysis of ENFit connectors | Compliance with ISO 80369-3 |
| Biocompatibility testing | Compliance with ISO 10993 |
| Flow rate testing (water and enteral feeding formula) | Equivalent or superior performance to predicate device (e.g., 4.0 mm lumen > 3.4 mm predicate) |
| Tensile testing | Compliance with relevant standards (implied, likely ISO 80369-20) |
| Packaging validation | Adherence to industry best practices/standards for sterile barrier systems (implied) |
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 the exact sample sizes used for each bench test. It generally states that "Bench tests have been carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets."
- Data Provenance: The document implies that the testing was performed by or for the manufacturer (Cedic S.r.l., Italy, a contract manufacturer). The submission itself is from U Deliver Medical, LLC (USA). The testing is prospective (conducted specifically for this submission).
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 to this type of device and submission. This is a medical device for delivering nutritional formulas, not an imaging or diagnostic device that requires expert interpretation to establish a 'ground truth'. The "ground truth" here is compliance with technical standards and functional performance metrics, verified through engineering bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions. This submission relies on objective engineering measurements and compliance with recognized standards.
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 is not a software device, an AI-powered diagnostic tool, or a device that involves "human readers." It's a physical enteral feeding set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve algorithms or AI. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by:
- Technical Standards: Compliance with FDA-recognized international standards such as ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, and ISO 10993. These standards define the required physical dimensions, mechanical properties, and biocompatibility.
- Predicate Device Equivalence: Demonstrating that the subject device performs similarly to or better than the legally marketed predicate device (Metrixcare Enteral Feeding Sets, K132424) in relevant functional aspects (e.g., flow rate).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(81 days)
Medline Enteral Feeding Sets
Medline Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.
Medline Enteral Feeding Sets consist of the following three configurations:
- 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
- 2.) Medline Enteral Feeding Pump Spike Set
- 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)
The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.
Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consiting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors.
The provided text describes a 510(k) premarket notification for Medline Enteral Feeding Sets, comparing them to a predicate device. The core of the submission is the replacement of a 4-step Distal Tip Connector with an ENFit connector, aiming to improve safety by mitigating misconnections.
Here's an analysis of the acceptance criteria and the study information, focusing on what is explicitly stated and what cannot be determined from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists various performance tests conducted and generally states that the results demonstrated the device's function and performance were not altered, and that it met requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Mitigate risks of misconnections (with ENFit connector) | "replacement... does not alter the function or performance of the devices and does not raise additional questions or compromise the safety and/or effectiveness of the device." |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | Passed ISO 10993 standards. |
| Absence of toxicological health risks (Leachable and Extractable) | Completed analysis with comprehensive Toxicological Health Risk Assessment. |
| Performance: | |
| Resistance to misconnection (Enteral Connector Misconnection Assessment Study, PG-Lock Misconnection Data, Human Factors Validation) | Tested and evaluated to show resistance to misconnection. (Specific quantitative results not given). |
| Functional performance (Falling Drop Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load/Unscrewing/Overriding, Disconnection by unscrewing, ENFit Component Verification, Bond Strength, Connection Strength) | Tested and evaluated. "does not alter the function or performance..." (Specific quantitative results not given). |
| Compatibility with pumps (Pump Compatibility Testing) | Tested against predicate. (Specific results not given). |
| Flow rate similar to predicate (Flow Rate Testing) | Tested against predicate. (Specific results not given). |
| Bioburden control (Bioburden Testing) | Tested against predicate. (Specific results not given). |
| Manufacturing quality (Cross Cavity Metrology Testing) | Tested. (Specific results not given). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed (e.g., "Enteral Connector Misconnection Assessment Study," "Human Factors Validation Study").
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by Medline Industries, Inc. or their contracted labs.
- Retrospective or Prospective: Not specified. Performance testing is typically prospective, but the document does not confirm this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document details engineering and performance testing, not a study requiring expert clinical assessment for ground truth. The "Human Factors Validation Study" might involve user evaluation, but the number or qualifications of "experts" are not mentioned.
4. Adjudication Method for the Test Set
This is not applicable as the studies described are performance and engineering tests, not clinical evaluations requiring adjudication of subjective assessments.
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 is not applicable. This document describes a medical device (enteral feeding sets), not an AI/imaging diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and component designs, and their adherence to engineering standards (e.g., ISO 80369-1 for ENFit connectors) and device specifications. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI model development described here.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (see point 8).
In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on engineering performance, biocompatibility, and functional compatibility testing to demonstrate substantial equivalence to a predicate device, particularly concerning a design change to incorporate an ENFit connector. It does not contain information typically found in studies for AI/software as a medical device (SaMD) or clinical diagnostic studies that would involve "test sets," "training sets," "experts," or "adjudication."
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(102 days)
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.
Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic and Parameters | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Product Code | KNT | KNT |
| Intended Use | "The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or spike to connect to a per-filled container." | Same |
| Luer Adapter | Slip Loc design, PVC USP Class VI Material | Standard Adapter USP Class VI Material |
| Luer Cap | Designed to fit Slip Loc, PE | Standard design fit Same Material (PE) |
| Feed Tubing (All) | PVC, USP Class VI Material | Same (PVC, USP Class VI Material) |
| Pump Tubing (Pump and Spike Set) | Silicone, USP Class VI Material | Same (Silicone, USP Class VI Material) |
| Bag Assembly (Gravity & Pump Set) | 500 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Bag Assembly (Gravity & Pump Set) | 1200 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Clamp (All) | ABS | Same (ABS) |
| Materials in Fluid Pathway (All) | USP Class VI Material | Same (USP Class VI Material) |
| Spike Adapter (Spike Set Only) | ABS, USP Class VI Material | Same (ABS, USP Class VI Material) |
| Spike Adapter Cap (Spike Set Only) | PE | Same (PE) |
| Performance Tests | ||
| Intracutaneous Reactivity Test | Class VI USP (Pass) | Passes |
| Systemic Injection Test | Class VI USP (Pass) | Passes |
| Muscle Implantation Test | Class VI USP (Pass) | Passes |
| Luer Taper Inspection | AAMI/ANSI ID54.1996/(R)2005 Sect. 4.1 & 4.2 (Pass) | Passes |
| Erythema and Edema Scores | Meets requirements | Meets requirements |
| Physical Specifications and Dimensions | Meets requirements | Meets requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a separate "test set" in the sense of a clinical or image-based dataset. The testing described focuses on material properties and physical conformance.
- Sample Size for testing: Not explicitly stated for each test (e.g., number of devices tested for Luer taper inspection). However, it implies testing was conducted on samples of the Dynarex Enteral Feeding Sets.
- Data Provenance: The testing was conducted by Dynarex Corporation to demonstrate substantial equivalence to the predicate device. The document does not specify a country of origin for the data beyond Dynarex being a US-based company, and the nature of the tests suggests laboratory or bench testing rather than patient data. It is therefore prospective with respect to the device's design and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device clearance based on substantial equivalence to a predicate device, primarily through material and functional characteristic comparison, and safety testing (biocompatibility, physical standards). It does not involve expert interpretation of medical images or patient outcomes in the way an AI/ML device would.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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 is not an AI/ML device, nor does it involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on established industry standards and validated test methods for material biocompatibility (Class VI USP) and physical performance (AAMI/ANSI ID54.1996/(R)2005). The comparison is also made against the specifications and performance of the legally marketed predicate device (Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use K012147), which serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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(97 days)
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding, pump and pump set. The pump and feeding sets are intended to be used in alternate, acute and home care settings by users ranging from laypersons to clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patients gastrointestinal system.
The ePump "" platform is a new enteral feeding system comprised of an enteral feeding pump and disposable Enteral Feeding Sets. This Class II device is an enteral feeding pump that delivers formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. This enteral feeding pump is an attitude independent pump offering a streamlined graphical user interface that walks the user through the ePump" setup and operation with many new features to allow the ability to both feed nutrition and flush when required.
The ePump™ Enteral Feeding Pump Sets are compatible with standard prefilled formula containers presently available on the market. The ePump" enteral feeding pump sets are also designed to be compatible with present marketed enteral access devices and accessories (extension sets).
The provided text describes the Kendall ePump™ Enteral Feeding Pump and Enteral Feeding Sets, submitted for 510(k) clearance in 2004. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics, especially in the context of AI/ML or diagnostic performance studies.
Instead, this document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: For whom and in what settings the device is to be used.
- Predicate Device Comparison: Establishing substantial equivalence to an already marketed device (Kangaroo 524 Enteral Feeding Pump & Administration Sets).
- Nonclinical Testing (Biocompatibility): Mention of biocompatibility testing according to ISO Standard 10993, Part 1. This is a safety test, not a performance study as typically understood for AI/ML devices.
- FDA Clearance Letter: Official communication from the FDA granting 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. The document is for a medical device approval that predates the common application of AI/ML in medical diagnostics and does not include the type of performance study details you are asking for.
If you have a different document that describes such acceptance criteria and a study for an AI-powered device, please provide that text.
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(115 days)
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include an interesting point on a spike to connect to a pre-filled container.
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a use gravity of an interesting point on a spike to connect to a pre-filled container.
The provided document is a 510(K) summary for ZEVEX, Inc.'s Enteral Feeding Sets for Gravity and Pump Use. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study showing device performance against specific acceptance criteria.
The document discusses various modifications to the enteral feeding sets, including a new "Slip Loc" enteral adapter design, a modified cap, an Anti Free Flow Fitting for pump models, and smaller surface area bags for some models. The "study" mentioned isn't a complex clinical trial but rather a series of engineering tests to confirm the modifications do not reduce safety or effectiveness.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical clinical study. However, it lists tests performed and a general conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: USP Class VI for new materials and colorants approved by FDA for food grade applications. | New materials ('Slip Loc' enteral adapter and anti free flow fitting) are USP Class VI. Colorants are approved by FDA for food grade applications. Cytotoxicity test results indicated biocompatibility met requirements. |
| Volumetric Accuracy: (for pump sets, implied to be within acceptable limits for nutrient delivery) | Testing included a volumetric accuracy test. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Blow-by Pressure: (for anti free flow fitting, implied to be sufficient to prevent flow) | Testing included a test to check the blow-by pressure of the anti free flow fitting. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Bond Strength: (between components, implied to be sufficient for structural integrity) | Testing included a bond test to check the bond strength between components. Results "indicated that the modifications have not reduced the safety or effectiveness of the product." (No specific quantitative results provided) |
| Safety and Effectiveness: (Overall, modifications should not reduce these) | "The test results indicated that the modifications have not reduced the safety or effectiveness of the product or created new issues regarding safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The tests mentioned (volumetric accuracy, blow-by pressure, bond test, cytotoxicity) likely involved a representative number of samples of the modified components and complete sets, but the exact count is not provided.
- Data Provenance: Not specified, but given it's a 510(k) submission, the testing would have been conducted by the manufacturer (ZEVEX, Inc.) in a controlled environment. The data is prospective for the modified devices. There is no mention of country of origin for the data, but it can be assumed to be from the US, where ZEVEX is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of this device and testing. The "ground truth" for these engineering tests is established through objective measurement against engineering specifications and regulatory standards (e.g., USP Class VI, FDA food-grade approval).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of testing does not involve expert adjudication in the way a clinical study with subjective assessments would. The results are based on objective measurements against predefined criteria or established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human interpretation is involved. The ZEVEX enteral feeding sets are medical devices concerned with physical performance and material safety, not diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This document describes physical medical devices, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this submission are objective engineering specifications, material standards (e.g., USP Class VI), and regulatory requirements (e.g., FDA approval for food-grade colorants). For example, a material either is USP Class VI or it isn't.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no "training set" in the context of physical device testing as described. Machine learning models use training sets, not directly manufactured products undergoing physical performance tests.
9. How the Ground Truth for the Training Set Was Established
- Establishment of Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
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