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510(k) Data Aggregation
(143 days)
The Compat® Enteral Delivery Pump Sets are intended to deliver liquid nutition formulas or hydration to an enteral access device (a feeding tube).
Five configurations of enteral delivery sets: Standard Bag, Standard SpikeRight® PLUS, DualFlo Bag/SpikeRight PLUS, DualFlo Bag/Bag and Gravity Set for administering liquid nutrition or hydration to an enteral access device (feeding tube).
This document is a 510(k) premarket notification for the Compat® Enteral Delivery Pump Set, which is a medical device. The information provided heavily emphasizes regulatory compliance and substantial equivalence to a predicate device, rather than detailed studies proving performance against acceptance criteria in the typical sense of a clinical trial or algorithm validation study.
Based on the provided text, the device is an enteral delivery pump set, and the "acceptance criteria" and "study" are primarily focused on bench testing to demonstrate that the redesigned connector (ENFit) is safe and performs comparably to the predicate device's connector or meets specified standards.
Here's the breakdown of what can be extracted from the provided text regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
It's challenging to create a direct table of acceptance criteria in the format often seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the document lists various performance tests conducted, and the implication is that the device met the acceptance criteria for each of these tests, demonstrating substantial equivalence. The document does not explicitly state the specific pass/fail values for each test, only that the tests were performed.
| Acceptance Criteria (Inferred from Tests Performed) | Reported Device Performance (Inferred as 'Met Criteria') |
|---|---|
| Risk Assessment: FMECA conducted | Risk assessed, criticalities analyzed |
| ENFit Component Verification: Tested for proper function | Components verified (presumably, passed verification) |
| ENFit Bond Strength: Measured | Bond strength met requirements (presumably) |
| PGLOCK Administration Validation: Tested | Validation completed (presumably, passed validation) |
| Tensile Properties (ASTM D638-10): Plastics tested | Tensile properties met standard (presumably) |
| Performance with/without Reference Connectors: | |
| - Falling drop positive pressure liquid leakage | No leakage (presumably, met criteria) |
| - Stress cracking | No stress cracking (presumably, met criteria) |
| - Resistance to separation from axial load | Resistance met requirements (presumably) |
| - Resistance to separation from unscrewing | Resistance met requirements (presumably) |
| - Resistance to overriding | Resistance met requirements (presumably) |
| - Disconnection by unscrewing | Disconnection as expected (presumably) |
| - Falling drop positive pressure liquid leakage after 20 cycles | No leakage (presumably, met criteria) |
| Enteral Connector Misconnection Assessment: Studied | Misconnection risk assessed and managed (presumably, acceptable) |
| Failure Modes and Effects Analysis (FMEA): Conducted | Failure modes analyzed, effects mitigated (presumably, acceptable) |
| Risk Analysis: Conducted | Risks analyzed and managed (presumably, acceptable) |
| Human Factors Testing: Performed | Human factors considered and addressed (presumably, acceptable) |
| Biocompatibility Testing (ISO 10993): | |
| - Part 5: In Vitro Cytotoxicity | Passed cytotoxicity tests |
| - Part 10: Irritation and Delayed-Type Hypersensitivity (Intracutaneous - rabbits) | Passed irritation tests |
| - Part 10: Irritation and Delayed-Type Hypersensitivity (Sensitization - guinea pig) | Passed sensitization tests |
| Flow Rate Testing (ENFit vs. Step Connector): | ENFit flow rate equals or exceeds step connector flow rate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test. For example, for "falling drop positive pressure liquid leakage" or "bond strength testing," a specific number of samples would have been tested, but this detail is not provided.
- Data Provenance: The studies are "bench testing," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data; it would typically be conducted by the manufacturer or a contract lab. The studies are by nature prospective in the sense that they were designed and executed to test the device's performance attributes after its design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this type of device and study. The "ground truth" for verifying mechanical and material properties (e.g., bond strength, flow rate, biocompatibility) is established by adherence to specified standards (e.g., ASTM, ISO) and physical measurements, not by expert consensus or interpretation of images/data. The experts involved would be engineers, material scientists, and toxicologists conducting the tests.
4. Adjudication Method
This concept is not applicable. Adjudication is typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies or establish a consensus ground truth. For bench testing of a physical device, results are objective measurements against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, often with and without AI assistance. The Compat® Enteral Delivery Pump Set is a physical delivery system, not a diagnostic tool requiring human interpretation in this manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is derived from objective physical and chemical measurements against established industry standards and regulatory requirements (e.g., ISO 10993 for biocompatibility, ASTM D638-10 for tensile properties, and performance benchmarks for flow rates and leakage). For example, "ground truth" for bond strength would be the measured force required to break the bond, compared against a predefined acceptable limit.
8. The Sample Size for the Training Set
This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The development process involved engineering design, material selection, and iterative physical prototyping and testing, not data training.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the same reason as point 8.
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