(78 days)
ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.
ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. The device consists of 100ml of Saline Solution at a concentration of 0.9% or Water contained within a 100cc polyethylene wide mouthed bottle. The closure is a 38/400 white polypropylene cap fitted with an F 217 liner. A printed tamper-evident band is placed over the top of the bottle. Each bottle contains a product label displaying a lot code and expiration date.
The provided text is a 510(k) summary for a medical device: ACU-PAK Sterile Saline Solution 0.9% and Sterile Water. This document is a premarket notification for a Class II medical device, indicating that the manufacturer believes it is substantially equivalent to legally marketed predicate devices.
The information provided does not include a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, statistical analysis, or clinical trial results). This is because the 510(k) process for devices like sterile saline or water for irrigation typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies with specific acceptance criteria that need to be met by the new device itself.
Instead, the submission focuses on demonstrating that the ACU-PAK product has the same intended use and technological characteristics as predicate devices. The "performance" in this context refers to its similarity to already approved products.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a traditional performance study, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. These types of studies are typically required for more novel or higher-risk devices where substantial equivalence cannot be solely established through technological comparison.
However, I can extract the relevant information from the provided text demonstrating how the device meets the criteria for substantial equivalence based on its comparison to predicate devices.
Summary of Acceptance Criteria and Device Performance (as per 510(k) submission for Substantial Equivalence):
This 510(k) submission relies on demonstrating substantial equivalence to predicate devices rather than meeting new, unique performance criteria through a standalone study. The "acceptance criteria" here are the characteristics and intended use that must match or be equivalent to already approved devices.
| Acceptance Criteria (based on Predicate Device Equivalence) | Reported Device Performance (ACU-PAK Product) |
|---|---|
| Intended Use: Irrigation of medical devices (Not for injection) | Intended Use: Irrigation of medical devices (Not for injection) |
| Composition: 0.9% Saline Solution or Water | Composition: 0.9% Saline Solution or Water |
| Volume: 100ml | Volume: 100ml |
| Container: Polyethylene wide-mouthed bottle (100cc) | Container: Polyethylene wide-mouthed bottle (100cc) |
| Closure: 38/400 white polypropylene cap with F 217 liner | Closure: 38/400 white polypropylene cap with F 217 liner |
| Tamper-Evident Feature: Printed tamper-evident band | Tamper-Evident Feature: Printed tamper-evident band |
| Labeling: Product label displaying lot code and expiration date | Labeling: Product label displaying lot code and expiration date |
| Manufacturing: Same contract manufacturer for over 9 years | Manufacturing: Same contract manufacturer (ACU-PAK, Inc.) for predicate devices for over 9 years |
Information Regarding Study and Ground Truth (for Substantial Equivalence):
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Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on a comparison of device characteristics to predicate devices, not a test set of data. The "data provenance" is the existence of legally marketed predicate devices.
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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 test set is not established in this type of submission. The "ground truth" for substantial equivalence is that the predicate devices are legally marketed and safe/effective. The FDA regulatory reviewers eventually make the determination of substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set or adjudication process as typically understood in performance studies.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sterile solution, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a sterile solution, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The new device demonstrates substantial equivalence to these predicate devices. The manufacturer states, "ACU-PAK Sterile Saline Solution 0.9% and Sterile Water is identical to predicate devices."
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The sample size for the training set: Not applicable. No training set is used for this type of device submission.
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How the ground truth for the training set was established: Not applicable. No training set is used.
Conclusion:
The ACU-PAK Sterile Saline Solution 0.9% and Sterile Water device meets its "acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and manufacturing processes. The "study" proving this is the 510(k) submission itself, which provides a detailed comparison of the new device to the predicate devices. The FDA's clearance (letter dated AUG 18 1998) confirms this finding of substantial equivalence.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).