(15 days)
The ANTILIA 1™ Wound Irrigation System device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The ANTLIA 1 TM Wound Irrigation System is intended for patients with chronic, acute, traumatic, subacute, and dehised wounds, diabetic with with with churches, filaps and grafts.
The ANTLIA I™ Wound Irrigation System is an AC-powered, portable suction device with battery back-up that provides vacuum assisted drainage and irrigation of a wound site by controlled delivery of topical wound treatment solutions over the wound bed.
The specifically designed Aquarius I™ dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
Here's a summary of the acceptance criteria and study information for the ANTLIA I™ Wound Irrigation System, based on the provided 510(k) summary:
This device is cleared through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to prove device performance against specific acceptance criteria. Therefore, the information provided focuses on the technological characteristics and safety standards the device meets, rather than clinical performance metrics.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standards Met | Reported Device Performance / Assessment |
|---|---|---|
| Safety and Electrical Standards | IEC 60601-1 + US deviations (UL60601-1): Medical Electrical Equipment-● Part1:General Requirements for Safety; 1. Collateral Standard: Safety Requirements for Medical electrical Systems | The device has been "independently tested and successfully approved" to these standards. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2: 2001 version (244 Edition): Medical Electrical Equipment -- Part 1-2: . Requirements for Safety-2. Collateral Standard: Electromagnetic General Compatibility Requirements and Tests | The device has been "independently tested and successfully approved" to these standards. |
| Programmable Electrical Medical Systems | IEC 60601-1-4: Medical Electrical Equipment Part 1: General Requirements for . Safety -4.Collateral Standard: Programmable Electrical Medical Systems | The device has been "independently tested and successfully approved" to these standards. |
| Substantial Equivalence | Same indications, intended use, and technological features as the predicate device (V.A.C.® Instill™ 510(k) No.K021501). | The substantial equivalence is based on these similarities. |
Study Details (if applicable)
For 510(k) submissions based on substantial equivalence, robust clinical studies with human participants demonstrating performance against acceptance criteria are typically not required unless there are significant differences in technological characteristics or intended use compared to the predicate device. The provided document for K071301 does not describe a clinical study in the traditional sense, but rather a demonstration of compliance with recognized safety and performance standards and a comparison to a predicate device.
Given that this is a 510(k) summary for a Class II device, the process focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance metric against acceptance criteria through a clinical trial. Therefore, the following points address what would typically be included for a clinical performance study, but clarifies their absence or alternative assessment in this 510(k) context.
- Sample size used for the test set and the data provenance: Not applicable. The submission refers to independent testing against safety and EMC standards, not a clinical test set for performance. The "test set" would be the device itself undergoing engineering and safety evaluations, not 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 clinical performance is not established in this type of submission. The "experts" would be the engineers and regulatory bodies verifying compliance with medical device safety standards.
- Adjudication method for the test set: Not applicable. There is no clinical test set requiring adjudication in this document.
- 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 not an AI-powered diagnostic imaging tool. It is a wound irrigation system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm" in the sense of AI or image analysis. It's an electro-mechanical system. Its standalone performance refers to its ability to operate according to its specifications (e.g., maintaining negative pressure, controlling fluid delivery). This is assessed through engineering tests and compliance with safety standards, not a clinical trial.
- The type of ground truth used: Not applicable in the clinical sense. The "ground truth" here is compliance with recognized engineering and safety standards (e.g., IEC 60601 series) and the functional specifications of the device.
- The sample size for the training set: Not applicable. This device does not use machine learning, so there is no training set.
- How the ground truth for the training set was established: Not applicable. As there is no training set for machine learning, this is irrelevant.
In conclusion, K071301 demonstrates substantial equivalence by:
- Sharing the same indications for use with the predicate device.
- Having the same intended use as the predicate device.
- Possessing similar technological characteristics to the predicate device.
- Successfully passing independent tests against recognized medical device safety and performance standards (IEC 60601-1, EN 60601-1-2, IEC 60601-1-4).
This approach satisfies the requirements for 510(k) clearance for this type of device, focusing on safety and equivalence rather than new clinical efficacy trials against specific performance criteria.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.