(99 days)
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient
Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use.
This document is a 510(k) premarket notification for a medical device called Exsalta, a powered suction pump. The FDA has reviewed the submission and determined the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed acceptance criteria for specific performance metrics or a study demonstrating that the device meets those criteria with statistical significance. Instead, it broadly states that "The subject device met all performance criteria" based on non-clinical testing.
Here's an analysis of what information is present and what is missing, structured according to your request:
1. A table of acceptance criteria and the reported device performance
The document provides some specifications for the Exsalta device and compares them to its predicate (Medela Vario 8/18/ci Suction Pumps K153663). However, it does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific performance tests. It lists specifications and general compliance with standards.
| Attribute | Predicate Vario 8/18/ci (K153663) | Proposed Device (Exsalta) | "Acceptance Criteria" (Implicit from specifications and standards) | Reported Device Performance |
|---|---|---|---|---|
| Regulation | 21CFR 878.4780 | 21CFR 878.4780 | N/A (Regulatory classification) | Met |
| Product Code | BTA | BTA | N/A (Regulatory classification) | Met |
| Indications for Use | Aspiration and removal of surgical fluids, etc. (similar) | Help evacuate saliva, mucous, vomit, etc. (similar) | Similar to predicate | Met |
| Environment of Use | Professional healthcare facility environment | Professional healthcare facility environment | Similar to predicate | Met |
| Flow liters/min | Vario 8/8 c/i: 8 L/min; Vario 18: Not specified | 1.4 L/min | Consistent with intended use/safe operation | (Stated as 1.4 L/min fixed) |
| Maximum vacuum mmHg/kPa | Vario 8/8 c/i: -68 mmHg / -9 kPa; Vario 18: -563 mmHg / -75 kPa; Vario 18 c/i: -413 mmHg / -55 kPa | 60-300 mmHg / 8-40 kPa | Within appropriate range for medical suction (e.g., ISO 10079-1) | (Stated as 60-300 mmHg / 8-40kPa) |
| Therapy modes | Continuous / Intermittent | Continuous | Appropriate for intended use | (Stated as Continuous) |
| Power Source | AC versions: various; AC/DC versions: various | AC-120V, 60 Hz, 2A | Functionality under specified power | Met |
| Electrical Protection | Class II | Class I | Compliance with electrical safety standards (AAMI/ANSI ES 60601-1) | Met |
| Ingress Protection | IP21 | IP21 | Maintained as per predicate | Met |
| Applied Part Type | CF | B | Safety for applied parts (AAMI/ANSI ES 60601-1) | Met |
| Operating Ambient Temp | +5...+40°C | +5 to 40°C | Operation within specified temperature range | Met |
| Operating Ambient Humidity | 15...93% R.L. | 15 to 93% RH | Operation within specified humidity range | Met |
| Operating Pressure | 70-106 kPa | 70 to 106 kPa | Operation within specified atmospheric pressure range | Met |
| Storage Ambient Temp | -25 to +70°C | -25 to +70°C | Storage suitability | Met |
| Storage Ambient Humidity | 15 to 93% RH | 15 to 93% RH | Storage suitability | Met |
| Storage Pressure | 70-106 kPa | 70 to 106 kPa | Storage suitability | Met |
| Standards Compliance | AAMI/ANSI ES60601-1:2005, IEC 60601-1-2: 2007, ISO 10079-1: 2009 | AAMI/ANSI ES60601-1:2005 + A1: 2012, IEC 60601-1-2: 2014, ISO 10079-1: 2015 | Compliance with updated versions of relevant safety and performance standards | Met (as stated) |
| Safety Features | Not detailed in comparison table | Suction circuit/collection container isolation, viral filter, full container float valve/microprocessor stop. | Effective protection against contamination and overflow | "Providing for safe handling and disposal" (Stated) |
| Flow Control | Mechanical regulator | Touch screen slide bar with digital display | User-friendly and accurate vacuum level adjustment | (Stated as Touch screen controlled) |
| Vacuum Regulation | Mechanical regulator | Microprocessor controlled Proportional valve, Mechanical regulator | Accurate and responsive vacuum control | (Stated as Microprocessor controlled) |
| Vacuum Gauge | Analog vacuum gauge | Digital vacuum display | Clear and accurate vacuum reading | (Stated as Digital display) |
Note: The "Reported Device Performance" column reflects what the document states the device features or complies with, rather than quantitative results from a specific study against predefined acceptance criteria. The document claims "The subject device met all performance criteria" after listing non-clinical tests.
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: This information is not provided in the document. The filing is for a physical medical device (powered suction pump), not an AI/software device that would typically have a test "dataset" for performance evaluation in the context of your request. The testing mentioned (Shelf-life/Aging, Software V&V, IEC 60601-1, IEC 60601-1-2, ISO 10079-1:2015) refers to engineering and quality assurance tests on the device hardware and software. It does not involve a "test set" of patient data as assumed by the prompt.
- Data Provenance: Not applicable, as there's no patient data "test set" involved in this type of device clearance based on the provided text.
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)
- Not applicable. As this is a hardware medical device (a suction pump), there wouldn't be a "ground truth for the test set" established by experts in the context of clinical interpretation or diagnosis. Performance is evaluated against engineering specifications and international standards through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" requiring adjudication in the context of clinical agreement or AI output.
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. The document explicitly states: "No human clinical testing was performed." and "No animal testing was performed." This device is a powered suction pump, not an AI or imaging device where MRMC studies would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of AI performance. While "Software Verification and Validation" was performed, this refers to the embedded software controlling the pump's mechanical functions, not a standalone AI algorithm for interpretation or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this device, "ground truth" would relate to the physical and electrical safety and performance of the pump itself, verified through engineering tests against industry standards (e.g., ISO 10079-1 for medical suction equipment, IEC 60601-1 for electrical safety).
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a training set.
In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and compliance with recognized non-clinical performance and safety standards. It does not provide information about clinical studies, expert-adjudicated test sets, or AI performance metrics, as these are not relevant to the type of device being cleared. The device met "all performance criteria" through non-clinical testing, but specific acceptance thresholds and detailed test results are not included in this summary.
§ 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.