(187 days)
The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.
The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.
The provided text describes the performance testing and validation for the AViTA Nasal Aspirator (Model NS13). However, it does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria for a "device" in the context of an AI/ML medical device. This document describes a physical medical device (nasal aspirator), not an AI/ML algorithm. Therefore, many of your questions related to AI/ML specific criteria (such as "sample size for the training set," "number of experts used to establish ground truth," "MRMC comparative effectiveness study," etc.) are not applicable to the information provided.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document lists performance specifications for the device and indicates that testing was conducted to demonstrate these specifications were met. While it doesn't provide a direct "acceptance criteria vs. reported performance" table for each specific parameter, it states that "The results of those testing show that the required limits for mean difference and standard deviation are fulfilled by the subject device."
| Criterion Category | Specifics Mentioned in Document | Performance/Compliance Statement |
|---|---|---|
| Biocompatibility | - In vitro cytotoxicity (ISO 10993-5) |
- Irritation and skin sensitization (ISO 10993-10)
- Systemic toxicity (ISO 10993-11)
- Irritation (ISO 10993-23) | "The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance... [and passed]." |
| Cleaning and Disinfecting | - 1000 times cleaning verification with mild non-abrasive soap and 70℃ water and soft dry cloth wiping | "This product has passed the cleaning verification... confirming that the product can be used continuously without any functional abnormalities." |
| Safety (Electrical/Medical Device Standards) | - IEC 60601-1:2005+A1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance) - IEC 60601-1-11:2010 (Medical electrical equipment - Requirements for medical electrical systems used in the home healthcare environment) | "the subject device has passed the relevant tests of IEC 60601-1" and "has passed the relevant tests in accordance with IEC 60601-1-11" |
| Software Verification and Validation | - "Basic documentation" level of concern | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." |
In the comparison table on page 8, the subject device's performance specifications are listed, which can be interpreted as its target acceptance criteria for technical performance:
| Parameter | Acceptance Criteria (Subject Device NS13) | Reported Performance (Assumed to meet criteria) |
|---|---|---|
| Effective Vacuum Pressure | 100-120 mmHg | Assumed to be 100-120 mmHg |
| Sound Pressure Level | ≤60dB | Assumed to be ≤60dB |
| Spray Capacity | 0.4 | Assumed to be 0.4 |
| Operating Temperature Range | 16°C ~ 35°C (60.8°F ~ 95°F), 15%~85% RH | Assumed to operate within this range |
| Storage Temperature Range | -25°C ~ 55°C (-13°F ~ 131°F), 15%~85% RH | Assumed to store within this range |
2. Sample sized used for the test set and the data provenance
The document does not specify "sample size" in terms of patient data or clinical study cohorts, as this is a K510 submission for a physical device, not an AI/ML algorithm. The performance testing refers to engineering and laboratory tests on the device itself.
- Data Provenance: Not applicable in the sense of patient data. The tests are conducted on the device hardware and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the testing of this physical nasal aspirator. The "ground truth" here is the adherence to established technical standards and engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of results in the context of an AI/ML algorithm.
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. No MRMC study was performed as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical Studies None."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to established international standards (e.g., ISO, IEC) for biocompatibility, electrical safety, and general performance, as well as the manufacturer's own internal specifications (e.g., vacuum pressure, sound level).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The document states that the AViTA Nasal Aspirator (Model NS13) meets its acceptance criteria through a series of non-clinical performance tests, biocompatibility tests, cleaning and disinfecting tests, and safety tests (electrical and general).
- Non-Clinical Performance Testing: Implied to include assessments of vacuum pressure, sound level, spray capacity, and operating/storage conditions. The document states these tests "show that the required limits for mean difference and standard deviation are fulfilled."
- Biocompatibility Testing: Conducted in accordance with recognized ISO 10993 standards (Parts 5, 10, 11, and 23) for cytotoxicity, irritation, skin sensitization, and systemic toxicity. The device "passed" these evaluations.
- Cleaning and Disinfecting Test: The device underwent "1000 times" of cleaning verification, confirming its ability for continuous use without functional abnormalities.
- Safety Testing: Compliance with IEC 60601-1 and IEC 60601-1-11 for basic safety and essential performance, particularly for home healthcare environments, was verified. The device "passed" these relevant tests.
- Software Verification and Validation: Performed according to FDA guidance for "Basic documentation" level of concern software in medical devices, demonstrating the software performs as intended.
The overall conclusion is that these non-clinical data support the device's safety and effectiveness, and its comparable performance to predicate devices already on the market.
§ 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.