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510(k) Data Aggregation
(261 days)
The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
This document outlines the acceptance criteria and the studies conducted to prove that the FORA NAS100 Electronic Nasal Aspirator meets these criteria.
1. Acceptance Criteria and Reported Device Performance
| Standard | Intended Use / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IEC 60601-1: General requirements for basic safety and essential performance | To evaluate the basic safety and essential performance of medical electrical equipment and medical electrical systems. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-11: Requirements for medical electrical equipment and systems used in the home healthcare environment | To evaluate the basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-2: EMC Test Report | To maintain the essential performance and basic safety of EMC requirements in the presence of electromagnetic disturbances and emitted disturbances. | All 5 EMC requirements met (Pass): Enclosure port, ESD, RS, RF, PFMF. |
| ISO 14971: Risk Management Report | To ensure all hazards are controlled in an "acceptable region" before/after risk analysis, addressing wrong analytical results and serious impairment to patient health. | Risk distribution showed that all hazards are controlled in the "acceptable region". |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Thermometer (example component) | To assess if the device poses any direct or indirect tissue-contacting risks, indicated by Cytotoxicity, Skin Sensitization, and Irritation tests. | Cytotoxicity Test: No potential toxicity to L-929 cells (Test article extract did not show potential toxicity to L-929 cells, implying cell viability was not reduced to <70%). Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs (0% positive/negative rate, grades less than 1). Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits (Irritation index of 0), normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Stainless Steel Cap | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Elastic Band | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Silicon belt | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test listed (e.g., number of devices tested for IEC standards, number of animals for biocompatibility tests). The tests are based on established international standards (IEC, ISO), which typically outline the methodologies and sample size considerations for compliance. The document implies that sufficient samples were used to meet the requirements of these standards.
Data provenance (e.g., country of origin, retrospective/prospective) is not specified for the performance studies described in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance tests described (e.g., IEC electrical safety, EMC, ISO biocompatibility) rely on standardized testing protocols and objective measurements rather than expert consensus on medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since the tests described are primarily objective engineering and biological safety evaluations according to international standards, an adjudication method for a test set in this context is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed as this device is an electronic nasal aspirator, not an AI-assisted diagnostic device where human reader performance would be a relevant metric.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The device is a physical electronic nasal aspirator, not an algorithm or AI system for which a standalone performance study would be relevant.
7. Type of Ground Truth Used
The "ground truth" for the tests performed is based on adherence to the defined limits and criteria set by international safety, performance, and biocompatibility standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 14971, ISO 10993 series). This includes:
- Objective measurements and observations: For electrical safety (e.g., temperature, current leakage, noise levels, electromagnetic compatibility), physical construction, and operational performance.
- Biological responses: For biocompatibility tests (e.g., cell viability in cytotoxicity, skin reactions in sensitization and irritation tests).
- Risk assessment: Evaluation against defined risk criteria in the risk management report.
8. The Sample Size for the Training Set
This information is not applicable. The FORA NAS100 Electronic Nasal Aspirator is a hardware medical device, and the evaluation described involves traditional engineering and biological safety testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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