(127 days)
Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.
Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.
The Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Geon S2) | Predicate Device (K220126) Claimed Performance | Predicate Device (K220126) Head-to-head Test Performance |
|---|---|---|---|
| Suction Vacuum | 54kPa ~ 66kPa (tolerance: 3 kPa) | 52-64 Kpa | 57~60 Kpa |
| Noise | 55dB ~ 60dB (tolerance: 5 dB) | 55dB~60dB | 57~60dB |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of clinical or comparative studies with a patient population. Instead, the performance evaluations were conducted through verification testing of the device's technical specifications.
- Sample Size: The document doesn't explicitly state the number of units tested for suction vacuum and noise. However, it indicates that "For Model S2, no individual differences exceed the spective tolerance of suction vacuum and noise after the cleaning and disinfection procedure," implying multiple units or multiple measurements were taken to confirm consistency.
- Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be bench-top engineering verification rather than a clinical study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. The ground truth for this device's performance is based on engineering specifications and direct physical measurements (suction vacuum and noise levels) rather than expert interpretation of clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. As a bench-top engineering verification, there was no subjective judgment from experts requiring an adjudication method. The measurements against the specified tolerances determined success or failure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Geon (S2) Nasal Aspirator is a therapeutic/extraction device, and its performance is evaluated based on physical parameters like suction and noise, not diagnostic accuracy requiring human interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, the testing described is a standalone performance evaluation of the device. The device's performance (suction vacuum and noise) was measured directly on the device itself without human intervention in operating it beyond standard use, or human interpretation of outputs.
7. Type of Ground Truth Used:
The ground truth used was engineering specifications and direct physical measurements. The device's suction vacuum was measured in kPa and its noise level in dB, and these measurements were compared against pre-defined tolerance ranges established by the manufacturer.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.