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510(k) Data Aggregation
(348 days)
The Krömker Medizintechnik Nebulizer Model Ultra-Neb 2010 is designed to aerosolize saline solution and liquid medication by ultrasonic energy. A single patient use medication cup is available for use with medications.
The device is intended for use on adult and pediatric patients who have been prescribed inhalation therapy, sputum induction, or medication for nebulization. The device is intended for use in hospitals, hospital-type facilities, nursing home, sub-acute institutions, and home environments.
Caution: Federal law restricts this device to sale by or on the order of a physician.
The Ultra-Neb 2010 Ultrasonic Nebulizer is a reusable ultrasonic nebulizer for the inhalation therapy of saline solution, or of aerosol medications. It is a desktop or pole stand mounted device, containing a nebulizing chamber that can be filled by the user. Power input is provided by AC mains.
The provided document describes the Wilfried Krömker Medizintechnik GmbH Ultra-Neb 2010 Ultrasonic Nebulizer, a device intended for inhalation therapy.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with applicable standards for medical device electrical safety. | "The device was tested in accordance with applicable standards for medical device electrical safety... The Ultra-Neb 2010 Ultrasonic Nebulizer passed all of the tests." |
| Electromagnetic Compatibility (EMC) | Compliance with applicable standards for electromagnetic compatibility. | "The device was tested in accordance with applicable standards for medical device... electromagnetic compatibility (EMC)... The Ultra-Neb 2010 Ultrasonic Nebulizer passed all of the tests." |
| Environmental (Temperature and Humidity) | Compliance with applicable standards for environmental temperature and humidity. | "The device was tested in accordance with applicable standards for medical device... environmental temperature and humidity... The Ultra-Neb 2010 Ultrasonic Nebulizer passed all of the tests." |
| Shock and Vibration | Compliance with applicable standards for shock and vibration. | "The device was tested in accordance with applicable standards for medical device... shock and vibration. The Ultra-Neb 2010 Ultrasonic Nebulizer passed all of the tests." |
| Dead Volume | Performance comparable to the predicate device (Ultra-Neb 99 Ultrasonic Nebulizer). | "Performance testing was conducted in comparison with the predicate devices for dead volume... The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Aerosol Particle Characteristics | Performance comparable to the predicate device (Ultra-Neb 99 Ultrasonic Nebulizer). | "Performance testing was conducted in comparison with the predicate devices for... aerosol particle characteristics... The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Aerosol Output | Performance comparable to the predicate device (Ultra-Neb 99 Ultrasonic Nebulizer). | "Performance testing was conducted in comparison with the predicate devices for... aerosol output. The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Biocompatibility | Materials used in the device comply with biocompatibility requirements appropriate for the intended use. | "The materials utilized in the device comply with biocompatibility requirements appropriate for the intended use." |
| Substantial Equivalence | The device is as safe and effective and performs in a manner equivalent to the predicate device (Ultra-Neb 99 Ultrasonic Nebulizer). This is the overarching regulatory acceptance criterion for 510(k) submissions. | "The function of the Model Ultra-Neb 2010 Ultrasonic Nebulizer is substantially equivalent to the predicate device. Laboratory and standards compliance tests are provided to support the safety and performance of the device. As described above, all of the testing demonstrates that the Wilfried Krömker Medizintechnik GmbH Ultra-Neb Model 2010 Ultrasonic Nebulizer is as safe and effective and performs in a manner equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for "dead volume, aerosol particle characteristics and aerosol output" testing. It mentions "Performance testing was conducted in comparison with the predicate devices," suggesting the predicate device served as the benchmark.
The data provenance is not explicitly stated as country of origin, retrospective, or prospective. However, the testing was "Non-Clinical Tests Submitted," implying laboratory testing. The manufacturer is based in Germany (Wilfried Krömker Medizintechnik GmbH, Bückeburg, Germany).
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)
This information is not applicable to this type of device and study. The testing for a nebulizer focuses on physical and electrical performance characteristics, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in the medical sense (e.g., pathology, clinical outcomes).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically associated with studies involving human interpretation or clinical endpoints that require consensus among experts. The tests performed for this nebulizer are objective measurements of physical and electrical properties.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices, not for a basic medical device like an ultrasonic nebulizer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a mechanical/electrical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (electrical safety, EMC, environmental, shock/vibration, dead volume, aerosol particle characteristics, aerosol output) was compliance with established industry standards and the specifications of the legally marketed predicate device. For biocompatibility, the ground truth was compliance with biocompatibility requirements appropriate for the intended use.
8. The sample size for the training set
There was no training set for this device. This is a conventional medical device, not an AI/machine learning product.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
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