(83 days)
The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
The PARI eFlow® Electronic Nebulizer is a small, single-patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device, containing a capped medication cup that can be filled by the user. Power input is provided by either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.
Here's a breakdown of the acceptance criteria and study information for the eFlow® Electronic Nebulizer, based on the provided text:
Based on the provided text, the device in question is a modified eFlow® Electronic Nebulizer, specifically the addition of a new control unit with an LCD. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trials with specific acceptance criteria in the same way a new drug or high-risk medical device might.
The "acceptance criteria" here are implicitly tied to demonstrating that the modifications do not adversely affect safety or performance and that the modified device remains substantially equivalent to the predicate. The study described focuses on technical verification and validation, not on clinical performance metrics like sensitivity, specificity, or reader agreement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Verification & Validation | |
| (Adherence to applicable requirements) | Testing performed to the applicable requirements of "k PARI SOP PV 02 70014 Version 00 (Release Software 678*)." |
| Electromagnetic Compatibility & Electrical Safety | |
| (Compliance with specified standards for intended operational environment) | Testing performed to the applicable requirements of: |
- IEC 60601-1-2
- CAN/CSA C22.2 NO 601.1-M90
- UL 1431 |
| Stress Testing
(Compliance with specified standards for intended operational environment) | Testing performed to the applicable requirements of: - IEC/EN/DIN 60068-2-3
- 60068-2-6
- 60068-2-14
- 60068-2-29
- 60068-2-64
- 60068-2-78 |
| Overall Impact on Performance, Safety, or Effectiveness
(No new issues or adverse effects) | "Testing demonstrated that the modifications to the new, optional control unit do not affect the performance of the eFlow Electronic Nebulizer, and raise no new issues of safety or effectiveness."
"The addition of the modified unit does not affect the intended use, or alter the fundamental scientific technology of the legally-marketed PARI eFlow."
"Additionally, there is no change to the legally-marketed device's: (1) materials; (2) performance specifications; (3) dimensional specifications: (4) environmental specifications: (5) energy sources; or; (6) packaging." |
| Substantial Equivalence to Predicate Device
(Based on 21 CFR 807.87 and New 510(k) Paradigm) | The manufacturer believes the modifications are substantially equivalent to the eFlow® Electronic Nebulizer (K033833), cleared on May 5, 2004.
(The FDA's letter concurs with this finding of substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a "test set" in the context of patient data. The testing described is primarily engineering and software verification/validation on the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable to the reported studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of testing described. The studies focus on technical compliance with standards and the functionality of the device's new components, not on medical diagnoses or interpretations by experts for a clinical "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a "test set" requiring adjudication by experts in the context of medical diagnoses.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This submission focuses on the technical aspects of a device modification, not on clinical performance comparisons of human readers with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is an electronic nebulizer, which is a physical medical device for drug delivery, not an AI algorithm. Its performance is inherent in its electromechanical function and software control, not in an "algorithm only" sense like a diagnostic AI.
7. The Type of Ground Truth Used
The "ground truth" for the reported studies is primarily the technical specifications and requirements defined by the referenced industry standards (e.g., IEC, CAN/CSA, UL, DIN) and the manufacturer's own SOPs. For software, it's the expected functional behavior as defined in specifications. For electrical safety and EMC, it's compliance with the limits and conditions of the standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical electronic nebulizer, and the testing described is not related to training an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above – no AI algorithm training is described.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).