(363 days)
The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.
The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer. The nebulization functionality is implemented by: a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators. The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation. The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.
This document describes the 700 Series Ventilator, which includes an optional EasyNeb Nebulizer accessory. The original text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for novel performance claims.
Based on the provided text, the device is a continuous ventilator intended for pediatric and adult patients. The key new feature is the nebulization functionality through the EasyNeb Nebulizer, which is controlled by modifications to the ventilator's software.
Here's an analysis of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the device meets safety and effectiveness standards comparable to those already marketed.
Instead of performance metrics, the document highlights compliance with regulatory guidance and international standards for design, testing, and quality.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Safety and Effectiveness for Intended Use (Overall) | "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." |
| "In summary Puritan-Bennett Corp. has demonstrated the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, to be safe and effective." | |
| "The technical characteristics of the 700 Series Ventilator do not introduce new questions regarding safety or effectiveness of critical care ventilators." | |
| Nebulization Functionality without affecting ventilator performance or patient data | The EasyNeb Nebulizer "is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data." (This is a design claim, not a measured performance reporting, but implies a performance goal.) |
| Compliance with Regulatory Guidance for Software Design | "Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 29 1998, as a guidance and per internal company requirements." (This implies a process-based acceptance criterion for software quality, not a functional performance metric). |
| Compliance with Environmental Testing Standards | "Environmental testing was conducted using FDA's Reviewers Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline and per internal company requirements." (Similar to software, this is a process/compliance criterion). |
| Compliance with International Standards | "The 700 Series Ventilator and EasyNeb Nebulizer device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive." (This indicates that the device met the requirements of these standards, which encompass various safety and performance aspects, but specific performance values are not detailed in this summary). |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set (e.g., for clinical trials or formal performance testing with human subjects or specific clinical data).
The term "test set" in the context of device performance usually refers to data used to evaluate a device's effectiveness. This 510(k) summary focuses on demonstrating equivalence through design, functionality descriptions, and compliance with standards rather than presenting results from a specific clinical performance test set.
Data provenance is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Given the nature of a continuous ventilator and nebulizer (which are physical devices with mechanical and software functions), the "ground truth" for performance would likely come from instrumental measurements and technical testing to verify specifications, rather than expert consensus on interpretive data like medical imaging.
4. Adjudication Method for the Test Set
Since no specific test set or clinical evaluation requiring adjudication is described, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for interpretive medical devices (like imaging AI diagnostics) to compare the performance of human readers with and without AI assistance. The 700 Series Ventilator and EasyNeb Nebulizer are not interpretive devices in this sense. Therefore, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. No effect size for human readers improving with AI assistance is reported.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. The "algorithm" here would refer to the ventilator's control software and the nebulizer's activation logic. The performance of these components is evaluated as part of the integrated device's overall functionality and compliance with standards, rather than as a separate "algorithm only" study as one might see for an AI diagnostic tool.
7. Type of Ground Truth Used
For a device like a ventilator and nebulizer, the "ground truth" would be established through:
- Engineering specifications and measurements: Verifying parameters like tidal volume delivery, breath rate, oxygen concentration, nebulization rate, power control, and timing.
- Compliance with recognized standards: Meeting the functional and safety requirements defined by standards like EN60601-1.
- Verification and validation testing: This would involve testing the software and hardware against design requirements to ensure it performs as intended.
The document generally refers to "combined testing and analysis of results" and "verification and validation testing" without specifying the exact nature of the "ground truth" for each test.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The 700 Series Ventilator is a rule-based or deterministic medical device, not an AI/machine learning system that requires a "training set" in the conventional sense. Its software controls are programmed based on engineering principles and medical requirements, not learned from data.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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).