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510(k) Data Aggregation
(167 days)
Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.
The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).
| Test Method & Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|
| ISO 9360-1:2000 - Determination and Evaluation of Pneumatic Compliance | Compliance is less than or equal to 1mL/kPa at 15, 30, 60, and 70 hPa | PASSED |
| ISO 9360-1:2000 - Determination and Evaluation of Pneumatic Leakage | Pneumatic leakage is less than or equal to 50mL/min at 70hPa. | PASSED |
| ISO 9360-1:2000 - Determination and Evaluation of Pressure Drop (Pneumatic Resistance) | Pneumatic resistance/pressure drop is acc. to IfU value | PASSED |
| ISO 5356-1:2015 - Evaluation of Conical Connectors (ISO 5356-1) | Cone dimensions comply with ISO 5356-1. | PASSED |
| ISO 80369-7:2021 - Luer Lock Connector (ISO 80369-7) | Luer-Lock connector fulfills the requirements laid out in ISO 80369-7. | PASSED |
| IEC 60601-1:2005 - Product's Ability to Withstand Damage from Dropping | When dropped, the product should not suffer any damage which influences its function. | PASSED |
| ISTA 3A - Product Durability During Transport, Mechanical Aspects | - The packaging shows no or minor damage- The DUT (Device Under Test) shows no signs of damage and retains functionality after simulated transport. | PASSED |
| ISO 23328-1:2003 - Filtration Efficiency (Particulate Matter) incl. Usage Time | - Adult and pediatric electrostatic filters achieve a filtration efficiency of >90% before and after the specified usage time- Neonatal filters achieve a filtration efficiency of >75% before and after the specified usage time- Mechanical filters achieve a filtration efficiency of >99% before and after the specified usage time- Mechanical filters achieve a HEPA classification ≥ class H13 | PASSED |
| ASTM F2101:2019 - Filtration Efficiency (Viral and Bacterial) | - Electrostatic filters achieve 99.99% (bacterial) and 99.9% (viral) filtration efficiency- Electrostatic filters for neo applications achieve 99.98% (bacterial) and 99.9% (viral) filtration efficiency. | PASSED |
| ISO 10993:2018 and ISO 18562-1:2017 - Evaluation of Product's Biological Compatibility | Evaluation according to ISO 10993:2018 and/or ISO 18562-1:2017 | PASSED |
| ISO 9360-1:2000 - Evaluation of HME Water Loss, Resistance | · pediatric/neonatal: The moisture loss shall be <=11mg/L at VT=50ml· pediatric: The moisture loss shall be <=12mg/L at VT=250ml· adult: The moisture loss shall be <=11mg/L at VT=500ml | PASSED |
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 used for each non-clinical test. It mentions that "The devices... have undergone extensive testing" but does not detail the number of units tested for each criterion. The data provenance is also not specified; however, given that the submitter is "Drägerwerk AG & Co. KGaA" based in "Lübeck, Germany" and they tested against international standards (ISO, ASTM, IEC), it is likely that the testing was conducted in a controlled laboratory environment, potentially in Germany or by a certified testing facility adhering to these standards. The testing appears to be prospective, specifically designed to verify the devices' adherence to the mentioned standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the non-clinical test set. The validation relies on adherence to established international and national standards (e.g., ISO, ASTM, IEC) rather than expert consensus on a test set. This implies that the "ground truth" is defined by the objective metrics and methodologies outlined in these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There is no mention of an adjudication method in the text for the non-clinical test set. Given the nature of the tests (physical and performance characteristics against standards), it's a pass/fail determination based on quantitative measurements against predefined criteria, not a subjective assessment requiring adjudication.
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
The document explicitly states "Summary of Clinical Testing N/A" (page 20). This indicates that no clinical studies, including MRMC comparative effectiveness studies involving human readers or AI assistance, were performed or submitted. The entire submission focuses on non-clinical performance and substantial equivalence based on technical characteristics and adherence to standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Since the devices are breathing circuit filters and not software or AI-powered devices, the concept of a "standalone (algorithm only)" performance study is not applicable. The device's performance is intrinsically mechanical and material-based, not algorithmic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this submission is based on established international and national consensus standards (e.g., ISO 9360-1, ISO 5356-1, ISO 80369-7, IEC 60601-1, ISTA 3A, ISO 23328-1, ASTM F2101, ISO 10993, ISO 18562-1). The device's performance is measured against the quantitative requirements and methodologies specified within these standards.
8. The sample size for the training set
This question is not applicable. The document describes physical medical devices (filters), not machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for these devices.
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