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Intended use

This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions:

• Ventilation monitoring
• Inspiratory 02 measurement
• Device monitoring
• Anesthetic gas receiving system

The following options are additionally available:

• Patient-gas measurement module for 02, CO2, N2O, and anesthetic gases
• 02 insufflation

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).

Indications

The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Atlan anesthesia workstation was developed and is manufactured by Dräger in Lübeck, Germany. The anesthesia workstation is specified for inhalational anesthesia using volatile anesthetic agents and/or patient ventilation, including the delivery of oxygen and the monitoring of device functions as well as the patient's and/or anesthetic parameters. Atlan is available in different device variants and can be upgraded by software and hardware options as well as attachable accessories.

The Atlan anesthesia workstation consists of four major subsystems, each of which operates on its own specific principle while interacting with the other subsystems to achieve the intended use. These major subsystems include:

• Gas reception and delivery, i.e., gas mixer o
• o Anesthetic breathing system
• o Anesthetic ventilator
• o Anesthetic gas scavenger

The Atlan anesthesia workstation receives medical gases from a cylinder or central gas supply, creates a gas mixture, or composition, and delivers this mixture at a determined flow rate to the anesthetic breathing system.

Atlan's anesthetic breathing system is the interface between the anesthesia workstation and the patient. Its purpose is to deliver the gas composition to the patient. While doing so, the anesthetic breathing system converts the continuous gas flow to the patient's intermittent respiratory flow, supports controlled or assisted ventilation, and allows for gas sampling and pressure measurements. Furthermore, the anesthetic breathing system conditions the inspiratory gas by means of a heater and removes carbon dioxides from the patient's expired qas.

The anesthetic ventilator drives fresh gas from the anesthetic breathing system to the patient and expired gas to the anesthetic gas scavenger.

Atlan's integrated anesthetic gas scavenger collects all waste anesthetic gases received from the breathing circuit and passes it on to a hospital disposal system.

The anesthesia workstation is also comprised of several minor subsystems whose interactions with the main subsystems help to address considerations of patient safety and system integrity. The minor subsystems include:

• o Gas monitoring
• o Ventilation and airway monitoring
• Device monitoring, including system self test o
• Embedded control display o
• RFID capabilities o

The provided text is a 510(k) Premarket Notification Summary for the "Atlan" anesthesia workstation. It describes the device, its intended use, and compares it to a predicate device (Perseus A500, K133886) and several reference devices.

However, the document does not contain specific acceptance criteria tables, reported device performance metrics, sample sizes for test sets, data provenance, information about expert ground truth establishment, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance data, or details about training set ground truth establishment.

Instead, it states that "The Atlan anesthesia workstation is a new device and has undergone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements." It then lists the types of verification and validation activities performed, such as:

• Sterilization
• Biocompatibility
• Software, including cybersecurity
• Electrical safety
• Electromagnetic compatibility (EMC)
• Compliance with various IEC and ISO standards (e.g., IEC 60601-1-8 for alarm systems, ISO 80601-2-13 for anesthetic workstations, ISO 80601-2-55 for respiratory gas monitors)
• Waveforms, including comparisons to the predicate device and performance as per ASTM-F1101
• Technical System Requirements (risk control measures, technical data, essential safety and performance)
• Accessories compatibility
• Human factors engineering (IEC 60601-1-6 for Usability, IEC 62366-1 for the application of usability engineering to medical devices)

The document concludes that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Atlan is as safe, as effective and performs as well as or better than the legally marketed device Perseus K133886 as identified in this section of the submission."

Therefore, I cannot provide the requested table and detailed study information because it is not present in the provided text. The document summarizes the types of testing performed and the conclusion of those tests but does not offer the specific data points requested in your prompt.

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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).

• 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

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