(111 days)
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 23, 2023
Drägerwerk AG Co. KGaA Marianne Selent Regulatory Affairs Manager Moislinger Allee 53-55 Lübeck, Schleswig-Holstein 23542 Germany
Re: K230931
Trade/Device Name: Atlan Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia Or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: June 23, 2023 Received: June 23, 2023
Dear Marianne Selent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230931
Device Name Atlan
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Premarket Notification Summary
| Submitter: | Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 Lübeck, GermanyEstablishment's registration number: 9611500 | |
|---|---|---|
| Official correspondent: | Dr. Marianne SelentRegulatory Affairs ManagerE-Mail: marianne.selent@draeger.comTelephone: +49 451 882 1602 | |
| US agent: | Darlene ThibodeauHead of Quality Assurance and ComplianceE-mail: darlene.thibodeau@draeger.comTelephone: (978) 773 0160 | |
| Date prepared: | July 18, 2023 | |
| Device Name: | Trade name:Common name:Classification name:Regulation number:Product code:Class: | AtlanAnesthesia machineGas-machine, anesthesia21 CFR §868.5160BSZII |
| Predicate Device: | Perseus A500, K133886 | |
| Reference Devices: | Dräger Primus US Apollo, K042607Maquet Flow-I, K191027GE Aisys CS2, K170872Dräger Fabius CS/Fabius Tiro, K042419 |
Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, the Atlan anesthesia workstation.
Device Description
The Atlan anesthesia workstation was developed and is manufactured by Dräger in Lübeck, Germany. The anesthesia workstation is specified for inhalational anesthesia using volatile
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Image /page/4/Picture/1 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is in blue and features the company's name in a bold, sans-serif font. The two dots above the 'a' in Dräger are a distinctive feature of the logo. The logo is simple and modern, and it is easily recognizable.
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
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Indications for Use
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 O2 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.
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List of Consensus Standards
| Standard Number and Version | Title |
|---|---|
| AAMI ANSI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests |
| AIM 7351731 Rev. 2.00 2017-02-23 | Medical Electrical Equipment and System ElectromagneticImmunity Test for Exposure to Radio FrequencyIdentification Readers - An AIM Standard |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability |
| ANSI AAMI IEC 60601-1-8:2012 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance -Collateral Standard: General requirements, tests andguidance for alarm systems in medical electrical equipmentand medical electrical systems |
| ISO 80601-2-13:2011 AMD 1 2015 AMD2 2018 | Medical electrical equipment -- Part 2-13: Particularrequirements for basic safety and essential performance ofan anaesthetic workstation |
| ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particularrequirements for the basic safety and essential performanceof respiratory gas monitors |
| ISO 14971:2019-12 | Medical devices - Application of risk management tomedical devices |
| IEC 62366-1 Edition 1.0 2015-02Including Corrigendum 1 (2016)] | Medical devices - Part 1: Application of usability engineeringto medical devices |
| ANSI AAMI IEC 62304 Edition 1.1 2015-06 | Medical device software - Software life cycle processes |
| ANSI AAMI ISO 10993-1: 2018-08 | Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process |
| ISO 18562-1:2017-03 | Biocompatibility evaluation of breathing gas pathways inhealthcare applications - Part 1: Evaluation and testingwithin a risk management process |
| ANSI AAMI ISO 17664:2017 | Processing of health care products - Information to beprovided by the medical device manufacturer for theprocessing of medical devices |
| IEC/TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance ofmedical electrical equipment and medical electrical systems |
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Comparison to Predicate and Reference Devices
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
|---|---|---|---|
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | - |
| 510(k) Number | - | K133886 | - |
| Regulation Number | 868.5160 | 868.5160 | - |
| Product Code | BSZ | BSZ | - |
| Classification name | Gas-machine - Anesthesia | Gas-machine - Anesthesia | - |
| Regulatory Class | 2 | 2 | - |
| Indications for Use | The device is specified for inhalational anesthesiaand/or patient ventilation in accordance with theintended use during surgical or diagnostic inter-ventions. | Perseus is specified for inhalational anesthesia and/orpatient ventilation in accordance with the intended useduring surgical or diagnostic interventions. | - |
| Target Population /Patient Population | This device is intended for use in anesthetizing adults,pediatric patients, and neonates. | The Perseus anesthesia workstation is intended foruse in anesthetizing adults, children, and neonates. | - |
| Technological Characteristics | |||
| Gas reception,supplies | Via:• Central gas supply• Reserve gas cylinder | Via:• Central gas supply• Reserve gas cylinder | - |
| Gas reception,reserve gas cylinder | • Basic cylinder support (cylinders closed if centralsupply available to prevent unintentional emptyingif the central supply fails or falls below thespecified level; the backup cylinders must beopened manually) or• Advanced cylinder support (cylinders open even ifcentral supply available; if the central supply fails,cylinder supply automatically used) | • Basic cylinder support (cylinders closed if centralsupply available to prevent unintentional emptyingif the central supply fails or falls below thespecified level; the backup cylinders must beopened manually) or• Advanced cylinder support (cylinders open even ifcentral supply available; if the central supply fails,cylinder supply automatically used) | - |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| Gas delivery,gases/gascomposition | Electronically controlled mixer• Air/O2• O2/N2O (optional)• O2 flush (button on mixer front)Mechanically controlled mixer• Air/O2/N2O (N2O optional)• O2 flush (button on mixer front) | Electronically controlled mixer• Air/O2• O2/N2O (optional)• O2 flush (button on mixer front)Mechanically controlled mixer• Air/O2/N2O (N2O optional)• O2 flush (button on mixer front) | - |
| Gas delivery, SafetyOxygen RatioController (SORC) | YesElectronically controlled gas mixer:O2 to N2O ≥25%Mechanically controlled gas mixer:O2 to N2O ≥21% | YesElectronically controlled gas mixer:O2 to N2O ≥25%Mechanically controlled gas mixer:O2 to N2O ≥21% | - |
| Gas delivery, control | Electronically or manually | Electronically or manually | - |
| Gas delivery, auxiliaryoxygen | Optionally in one of three ways:• integrated in the gas mixer front for bothelectronically and mechanically controlled gasmixer variants• externally mounted as a flowmeter for themechanically controlled gas mixer variant only• not included at all, but only if the mechanicallycontrolled gas mixer is configured | • integrated in the gas mixer front for bothelectronically and mechanically controlled gasmixer variants | - |
| Anesthetic breathingsystem | Integrated, supports partial rebreathing• low-flow anesthesia• minimum-flow anesthesia | Integrated, supports partial rebreathing• low-flow anesthesia• minimum-flow anesthesia | - |
| Anesthetic ventilator,drive type | Piston | Blower | Primus US Apollo (K042607):Piston |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| Anesthetic ventilator,basic ventilation types | • Spontaneous breathing• Manual ventilation• Automatic (or controlled) ventilation○ Pressure-controlled○ Volume/flow-controlled | • Spontaneous breathing• Manual ventilation• Automatic (or controlled) ventilation○ Pressure-controlled○ Volume/flow-controlled | - |
| Anesthetic ventilator,features | • Compliance compensation• Fresh-gas decoupling | • Compliance compensation• Fresh-gas decoupling | - |
| Anesthetic ventilator,ventilation modes,applicable to allpatient populations | Manual / SpontaneousMan/Spon | Manual / SpontaneousMan/Spon | - |
| - | Manual / Spontaneous with CPAP, optional when PS option enabled | - | |
| Continuous positive airway pressure / Pressure-controlled ventilation,CPAP / PSV | CPAP / Pressure Support | - | |
| Pressure-controlled ventilation – Controlled mandatory ventilation,PC – CMV | Pressure Control - CMV | - | |
| Pressure-controlled ventilation – Synchronized intermitted mandatory ventilation,PC – SIMV | Pressure Control - SIMV+ | - | |
| Pressure-controlled ventilation – Synchronized intermitted mandatory ventilation – Pressure support,PC – SIMV/PS | Pressure Control - SIMV+ / PS | - | |
| Volume-controlled ventilation – Controlled mandatory ventilation / AutoFlow,VC – CMV/AutoFlow | Volume Control - CMV / AF | - | |
| Volume-controlled ventilation – Synchronized intermittent mandatory ventilation/AutoFlow,VC – SIMV/AutoFlow | Volume Control - SIMV / AF | - | |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| Volume-controlled ventilation – Synchronizedintermittent mandatory ventilation/Pressuresupport/AutoFlow,VC - SIMV/PS/AutoFlow | Volume Control - SIMV / AF / PS | ||
| Volume-controlled ventilation – Controlled mandatoryventilation,VC - CMV | Volume Control - CMV | ||
| Volume-controlled ventilation – Synchronizedintermittent mandatory ventilation,VC - SIMV | Primus US Apollo (K042607):Volume-controlled ventilationwith SynchronizationVolume Mode Sync. | ||
| Volume-controlled ventilation – Synchronizedintermittent mandatory ventilation/Pressure support,VC – SIMV/PS | Primus US Apollo (K042607):Volume-controlled ventilationwith Pressure SupportVolume Mode Press. Support | ||
| Anesthetic ventilator,ventilation modes,applicable to allpatient populations,maneuvers | Inspiration hold, or “inspiratory pause” or “manualinspiration”Insp. Hold | Maquet Flow-i (K191027):Inspiratory Hold | |
| Expiration hold, or “expiratory pause”Exp. Hold | Maquet Flow-i (K191027):Exspiratory Hold | ||
| One-step recruitment, or “sustained inflation” | GE Aisys CS2 (K170872):Procedure “Vital capacity” | ||
| Multi-step recruitment, or “incremental PEEP” | Pressure Control - APRV | GE Aisys CS2 (K170872):Procedure “Cycling” | |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| Anesthetic ventilator,additional operationmodes | External fresh-gas outlet (optional) | ||
| Cardiac Bypass Mode (CBM) | Cardiac Bypass Mode (CBM) | ||
| Monitoring mode- the anesthesia machine must be equipped with anintegrated respiratory gas measurement module- for patient gas monitoring- no fresh-gas delivery | Primus US Apollo (K042607):Monitoring mode- for use during standby (notavailable during automaticventilation)- no fresh-gas delivery- general time function displayedon screen for timing events | ||
| Pause mode- ventilation stopped- if equipped with an electronically controlled gasmixer, gas delivery also stopped- gas concentration measurement active, waiting forrespiratory phases- remains in this operation mode until deliberatelyswitched to a specific ventilation mode- configurable Timer [for all patient categories]allows defined period after which an alarm isposted to remind user to initiate ventilationmanually- total elapsed time displayed | Pause mode- ventilation is stopped- if equipped with an electronically controlled gasmixer, gas delivery also stopped- gas concentration measurement active, waiting forrespiratory phases- remains in current operation mode untildeliberately switched to a specific ventilationmode- equipped with an adjustable Timer depending onthe patient category; when set time elapses, alarmposted as a reminder that ventilation should beresumed- total elapsed time displayed |
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Traditional 510(k)
510(k) Summary
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Image /page/9/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is the logo for the Dräger company, which specializes in medical and safety technology products.
Traditional 510(k)
510(k) Summary
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Dräger
Traditional 510(k)
510(k) Summary
Section 005
Atlan
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Traditional 510(k)
510(k) Summary
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Traditional 510(k)
510(k) Summary
| Specification | Subject Device | Predicate Device | Reference Device(s) |
|---|---|---|---|
| Anesthetic ventilator,manual overrideoperation | AtlanEmergency oxygen deliveryAdd. O2 | Perseus A500Emergency oxygen deliveryAdd. O2 | - |
| Backup manual mode:- enables direct change to manual ventilation [viaAdd. O2]- with acoustic and optical alarm signals of highpriority- automatic downgrade to low priority after 20 s | Fresh-gas delivery failure:- current ventilation mode remains active- gas delivery via emergency O2 [Add. O2] deliveryor ambient air- with acoustic and optical alarm signals of highpriority- downgrade to low priority via rotary confirmationknob | - | |
| Anesthetic gasscavenger | active, integratedpassive | active, integrated | - |
| Anesthetic gasscavenger, active,type | open reservoir system | open reservoir system | GE Aisys CS2 (K170872):passive |
| Anesthetic gasscavenger, passive | - for gas disposal without an active disposalsystem- anesthetic gas transported by overpressurewithin the breathing systempositive and negative release valves | GE Aisys CS2 (K170872):- positive and negativerelease valves- negative pressure relief 0.3cmH2O- for use with a non-recirculating ventilationsystem | |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| General monitoring, alarm principles | optical and acoustical alarm signaling adjustable alarm volume high, medium, and low alarm priorities alarm silence key available downgrading for some alarms alarm logbook user-adjustable alarm limits automatic alarm settings adaptation when changing ventilation modes | optical and acoustical alarm signaling adjustable alarm volume high, medium, and low alarm priorities alarm silence key available downgrading for some alarms alarm history user-adjustable alarm limits automatic alarm settings adaptation when changing ventilation modes | - |
| Gas monitoring, types | integrated patient-gas measurement module for O2, CO2, N2O, and anesthetic gasesorintegrated inspiratory O2 sensor | Integrated patient-gas measurement module for O2, CO2, N2O, and anesthetic gases | - |
| Gas monitoring, integrated patient-gas measurement module for O2 | paramagnetic (consumption-free) side-stream | paramagnetic (consumption-free) side-stream | - |
| Gas monitoring, integrated patient-gas measurement module for CO2 | infrared spectrometry (consumption-free) side-stream | infrared absorption (consumption-free) side-stream | - |
| Gas monitoring, integrated patient-gas measurement module for N2O and anesthetic gases | infrared spectrometry (consumption-free) side-stream | infrared absorption (consumption-free) side-stream | - |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| Gas monitoring,integrated inspiratoryO2 | electrochemical mainstream, inspiratory limb | Fabius (K011404):electrochemicalmainstream, inspiratoryvalve | |
| Gas monitoring,parameter O2 | inspiratory O2 concentration | inspiratory O2 concentration | |
| Gas monitoring, otherparameters | with the integrated patient-gas measurement modulefor O2, CO2, N2O, and anesthetic gases expiratory O2 concentration inspiratory and expiratory CO2 concentrations inspiratory and expiratory N2O concentrations inspiratory and expiratory anesthetic gasconcentrations occurrence of anesthetic gas mixtures | expiratory O2 concentration inspiratory and expiratory CO2 concentrations inspiratory and expiratory N2O concentrations inspiratory and expiratory anesthetic gasconcentrations occurrence of anesthetic gas mixtures | |
| Ventilation / airwaymonitoring,parameters | airway pressure minute volume / tidal volume respiratory rate, apnea (derived from pressure,flow, and CO2) apnea (pressure, flow, and CO2) lack of fresh gas in the breathing system and thebreathing circuit | airway pressure minute volume / tidal volume respiratory rate, apnea (derived from pressure,flow, and CO2) apnea (pressure, flow, and CO2) degree of filling of the breathing bag | |
| Device monitoring,supply pressuremonitoring | electronically monitored and status displayed onthe mixer front | electronically monitored and status displayed onthe mixer front | |
| Device monitoring,system self test | covering all system-relevant functions fully automatic can be cancelled in case of emergency can be set for automated start-up | covering all system-relevant functions fully automatic can be cancelled in case of emergency can be set for automated start-up | |
| Specification | Subject DeviceAtlan | Predicate DevicePerseus A500 | Reference Device(s) |
| User interface,hardware | • 15" TFT LCD touchscreen display• rotary knob for selecting, adjusting, andconfirming therapy parameters• alarm silence key• LED lighting key• power ON/OFF key | • 15" TFT LCD touchscreen display• rotary knob for selecting, adjusting, andconfirming therapy parameters• alarm silence key• LED lighting key• power ON/OFF key | - |
| User interface,displaying information | • waveforms• graphical trends• numeric trends• loops• alarm logbook• logbook• numeric parameters• low-flow wizard | • waveforms• graphical trends• numeric trends• loops• alarm history• logbook• numeric parameters• low-flow wizard | - |
| RFID capabilities | utilization of radio-frequency identification (RFID)wireless technology• Infinity ID water trap for compatibility andexchange control, i.e., replacement interval(maximum period of use)• Infinity ID flow sensors for compatibility andexchange control, i.e., replacement interval• Infinity ID CLIC absorber for compatibility,exchange control, and detection for "absorberlocked in position"• Infinity ID breathing circuits for compatibility,exchange control, and identifying and reportingpossible breathing hose or breathing bagmismatches | utilization of radio-frequency identification (RFID)wireless technology• Infinity ID water trap for compatibility andexchange control, i.e., replacement interval(maximum period of use)• Infinity ID flow sensors for compatibility andexchange control, i.e., replacement interval• Infinity ID CLIC absorber for compatibility,exchange control, and detection for "absorberlocked in position"• Infinity ID breathing circuits for compatibility,exchange control, and identifying and reportingpossible breathing hose or breathing bagmismatches | - |
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Image /page/13/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology. The logo is simple and recognizable, and it is often used on the company's products and marketing materials. The font is sans-serif and the color is a deep blue.
Traditional 510(k)
510(k) Summary
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Dräger
Atlan
Traditional 510(k)
510(k) Summary
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Traditional 510(k)
510(k) Summary
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Image /page/16/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The word is horizontally oriented and centered.
Discussion of Non-clinical Testing
The Atlan anesthesia workstation is a new device and has underqone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements. The following verification and validation activities were deemed necessary to establish substantial equivalence to the predicate device and were carried out under well-established methods, their results summarized in Test Summary tables and the evidence included in this submission.
- . Sterilization
- Biocompatibility
- Software, including cybersecurity ●
- Electrical safety ●
- Electromagnetic compatibility (EMC)
- IEC 60601-1-8 for alarm systems in medical electrical equipment ●
- 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, covering:
- Risk control measures o
- o Technical data
- Essential safety and performance o
- Accessories compatibility
- . Human factors engineering
- IEC 60601-1-6 for Usability ●
- IEC 62366-1 for the application of usability engineering to medical devices
Conclusion
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.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).