(111 days)
No
The summary describes a standard anesthesia workstation with various monitoring and control functions, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as an "anesthesia workstation" used for "inhalational anesthesia and/or patient ventilation during surgical or diagnostic interventions," implying its direct involvement in patient treatment and life support, which are therapeutic functions.
Yes
The device is described as an "anesthesia workstation" intended for "inhalational anesthesia and/or patient ventilation." It includes functions for "Ventilation monitoring," "Inspiratory O2 measurement," "Device monitoring," and an "Anesthetic gas receiving system." Additionally, it has "Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases." These measurement and monitoring capabilities are used to assess patient and anesthetic parameters, which are diagnostic in nature to ensure proper anesthesia and ventilation. The text explicitly states it monitors "the patient's and/or anesthetic parameters."
No
The device description clearly outlines multiple hardware components including gas reception and delivery, anesthetic breathing system, anesthetic ventilator, and anesthetic gas scavenger, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for delivering anesthesia and providing ventilation to patients during surgical or diagnostic interventions. This involves delivering gases and monitoring physiological parameters in vivo (within the living body).
- Device Description: The description details the components and functions of an anesthesia workstation, including gas delivery, breathing systems, ventilators, and gas scavenging. These are all related to supporting respiration and delivering anesthetic agents directly to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the living body) to diagnose a condition or monitor a patient's health status. The monitoring functions described are related to the delivery of gases and the patient's respiratory response to the anesthesia.
Therefore, the device described is an anesthesia workstation, which is a medical device used for patient care in vivo, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatric patients, and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Perseus A500, K133886
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Dräger Primus US Apollo, K042607, Maquet Flow-I, K191027, GE Aisys CS2, K170872, Dräger Fabius CS/Fabius Tiro, K042419
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/3 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 centered in the image.
510(k) Premarket Notification Summary
| Submitter: | Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23542 Lübeck, Germany
Establishment's registration number: 9611500 | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Official correspondent: | Dr. Marianne Selent
Regulatory Affairs Manager
E-Mail: marianne.selent@draeger.com
Telephone: +49 451 882 1602 | |
| US agent: | Darlene Thibodeau
Head of Quality Assurance and Compliance
E-mail: darlene.thibodeau@draeger.com
Telephone: (978) 773 0160 | |
| Date prepared: | July 18, 2023 | |
| Device Name: | Trade name:
Common name:
Classification name:
Regulation number:
Product code:
Class: | Atlan
Anesthesia machine
Gas-machine, anesthesia
21 CFR §868.5160
BSZ
II |
| Predicate Device: | Perseus A500, K133886 | |
| Reference Devices: | Dräger Primus US Apollo, K042607
Maquet Flow-I, K191027
GE Aisys CS2, K170872
Dräger 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
4
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
5
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.
6
Image /page/6/Picture/3 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.
List of Consensus Standards
| Standard Number and Version | Title |
|---|---|
| AAMI ANSI ES60601-1:2005/(R)2012 | |
| and A1:2012, C1:2009/(R)2012 and | |
| A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements |
| for basic safety and essential performance | |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General |
| requirements 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 Electromagnetic |
| Immunity Test for Exposure to Radio Frequency | |
| Identification Readers - An AIM Standard | |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Usability | |
| ANSI AAMI IEC 60601-1-8:2012 | Medical electrical equipment - Part 1-8: General |
| requirements for basic safety and essential performance - | |
| Collateral Standard: General requirements, tests and | |
| guidance for alarm systems in medical electrical equipment | |
| and medical electrical systems | |
| ISO 80601-2-13:2011 AMD 1 2015 AMD | |
| 2 2018 | Medical electrical equipment -- Part 2-13: Particular |
| requirements for basic safety and essential performance of | |
| an anaesthetic workstation | |
| ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular |
| requirements for the basic safety and essential performance | |
| of respiratory gas monitors | |
| ISO 14971:2019-12 | Medical devices - Application of risk management to |
| medical devices | |
| IEC 62366-1 Edition 1.0 2015-02 | |
| Including Corrigendum 1 (2016)] | Medical devices - Part 1: Application of usability engineering |
| to 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: Evaluation |
| and testing within a risk management process | |
| ISO 18562-1:2017-03 | Biocompatibility evaluation of breathing gas pathways in |
| healthcare applications - Part 1: Evaluation and testing | |
| within a risk management process | |
| ANSI AAMI ISO 17664:2017 | Processing of health care products - Information to be |
| provided by the medical device manufacturer for the | |
| processing of medical devices | |
| IEC/TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidance and |
| interpretation - Electromagnetic immunity: performance of | |
| medical electrical equipment and medical electrical systems |
7
Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is colored in a dark blue. The two dots above the "a" are also dark blue.
Comparison to Predicate and Reference Devices
| Specification | Subject Device
Atlan | Predicate Device
Perseus 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 anesthesia
and/or patient ventilation in accordance with the
intended use during surgical or diagnostic inter-
ventions. | Perseus is specified for inhalational anesthesia and/or
patient ventilation in accordance with the intended use
during 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 for
use 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 central
supply available to prevent unintentional emptying
if the central supply fails or falls below the
specified level; the backup cylinders must be
opened manually) or
• Advanced cylinder support (cylinders open even if
central supply available; if the central supply fails,
cylinder supply automatically used) | • Basic cylinder support (cylinders closed if central
supply available to prevent unintentional emptying
if the central supply fails or falls below the
specified level; the backup cylinders must be
opened manually) or
• Advanced cylinder support (cylinders open even if
central supply available; if the central supply fails,
cylinder supply automatically used) | - |
| Specification | Subject Device
Atlan | Predicate Device
Perseus A500 | Reference Device(s) |
| Gas delivery,
gases/gas
composition | 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, Safety
Oxygen Ratio
Controller (SORC) | Yes
Electronically controlled gas mixer:
O2 to N2O ≥25%
Mechanically controlled gas mixer:
O2 to N2O ≥21% | Yes
Electronically 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, auxiliary
oxygen | Optionally in one of three ways:
• integrated in the gas mixer front for both
electronically and mechanically controlled gas
mixer variants
• externally mounted as a flowmeter for the
mechanically controlled gas mixer variant only
• not included at all, but only if the mechanically
controlled gas mixer is configured | • integrated in the gas mixer front for both
electronically and mechanically controlled gas
mixer variants | - |
| Anesthetic breathing
system | 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 Device
Atlan | Predicate Device
Perseus 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 all
patient populations | Manual / Spontaneous
Man/Spon | Manual / Spontaneous
Man/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 Device
Atlan | Predicate Device
Perseus A500 | Reference Device(s) |
| | Volume-controlled ventilation – Synchronized
intermittent mandatory ventilation/Pressure
support/AutoFlow,
VC - SIMV/PS/AutoFlow | Volume Control - SIMV / AF / PS | |
| | Volume-controlled ventilation – Controlled mandatory
ventilation,
VC - CMV | Volume Control - CMV | |
| | Volume-controlled ventilation – Synchronized
intermittent mandatory ventilation,
VC - SIMV | | Primus US Apollo (K042607):
Volume-controlled ventilation
with Synchronization
Volume Mode Sync. |
| | Volume-controlled ventilation – Synchronized
intermittent mandatory ventilation/Pressure support,
VC – SIMV/PS | | Primus US Apollo (K042607):
Volume-controlled ventilation
with Pressure Support
Volume Mode Press. Support |
| Anesthetic ventilator,
ventilation modes,
applicable to all
patient populations,
maneuvers | Inspiration hold, or “inspiratory pause” or “manual
inspiration”
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 Device
Atlan | Predicate Device
Perseus A500 | Reference Device(s) |
| Anesthetic ventilator,
additional operation
modes | | External fresh-gas outlet (optional) | |
| | Cardiac Bypass Mode (CBM) | Cardiac Bypass Mode (CBM) | |
| | Monitoring mode
- the anesthesia machine must be equipped with an
integrated respiratory gas measurement module - for patient gas monitoring
- no fresh-gas delivery | | Primus US Apollo (K042607):
Monitoring mode - for use during standby (not
available during automatic
ventilation) - no fresh-gas delivery
- general time function displayed
on screen for timing events |
| | Pause mode - ventilation stopped
- if equipped with an electronically controlled gas
mixer, gas delivery also stopped - gas concentration measurement active, waiting for
respiratory phases - remains in this operation mode until deliberately
switched to a specific ventilation mode - configurable Timer [for all patient categories]
allows defined period after which an alarm is
posted to remind user to initiate ventilation
manually - total elapsed time displayed | Pause mode
- ventilation is stopped
- if equipped with an electronically controlled gas
mixer, gas delivery also stopped - gas concentration measurement active, waiting for
respiratory phases - remains in current operation mode until
deliberately switched to a specific ventilation
mode - equipped with an adjustable Timer depending on
the patient category; when set time elapses, alarm
posted as a reminder that ventilation should be
resumed - total elapsed time displayed | |
8
Image /page/8/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The "a" in the word has two dots above it, which is called an umlaut. The word is centered and takes up most of the image.
Traditional 510(k)
510(k) Summary
9
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
10
Dräger
Traditional 510(k)
510(k) Summary
Section 005
Atlan
11
Image /page/11/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 centered in the image and takes up most of the space.
Traditional 510(k)
510(k) Summary
12
Image /page/12/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 centered in the image and takes up most of the space.
Traditional 510(k)
510(k) Summary
| Specification | Subject Device | Predicate Device | Reference Device(s) |
|---|---|---|---|
| Anesthetic ventilator, | |||
| manual override | |||
| operation | Atlan | ||
| Emergency oxygen delivery | |||
| Add. O2 | Perseus A500 | ||
| Emergency oxygen delivery | |||
| Add. O2 | - | ||
| Backup manual mode: |
- enables direct change to manual ventilation [via
Add. O2] - with acoustic and optical alarm signals of high
priority - automatic downgrade to low priority after 20 s | Fresh-gas delivery failure:
- current ventilation mode remains active
- gas delivery via emergency O2 [Add. O2] delivery
or ambient air - with acoustic and optical alarm signals of high
priority - downgrade to low priority via rotary confirmation
knob | - |
| Anesthetic gas
scavenger | active, integrated
passive | active, integrated | - |
| Anesthetic gas
scavenger, active,
type | open reservoir system | open reservoir system | GE Aisys CS2 (K170872):
passive |
| Anesthetic gas
scavenger, passive | - for gas disposal without an active disposal
system - anesthetic gas transported by overpressure
within the breathing system
positive and negative release valves | | GE Aisys CS2 (K170872): - positive and negative
release valves - negative pressure relief 0.3
cmH2O - for use with a non-
recirculating ventilation
system |
| Specification | Subject Device
Atlan | Predicate Device
Perseus 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 gases
or
integrated 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 Device
Atlan | Predicate Device
Perseus A500 | Reference Device(s) |
| Gas monitoring,
integrated inspiratory
O2 | electrochemical mainstream, inspiratory limb | | Fabius (K011404):
electrochemical
mainstream, inspiratory
valve |
| Gas monitoring,
parameter O2 | inspiratory O2 concentration | inspiratory O2 concentration | |
| Gas monitoring, other
parameters | with the integrated patient-gas measurement module
for O2, CO2, N2O, and anesthetic gases expiratory O2 concentration inspiratory and expiratory CO2 concentrations inspiratory and expiratory N2O concentrations inspiratory and expiratory anesthetic gas
concentrations occurrence of anesthetic gas mixtures | expiratory O2 concentration inspiratory and expiratory CO2 concentrations inspiratory and expiratory N2O concentrations inspiratory and expiratory anesthetic gas
concentrations occurrence of anesthetic gas mixtures | |
| Ventilation / airway
monitoring,
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 the
breathing 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 pressure
monitoring | electronically monitored and status displayed on
the mixer front | electronically monitored and status displayed on
the 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 Device
Atlan | Predicate Device
Perseus A500 | Reference Device(s) |
| User interface,
hardware | • 15" TFT LCD touchscreen display
• rotary knob for selecting, adjusting, and
confirming therapy parameters
• alarm silence key
• LED lighting key
• power ON/OFF key | • 15" TFT LCD touchscreen display
• rotary knob for selecting, adjusting, and
confirming 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 and
exchange control, i.e., replacement interval
(maximum period of use)
• Infinity ID flow sensors for compatibility and
exchange control, i.e., replacement interval
• Infinity ID CLIC absorber for compatibility,
exchange control, and detection for "absorber
locked in position"
• Infinity ID breathing circuits for compatibility,
exchange control, and identifying and reporting
possible breathing hose or breathing bag
mismatches | utilization of radio-frequency identification (RFID)
wireless technology
• Infinity ID water trap for compatibility and
exchange control, i.e., replacement interval
(maximum period of use)
• Infinity ID flow sensors for compatibility and
exchange control, i.e., replacement interval
• Infinity ID CLIC absorber for compatibility,
exchange control, and detection for "absorber
locked in position"
• Infinity ID breathing circuits for compatibility,
exchange control, and identifying and reporting
possible breathing hose or breathing bag
mismatches | - |
13
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
14
Dräger
Atlan
Traditional 510(k)
510(k) Summary
15
Image /page/15/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 centered and takes up most of the image.
Traditional 510(k)
510(k) Summary
16
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.