(335 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on traditional anesthesia system functionalities and software control.
Yes
The device administers inhalation anesthesia and controls/supports ventilation, which are therapeutic actions to manage a patient's physiological state during medical procedures.
No
This device is an anesthesia system designed for administering inhalation anesthesia and controlling ventilation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a "core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Flow-c/Flow-e Anesthesia System is used for administering inhalation anesthesia and controlling/supporting patient ventilation. This is a direct therapeutic and life-support function performed on the patient's body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is focused on delivering anesthesia and managing breathing during medical procedures.
- Device Description: The description details a system for mixing and administering gases, and a user interface for settings and monitoring. This aligns with an anesthesia delivery system, not a diagnostic testing device.
Therefore, the Flow-c/Flow-e Anesthesia System falls under the category of a therapeutic or life-support medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.
Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.
The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.
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
neonatal to adult patient populations.
Intended User / Care Setting
hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.
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)
Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified devices meets the design input requirements:
Software
- Code review
- Static code analysis
- System testing
Performance
- System testing
- Regression
- Free User testing
- Waveform testing
- Comparative testing for MAC Brain
- Comparative testing for Recruitment Maneuver
Biocompatibility
- Volatile Organic Compounds
- Particulate Testing
Human Factors Validation Testing
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.
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.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Maquet Critical Care AB % Mark Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K191027
Trade/Device Name: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: February 17, 2020 Received: February 18, 2020
Dear Mark Smith:
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 medical devices and radiation-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,
Todd Courtney Assistant Director DHT1C: Division of ENT, 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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Indications for Use
510(k) Number (if known) K191027
Device Name Flow-i Anesthesia System Flow-c Anesthesia System Flow-e Anesthesia System
Indications for Use (Describe)
The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the text "Page 1 of 8" at the top. Below that is the word "GETINGE" in large, bold, blue letters. To the right of the word is a blue abstract symbol that looks like three curved arrows pointing inward.
510(k) SUMMARY
as required by section 21 CFR 807.92
| Device owner | Maquet Critical Care AB |
|---|---|
| Röntgenvägen 2 | |
| SE-171 54 Solna, Sweden | |
| Tel: (011) 46 10 335 7300 | |
| Contact Persons for this submission: | Ms. Kribu Valdre |
| Regulatory Affairs Manager | |
| Phone: direct: (011) 46 10 335 7300 | |
| Email: kribu.valdre@getinge.com | |
| Application Correspondent: | Mr. Mark N. Smith |
| Manager, Regulatory Affairs | |
| Getinge | |
| 45 Barbour Pond Drive | |
| Wayne, NJ 07470 | |
| Email: mark.n.smith@getinge.com | |
| Phone: 585-272-5274 | |
Date prepared: March 18, 2020
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Image /page/4/Picture/2 description: The image shows the logo for GETINGE. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol. The symbol is composed of four curved shapes arranged in a circular pattern, resembling a stylized flower or asterisk. The logo is simple and modern, with a clean and professional appearance.
| Trade Name: | Model: |
|---|---|
| Flow-i Anesthesia System | Flow-i C20 |
| Flow-i C30 | |
| Flow-i C40 | |
| Flow-c Anesthesia System | Flow-c |
| Flow-e Anesthesia System | Flow-e |
| Device Classification | |
| Common Name | Gas-Machine, Anesthesia |
| Classification Number | BSZ |
| Class | II |
| Regulation Number | 21 CFR 868.5160 |
| Predicate Device Identification | |
| Maquet FLOW-i Anesthesia System | K160665 |
| Reference Device Identification | |
| GE Aisys CS2 | K170872 |
Indications for Use
The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.
Intended use of the Device
The system is intended for use in administering Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
The system is intended for use by healthcare professionals, trained in the administration of Anesthesia.
The system is intended for use on neonatal to adult patient populations.
The system is intended for use in hospital environments, except MRI environment. When not in operation, the system is designed for in-hospital transport.
Device Description
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Image /page/5/Picture/2 description: The image shows the logo for GETINGE. The text "GETINGE" is in a bold, sans-serif font and is colored in a dark blue. To the right of the text is a stylized symbol that appears to be made up of four curved arrows pointing inward towards a central point, also in varying shades of blue.
Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.
Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.
The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.
COMPARISON TO PREDICATE
Comparison of Intended Use
The Intended Use for the modified Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 is identical to the predicate device, FLOW-i Anesthesia System version 4.2 (K160665).
Comparison of Technology Characteristics
The following changes have been made to Flow-i/-c/e 4.7 compared to the cleared predicate device FLOW-i 4.2 (K160665) without significant change with regards to safety and/or effectiveness:
- A new function that supports lung recruitment of patients
The subject devices Flow-i, Flow-e and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 introduces a function that facilitates the lung recruitment maneuver (RM) by displaying a breath-by-breath presentation of relevant breathing parameters, i.e. End Inspiratory Pressure (EIP), Positive End Expiratory Pressure (PEEP) and Dynamic Compliance (Cdyn). It is available as Automatic RM and as RM trends (manual recruitment).
The added function RM is substantially equivalent to the recruitment maneuver in the reference device (K170872) and does not affect the overall performance or technology of the device.
- Modifications of the Patient Gas Analyzer (PGA)
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The subject devices' PGA component has been updated from the AION™ to the AION™ Platinum version. The AIONTM PGA had the patient O2 sensor as a stand-alone component within the AION™ PGA, whereas the updated AION™ Platinum includes the O2 sensor and the gas analyser within the same component housing.
The exchange of the Patient Gas Analyzer AION™ to the AION™ Platinum does not affect the overall performance or technology of the device, as it does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling.
A new user interface indicator, MAC Brain ●
The display of the MAC value has been updated to include a bar indicator on the user interface. This bar indicator now includes MAC Brain and is shown side by side with the MAC value. The purpose of MAC Brain is to display the delay of the variation of agent level in the brain compared to the observed exhaled agent level. The MAC Brain value is based on the MAC value and is trended.
The addition of MAC Brain does not affect the overall performance or technology of the device, as it does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling.
Addition of a Pause function ●
A new pause function is introduced in the subject devices for the possibility to temporarily disconnect the breathing circuits in clinical situations (e.g. for removing condensed water or repositioning the patient). The pause function can be used both in both automatic and manual ventilation.
The Pause function is present in the cleared predicate device FLOW-i 4.2 through a manual action. In the subject device the Pause function is now supported by automatic timings.
- Option to set lower fresh gas flow ●
The lower level for the fresh gas flow into the breathing system will be possible to adjust from 0.1 1/min, as compared to 0.3 1/min in the predicate device FLOWi 4.2.
Oxygen supply is maintained through the rebreathing system via the volume reflector in the same way as in the cleared predicate device FLOW-i 4.2. This change does not affect the overall performance or technology of the device.
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Image /page/7/Picture/2 description: The image shows the logo for GETINGE. The word "GETINGE" is written in a bold, sans-serif font in dark blue. To the right of the word is a stylized symbol that looks like four curved arrows pointing towards the center, also in shades of blue.
- Hardware changes to the subject devices to improve supply and production .
- o A new battery.
- o Modified inspiratory channel and pneumatic block.
- o Removal of the secondary, electronically controlled, locking of the vaporizer latch.
- o Introduction of a new Power Supply Unit (PSU) with the same specifications as used in the predicate device FLOW-i 4.2.
These hardware changes do not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling.
- Minor changes to equipment labels. .
- o Adding equipment enclosure IP21 rating.
The change of IP classification improves the rating of the electrical protection for the cabinet, but does not affect the anesthesia delivery, the monitoring of ventilation or the alarm handling in the sense that it affects the substantial equivalence.
- Minor Software updates. ●
- o Adaption of the software to the changes stated above, i.e. patient gas analyzer modifications, battery handling and modifications of the inspiratory channel and pneumatic block.
- o Adaption in the software to support SW options for Flow-c and Flow-e. These SW options are included in the standard settings for Flow-i.
- O Updated range for Air, O2, N2O supply pressure
- 0 Updated accuracy of CO2 gas measurement range 0-1%.
- o Quick settings in the user interface for O2 concentration, Fresh gas flow (FGF) and agent concentration.
- o System Check Out (SCO) improvements.
These minor software changes do not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling.
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Image /page/8/Picture/2 description: The image shows the logo for Getinge, a company that provides equipment and systems for healthcare and life sciences. The logo consists of the word "GETINGE" in a bold, sans-serif font, followed by a stylized symbol that resembles four arrows pointing towards a central point. The logo is in a dark blue color, which gives it a professional and trustworthy appearance.
-
Addition of two new device models Flow-c Anesthesia System and Flow-e ● Anesthesia System.
The addition of two new models does not affect the overall performance or technology, as they do not change the anesthesia delivery, the monitoring of ventilation or the alarm handling. -
Material changes in:
- o The filter in the patient gas pathway
- o Volume reflector
- o Vaporizers
- o Inspiratory and pneumatic block
- o The water trap membrane (used in the Patient Gas Analyzer)
These material changes do not affect the overall performance or technology, nor were they found to raise different questions about safety and effectiveness compared to the cleared predicate device.
Similarities and differences
The subject devices are similar in all aspects, except from what is stated above, to the cleared predicate device. The modifications above do not individually, or as a sum. impact device safety and effectiveness or change the technology or performance compared to the cleared predicate device (K160665).
Non-clinical Testing and Performance
Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified devices meets the design input requirements:
Software
- Code review
- Static code analysis ●
- System testing ●
Performance
- . System testing
9
- Regression ●
- Free User testing
- Waveform testing
- Comparative testing for MAC Brain ●
- Comparative testing for Recruitment Maneuver ●
Biocompatibility
- . Volatile Organic Compounds
- Particulate Testing ●
Human Factors Validation Testing
The following product standards are included in the verification:
- ANSI/AAMI ES 60601-1:2005 + A1:2012. Medical electrical equipment . Part 1: General requirements for basic safety and essential performance, Recognition Number 19-4
- 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 Test, Recognition Number 19-8
- IEC 60601-1-8:2006 + A1:2012, 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, Recognition Number 5-76
- ISO 80601-2-13:2011, Medical electrical equipment -- Part 2-13: Particular ● requirements for basic safety and essential performance of an anaesthetic workstation, Recognition Number 1-104
- . ISO 80601-2-55:2011, Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors, Recognition Number 1-96
The connector to high-pressure gas is verified according to CGA V-5:2008, Recognition Number 1-81.
Conclusion for Substantial Equivalence
The Flow-i/-c/-e Anesthesia Systems version 4.7 have identical intended use and indications for use as the predicate FLOW-i version 4.2 (K160665). Maquet has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. The proposed changes do not affect the safety and effectiveness compared
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to the predicate device FLOW-i Anesthesia System. Maquet Critical Care AB has concluded that the Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family version 4.7 (K191027) is substantially equivalent to the cleared predicate device, FLOW-i Anesthesia System version 4.2 (K160665).