(172 days)
No
The document describes a software-controlled anesthesia system with various ventilation modes and safety features. There is no mention of AI, ML, or any related concepts in the description of the device's functionality or performance testing.
Yes.
The device is an anesthesia system that supports patients' breathing during inhalation anesthesia, which is a therapeutic intervention.
No
The device is an anesthesia system intended for administering inhalation anesthesia and controlling/supporting patient ventilation, not for diagnosing medical conditions.
No
The device description explicitly states that FLOW-i is a "software-controlled semi-closed system for inhalation Anaesthesia" and lists several hardware components like a ventilator, volume reflector technology, and electronically controlled injector vaporizers. The performance studies also include testing of electrical and mechanical safety, indicating a significant hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer inhalation anesthesia and control/support patient ventilation. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description focuses on the system's ability to deliver anesthesia gases and provide ventilation, highlighting features like the ventilator, volume reflector, and vaporizers. These are all related to patient treatment and support.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are specifically designed for this purpose.
The device is clearly an anesthesia delivery and ventilation system used in a clinical setting for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The indication for FLOW-i 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
BSZ
Device Description
FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.
FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The most important performance features of the FLOW-i Anaesthesia system are:
- o a ventilator whose functionality is based on ICU-ventilator technology,
- o the volume reflector technology,
- o the electronically controlled injector vaporizers and
- o the ergonomic design.
The proposed modification (K112114) includes two additional ventilation modes and a backup function:
- o PRVC, Pressure Regulated Volume Control
- O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
- o Pressure Support with Backup
In addition to the new ventilation modes the proposed modification includes a number of minor changes.
PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.
SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.
Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.
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
healthcare professionals trained in inhalation Anaesthesia administration.
in hospital environments, except MRI environment
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)
Performance testing has demonstrated that the FLOW-i Anaesthesia System performs within its specifications and within the limits of the applied performance standards. The following performance characteristics of FLOW-i Anaesthesia System were thoroughly tested: technical data, measurement ranges and measurement accuracy, delivery accuracy, construction, features, interfaces, handling, critical situations and interventions.
To evaluate the safety and effectiveness of the FLOW-i Anaesthesia System the following areas have been covered:
- Electrical and mechanical Safety .
- Electromagnetic Compatibility .
- Software Validation .
- Usability .
- Tightness .
- Verification of Alarms .
- Packaging ●
- Verification of Operating Data and Accuracy of Measurements .
- Performance .
- t Biocompatibility
- Vaporizer filling system .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
MAQUET
GETINGE GROUP
510 (K) Summary [as required by 21 CFR 807.92(c)]
JAN 1 3 2012
Date July 22, 2011 K 112114
Submitter's Name & Address Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Phone: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38
Mr. Karl-Yngve Keck Submitter of this submission: Phone: (011) 46 8 730 72 65 Email: karl-yngve.keck(@maquet.com
Applicant Correspondent:
Ms. Whitney Törning Director, Regulatory Affairs Maquet Inc. 45 Barbour Pond Drive Wayne, NJ 07470 Phone: 973-709-7994 Fax: 973-973-807-9210 Email: whitney.torning@maquet.com
| Trade name: | Model: | Model number: |
|---|---|---|
| FLOW-i Anaesthesia System | MAQUET FLOW-i C20 | |
| MAQUET FLOW-i C30 | ||
| MAQUET FLOW-i C40 | 6677200 | |
| 6677300 | ||
| 6677400 |
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|--------------------------|--------------------------|-------|-------------------|
| Gas-Machine, Anaesthesia | 73 BSZ | II | 21 CFR 868.5160 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Maquet FLOW-i Anesthestia System | K102182 |
| GE Datex-Ohmeda, Aisys Anaesthesia System | K090233 |
1
Device Description
FLOW-i (K102182 SE5/9/2011) is a high-performance Anaesthesia system designed to meet the many ventilatory challenges within Anaesthesia, as well as to provide inhalation Anaesthesia. It is intended to serve a wide range of patients from neonatal to adult.
FLOW-i is a software-controlled semi-closed system for inhalation Anaesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).
The most important performance features of the FLOW-i Anaesthesia system are:
- o a ventilator whose functionality is based on ICU-ventilator technology,
- o the volume reflector technology,
- o the electronically controlled injector vaporizers and
- o the ergonomic design.
The proposed modification (K112114) includes two additional ventilation modes and a backup function:
- o PRVC, Pressure Regulated Volume Control
- O SIMV (VC and PC), Synchronized Intermittent Mandatory Ventilation
- o Pressure Support with Backup
In addition to the new ventilation modes the proposed modification includes a number of minor changes.
PRVC is a controlled mode of ventilation which combines the advantages of volume controlled and pressure controlled ventilation. FLOW-i assures that the preset tidal volume is delivered at the lowest possible pressure in order to protect the lungs. The flow during inspiration is decelerating and patient can trigger extra breaths.
SIMV is designed to improve synchronization of breaths which can decrease patient's tendency to fight against the Anaesthesia ventilator.
Backup functionality has been added to Pressure Support to add safety for the patient and improve the work flow for the users by minimizing apnea alarms.
Indications for Use
The indication for FLOW-i Anaesthesia System is administering inhalation Anaesthesia 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 MRJ environment, by healthcare professionals trained in inhalation Anaesthesia administration.
Non-clinical Testing and Performance
Performance testing has demonstrated that the FLOW-i Anaesthesia System performs within its specifications and within the limits of the applied performance standards. The following performance characteristics of FLOW-i Anaesthesia System were thoroughly tested: technical data, measurement ranges and measurement accuracy, delivery accuracy, construction, features, interfaces, handling, critical situations and interventions.
2
To evaluate the safety and effectiveness of the FLOW-i Anaesthesia System the following areas have been covered:
- Electrical and mechanical Safety .
- Electromagnetic Compatibility .
- Software Validation .
- Usability .
- Tightness .
- Verification of Alarms .
- Packaging ●
- Verification of Operating Data and Accuracy of Measurements .
- Performance .
- t Biocompatibility
- Vaporizer filling system .
Comparison of Technological Characteristics to Predicate Devices
The indications for use and fundamental technology for the modified FLOW-i Anaesthesia System is identical to the cleared FLOW-i Anaesthesia System K102182.
Comparison of Intended Use
The Intended Use for the modified FLOW-i Anaesthesia System (K112114) and the predicate devices FLOW-i Anaesthesia System and Aisys (K090233) are in all essentials the same.
Comparison of Technology Used
The modified device has the same technological characteristics as the cleared FLOW-i Anaesthesia System (K102182). The functionality of the new ventilation modes is equivalent to the predicate anaesthesia machine Aisys (K090233).
Conclusion
MAOUET believes that the modified FLOW-i Anaesthesia System (K112114) is substantially equivalent to the cleared FLOW-i Anaesthesia System (K102182) and Aisys (K090233) regarding intended use of the devices, the indications for use and the fundamental technology of the devices. Based on the risk analysis, MAQUET has conducted the necessary design verification and validation activities to demonstrate that the design outputs of the subject device meet the design input requirements. MAQUET has concluded that FLOW-i is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Maquet Critical Care AB C/O Ms. Whitney Torning Director, Regulatory Affairs Maquet Incorporated 45 Barbour Pond Drive Wayne, New Jersey 07470
JAN 1 3 2012
Re: K112114
.
Trade/Device Name: FLOW-I Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: January 3, 2012 Received: January 4, 2012
Dear Ms. Torning:
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. 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.
4
Page 2 - Ms. Torning
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K112114
Device Name: FLOW-i Anesthesia System
Indications for Use:
The indication for FLOW-i 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Y. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k 11 2 114