(167 days)
Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.
Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.
Servo-air Lite Ventilator System is to be used only by healthcare professionals.
Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.
The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.
The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).
The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.
Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).
Accessories for CO2 monitoring are available as options.
The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.
The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
The provided text describes a 510(k) submission for the Servo-air Lite Ventilator System, which is a medical device and not an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable in the context of an AI/ML device.
The document discusses non-clinical testing and performance for the ventilator system, focusing on:
- Software: Code review, static code analysis, unit tests, and integration tests.
- Performance: System testing, regression testing, free user testing, and waveform testing.
- Biocompatibility: Volatile Organic Compounds, Particulate Testing, Leachable testing.
- Human Factors Validation Testing.
- Compliance with various product standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2) and biocompatibility standards (AAMI/ANSI/ISO 10993-1).
The conclusion states that the device is substantially equivalent to the predicate device (Respironics V60 K102985) based on equivalent indications for use and that no new questions of safety and effectiveness are raised. They have conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output meets the design input requirements and appropriate product standards.
However, the document does not provide specific acceptance criteria in a table or detailed results of these tests that would typically be presented for an AI/ML device's performance metrics like sensitivity, specificity, or AUC.
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July 6, 2023
Maquet Critical Care AB % Barb Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K230173
Trade/Device Name: Servo-air Lite Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNT Dated: June 5, 2023 Received: June 6, 2023
Dear Barb 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.
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lence determination does not mean that FDA
Page 2
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 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.
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant 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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Indications for Use
510(k) Number (if known) K230173
Device Name Servo-air Lite Ventilator System
Indications for Use (Describe)
Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.
Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.
Servo-air Lite Ventilator System is to be used only by healthcare professionals.
Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.
| 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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510(k) SUMMARY
as required by section 21 CFR 807.92
| Device owner | Maquet Critical Care ABRöntgenvägen 2SE-171 54 Solna, SwedenTel: (011) 46 10 335 7300 |
|---|---|
| Contact Persons for this submission: | Mrs Elise BrunRegulatory Affairs ManagerPhone: direct: (011) 46 10 335 7300Email: elise.brun@getinge.com |
| Application Correspondent: | Mrs Barb SmithSr. Regulatory Affairs SpecialistGetinge45 Barbour Pond DriveWayne, NJ 07470Email: barb.smith@getinge.comPhone: 585-370-6101 |
Date prepared: June 2, 2023
Copies must not be used unless their validity has been verified.
Maquet Critical Care AB
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| Trade Name :Servo-air Lite Ventilator System | Model:Servo-air Lite | Model no:68 93 200 |
|---|---|---|
| Device Classification | ||
| Common Name | Ventilator, Continuous, Minimal VentilatorySupport, Facility Use | |
| Classification Number | MNT | |
| Class | II | |
| Regulation Number | 21 CFR 868.5895 | |
| 510(k) Number | K230173 | |
| Predicate Device Identification | ||
| Respironics V60 | K102985 | |
| Reference Device Identification | ||
| Maquet Servo-air Ventilator System | K192604 | |
| Maquet Servo-u Ventilator System | K201874 | |
| Nihon Kohden NKV-330 Ventilator | K213521 | |
| Fisher&Paykel Airvo 2 Humidifier | K131895 |
Indications for Use
Servo-air Lite Ventilator System is an assist ventilator indicated for augmenting ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers non-invasive ventilation, invasive ventilation, and respiratory monitoring.
Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.
Servo-air Lite Ventilator System is to be used only by healthcare professionals.
Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.
opies must not be used unless their validity has been verified.
Maquet Critical Care AB
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Image /page/5/Picture/0 description: The image shows the word "GETINGE" in all caps, with a stylized logo to the right. The font is a sans-serif typeface, and the letters are a dark color, possibly black or a dark shade of blue. The logo consists of four arrow-like shapes pointing towards a central point, creating a symmetrical design. The logo is also in a dark color, matching the text.
Device Description
The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.
The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).
The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.
Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).
Accessories for CO2 monitoring are available as options.
The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.
The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
Comparison to Predicate Device
Comparison of Intended Use/Indications Use
The Indications for Use for the proposed Servo-air Lite Ventilator System are equivalent to the Indications for Use for the predicate device Respironics V60 K102985.
MAQUET bases this 510(k) notification on that the Servo-air Lite Ventilator System fulfils the appropriate product standards and is substantially equivalent with the already cleared predicate Respironics V60 (K102985).
Comparison of Technology Characteristics
The technology is similar between predicate device Respironics V60 (K102985) and subject device Servo-air Lite.
ot be used unless their validity has been verified.
Maquet Critical Care AB
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Product codes
The predicate device Respironics V60 (K102985) has the same product code (MNT) as the subject device Servo-air Lite.
Additions
The subject device also includes:
- -Nebulizer from Aerogen
- Dual limb VBS -
- -High Flow Therapy
- Hot swappable batteries -
- CO2 monitoring (Optional) -
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 meet the design input requirements:
Software
- . Code review
- Static code analysis
- Unit tests
- Integration tests
Performance
- . System testing
- Regression .
- Free User testing
- Waveform testing
Biocompatibility
- Volatile Organic Compounds .
must not be used unless their validity has been verified.
Maquet Critical Care AB
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Image /page/7/Picture/0 description: The image shows the word "GETINGE" in a sans-serif font, followed by a stylized asterisk symbol. The word is in all caps and appears to be a logo or brand name. The asterisk symbol is composed of four arrow-like shapes pointing outwards from a central point. The color of the text and symbol is a dark blue or gray.
- Particulate Testing
- Leachable 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 80601-2-12:2020, Medical electrical equipment -- Part 2-1: Particular Requirements For The Safety Of Lung Ventilators - Critical Care Ventilators, Recognition Number 1-98
- . ISO 80601-2-55:2018, Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors, Recognition Number 1-140
- EN13544-1:2007, this standard is not recognized by FDA .
Biocompatibility evaluation of the Servo-air Lite is in accordance with AAMI / ANSI / ISO 10993-1:2018, recognition number 2-258 included the extent of recognition. The connector to High-Pressure gas is in accordance with CGA V-5:2008, Recognition Number 1-81.
Conclusion for Substantial Equivalence
The proposed Servo-air Lite Ventilator System and the predicate device Respironics V60 (K102985) have the equivalent indications for use and no new questions of safety and effectiveness that pose significant safety or effectiveness concerns are raised. Additional reference devices have been used to demonstrate substantial equivalence for specific features.
es must not be used unless their validity has been verified.
Maquet Critical Care AB
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Image /page/8/Picture/0 description: The image shows the word "GETINGE" in a sans-serif font, followed by a stylized asterisk symbol. The word is in all caps and appears to be a logo or brand name. The asterisk symbol is composed of four arrow-like shapes pointing outwards from a central point.
Maquet Critical Care has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the modified device meet the design input requirements and the appropriate product standards.
Maquet Critical Care has concluded that the Servo-air Lite Ventilator System is substantially equivalent to the predicate devices Respironics V60 (K102985).
Copies must not be used unless their validity has been verified.
Maquet Critical Care AB
Template:
- 510(k) Summary - Servo-air Lite 510(k) Version: 04 Approved at 2023-07u2773956,
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).