(18 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on selectable modes and previous predicate devices without mentioning AI/ML capabilities.
Yes
The 'Intended Use / Indications for Use' explicitly states that the device "is intended for treatment and monitoring of patients... with respiratory failure or respiratory insufficiency." This indicates a therapeutic purpose.
No
Explanation: The device is described as a ventilator system intended for "treatment and monitoring of patients... with respiratory failure or respiratory insufficiency," indicating it is a therapeutic device, not diagnostic.
No
The device description explicitly states "The ventilator is a ventilator with several selectable modes..." and refers to previous K numbers for a "Ventilator System," indicating a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "ventilator system" for "treatment and monitoring of patients" with respiratory issues. This describes a device used directly on a patient to support their breathing, not a device used to examine samples taken from a patient (which is the definition of an IVD).
- Device Description: The description reinforces that it's a "ventilator" with "selectable modes to individually monitor and treat patients whom needs respiratory assistance."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on sample analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ventilator does not fit that description.
N/A
Intended Use / Indications for Use
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo' is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.
Product codes
73 CBK
Device Description
The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).
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
The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Infant for patient weight 0.5-30 kg Servo-i
Intended User / Care Setting
Servo-i is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.
Servo-is a ventilator system with advanced functionality. It may be used only by professional health care providers who have sufficient experience in ventilator treatment.
The Servo-i Ventilator System is designed to be used at the bedside and for in-hospital transport.
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)
Not Found
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
Not Found
§ 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).
0
Document Type
Special 510(k)
Section-Page 17(38) Dxc-ID Issue no EVU-111185 - 02
Servo-iVentilator System -510(k) Summary
510 (k) Summary as required by section 807.92(c)
Subscribers Name & Address
Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38 Contact Person for this submission: Official Correspondent:
Anders Palm tele. direct; (011) 46 8 730 74 88 anders.palm@maquet.com
USA Contact :
Jamie Yieh Manager Regulatory Submissions, Maquet Inc. Cellphone; 908-227-8807 jyich@maquet-inc.com
Trade Names
Servo-i Ventilator System
article no .; 64 87 800 E407E
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|-------------------------------------|--------------------------|-------|-------------------|
| Ventilator, Continuous (Respirator) | 73 CBK | II | 868.5895 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Servo Ventilator 300 A, | K970839 |
| Servo-i Ventilatory System | K022132 |
| Evita 4, | K980642 |
1
| MAQUET | Document Type
Special 510(k) | Section-Page
18(38) | |
|------------------------------------------|---------------------------------|------------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo-iVentilator System -510(k) Summary | | EVU-111185 | - 02 |
Device Description (for detailed description see Section F)
The ventilator is a ventilator with several selectable modes to individually monitor and treat patients whom needs respiratory assistance. The ventilator is the same as described in the notification K010925 and K022132 (addition of BiVent mode and CO2 module).
Summary of technological characteristics of modified Device and Predicate Device:
Low minute volume alarm
The Servo-i low minute volume alarm for infants has been changed from 0,10 l/min to 0,06 1/min, the same as that of the Servo-i's predicate, the SV300 ventilator.
Intended Use of the Device:
The intended use(s) and indications of the Servo-i application, as described in its labelling, are the same as the intended uses and indications for the unmodified Servo-i.
The intended use is the same including;
- the proposed change of the low minute volume alarm from 0,10 to 0,06 I/min -
Intended Use of the Device:
The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.
Note: The Servo-i Ventilator System is not intended to be used with any anesthetic agents.
Intended operator:
Servo-is a ventilator system with advanced functionality. It may be used only by professional health care providers who have sufficient experience in ventilator treatment.
Intended Patient Population:
Infant for patient weight 0.5-30 kg Servo-i
Intended Use Environment:
The Servo-i Ventilator System is designed to be used at the bedside and for in-hospital transport. The Servo-i Ventilator System is not intended to be used with any anesthetic agents. The Servo-i Ventilator System is not compatible for use in a MRI magnetic field
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
FEB 2,0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Critical Care AB c/o Mr. Jamic Yieh Maquet, Incorporated 186 Wood Avenue South Iselin, New Jersey 08830
Re: K040221
K040221
Trade/Device Name: Servo-i Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 26, 2004 Received: February 2, 2004
Dear Mr. Yieh:
We have reviewed your Section 510(k) premarket not intent to market the device the device t We have reviewed your Scellon 910(t) promised is substantially equivalent (for the referenced above and have determined the use the marketed predicate devices marketed in
indications for use stated in the enclosure) to legally af the Modical Device indications for use stated in the chelosares to tegation date of the Medical Device interstate commerce pror to May 20, 1770, the ssifted in accordance with the provisions of
Amendments, or to devices that have been recessive annrovel of a premated Amendments, of to devices mat nave been rocability that do not require approval of a premaint the Federal Food, Drug, and Cosmene Acc (recre, market the device, subject to the general approval appircation (r.MA). Tod may, moreloroplans of the Act include controls provisions of the Act. "The general of and of any and on any and on requirements for annual regainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III ( If your device is classified (sec above) into entrols. Existing major regulations affecting (PMA), it may be subject to such additional confress and regulations, Title 21, Yarts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Feder your device can be found in the Code of I eachd regulation in the Ecderal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a substanter with other requirements
mean that FDA has made a determination that your device Foderal agencies mean that FDA has made a decemination that Jour and Jour and Submissered by other Federal agencies.
3
Page 2 – Mr. Jamie Yieh
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801 CFR Part 800'; and i and listing (21 CFR I art 607), labeling (27 cms (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections as decembed applicable, the electronic product radiation you to begin marketing your device as described.
21 CFR 1000-1050. This letter will allow you to man and substantial squivelance 21 CFR 1000-1030. This letter will and 1000 of substantial equivalence in your Section 510(k) premance from to the results in a classification for your of your device to trigate your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de at (301) 594-4646. Also, please note the regulation please contact the entification of Complains of (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinan 2001 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clu L
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040221
Device Name: Servo-i Ventilator System
Indications For Use:
Indications For Use:
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range The Servo' Ventilator System is miended jor treatinent instituting of pfficiency. Servo' is
of neonates, infants and adults with respiratory failure or respiratory insuffici of neonates, infanis and dauls want respiratory Jalane of respective or healthcare facilities and for in-hospital transport.
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)
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