(142 days)
No
The description focuses on detecting physiological signals (Edi) to improve synchrony, which is a form of biofeedback control, not explicitly AI/ML. There is no mention of learning, training data, or complex algorithms typically associated with AI/ML in this context.
Yes
The device is a ventilator, which is used for the "treatment and monitoring to improve synchromy between the ventilator and patients" for individuals with "respiratory failure or respiratory insufficiency." This indicates a therapeutic purpose.
No
The device is a ventilator (Servo-i with NAVA option) that provides respiratory support and improves synchrony between the patient and the ventilator. While it detects signals from the diaphragm (Edi) to assist ventilation, its primary purpose is treatment (ventilation), not diagnosing a medical condition.
No
The device description explicitly states that the NAVA option is a "HW module with SW for Servo-i integration," indicating the presence of hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The Servo-i ventilator with NAVA option is a life support device that assists patients with breathing. It works by providing mechanical ventilation and using signals from the diaphragm (Edi) to improve synchrony with the patient's natural breathing efforts.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's physiological signals (electrical activity of the diaphragm) to control the ventilator.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics. It is a therapeutic and monitoring device used in a clinical setting.
N/A
Intended Use / Indications for Use
The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchromy between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the brain to the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.
Product codes
CBK
Device Description
The predicate device Servo-i is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's The modified device is an option, called NAVA option (Neurally Adjusted Ventilatory Assist) which is a HW module with SW for Servo-i integration, which are added to the predicate device. The Nava option uses an amplifier which in conjunction with a nasogastric feeding tube with microelectrodes detects signals to the diaphragm (Edi). The Edi is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diaphragm, esophagus
Indicated Patient Age Range
neonates, infants and adults
Intended User / Care Setting
healthcare providers in hospitals or healthcare facilities 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)
Clinical and non clinical data is submitted to verify that the safe performance is substantial equivalent to the Servo-i ventilator with NAVA option. The combination of known technology, physiological and medical knowledge and the information above together with a risk analysis comes to the conclusion that the NAVA option connected to a cleared Servo-i ventilator will give equal or more efficient ventilation and be as safe as the predicate Servo-i ventilator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061090, K053388, K051263, K040221, K013642
Reference Device(s)
K942852, K935788, K920121, K923704, K903136, K905831, K925854, K940870
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
AQUET
Servo-i ventilator with NAVA option
. . .
Document Type 510(k)
Section-Page 11 (55) Doc-ID Issue no. EVU-120018 - 00
510(k) Summary 5
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 Persons for this submission:
Mr. Anders Palm Tele. direct; (011) 46 8 730 74 88 Email: anders.palm@maquet.com
USA Contact:
Mr. Jamie Yieh Director, Regulatory Affairs Maquet Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807 Phone: 908-947-2311 Fax: 908-947-2301 Email: jamie.yieh@maquet-inc.com
Trade Names
Servo-i ventilator with NAVA option Preparation date 2006-09-17
article no .; 66 71 957
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|----------------------------------------------------------------|--------------------------|-------|-------------------|
| Ventilator, continuous (Respirator) | 73 CBK | II | 21 CFR 868.5895 |
| Predicate Device Identification | | | |
| Legally marketed devices to which equivalence is being claimed | | | |
| Galileo Gold Hamilton w ASV option | | | K061090 |
| Puritan Bennett w PAV+ option | | | K053388 |
| Dräger EVITA XL w Smart Care | | | K051263 |
| Servo-i ventilator family | | | K040221 |
| Avea with Bicore option | | | K013642 |
7 2007 FEB
1
| MAQUET | Document Type
510(k) | Section-Page
12 (55) |
|-------------------------------------|-------------------------|-------------------------|
| Object/Subject | | Doc-ID
Issue no. |
| Servo-i ventilator with NAVA option | | EVU-120018 - 00 |
| Respitrace | K942852 |
|---|---|
| Bicore | K935788 |
| Sechrist Savi | K920121 |
| Infant Star | K923704 |
| Arzco esophagus electrodes (bi-polar) | K903136 |
| Arzco esophagus electrodes (8 electrodes) | K905831 |
| Vygon Gastric Feeding tube - for function | K925854 |
| Utah medical (Gesco) Umbilical catheter - for material | K940870 |
Device Description
Summary of technological characteristics of modified Device and Predicate Device: The predicate device Servo-i is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's The modified device is an option, called NAVA option (Neurally Adjusted Ventilatory Assist)
which is a HW module with SW for Servo-i integration, which are added to the predicate device.
The Nava option uses an amplifier which in conjunction with a nasogastric feeding tube with microelectrodes detects signals to the diaphragm (Edi). The Edi is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support.
Intended Use of the Device:
The intended use with the NAVA option is identical to the cleared Servo-i ventilator (K040221). The patient ranges are also the same.
The added indications for use of the NAVA option is that the electrical signal from the brain to the diaphragm is intact, and no contraindication for insertion/exchange of NG-tube
Comparison to predicate devices.
The activity of the diaphragm can be measured with changes in air flow/pressure at the mouthpiece or closer to origin by the pressure in esophagus, impedance changes of the thorax or through the electrical signal to the diaphragm (Edi). Predicate devices are using the mentioned physiologic phenomena to improve synchrony either through direct measurements or by using calculations of ventilatory related parameters detected at the mouthpiece. All methods have the same goal to improve synchrony and detection of the patient's need and/ or to simplify the weaning.
The predicate devices Puritan Bennett. PAV+ (K053388) , Hamilton GALILEO Gold ASV (K061090) and Drager Evita XL with SmartCare (K051263) regulates the pressure related to patient efforts.
The predicate device Bicore (K935788) measures the esophageal pressure with a nasogastric tube or an esophageal tube. The trigger signal (Trig Detector) is used to improve synchrony (today in the Avea K013642).
2
| MAQUET | Document Type
510(k) | Section-Page
13 (55) |
|-------------------------------------------------------|-------------------------|---------------------------|
| Object/Subject
Servo-i ventilator with NAVA option | | Doc-ID
EVU-120018 - 00 |
Sechrist SAVI (K920121) uses impedance changes in thorax to improve the synchrony based on the same physiology.
Detection of the electrical activity to the diaphragm is substantial equivalent to monitoring system, which can be used to detect electro physiological signals from the esophagus as well as normal nasogastric feeding tubes.
Examples are Arzco electrodes for esophagus recording of the p-wave of the electrocardiogram as K903136 (bipolar) and K905831 (octa electrode catheter).
The polyurethane material are substantially equivalent to Umbilical catheters and venous catheter PICC-NATE (K940870, Gesco-Utahmedical).
Additional SE determination claims
The Servo-i ventilator with NAVA option meets the IEC 60601-2-12 standard for critical care ventilators.
Clinical and non clinical data is submitted to verify that the safe performance is substantial equivalent to the Servo-i ventilator with NAVA option.
The combination of known technology, physiological and medical knowledge and the information above together with a risk analysis comes to the conclusion that the NAVA option connected to a cleared Servo-i ventilator will give equal or more efficient ventilation and be as safe as the predicate Servo-i ventilator.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Critical Care AB C/O Mr. Jamie Yieh Director, Regulatory Affairs Maquet, Incorporated 1140 Route 22 East, Suite 202 Bridgewater, New Jersey 08807
FEB 7 2007
Re: K062793
Trade/Device Name: Servo-i Ventilator with NAVA Option Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 26, 2007 Received: January 26, 2007
Dear Mr. Yieh:
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,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 – Mr. Yieh
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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
5
| Document Type | 510(k) |
|---|---|
| Section-Page | 10 (57) |
| Object/Subject | Servo-i ventilator with NAVA option |
| Doc-ID | EVU-120018 |
| Issue no. | - 01 |
Indications for Use Statement 4
510(k) Number (if known): K062796
Device Name: Servo-i ventilator with NAVA option
Indications For Use:
The Servo-i ventilator with NAVA option is intended for treatment and monitoring to improve synchromy between the ventilator and patients. The Servo-i with NAVA option is suitable for patient ranges of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the brain to the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso Gastric tube.
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)
Chrit Uhlen
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