SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION

K062793 · Maquet Critical Care AB · CBK · Feb 7, 2007 · Anesthesiology

Device Facts

• Record ID: K062793
• Device Name: SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
• Applicant: Maquet Critical Care AB
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Servo-i ventilator with NAVA (Neurally Adjusted Ventilatory Assist) option; hardware module and software integration for existing Servo-i ventilator. Input: electrical activity of diaphragm (Edi) via nasogastric feeding tube with microelectrodes. Operation: amplifier detects Edi signals; ventilator adjusts support based on patient's neural respiratory effort to improve patient-ventilator synchrony. Used in hospitals/healthcare facilities by clinicians. Output: synchronized ventilatory support. Benefits: improved synchrony, simplified weaning, and patient-tailored support. Healthcare providers use output to monitor respiratory effort and adjust ventilation parameters.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, risk analysis, and comparison of technological characteristics to predicate devices.

Technological Characteristics

Hardware module and software integration for Servo-i ventilator. Uses nasogastric feeding tube with microelectrodes for Edi signal detection. Materials (polyurethane) equivalent to venous catheters (K940870). Complies with IEC 60601-2-12 for critical care ventilators. Connectivity: integrated into ventilator system.

Indications for Use

Indicated for neonates, infants, and adults with respiratory failure or insufficiency requiring ventilatory support. Requires intact brain-to-diaphragm electrical signaling. Contraindicated if nasogastric tube insertion/exchange is contraindicated.

Regulatory Classification

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.

Predicate Devices

• 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)

Reference Devices

• 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 (K925854)
• Utah medical (Gesco) Umbilical catheter (K940870)

Submission Summary (Full Text)

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# 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

K062793

Summary as required by section 807.92(c)

## Subscribers Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: [phone] Fax: [phone]

Contact Persons for this submission:

Mr. Anders Palm Tele. direct; (011) 46 8 730 74 88 Email: [e-mail]

USA Contact:

Mr. Jamie Yieh Director, Regulatory Affairs Maquet Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807 Phone: [phone] Fax: [phone] Email: [e-mail]

### Trade Names

Servo-i ventilator with NAVA option Preparation date 2006-09-17

article no .; 66 71 957

### Device Classification

| Common Name | Classification<br>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

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| MAQUET | Document Type<br>510(k) | Section-Page<br>12 (55) |
|-------------------------------------|-------------------------|-------------------------|
| Object/Subject | | Doc-ID<br>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).

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| MAQUET | Document Type<br>510(k) | Section-Page<br>13 (55) |
|-------------------------------------------------------|-------------------------|---------------------------|
| Object/Subject<br>Servo-i ventilator with NAVA option | | Doc-ID<br>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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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| 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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