ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000

K051262 · Respironics California, Inc. · CBK · Jul 8, 2005 · Anesthesiology

Device Facts

• Record ID: K051262
• Device Name: ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
• Applicant: Respironics California, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.

Device Story

Esprit Ventilator Neonatal Option is a software-based modification to the existing Esprit Ventilator; enables neonatal-specific ventilation modes. Input: patient physiological parameters; Output: controlled mechanical ventilation. Modes include Assist/Control, SIMV, CPAP, Pressure-Controlled (PC), Pressure Support (PS), and Apnea Ventilation. Used in clinical settings for invasive applications; operated by qualified medical personnel. Software algorithms control breath delivery; healthcare providers monitor output to adjust ventilatory support. Benefits include expanded patient population coverage for neonates requiring respiratory assistance.

Clinical Evidence

Bench testing only. Software verification and validation testing performed per FDA guidance. Performance testing confirmed that all design and system-level requirements for the Neonatal Option were met.

Technological Characteristics

Software-based modification to existing Esprit Ventilator. Breath delivery controlled by software algorithms equivalent to those in reference device K981072. Supports invasive ventilation modes: A/C, SIMV, CPAP, PC, PS, and Apnea ventilation. No new hardware or technological characteristics introduced.

Indications for Use

Indicated for intubated neonatal patients (0.5 kg to 6.5 kg ideal body weight; 2.5–4.0 mm endotracheal tube I.D.) requiring continuous or intermittent mechanical ventilatory support.

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

• P-B 840 Ventilator NeoMode Option (K001646)
• Event Medical Inspiration Ventilator (K021112)
• Siemens Servo 300 Ventilator (K970839)
• Dräger Evita 4 Ventilator NeoFlow Option (K983219)

Reference Devices

• Respironics Esprit ventilator (K981072)

Submission Summary (Full Text)

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# JUL. - 8 2005

# Modification to the Esprit Ventilator 510(k) Premarket Notification for the Neonatal Option

## 510(k) SUMMARY 16

| Company<br>Information: | Respironics, California Inc.<br>2271 Cosmos Court<br>Carlsbad, CA. 92009 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Information: | Mary Funk<br>Regulatory Affairs Project Manager |
| | Phone Number: [phone]<br>Fax Number: [phone] |
| Date Prepared: | May 12, 2005 |
| Product Name: | Esprit Ventilator Neonatal Option |
| Common Name: | Ventilator |
| Classification: | Class II<br>Continuous Ventilator (per 21 CFR 868.5895) |
| Predicate<br>Devices: | P-B 840 Ventilator NeoMode Option K001646 Event Medical Inspiration Ventilator K021112 Siemens Servo 300 Ventilator K970839 Dräger Evita 4 Ventilator NeoFlow Option K983219 |

### 16.1 Device Description:

The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only:

- Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
- Pressure-Controlled (PC). Available in A/C and SIMV. .
- Pressure Support (PS). Available in SIMV and SPONT. .
- . Apnea Ventilation

Note: certain features of the currently marketed Esprit are not available to neonatal patient types. Refer to the Neonatal Option instructional information for details.

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#### Intended Use: 16.2

The currently marketed Esprit ventilator is intended for use by qualified medical rne ourrelity many many or intermittent ventilatory support for adult and performer and prescribed by a physician. It is intended for use in either invasive or non-invasive applications.

With the Neonatal Option, the intended patient population is expanded to include intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.

The Esprit Ventilator is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.

#### Technological Characteristics: 16.3

The addition of the Neonatal Option to the currently marketed Esprit does not result in the use of any new technological characteristics. Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator (reference K981072).

## Determination of Substantial Equivalence: 16.4

The modes/types of ventilation on the Esprit Ventilator with Neonatal Option are similar to those on other currently marketed continuous ventilators. The modified Esprit has similar performance characteristics, similar intended use and similar patient populations to the predicate devices. The addition of the Neonatal Option does not raise new questions of safety or effectiveness. The labeling and instructional information for the Neonatal Option is similar to that of the predicate devices.

#### 16.5 Summary of Performance Testing:

Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met.

#### 16.6 Conclusion:

The addition of the Neonatal Option to the Esprit Ventilator does not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2005

Ms. Mary Funk Regulatory Affairs Project Manager Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92009

Re: K051262

Trade/Device Name: Esprit Ventilator with Neonatal Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 12, 2005 Received: May 16, 2005

Dear Ms. Funk:

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 – Ms. Funk

Please be advised that FDA's issuance of a substantial equivalence determination does not I Tease be advisod that 12 a determination that your device complies with other requirements mean that I DA mas made statutes and regulations administered by other Federal agencies. or the Fet of all , a vary - eath s requirements, including, but not limited to: registration 1 ou intiles comprise to Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 es reas of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quartify tion 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) This letter will and if your even finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits 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 desite of 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 may of any 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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Modification to the Esprit Ventilator Mountcation to the Esphe For the Neonatal Option

# INDICATIONS FOR USE STATEMENT

| Applicant: | Respironics California, Inc.<br>2271 Cosmos Court<br>Carlsbad, CA 92009<br>USA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K051262 |
| Device Name: | Esprit Ventilator with Neonatal Option |
| Indications for use: | The intended use of the Esprit Ventilator Neonatal Option is to provide<br>continuous or intermittent ventilatory support for the care of individuals<br>who require mechanical ventilation.<br>The intended patient population includes intubated neonatal patients<br>with an ideal body weight range from 0.5 kg to 6.5 kg and an<br>endotracheal tube I.D. range from 2.5 – 4.0 mm. |
| Prescription Use: | Yes (Per 21 CFR 801.109) |

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

Oeen Sulam K051262

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesion Control, Devices

510(k) Number -