ESPRIT VENTILATOR

K981072 · Respironics, Inc. · CBK · Nov 12, 1998 · Anesthesiology

Device Facts

• Record ID: K981072
• Device Name: ESPRIT VENTILATOR
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 12, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.

Device Story

Esprit is a microprocessor-controlled, electrically powered mechanical ventilator; provides continuous or intermittent ventilatory support. Features include integrated air source (eliminating need for central/stand-alone compressors), variable oxygen concentration (21-100%), and battery backup (30-min primary, 3-hour secondary). User interface utilizes touch screen and graphical display. Used in hospitals (ICU, surgical recovery), subacute facilities, and surgery centers; operated by qualified medical personnel. Device delivers prescribed flows and pressures to patients. Reliability enhanced via HALT and ESS manufacturing processes. Healthcare providers monitor patient status via ventilator output; supports clinical decision-making for respiratory management.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, environmental testing, and performance comparisons. Testing includes dielectric strength, electromagnetic emissions/susceptibility, vibration, shock, and ingress of liquids per IEC and MIL-STD standards. Waveform performance was compared to the 7200 ventilator predicate. Compliance with 'Draft Reviewer Guidance for Ventilators, July 1995' was demonstrated.

Technological Characteristics

Microprocessor-controlled, electrically powered mechanical ventilator. Features touch screen GUI. Integral air source (blower) or wall air supply. Oxygen mixing (21-100%). Power: AC, 30-min internal battery, 24 VDC secondary source. Tested to IEC 601-1, CISPR 11, IEC 801 series, and MIL-STD-461D. Manufacturing utilizes HALT and ESS. Software-controlled breathing system.

Indications for Use

Indicated for adult and pediatric patients requiring continuous or intermittent ventilatory support in invasive or non-invasive applications, as prescribed by a physician.

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

• 7200 ventilator (Nellcor-Puritan-Bennett)
• BIRD Tbird (BIRD Medical Products)
• Siemens SV300 (Siemens-Elema AB)

Reference Devices

• Quantum non-invasive ventilator (Healthdyne Technologies)

Submission Summary (Full Text)

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NOV 1 2 1998

K981072

## 2. 510(k) Summary

This 510/k) is being submitted by: Respironics. 1261 Liberty Way Vista CA., 92083. Phone number : 760-727-3500 FAX number: 760-727-8349

The contact personnel for this submittal are:

Paul L. Woodring, primary contact 760-734-3202

Kathy E. Moore, secondary contact 760-734-3221

This summary was prepared on March 23, 1998.

This 510(k) is for the Esprit critical care ventilator, product code (21CFR 868.5895, 73 CBK) The legally marketed predicate devices are the 7200 ventilator offered for sale by Nellcor-Puritan-Bennett; the BIRD Tbird offered for sale by BIRD Medical Products; and the Siemens SV300 offered for sale by Siemens-Elema AB, Electromedical Systems Division. The 7200 ventilator is currently used in both invasive and noninvasive applications. A comparison is also made to the Quantum non-invasive ventilator offered for sale by Healthdyne Technologies (now part of Respironics). Detailed comparisons of the devices can be found in Section 8- Comparative Analysis to Predicate Devices.

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The specific features of the product include:

- . Breathing system under microprocessor control.
- · User interface under microprocessor control. Uses "hyman interface" features associated with touch screen and graphical user interface technology. The specifics of the particular touch screen technology and its suitability to medical applications is covered in more detail in the principle of operation section.
- · Integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual, stand alone compressor for each ventilator. The product will also be offered in a configuration without the blower in which case it will operate from a wall air supply.
- · Ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical grade, oxygen gas source, including medical grade gas cylinders with suitable regulators.
- · Ability to operate on a re-chargeable primary battery for 30 minutes (nominal).

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## K981072 2. 510(k) Summary

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- · Ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours.
- · Provide high product quality and reliability. ESPRIT has been designed using Highly Accelerated Life Testing (HALT), coupled with Environment Stress Screening (ESS) during manufacturing. Studies have shown that these techniques greatly eliminate reliability problems and are integral to the reliability of the product.

The Esprit Ventilator is intended for use by aualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.

The ESPRIT ventilator is intended to be marketed worldwide as a new ventilator that shall address the needs of low and moderate acuity subacute facilities in the US, surgical recovery units in hospitals, in ICU applications where more expensive options such as trending and waveforms are not required, in stand alone surgery centers in the US and international markets, as well as high acuity intensive care units (ICUs) in undeveloped and emerging nation, rest-of-world (ROW) markets. No medical claims are made regarding the ventilator. It produces the flows and pressures detailed in Section 8 - Comparative Analysis to Predicate Devices. These performance characteristics have been validated with the testing that is summarized in Sections 7 -Table Of Ventilator Requirements, 8 - Comparative Analysis to Predicate Devices and 10 - Environmental Testing.

The determination of equivalence is also based on environmental and lab testina. The ventilator has been tested according to the following environmental standards:

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| TEST | BASIS |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dielectric Strength | IEC 601-1, Clause 20 |
| Leakage Current | IEC 601-1, Clause 19 |
| Radiated and Conducted<br>Electromagnetic Emissions | CISPR 11 |
| Magnetic Field Emissions | RE101 of MIL-STD 461D at 7 cm |
| Electrostatic Discharge | IEC 801-2 |
| Radiated Electromagnetic Fields<br>Susceptibility | IEC 801-3 |
| AC Voltage Fluctuation: Steady State,<br>Dropout, Slow Sags and Surges | IEC 801-11 |
| AC Voltage Fluctuation: Fast Transient<br>Bursts | IEC 801-4 |
| AC Voltage Fluctuation: Fast Surges | IEC 801-5 |
| Conducted Electromagnetic Energy<br>Susceptibility | MIL-STD-461D, CS114 |
| Magnetic Fields Susceptibility | RS101 (Army) of MIL-STD-461D |
| Quasi-static Electric Fields Susceptibility | Reviewer Guidance for Premarket<br>Notification Submissions, November,<br>1993 |
| Random Vibration | Reviewer Guidance for Premarket<br>Notification, Submissions,<br>November, 1993 |
| Shock | Test conditions based on IEC 68-2-<br>27 |
| Ingress of Liquids | IEC 601-1, Clause 44.6, and IEC 529 |
| Temperature/Humidity | Reviewer Guidance for Premarket<br>Notification Submissions, November,<br>1993. |
| Surface Temperature | Reviewer Guidance for Premarket<br>Notification Submissions, November,<br>1993 |

## Table 1 - Environmental Standards

Section 7 - Table Of Ventilator Requirements includes a table demonstrating how the Esprit ventilator meets the requirements called out in the "Draft Reviewer Guidance for Ventilators, July, 1995" Finally, Section 8 - Comparative Analysis to Predicate Devices includes a summary of performance testing comparing the Esprit ventilator to the 7200 predicate device.

A description of waveform performance is covered in 8.3 - Waveform Comparisons to 7200 Ventilator predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, overlaid with three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

Mr. Paul L. Woodring Respironics Inc. 1261 Liberty Way Vista, Ca. 92083

Re: K981072 Esprit Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: August 14, 1998 Received: August 18, 1998

Dear Mr. Woodring:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Paul L. Woodring

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): K981072

Device Name: Esprit Ventilator

Indications for Use:

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1981072 510(k) Number _

prescriptions use

OTC