BLEASE700/900 SERIES VENTILATORS

K112729 · Spacelabs Healthcare · CBK · Jun 11, 2012 · Anesthesiology

Device Facts

• Record ID: K112729
• Device Name: BLEASE700/900 SERIES VENTILATORS
• Applicant: Spacelabs Healthcare
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Blease 900 Series Ventilators are advanced, microprocessorcontrolled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

Device Story

Microprocessor-controlled, pneumatically driven ventilator; designed for adult and pediatric patients under general anesthesia. System includes electronic/pneumatic control unit and bellows assembly; integrates with circle-type absorber. Operates in volume control, pressure control, and SIMV/PSV modes. Provides real-time monitoring of oxygen, volume, airway pressure, and waveforms; displays data on color touchscreen. Clinicians set ventilation parameters (tidal volume, frequency, I:E ratio, PEEP, pressure limits) via interface. Device generates alarms for pressure, volume, oxygen, and system errors. Benefits include precise ventilation control and monitoring during anesthesia, supporting both low- and high-flow applications. Used in clinical settings by anesthesia providers.

Clinical Evidence

Bench testing only. Performance verified against IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and ASTM D4169-05 (shipping/packaging). Results confirmed compliance with predetermined specifications and safety standards.

Technological Characteristics

Microprocessor-controlled, pneumatically driven ventilator. Features color touchscreen interface (8.4 inch). Ventilation modes: Volume Control, Pressure Control, SIMV+PSV, Precision Pressure Support. Connectivity: Data output. Standards: IEC 60601-1, IEC 60601-1-2, ASTM D4169-05. Stand-alone form factor.

Indications for Use

Indicated for mechanical ventilation of adult and pediatric patients undergoing general anesthesia.

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

• Spacelabs BleaseSirius Anesthesia Workstation (K101850)

Submission Summary (Full Text)

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K112729

JUN 1 1 2012

# 510(k) Premarket Notification Spacelabs Healthcare Blease 900 Series Ventilators 510(k) Summary

| Submission Date: | 24 May 2012 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------|
| Submitter: | Spacelabs Healthcare Ltd.<br>1 Harforde Court, John Tate Road<br>Hertford, SG13 7NW United Kingdom | | |
| Submitter Contact: | Mr. David J. Geraghty<br>Spacelabs Medical, Inc. (for Spacelabs Healthcare, Ltd.)<br>Phone: [phone], ext 5889<br>Fax: [phone]<br>Email: [e-mail] | | |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | |
| Manufacturing Site: | Spacelabs Medical, Inc.<br>5150 220th Avenue SE<br>Issaquah, WA 98029 USA | | |
| Trade Name: | Spacelabs Blease 900 Series Ventilators | | |
| Common Name: | Continuous Ventilator | | |
| Classification Name: | Continuous Ventilator | | |
| Classification<br>Regulation: | 21 CFR §868.5895 | | |
| Product Code: | CBK | | |
| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Spacelabs Blease 900<br>Series Ventilators | K101850 | Spacelabs BleaseSirius<br>Anesthesia Workstation |

Blease 900 Series Ventilators 510(k) Summary Updated

24 May 2011 Page 1 of 5

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#### The Spacelabs Healthcare (Spacelabs) Blease 900 Series Ventilators Device Description: (Blease 900) are advanced, microprocessor-controlled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

The unit houses the electronic and pneumatic control systems. It sets the desired ventilatory parameters and generates alarm, warning and status messages. The control unit also calculates and implements the functions necessary to drive the bellows pneumatically.

The bellows assembly consists of a base and a bellows housing.

The Spacelabs Blease 900 are designed for use with a circle-type absorber, and is ideally suited to both low- and high-flow applications.

| Model Number | | 900 Series | 950 | 970 | 990 |
|--------------------------------------------------------------------|----------------------|------------|-------------------------------|-------------------------------|-------------------------------|
| Screen size | | | 8.4 inches | 8.4 inches | 8.4 inches |
| Display | | | Color | Color | Color |
| Interface | | | Touch and Trak | Touch and Trak | Touch and Trak |
| Tidal volume compensation | | | | | |
| Fresh gas compensation | | | Optional for OEM/ stand alone | Optional for OEM/ stand alone | Optional for OEM/ stand alone |
| Configurable preset or measured compliance<br>Adult, and pediatric | | | Yes | Yes | Yes |
| Ventilation mode | | | | | |
| Volume control | | | Yes | Yes | Yes |
| Pressure control | | | Yes | Yes | Yes |
| SIMV + PSV (Volume and pressure mode options) | | | Yes | Yes | Yes |
| Precision pressure support | | | No | Yes | Yes |
| Ventilation monitoring | | | | | |
| Oxygen | | | Yes | Yes | Yes |
| Inhaled and exhaled volume monitoring | | | Yes | Yes | Yes |
| Airway pressure | | | Yes | Yes | Yes |
| Pressure waveform | | | Yes | Yes | Yes |
| Flow waveform | | | Yes | Yes | Yes |
| Spirometry loops | | | No | No | Yes |
| Data output | | | Yes | Yes | Yes |
| Parameters | | | | | |
| I:E ratio | 2.0:1 - 1:5 | | YES | YES | YES |
| Frequency | 2 - 99 bpm | | YES | YES | YES |
| Set tidal volume | 20 -1500 ml | | YES | YES | YES |
| Minute volume | 0.3 - 25 lpm | | YES | YES | YES |
| Pressure limit | Adult: 10 - 70 cmH20 | | YES | YES | YES |

Blease 900 Series Ventilators 510(k) Summary Updated

24 May 2011 Page 2 of 5

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| Model Number | | | 950 | 970 | 990 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------|--|-----|-----|-----|
| PEEP | 3 -20 cmH20 | | YES | YES | YES |
| Inspiratory pause | 0 - 50% | | YES | YES | YES |
| Sigh function | The delivered tidal volume is<br>increased by 10% every 10 breaths | | YES | YES | YES |
| Patient trigger | 1 - 15 Ipm | | YES | YES | YES |
| Pressure inspired | 10- 50 cmH20 | | YES | YES | YES |
| Max inspiratory flow | 100 Ipm | | YES | YES | YES |
| Support pressure | 5 - 30 cmH20 | | YES | YES | YES |
| User Set Alarms | | | | | |
| Pressure high | 10 - 70 cmH20 (equal to pressure limit in<br>volume control or pressure inspired + 25% in<br>pressure control) | | YES | YES | YES |
| Pressure low | 5 - 50 cmH20 | | YES | YES | YES |
| MV high | 1 - 25 Ipm | | YES | YES | YES |
| MV low | 0 - 24 Ipm | | YES | YES | YES |
| High bpm | 3 - 99 bpm | | YES | YES | YES |
| Low bpm | 0 - 98 bpm | | YES | YES | YES |
| High oxygen | 19 - 110% | | YES | YES | YES |
| Low oxygen | 18 - 109% | | YES | YES | YES |
| Apnea | | | YES | YES | YES |
| Sensor error | | | YES | YES | YES |
| Vent in operative | | | YES | YES | YES |
| Inspiratory flow transducer error | | | YES | YES | YES |
| Setting error | | | YES | YES | YES |
| Peep error | | | YES | YES | YES |
| Under pressure | | | YES | YES | YES |
| Low supply gas pressure | | | YES | YES | YES |
| No charge | | | YES | YES | YES |
| Power fail | | | YES | YES | YES |
| Battery low | | | YES | YES | YES |
| Comms fail | | | YES | YES | YES |
| Apnea alarms in bag mode | | | YES | YES | YES |
| Sustained pressure | | | YES | YES | YES |
| Fresh gas too high | | | YES | YES | YES |

Intended Use:

The Blease 900 Series Ventilators are advanced, microprocessorcontrolled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

Technology Comparison: The Spacelabs Blease 900 employ the same technological characteristics as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|-------------------------------------|--------------------------------------------------------------------------|---------------------|
| Mechanical Housing<br>Configuration | Integrated into an<br>anesthesia workstation | Stand-alone device. |
| Ventilation Delivery<br>Subsystem | Pneumatic flow control<br>valve with solenoid<br>driven exhalation valve | Same |

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| Ventilation Delivery<br>Modes | Volume Control;<br>Precision Pressure<br>Control™; Advanced<br>Pressure Support™;<br>SIMV-VC + PSV;<br>SIMV-PC + PSV | Same |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------|------|
|-------------------------------|----------------------------------------------------------------------------------------------------------------------|------|

#### Summary of Performance Testing:

| Electrical Safety<br>Testing | The Spacelabs Blease 900 was tested for performance in accordance<br>with the following Standard:<br>IEC 60601-1: 2005, Medical electrical equipment - Part 1: Gener<br>requirements for basic safety and essential performance. Test results indicated that the Spacelabs Blease 900 complies with the<br>Standards. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic<br>Compatibility<br>Testing | The Spacelabs Blease 900 was tested for performance in accordance<br>with the following Standard:<br>IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility - Requiremen<br>and tests. Test results indicated that the Spacelabs Blease 900 complies with the<br>Standards. |
| Performance Testing | The Spacelabs Blease 900 was tested for performance in accordance<br>with internal requirements and the following Standard:<br>ASTM D4169-05, Standard practice for performance testing of<br>shipping containers and systems. Test results indicated that the Spacelabs Blease 900 complies with its<br>predetermined specification and with the applicable Standards. |

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Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Spacelabs Blease 900. The results of these activities demonstrate that the Spacelabs Blease 900 is safe and effective when used in accordance with its intended use and labeling.

Therefore, the Spacelabs Blease 900 is considered substantially equivalent to the predicate device.

Blease 900 Series Ventilators 510(k) Summary Updated

24 May 2011 Page 5 of 5

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spacelabs Healthcare C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466

JUN 1 1 2012

Re: K112729

Trade/Device Name: Spacelabs Blease 900 Series Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 1, 2012 Received: June 4, 2012

Dear Mr. Kroenke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kroenke

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); medical device reporting (reporting of medical device-related adverse events) (21-CFR-803);-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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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#### Indications for Use

K :

510(k) Number (if known):

Device Name:

Indications for Use:

Spacelabs Blease 900 Series Ventilators

The Blease 900 Series Ventilators are advanced, microprocessorcontrolled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

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)

L. Schultheis

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

510(k) Number: K112729

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