(265 days)
Not Found
No
The summary describes a microprocessor-controlled ventilator with electronic and pneumatic control systems. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is a ventilator used for mechanical ventilation, which directly treats and supports a patient's respiratory function.
No
Explanation: The device is a ventilator, designed for mechanical ventilation, not for diagnosing medical conditions. It sets ventilatory parameters and generates alarms, but these are related to the operation of the ventilator itself, not to diagnosing a patient's underlying condition.
No
The device description explicitly states it is a "microprocessor-controlled, pneumatically driven ventilator" and describes physical components like the "unit houses the electronic and pneumatic control systems" and a "bellows assembly," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Blease 900 Series Ventilators are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the mechanical ventilation of adult and pediatric patients under general anesthesia. This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a device that controls and delivers air to a patient's lungs. This is a life support device, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a laboratory setting, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Blease 900 Series Ventilators do not fit this description.
N/A
Intended Use / Indications for 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.
Product codes
CBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
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)
Electrical Safety Testing: The Spacelabs Blease 900 was tested for performance in accordance with the following Standard: IEC 60601-1: 2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Test results indicated that the Spacelabs Blease 900 complies with the Standards.
Electromagnetic Compatibility Testing: The Spacelabs Blease 900 was tested for performance in accordance with the following Standard: IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. Test results indicated that the Spacelabs Blease 900 complies with the Standards.
Performance Testing: The Spacelabs Blease 900 was tested for performance in accordance with internal requirements and the following Standard: ASTM D4169-05, Standard practice for performance testing of shipping containers and systems. Test results indicated that the Spacelabs Blease 900 complies with its predetermined specification and with the applicable Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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. | ||
| 1 Harforde Court, John Tate Road | |||
| Hertford, SG13 7NW United Kingdom | |||
| Submitter Contact: | Mr. David J. Geraghty | ||
| Spacelabs Medical, Inc. (for Spacelabs Healthcare, Ltd.) | |||
| Phone: +1 (425) 657-7200, ext 5889 | |||
| Fax: +1 (425) 657-7210 | |||
| Email: david.geraghty@spacelabs.com | |||
| Official Contact: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | Spacelabs Medical, Inc. | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 USA | |||
| Trade Name: | Spacelabs Blease 900 Series Ventilators | ||
| Common Name: | Continuous Ventilator | ||
| Classification Name: | Continuous Ventilator | ||
| Classification | |||
| Regulation: | 21 CFR §868.5895 | ||
| Product Code: | CBK | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs Blease 900 | |||
| Series Ventilators | K101850 | Spacelabs BleaseSirius | |
| Anesthesia Workstation |
Blease 900 Series Ventilators 510(k) Summary Updated
24 May 2011 Page 1 of 5
1
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 | |||||
| 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
2
| 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 | ||||
| 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 | ||||
| volume control or pressure inspired + 25% in | |||||
| 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 | ||
| Configuration | Integrated into an | |
| anesthesia workstation | Stand-alone device. | |
| Ventilation Delivery | ||
| Subsystem | Pneumatic flow control | |
| valve with solenoid | ||
| driven exhalation valve | Same |
3
| Ventilation Delivery
Modes | Volume Control;
Precision Pressure
Control™; Advanced
Pressure Support™;
SIMV-VC + PSV;
SIMV-PC + PSV | Same |
| ------------------------------- | ---------------------------------------------------------------------------------------------------------------------- | ------ |
|---|
Summary of Performance Testing:
| Electrical Safety
Testing | The Spacelabs Blease 900 was tested for performance in accordance
with the following Standard:
IEC 60601-1: 2005, Medical electrical equipment - Part 1: Gener
requirements for basic safety and essential performance. Test results indicated that the Spacelabs Blease 900 complies with the
Standards. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic
Compatibility
Testing | The Spacelabs Blease 900 was tested for performance in accordance
with the following Standard:
IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requiremen
and tests. Test results indicated that the Spacelabs Blease 900 complies with the
Standards. |
| Performance Testing | The Spacelabs Blease 900 was tested for performance in accordance
with internal requirements and the following Standard:
ASTM D4169-05, Standard practice for performance testing of
shipping containers and systems. Test results indicated that the Spacelabs Blease 900 complies with its
predetermined specification and with the applicable Standards. |
4
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
5
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.
6
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 (800) 638-2041 or (301) 796-7100 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
7
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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