(265 days)
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.
The Spacelabs Healthcare (Spacelabs) Blease 900 Series Ventilators (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.
The provided text describes the Spacelabs Healthcare Blease 900 Series Ventilators, a medical device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way this request asks (e.g., performance metrics compared against thresholds for an AI/software device).
Instead, the document details performance testing related to electrical safety, electromagnetic compatibility, and general performance in accordance with recognized standards, which are a form of acceptance criteria for medical devices.
Here's an attempt to answer the questions based on the available information, noting when specific details are not present in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1: 2005 (General requirements for basic safety and essential performance) | The Spacelabs Blease 900 complies with the Standards. |
| Electromagnetic Compatibility: IEC 60601-1-2: 2007 (Collateral standard: Electromagnetic compatibility - Requirements and tests) | The Spacelabs Blease 900 complies with the Standards. |
| Performance Testing (Shipping Containers and Systems): ASTM D4169-05 (Standard practice for performance testing of shipping containers and systems) | The Spacelabs Blease 900 complies with its predetermined specification and with the applicable Standards. |
| Intended Use Safety & Effectiveness: | Safe and effective when used in accordance with its intended use and labeling. |
| Substantial Equivalence: | Considered substantially equivalent to the predicate device (K101850). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not provided in the document. The testing described appears to be device-specific, likely involving a single or small number of units, rather than a clinical study with a patient test set.
- Data Provenance: This information is not provided. The testing would have been conducted by or for the manufacturer (Spacelabs Healthcare Ltd., UK with manufacturing in Issaquah, WA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable/provided. The testing described is performance testing against engineering and safety standards, not a clinical study involving expert interpretation of data or images. "Ground truth" in this context would likely be defined by the technical specifications and standards themselves, and the experts would be engineers or testing personnel verifying compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on medical findings, which is not the type of testing described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a ventilator, not an AI/software diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- This device is a hardware-based ventilator, not a standalone algorithm. Performance testing was done on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing described is established by international and national standards (IEC 60601-1, IEC 60601-1-2, ASTM D4169-05) and the device's predetermined internal specifications. The device's functionality is compared against these engineering and safety benchmarks.
8. The sample size for the training set
- This information is not applicable. This device is a conventional medical device (ventilator), not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for this type of device.
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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 RoadHertford, SG13 7NW United Kingdom | ||
| Submitter Contact: | Mr. David J. GeraghtySpacelabs Medical, Inc. (for Spacelabs Healthcare, Ltd.)Phone: +1 (425) 657-7200, ext 5889Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com | ||
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 | ||
| Manufacturing Site: | Spacelabs Medical, Inc.5150 220th Avenue SEIssaquah, WA 98029 USA | ||
| Trade Name: | Spacelabs Blease 900 Series Ventilators | ||
| Common Name: | Continuous Ventilator | ||
| Classification Name: | Continuous Ventilator | ||
| ClassificationRegulation: | 21 CFR §868.5895 | ||
| Product Code: | CBK | ||
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Spacelabs Blease 900Series Ventilators | K101850 | Spacelabs BleaseSiriusAnesthesia 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 complianceAdult, 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 isincreased 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 involume control or pressure inspired + 25% inpressure 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 HousingConfiguration | Integrated into ananesthesia workstation | Stand-alone device. |
| Ventilation DeliverySubsystem | Pneumatic flow controlvalve with solenoiddriven exhalation valve | Same |
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| Ventilation DeliveryModes | Volume Control;Precision PressureControl™; AdvancedPressure Support™;SIMV-VC + PSV;SIMV-PC + PSV | Same |
|---|---|---|
| ------------------------------- | ---------------------------------------------------------------------------------------------------------------------- | ------ |
Summary of Performance Testing:
| Electrical SafetyTesting | The Spacelabs Blease 900 was tested for performance in accordancewith the following Standard:IEC 60601-1: 2005, Medical electrical equipment - Part 1: Generrequirements for basic safety and essential performance. Test results indicated that the Spacelabs Blease 900 complies with theStandards. |
|---|---|
| ElectromagneticCompatibilityTesting | The Spacelabs Blease 900 was tested for performance in accordancewith 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 - Requiremenand tests. Test results indicated that the Spacelabs Blease 900 complies with theStandards. |
| Performance Testing | The Spacelabs Blease 900 was tested for performance in accordancewith internal requirements and the following Standard:ASTM D4169-05, Standard practice for performance testing ofshipping containers and systems. Test results indicated that the Spacelabs Blease 900 complies with itspredetermined 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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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 (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
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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
Page 1 of 1
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§ 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).