(244 days)
The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
The device is intended for use only by a suitably qualified physician.
an anesthesia workstation that contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents in order to deliver them to a patient system. It is capable of delivering oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The Spacelabs BleaseSirius is the latest generation product in a family of anesthesia workstations. The same breathing circuits used with the predicate device, the Blease Frontline Sirius 2000, 3000 cleared by FDA in 510(k) premarket notification K051629, are used with the Spacelabs BleaseSirius.
This document describes the 510(k) Premarket Notification for the Spacelabs BleaseSirius Anesthesia Workstation. Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes general compliance with predetermined specifications and applicable standards for various types of testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | "The Spacelabs BleaseSirius was tested for patient safety in accordance with applicable Standards. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification and with the applicable Standards." |
| Electromagnetic Compatibility (EMC) | "The Spacelabs BleaseSirius was tested for EMC in accordance with applicable Standards. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification and with the applicable Standards." |
| Performance Testing | "The Spacelabs BleaseSirius was tested for performance in accordance with predetermined specifications and applicable Standards. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification and with the applicable Standards." (The specific performance metrics and their acceptance thresholds are not detailed in this summary.) |
| Software Testing | "Software for the Spacelabs BleaseSirius was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification." (The specific software performance metrics and their acceptance thresholds are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any of the tests (Electrical Safety, EMC, Performance, or Software). It also does not provide information on the data provenance, such as the country of origin or whether the studies were retrospective or prospective.
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 device is an anesthesia workstation, not an AI or diagnostic imaging device that typically requires expert-established ground truth for its performance evaluation (e.g., in terms of sensitivity/specificity). The compliance is based on engineering and safety standards. Therefore, information about experts establishing ground truth for a test set is not applicable and not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As the evaluation is based on compliance with predetermined specifications and standards for an anesthesia workstation, an adjudication method for a test set (as typically seen in AI or diagnostic studies) is not applicable and not mentioned in the document.
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 such study was conducted or is mentioned. The device is an anesthesia workstation, not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an algorithm without human intervention. Since the device is an anesthesia workstation and not an AI algorithm, this concept is not applicable. The device's "performance" is its ability to operate according to its specifications and standards, which is assessed through various engineering and safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's safety and performance is established by predetermined specifications and applicable international and national standards (e.g., for electrical safety, EMC, and general performance). This is a technical and engineering-based "ground truth" rather than a clinical one derived from patient outcomes or expert consensus on diagnoses.
8. The sample size for the training set
This device is a hardware/software system, not a machine learning model that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no training set for an AI model, this question is not applicable.
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510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary
KI01850 MAR - 2 2011
| Submission Date: | 28 June 2010 | ||
|---|---|---|---|
| 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 BleaseSirius Anesthesia Workstation | ||
| Common Name: | Anesthesia Gas Machine | ||
| Classification Name: | Gas-machine, Anesthesia | ||
| ClassificationRegulation: | 21 CFR §868.5160 | ||
| Product Code: | BSZ | ||
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Spacelabs BleaseSiriusAnesthesia Workstation | K051629 | Spacelabs BleaseFrontline Sirius 2000,3000 |
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510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary
The Spacelabs BleaseSirius Anesthesia Workstation (BleaseSirius) is Device Description: an anesthesia workstation that contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents in order to deliver them to a patient system. It is capable of delivering oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The Spacelabs BleaseSirius is the latest generation product in a family of anesthesia workstations. The same breathing circuits used with the predicate device, the Blease Frontline Sirius 2000, 3000 cleared by FDA in 510(k) premarket notification K051629, are used with the Spacelabs BleaseSirius. The Spacelabs BleaseSirius Anesthesia Workstation is intended for use Intended Use: in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. The Spacelabs BleaseSirius Anesthesia Workstation employs the same Technology technological characteristics as the predicate device. Comparison: Summary of Performance Testing: The Spacelabs BleaseSirius was tested for patient safety in accordance Electrical Safety with applicable Standards. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification and with the applicable Standards. The Spacelabs BleaseSirius was tested for EMC in accordance with Electromagnetic applicable Standards. Compatibility Test results indicated that the Spacelabs BleaseSirius complies with its Testing predetermined specification and with the applicable Standards.
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510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary
| Performance Testing | The Spacelabs BleaseSirius was tested for performance in accordancewith predetermined specifications and applicable Standards. |
|---|---|
| Test results indicated that the Spacelabs BleaseSirius complies with itspredetermined specification and with the applicable Standards. | |
| Software Testing | Software for the Spacelabs BleaseSirius was designed and developedaccording to a robust software development process, and was rigorouslyverified and validated. |
| Test results indicated that the Spacelabs BleaseSirius complies with itspredetermined specification. | |
| Conclusion | Based upon a comparison of devices and performance testing results,Spacelabs BleaseSirius is substantially equivalent to the predicatedevice. |
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized image of an eagle or bird with outstretched wings, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Spacelabs Healthcare Limited C/O Mr. Thomas Kroenke Speed to Market, Incorporated PO Box 3018 Nederland, Colorado 80466
MAR - 2 2011
Re: K101850
Trade/Device Name: Spacelabs BleaseSirius Anesthesia Workstation Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: February 18, 2011 Received: February 22, 2011
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 (OS) 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,
Anthony V. aver
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
| 510(k) Number (if known): | K101850 |
|---|---|
| Device Name: | Spacelabs BleaseSirius Anesthesia Workstation |
| Indications for Use: | The Spacelabs BleaseSirius Anesthesia Workstation is intendedfor use in the hospital environment and operating room. It maybe used for the delivery of oxygen, air and nitrous oxide in acontrolled manner to various patient breathing circuits with orwithout the use of mechanical ventilator, and may be used for thedelivery of anesthetic vapor by use of a dismountable vaporizer.The device is intended for use only by a suitably qualifiedphysician. |
X 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)
ce of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Control Coursel, Dental Devices Division of Antosthools - 1999
Infection Control, Dental Devices
510(k) Number: K101850
§ 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).