(244 days)
Not Found
No
The summary describes a traditional anesthesia workstation with pneumatic controls and monitoring, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
This device delivers oxygen, air, nitrous oxide, and anesthetic vapor to patients, which is a direct therapeutic intervention for anesthesia during medical procedures.
No
The device is an anesthesia workstation used for the delivery of medical gases and anesthetic agents, not for diagnosing medical conditions.
No
The device description explicitly states it contains "all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description and Intended Use: The description clearly states that the Spacelabs BleaseSirius Anesthesia Workstation is used for the "delivery of oxygen, air and nitrous oxide... and may be used for the delivery of anesthetic vapor" to a patient. This is a device that directly interacts with the patient's respiratory system, not with specimens taken from the patient.
- Lack of Specimen Handling: There is no mention of the device analyzing or processing any biological specimens.
Therefore, the Spacelabs BleaseSirius Anesthesia Workstation is a therapeutic device used for delivering gases and anesthetic agents to a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ, CBK
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.
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
Not Found
Intended User / Care Setting
hospital environment and operating room.
suitably qualified physician.
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: "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 Testing: "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."
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."
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
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 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 BleaseSirius Anesthesia Workstation | ||
| Common Name: | Anesthesia Gas Machine | ||
| Classification Name: | Gas-machine, Anesthesia | ||
| Classification | |||
| Regulation: | 21 CFR §868.5160 | ||
| Product Code: | BSZ | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs BleaseSirius | |||
| Anesthesia Workstation | K051629 | Spacelabs Blease | |
| Frontline Sirius 2000, | |||
| 3000 |
1
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.
2
510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary
| 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. |
| 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. |
| Conclusion | Based upon a comparison of devices and performance testing results,
Spacelabs BleaseSirius is substantially equivalent to the predicate
device. |
3
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.
4
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
5
Indications for Use
| 510(k) Number (if known): | K101850 |
|---|---|
| Device Name: | Spacelabs BleaseSirius Anesthesia Workstation |
| Indications for Use: | 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. |
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