(161 days)
No
The document describes a standard anesthesia workstation and does not mention AI, ML, or any related technologies in its description, intended use, or performance studies.
Yes
The device delivers oxygen, air, nitrous oxide, and anesthetic vapor to a patient, which are therapeutic interventions.
No
Explanation: The device is an "Anesthesia Workstation" intended for the delivery of medical gases and anesthetic vapor. Its function is to control and deliver substances to a patient, not to diagnose a condition or disease.
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". This indicates significant hardware components beyond just software. The performance studies also include testing for biocompatibility, electrical safety, and electromagnetic compatibility, which are relevant to hardware.
Based on the provided information, the Spacelabs Arkon Anesthesia Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used for the delivery of gases and anesthetic vapor to a patient's breathing circuit. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the pneumatic circuitry, controls, and delivery of gases and anesthetic agents. This aligns with a device used for patient support and anesthesia administration, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The Spacelabs Arkon Anesthesia Workstation is clearly described as a device used on a patient for the purpose of anesthesia and respiratory support.
N/A
Intended Use / Indications for Use
The Spacelabs Arkon 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
CBK, BSZ
Device Description
The Spacelabs Arkon Anesthesia Workstation (Arkon) is 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 a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
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
The device is intended for use only by a suitably qualified physician.
hospital environment and operating room.
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
Biocompatibility: Patient contact materials within the Arkon and its accessories were verified in accordance with ISO 10993-1: 2009. Results indicated that the materials comply with the standard.
Software Testing: The Arkon software was designed and developed according to a robust software development process, and was rigorously verified and validated in accordance with FDA guidance documents and IEC 62304: 2006, ISO 14971: 2007. Test results indicate that the Arkon complies with its predetermined specifications and the applicable standards and guidance documents.
Electrical Safety Testing: The Arkon was tested for patient safety in accordance with IEC 60601-1: 1988, Am1: 1991, Am2: 1995; and UL 60601-1: 2006. Test results indicated that the Arkon complies with the applicable Standards.
Electromagnetic Compatibility Testing: The Arkon was tested for EMC in accordance with IEC 60601-1-2: 2007. Test results indicated that the Arkon complies with the applicable Standard.
Performance Testing: The Arkon was tested for performance in accordance with internal Performance Testing requirements and the following standards: IEC 60601-1-6: 2004, IEC 60601-1-8: 2006, ASTM F1101-90 (2003) e1, CGA C-9: 2004, CGA V-5: 2008, IEC 60601-2-13: 2003, Am1: 2006, IEC 62366: 2007, ISO 5356-1: 2004, ISTA Procedure IB. Test results indicate that the Arkon complies with its predetermined specifications and the applicable standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Arkon. The results of these activities demonstrate that the Arkon is safe and effective when used in accordance with its intended use and labeling. Therefore, the Arkon is considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 2 2012
:
510(k) Summary
| Submission Date: | 11 October 2011 |
|---|---|
| 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) | |
| Phone: +1 (425) 657-7200, ext 5889 | |
| Fax: +1 (425) 657-7210 | |
| Email: david.geraghty@spacelabs.com | |
| Official | |
| Correspondent: | Thomas Kroenke |
| Principal Consultant | |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@speedtomarket.net | |
| +1 (303) 956 4232 | |
| Manufacturing Site: | Spacelabs Medical, Inc. |
| 5150 220th Avenue SE | |
| Issaquah, WA 98029 USA | |
| Trade Name: | Spacelabs Arkon Anesthesia Workstation |
| Common Name: | Anesthesia workstation with continuous ventilator |
| Classification Name: | Ventilator, continuous, facility use; |
| Gas-machine, anesthesia | |
| Classification | |
| Regulation: | 21 CFR §868.5895; |
| 21 CFR §868.5160 | |
| Primary Product | |
| Code: | CBK |
| Secondary Product | |
| Code: | BSZ |
1
510(k) Summary
| Substantially
Equivalent Devices: | New Spacelabs Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------|
| | Spacelabs Arkon
Anesthesia Workstation | K101850 | Spacelabs BleaseSirius
Anesthesia Workstation |
| Device Description: | The Spacelabs Arkon Anesthesia Workstation (Arkon) is 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 a mechanical ventilator, and may be used for the
delivery of anesthetic vapor by use of a dismountable vaporizer. | | |
| Intended Use: | The Spacelabs Arkon 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. | | |
| Technology
Comparison: | The Spacelabs Arkon Anesthesia Workstation employs the same
technological characteristics as the predicate device.fs | | |
| Summary of Performance Testing: | | | |
| Biocompatibility | Patient contact materials within the Arkon and its accessories were | | |
verified in accordance with the following standard: Verification ISO 10993-1: 2009, Biological evaluation of medical devices – Part .
- 1 : Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with the standard.
2
510(k) Summary
| Software Testing | The Arkon software was designed and developed according to a robust
software development process, and was rigorously verified and
validated. Software information is provided in accordance with internal
requirements and the following standards and guidance documents:
FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09
Sep 99; and FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02. IEC 62304: 2006, Medical device software – Software life cycle
processes. ISO 14971: 2007, Medical devices – Application of risk
management to medical devices Test results indicate that the Arkon complies with its predetermined
specifications and the applicable standards and guidance documents. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety
Testing | The Arkon was tested for patient safety in accordance with the
following standards:
IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical
Equipment, Part 1: General Requirements for Safety; and UL 60601-1: 2006, Medical Electrical Equipment, Part 1:
Particular Requirements for Safety. Test results indicated that the Arkon complies with the applicable
Standards. |
| Electromagnetic
Compatibility
Testing | The Arkon was tested for EMC in accordance with the following
standard:
IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part
1-2: General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Arkon complies with the applicable
Standard. |
.
・
3
510(k) Summary
The Arkon was tested for performance in accordance with internal Performance Testing requirements and the following standards:
- IEC 60601-1-6: 2004, Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance -Collateral standard: Usability.
- IEC 60601-1-8: 2006, Medical electrical equipment General . requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- ASTM F1101-90 (2003) e1, Standard Specification for ventilators . intended for use during anesthesia.
- CGA C-9: 2004, Standard Color Marking of Compressed Gas . Containers for Medical Use.
- CGA V-5: 2008, Diameter Index Safety System . (Noninterchangeable Low Pressure Connections for Medical Gas Applications).
- IEC 60601-2-13: 2003, Am1: 2006, Medical electrical equipment -. Particular requirements for the safety and performance of anesthetic systems.
- IEC 62366: 2007, Medical devices Application of usability . engineering to medical devices.
- ISO 5356-1: 2004, Anaesthetic and respiratory equipment Conical . connectors - Part I: Cones and sockets.
- ISTA Procedure IB, Non-simulation integrity performance test . procedure - Packaged-products over 150 lb (68 kg).
Test results indicate that the Arkon complies with its predetermined specifications and the applicable standards.
Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the Arkon. The results of these activities demonstrate that the Arkon is safe and effective when used in accordance with its intended use and labeling.
Therefore, the Arkon is considered substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAR 2 2 2012 .
Spacelabs Healthcare, LTD C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, Colorado 80466
Re: K113051
Trade/Device Name: Spacelabs Arkon Anesthesia Workstation Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, BSZ Dated: February 23, 2012 Received: February 24, 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.
5
Page 2 - Mr. Kroënke
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,
Nh 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
6
Indications for Use
K
510(k) Number (if known):
Device Name:
Indications for Use:
Spacelabs Arkon Anesthesia Workstation
The Spacelabs Arkon 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.
Prescription Use X (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)
for. L. Schutheis
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K11/3
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