(161 days)
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.
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.
The Spacelabs Arkon Anesthesia Workstation (Arkon) underwent various performance and safety tests to demonstrate substantial equivalence to its predicate device. This submission does not contain information typically associated with AI/ML device performance studies (e.g., sample sizes for test/training, number of experts, specific metrics like sensitivity/specificity for diagnostic tasks). Instead, it focuses on compliance with established medical device standards for hardware and software.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as compliance with the listed standards and its predetermined specifications. Since this is a traditional medical device submission, the "acceptance criteria" are the successful completion of tests outlined by the referenced standards, and "reported device performance" is the statement that the Arkon complies with these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-1: 2009 | Materials comply with the standard. |
| Software Testing: | Arkon software complies with predetermined specifications and applicable standards/guidance documents (FDA guidance: The content of premarket submissions for software, Off-the-shelf software use, General principles of software validation; IEC 62304: 2006, ISO 14971: 2007). |
| Electrical Safety Testing: IEC 60601-1: 1988 (Am1: 1991, Am2: 1995), UL 60601-1: 2006 | Arkon complies with the applicable standards. |
| Electromagnetic Compatibility Testing: IEC 60601-1-2: 2007 | Arkon complies with the applicable standard. |
| Performance Testing (Various 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 | Arkon complies with its predetermined specifications and the applicable standards. |
2. Sample size used for the test set and the data provenance:
- This is not applicable in the context of this 510(k) summary. The submission describes compliance with engineering and safety standards for a physical medical device, not a data-driven AI/ML system that would typically have a "test set" of patient data. The "tests" here refer to engineering verification and validation activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of medical device submission. Ground truth, in the AI/ML sense, is not established for this device's performance claims.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 an anesthesia workstation, not an AI-assisted diagnostic or decision-support tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical workstation that delivers gases and anesthetic agents, not a standalone algorithm. Its software is integral to its function, and its performance is assessed through compliance with software development and safety standards rather than standalone algorithmic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the traditional sense for AI/ML. The "ground truth" for the Arkon is defined by the technical specifications for its various components (pneumatic circuitry, controls, monitoring, etc.) and the requirements stipulated by the referenced industry and regulatory standards for safety and performance (e.g., electrical safety limits, biocompatibility profiles, ventilator performance parameters).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device relying on a "training set" of data.
9. How the ground truth for the training set was established:
- Not applicable.
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MAR 2 2 2012
:
510(k) Summary
| Submission Date: | 11 October 2011 |
|---|---|
| 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)Phone: +1 (425) 657-7200, ext 5889 |
| Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com | |
| OfficialCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc. |
| PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net+1 (303) 956 4232 | |
| Manufacturing Site: | Spacelabs Medical, Inc.5150 220th Avenue SEIssaquah, 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 |
| ClassificationRegulation: | 21 CFR §868.5895;21 CFR §868.5160 |
| Primary ProductCode: | CBK |
| Secondary ProductCode: | BSZ |
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510(k) Summary
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
|---|---|---|---|
| Spacelabs ArkonAnesthesia Workstation | K101850 | Spacelabs BleaseSiriusAnesthesia Workstation | |
| Device Description: | The Spacelabs Arkon Anesthesia Workstation (Arkon) is an anesthesiaworkstation that contains all the pneumatic circuitry, controls,monitoring, ancillaries and storage required to control, distribute andmix medical gases and anesthetic agents in order to deliver them to apatient system. It is capable of delivering oxygen, air and nitrous oxidein a controlled manner to various patient breathing circuits with orwithout the use of a mechanical ventilator, and may be used for thedelivery of anesthetic vapor by use of a dismountable vaporizer. | ||
| Intended Use: | The Spacelabs Arkon Anesthesia Workstation is intended for use in thehospital environment and operating room. It may be used for thedelivery of oxygen, air and nitrous oxide in a controlled manner tovarious patient breathing circuits with or without the use of mechanicalventilator, and may be used for the delivery of anesthetic vapor by useof a dismountable vaporizer. | ||
| The device is intended for use only by a suitably qualified physician. | |||
| TechnologyComparison: | The Spacelabs Arkon Anesthesia Workstation employs the sametechnological 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.
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510(k) Summary
| Software Testing | The Arkon software was designed and developed according to a robustsoftware development process, and was rigorously verified andvalidated. Software information is provided in accordance with internalrequirements and the following standards and guidance documents:FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99; and FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02. IEC 62304: 2006, Medical device software – Software life cycleprocesses. ISO 14971: 2007, Medical devices – Application of riskmanagement to medical devices Test results indicate that the Arkon complies with its predeterminedspecifications and the applicable standards and guidance documents. |
|---|---|
| Electrical SafetyTesting | The Arkon was tested for patient safety in accordance with thefollowing standards:IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical ElectricalEquipment, 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 applicableStandards. |
| ElectromagneticCompatibilityTesting | The Arkon was tested for EMC in accordance with the followingstandard:IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part1-2: General Requirements for Safety – Collateral Standard:Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Arkon complies with the applicableStandard. |
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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.
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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.
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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
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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
Page 1 of 1
§ 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).