(268 days)
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No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The description focuses on standard vital signs monitoring and software validation.
No
The device is a vital signs monitor used for diagnosis and monitoring of physiological parameters, not for treating a disease or condition.
No
The device is described as a "Vital Signs Monitor" that facilitates the "monitoring of" various physiological parameters. While it collects physiological data (e.g., ECG with arrhythmia detection, blood pressure, temperature), its primary stated purpose is monitoring, not specifically diagnosing conditions based on the interpretation of this data for a conclusive medical diagnosis.
No
The device description explicitly states "The Spacelabs Healthcare (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors" and mentions different sized viewing areas and housing colors, indicating a physical hardware component. While there is a software package for the Central Station, the core device is a hardware monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spacelabs élance Vital Signs Monitor and Central Station directly monitors physiological parameters from the patient's body (ECG, respiration, blood pressure, temperature, SpO2, EtCO2). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring vital signs of the patient, not analyzing samples from the patient.
Therefore, this device falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Device Name: élance Vital Signs Monitor and élance Central Station
Intended Use / Indications for Use
The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult
- Pediatric (1 year old and above)
The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of: - ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- End tidal CO2.
The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The Spacelabs Healthcare (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG with arrhythmia detection, respiration, NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features.
The Spacelabs élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult
Pediatric (1 year old and above)
Intended User / Care Setting
healthcare professionals in all areas of a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software
The élance VSM and élance CS contain MAJOR level of concern software. 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
- 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:
- FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and
- FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 14 Jun 13
Test results indicated that the élance VSM and élance CS software comply with predetermined specification.
Electrical Safety
The élance VSM was tested for patient safety in accordance with: IEC 60601-1:1988, Am1: 1991, Am2: 1995, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Test results indicated that the élance VSM complies with the applicable standards.
Electromagnetic Compatibility
The élance VSM was tested for EMC in accordance with: IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the élance VSM complies with the applicable standards.
Performance Testing – Bench
The élance VSM was tested for parameter performance in accordance with: ANSI/AAMI EC57: 1998/(R) 2003, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms; ANSI/AAMI SP10: 2002, Am1: 2003, Manual, electronic, or automated sphygmomanometers; EN 12470-4: 2009, Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement; EN 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; EN 62366: 2008, Medical devices - Application of usability engineering to medical devices; IEC 60601-2-27: 2005, Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment; IEC 60601-2-30: 1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment; IEC 60601-2-34: 2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment; IEC 60601-2-49: 2011, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment; ISO 80601-2-55: 2011, Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors; and ISO 80601-2-61: 2011, Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The élance CS was tested for parameter performance in accordance with: EN 60601-1-6: 2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability; EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; EN 62366: 2008, Medical devices Application of usability engineering to medical devices; Test results indicated that the élance VSM and élance CS comply with these Standards. Additionally, the élance VSM and élance CS were tested in accordance with internal requirements and procedures, and test results indicated that the devices comply with the predetermined requirements.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the élance VSM and élance CS. The results of these activities demonstrate that the élance VSM and élance CS are as safe, as effective, and perform as well as or better than the predicate devices. Therefore, the élance VSM and élance CS are considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
Spacelabs Healthcare % Thomas Kroenke, Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K150329
Trade/Device Name: élance Vital Signs Monitor and élance Central Station Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: October 1, 2015 Received: October 6, 2015
Dear Thomas 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K150329 510(k) Number (if known):
Device Name: élance Vital Signs Monitor and élance Central Station
Indications For Use: The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult ।
- -Pediatric (1 year old and above)
The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:
- ECG with arrhythmia detection -
- -Respiration
- Non-invasive blood pressures -
- -Invasive blood pressures
- -Body temperature
- Functional arterial oxygen saturation, and -
- -End tidal CO2.
The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
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 Center for Devices and Radiological Health (CDRH)
Page 1 of 1
3
| Submission Date: | 01 October 2015 | ||
|---|---|---|---|
| Submitter: | Spacelabs Healthcare | ||
| 35301 SE Center St | |||
| Snoqualmie, WA 98065 | |||
| Submitter Contact: | Mr. Al Van Houdt | ||
| Spacelabs Healthcare | |||
| Phone: +1 (425) 363- 5970 | |||
| Fax: +1 (425) 363-5762 | |||
| Email: al.vanhoudt@spacelabs.com | |||
| Application | |||
| Correspondent: | Thomas Kroenke | ||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | Spacelabs Healthcare | ||
| 35301 SE Center St | |||
| Snoqualmie, WA 98065 | |||
| Trade Name: | élance Vital Signs Monitor and élance Central Station | ||
| Common Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) | ||
| Classification Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) | ||
| Primary | |||
| Classification | |||
| Regulation: | 21 CFR §870.1025 | ||
| Primary Product | |||
| Code: | MHX | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs Healthcare élance | |||
| Vital Signs Monitor and | |||
| élance Central Station | K093501 | Spacelabs Healthcare élance | |
| Vital Signs Monitor and élance | |||
| Central Station | |||
| K033296 | Masimo Corporation Masimo | ||
| SET® Rad-5 Pulse Oximeter | |||
| K012891 | Nellcor Puritan Bennett | ||
| Incorporated OxiMAX Pulse | |||
| Oximetry System with N-595 Pulse | |||
| Oximeter and OxiMAX Sensors | |||
| and Cables |
4
| Device Description: | The Spacelabs Healthcare (Spacelabs) élance Vital Signs Monitor is a
family of portable patient monitors intended to be used by clinicians
and medical qualified personnel for monitoring ECG with arrhythmia
detection, respiration, NIBP, temperature, SPO2, invasive blood
pressure and EtCO2. Models within the Spacelabs élance family come
in two different sized viewing areas (10.2" and 12.1"), two different
housing colors (white and black) and offer selected monitoring
features. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Spacelabs élance Central Station software package is available for
use with a customer acquired computer based on specifications
provided by Spacelabs. This package allows monitoring of the élance
Vital Signs Monitor at a central workstation. |
| Intended Use: | The Spacelabs élance Vital Signs Monitor and élance Central Station is
indicated for use in patient populations for:
- Adult
- Pediatric (1 year old and above)
The Spacelabs élance Vital Signs Monitor and élance Central Station
facilitates the monitoring of: - ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- End tidal CO2.
The Spacelabs élance Vital Signs Monitor and élance Central Station is
a prescription device intended to be used by healthcare professionals in
all areas of a healthcare facility. |
5
Technology Comparison:
The Spacelabs Spacelabs élance Vital Signs Monitor and élance Central Station employs the same technological characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Parameters | ECG with arrhythmia | |
| detection | ||
| Respiration | ||
| Non-invasive blood pressure | ||
| Invasive blood pressure | ||
| Body temperature | ||
| Functional arterial oxygen | ||
| saturation, and | ||
| End tidal CO2. | Same | |
| Display Type | LCD | Same |
| Display Sizes | 10.2" and 12.1" | Same |
| VSM Variants | 5, 5i, 5c, 5 elite, 5i elite, 5c | |
| elite | ||
| 7, 7i, 7c, 7 elite, 7i elite, 7c | ||
| elite | Same | |
| Additional Options | - | 93300-M, Masimo SpO2 |
| 93300-N, Nellcor SpO2 | ||
| 93300-A: Arrhythmia | ||
| 93300-S: ST Segment Analysis |
Summary of Performance Testing:
Software
The élance VSM and élance CS contain MAJOR level of concern software. 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
- · 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:
- FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and
- · FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 14 Jun 13
Test results indicated that the élance VSM and élance CS software comply with predetermined specification.
6
| Electrical Safety | The élance VSM was tested for patient safety in accordance with:
IEC 60601-1:1988, Am1: 1991, Am2: 1995, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Test results indicated that the élance VSM complies with the applicable standards. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic Compatibility | The élance VSM was tested for EMC in accordance with:
IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the élance VSM complies with the applicable standards. |
| Performance Testing – Bench | The élance VSM was tested for parameter performance in accordance with:
ANSI/AAMI EC57: 1998/(R) 2003, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms; ANSI/AAMI SP10: 2002, Am1: 2003, Manual, electronic, or automated sphygmomanometers; EN 12470-4: 2009, Clinical thermometers – Part 4: Performance of electrical thermometers for continuous measurement; EN 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; EN 62366: 2008, Medical devices - Application of usability engineering to medical devices; IEC 60601-2-27: 2005, Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment; |
7
- Performance Testing – Bench (continued)
- · IEC 60601-2-30: 1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment;
- · IEC 60601-2-34: 2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment;
- · IEC 60601-2-49: 2011, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment;
- ISO 80601-2-55: 2011, Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors; and
- ISO 80601-2-61: 2011, Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The élance CS was tested for parameter performance in accordance with:
- EN 60601-1-6: 2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability;
- EN 60601-1-8 2007, Am1: 2013, AC: 2014, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems;
- · EN 62366: 2008, Medical devices Application of usability engineering to medical devices;
- · Test results indicated that the élance VSM and élance CS comply with these Standards. Additionally, the élance VSM and élance CS were tested in accordance with internal requirements and procedures, and test results indicated that the devices comply with the predetermined requirements.