(59 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard vital signs monitoring without mentioning any advanced analytical capabilities.
No
The device is described as a "Vital Signs Monitor" and "patient monitors" that facilitates "monitoring" of various physiological parameters. Its function is to observe and display patient data, not to treat or alleviate a disease or condition.
Yes
The device monitors vital signs such as ECG with arrhythmia detection, respiration, blood pressures, body temperature, oxygen saturation, and CO2, which are used to assess a patient's health status and identify potential medical conditions. While it doesn't explicitly state "diagnosis," the monitoring of these parameters is inherently part of a diagnostic process.
No
The device description explicitly states it is a "family of portable patient monitors" with different sized viewing areas and housing colors, indicating physical hardware components beyond just software.
Based on the provided text, the Spacelabs élance Vital Signs Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Spacelabs élance Vital Signs Monitor directly monitors physiological parameters of the patient (ECG, respiration, blood pressure, temperature, SpO2, CO2) in vivo (within the living body).
- The intended use and device description clearly state that it monitors vital signs directly from the patient. There is no mention of analyzing samples or specimens.
- The performance testing described is bench testing and does not involve the analysis of biological samples.
Therefore, the Spacelabs élance Vital Signs Monitor is a patient monitoring device, not an IVD device.
N/A
Intended Use / Indications for Use
The Spacelabs élance Vital Signs Monitor is indicated for use in patient populations for:
- Adult
- Pediatric
The Spacelabs élance Vital Signs Monitor facilitates the monitoring of:
- ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- Expired and/or inspired CO2.
The Spacelabs élance Vital Signs Monitor 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 Medical Equipment (Suzhou) Co., Ltd. (Spacelabs) élance Vital Signs Monitoring System (élance) is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, 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. See the following Product Configuration List for the identified models and Spacelabs defined monitoring features.
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
Adult, Pediatric
Intended User / Care Setting
prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
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
Test results indicated that the Spacelabs élance complies with its predetermined specification.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Testing: Software for the Spacelabs élance was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Spacelabs élance complies with its predetermined specification.
Electrical Safety: The Spacelabs élance was tested for patient safety in accordance with applicable Standards. Test results indicated that the Spacelabs élance complies with its predetermined specification.
Electromagnetic Compatibility Testing: The Spacelabs élance was tested for EMC in accordance with applicable Standards. Test results indicated that the Spacelabs élance complies with its predetermined specification.
Performance Testing – Bench: The Spacelabs élance was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and shipping and transportation testing.
Performance Testing – Animal: Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Spacelabs élance.
Performance Testing – Clinical: Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Spacelabs élance.
Conclusion: Based upon a comparison of devices and performance testing results, the Spacelabs élance is substantially equivalent to the predicate devices.
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.
K001775, K060065, K033296, K062144, K012891
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
§ 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
K090556
"
510(k) Summary
APR 3 0 2009
| Submission Date: | 23 February 2009 |
|---|---|
| Submitter: | Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. |
| Building 30, West Wing | |
| Chuang Tou Industrial Square, Yang Xian Road | |
| Submitter Contact: | Jennifer Cui |
| Phone: 011-086-0512-87178286 | |
| Fax: 011-086-0512-87178278 | |
| Email: Jennifer.Cui@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 | |
| Trade Name: | Spacelabs élance Vital Signs Monitoring System |
| Common Name: | Patient Physiological Monitor (with arrhythmia detection or alarms) |
| Classification Name: | Monitor, physiological, patient (with arrhythmia detection or alarms) |
| Classification | |
| Regulation: | 21 CFR §870.1025 |
| Product Code: | MHX |
Page 1 of 4
1
| Substantially
Equivalent Devices: | Spacelabs élance Vital Signs
Monitoring System | Predicate 510(k)
Number | Predicate
Manufacturer / Model |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------|
| | ECG component | K001775 | Zoe Medical Nightingale
Monitoring System |
| | Respiration component | | |
| | Non-invasive blood pressures
component | | |
| | Invasive blood pressures
component | | |
| | Temperature component | | |
| | Expired and/or inspired CO2
component | K060065 | Oridion Capnostream 20 |
| | Functional arterial oxygen
saturation component | K033296 | Masimo Corporation SET
Rad 5 MS-11 board |
| | Arrhythmia detection and
invasive pressure monitoring
(IBP) | K062144 | Invivo Escort M8 Vital
Signs Patient Monitor
Model 3810 |
| | Functional arterial oxygen
saturation component | K012891 | Nellcor Oximax N-595
pulse oximeter |
| Device Description: | The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd.
(Spacelabs) élance Vital Signs Monitoring System (élance) is a family
of portable patient monitors intended to be used by clinicians and
medical qualified personnel for monitoring ECG, 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. See the following Product
Configuration List for the identified models and Spacelabs defined
monitoring features. | | |
| Central Station: | A software package (93900) is available for use with customer acquired
computer based on specifications provided by Spacelabs Medical. This
package allows monitoring of the élance at a central workstation. | | |
| Technology
Comparison: | The élance utilizes the same or similar technology for each parameter
as utilized by the predicate devices. | | |
. . .
2
Intended Use:
The Spacelabs élance Vital Signs Monitor is indicated for use in patient populations for:
- Adult
- Pediatric
The Spacelabs élance Vital Signs Monitor facilitates the monitoring of:
- ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- Expired and/or inspired CO2.
The Spacelabs élance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Performance Testing:
| Sterilization
Validation | The Spacelabs élance is not sterilized or sterilizable, and therefore this
section does not apply to the monitor itself. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf Life Testing | The Spacelabs élance is not sterilized or sterilizable, and therefore this
section does not apply to the monitor itself. |
| Biocompatibility
Testing | The Spacelabs élance has no patient contact materials, and therefore
this section does not apply to the monitor itself. |
| Software Testing | Software for the Spacelabs élance was designed and developed according
to a robust software development process, and was rigorously verified
and validated. Test results indicated that the Spacelabs élance complies
with its predetermined specification. |
| Electrical Safety | The Spacelabs élance was tested for patient safety in accordance with
applicable Standards. Test results indicated that the Spacelabs élance
complies with its predetermined specification. |
| Electromagnetic
Compatibility Testing | The Spacelabs élance was tested for EMC in accordance with
applicable Standards. Test results indicated that the Spacelabs élance
complies with its predetermined specification. |
| Performance Testing
– Bench | The Spacelabs élance was tested in accordance with internal requirements
and procedures, and test results indicated that the device complies with
the predetermined requirements. This testing includes performance and
functional, environmental, and shipping and transportation testing. |
| Performance Testing
— Animal: | Animal performance testing was not performed and is not necessary to
demonstrate safety and effectiveness of the Spacelabs élance. |
Page 3 of 4
3
| Performance Testing | Clinical performance testing was not performed and is not necessary to |
|---|---|
| – Clinical: | demonstrate safety and effectiveness of the Spacelabs élance. |
| Conclusion | Based upon a comparison of devices and performance testing results, |
| the Spacelabs élance is substantially equivalent to the predicate devices. |
. . . .
4
Public Health Service
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the design.
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466
Re: K090556
Trade/Device Name: élance Vital Signs Monitoring System; and, élance Central Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 23, 2009 Received: March 2, 2009
Dear Mr. Kroenke:
This letter corrects our substantially equivalent letter of April 30, 2009.
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 (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.
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. Thomas 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number (if known): | K |
|---|---|
| Device Name: | Spacelabs Healthcare, Inc. (Spacelabs) élance Vital Signs |
| Monitoring System | |
| Indications for Use: | The Spacelabs élance Vital Signs Monitor is indicated for use in |
| patient populations for: |
- Adult
- Pediatric |
| | The Spacelabs élance Vital Signs Monitor facilitates the
monitoring of: - ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- End title CO2. |
| | The Spacelabs élance Vital Signs Monitor 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)
Over-The-Counter Use AND/OR (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)
(Division Sign-Off) Division of Cardiovascular Devices Division of Caraloversealar Bo
510(k) Number_Ko G0 53 G
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