(12 days)
Not Found
No
The document describes a standard vital signs monitor and central station with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a vital signs monitor used to measure physiological parameters, not to treat a disease or condition. While critical for patient assessment, it does not directly provide therapy.
No
The device is described as a "Vital Signs Monitor" that facilitates the "monitoring" of various physiological parameters. While monitoring vital signs is crucial for patient assessment, the provided text does not state that the device is intended to definitively diagnose a disease or condition. Its purpose is to observe and collect data on patient health, which can then be used by healthcare professionals for diagnosis, but the device itself does not perform the diagnostic step.
No
The device description explicitly states it is a "family of portable patient monitors" and mentions different sized viewing areas and housing colors, indicating hardware components. While a software package for a central station is mentioned, the primary device is a hardware monitor.
Based on the provided information, the Spacelabs élance Vital Signs Monitor and élance Central Station is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring various physiological parameters (ECG, respiration, blood pressure, temperature, SpO2, EtCO2) in patients. This involves directly measuring signals from the patient's body.
- Device Description: The description reinforces that it's a patient monitor used by clinicians to observe these vital signs.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a patient monitoring system, which falls under a different regulatory category than IVD devices.
N/A
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
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 Medical, Inc. (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, 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.
Central Station: The Spacelabs Medical, Inc. élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device modifications made to the élance Vital Signs Monitor and élance Central Station were appropriately verified to ensure that each modification was implemented correctly.
Verification results indicated that the élance Vital Signs Monitor and élance Central Station complies with predetermined specifications.
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
§ 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
.
510(k) Summary
1
くし
| Submission Date: | 03 November 2009 | NOV 2 4 2009 | |
|---|---|---|---|
| Submitter: | Spacelabs Medical, Inc. | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 USA | |||
| Submitter Contact: | David J. Geraghty | ||
| Phone: +1 (425) 657-7200, ext 5889 | |||
| Fax: +1 (425) 657-7210 | |||
| Email: david.geraghty@spacelabs.com | |||
| Trade Name: | élance Vital Signs Monitor and élance Central Station | ||
| 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 | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate 510(k) Number | Predicate |
| Manufacturer / Model | |||
| élance Vital Signs Monitor and | |||
| élance Central Station | K090556 | Spacelabs Healthcare | |
| Medical Equipment | |||
| (Suzhou) Co., Ltd. / | |||
| élance Vital Signs | |||
| Monitoring System; and, | |||
| élance Central Monitor | |||
| Device Description: | The Spacelabs Medical, Inc. (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, 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. | |||
| Central Station: | The Spacelabs Medical, Inc. élance Central Station software package is | ||
| available for use with a customer acquired computer based on |
specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation. .
:
" ·
1
Technology Comparison:
Intended Use:
The élance Vital Signs Monitor and élance Central Station utilize the same technology for each parameter as utilized by the predicate device.
The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult
- Pediatric
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.
Performance Testing:
Device modifications made to the élance Vital Signs Monitor and élance Central Station were appropriately verified to ensure that each modification was implemented correctly.
Verification results indicated that the élance Vital Signs Monitor and élance Central Station complies with predetermined specifications.
Conclusion
Based upon a comparison of devices and verification results, the Spacelabs élance Vital Signs Monitor and élance Central Station are substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV 2 4 2009
Mr. David J. Geraghty Manager, Regulatory & Quality Spacelabs Medical, Inc. 5150 220th Ave SE P.O. Box 7018 Issaquah, WA 98027-7018
Re: K093501
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 (Two) Product Code: MHX Dated: November 3, 2009 Received: November 12, 2009
Dear Mr. Geraghty:
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.
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.
3
Page 2 - Mr. David J. Geraghty
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
W.M.S. Jr.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K 09 350 1
Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor and élance Central Station
The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult
- Pediatric
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 CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K093501 |