(261 days)
No
The description focuses on data collection, display, editing, reporting, and management of vital signs data, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used for monitoring, measuring, and recording vital signs data for diagnostic purposes, not for providing therapy to treat a disease or condition.
Yes
The 'Device Description' explicitly states: "The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients..." This indicates its use for diagnostic purposes.
No
The device description explicitly states the system is comprised of a monitor (LifeSigns™Shuttle) and a cradle (LifeSigns144 Commander), which are hardware components that acquire patient data. While there is central station software, the system is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that the LifeSigns!™ Cardiac Monitoring System collects vital signs data from the patient (ECG, SpO2, heart rate, blood pressure). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description focus on monitoring physiological parameters. The system is designed to measure and record electrical activity of the heart, oxygen saturation in the blood, heart rate, and blood pressure directly from the patient.
- There is no mention of analyzing biological samples. The entire description revolves around the acquisition and management of real-time physiological data.
Therefore, the LifeSigns!™ Cardiac Monitoring System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.
Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease
Monitoring of patients in out-of-hospital convalescence settings
Monitoring of patients by physicians, clinics, or skilled care facilities
Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting
The device is not intended to sound real time alarms
This device does not replace physician's care
Product codes
74 DPS
Device Description
The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC.
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
out-of-hospital environment, physicians, clinics, or skilled care facilities, health care professional, out of hospital residence setting
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)
The LifeSigns System has been subjected to performance testing of vital sigms measurements, performance to specifications, and electromagnetic environmental susceptibility and emissions. The rests demonstrate that the LifeSigns System provides performance equivalent to the predicate devices and components, and meets applicable standards for performance and EMC compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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INSTROMEDIX
Image /page/0/Picture/2 description: The image contains the word "Instramedix" in a bold, sans-serif font. The text is black and appears to be printed on a white background. A horizontal line underlines the word, emphasizing it.
Tools for medicine to help humankind
@004
510(K) SUMMARY LIFESIGNS™ CARDIAC MONITORING SYSTEM INSTROMEDIX, INC. 510(k) Number K964408 Contact: Herbert J. Semler, M.D. 22 July, 1997
Jul 2 3 1997
The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.
The LifeSigns System is substantially equivalent to aspects of the predicate systems, the Cardiac Alliance Buddy System, K864318 and K871748, the Healthtech Service Corporation Home Assisted Nursing Care System. K952979, and has features that are equivalent to features found in the predicate devices Mortara Eli 100 12-lead cardiograph, (ref: K920627); the CAS Medical Oscillomate Model 9300 (ref: K925402) and the Nonin Onyx Pulse Oximeter Model 9500, (ref: K942248). The LifeSigns System and its predicate both have the same general intended use of monitoring vital signs of patients in out-of-hospital settings. These systems use previously cleared elements to acquire the ECG, blood pressure, and SpO2.
There are minor differences between the LifeSigns System and the predicates. For example, the Shuttle is physically much smaller and portable. With the Commander, three vital signs are measured. Simultaneous voice and data communications are possible between the patient site and the Central Station. And the Shuttle may be used separately by a healthcare professional to visualize the ECG, and obtain SpO2 readings and heart rate, and with the Commander to obtain blood pressure. The predicate devices are significantly larger. These differences are not deemed to be significant in terms of the performance in acquiring diagnostic vital signs from the patient. Performance, safety, and efficacy of the LifeSigns System are substantially equivalent as compared to the predicate devices and components.
The LifeSigns System has been subjected to performance testing of vital sigms measurements, performance to specifications, and electromagnetic environmental susceptibility and emissions. The rests demonstrate that the LifeSigns System provides performance equivalent to the predicate devices and components, and meets applicable standards for performance and EMC compliance,
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Herbert J. Semler, M.D. JUL 23 1997 Instromedix, Inc. One. Technology Center 7431 N.E. Evergreen Parkway Hillsboro, Oregon 97124-5898
Re: K964408 Poseidon Cardiac Monitoring System (PCMS) Requlatory Class: II (two) Product Code: 74 DPS Dated: April 23, 1997 Received: April 24, 1997
Dear Dr. Semler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Herbert J. Semler, M.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page l of
510(k) Number (if known): K964408
Device Name: LifeSigns™ Cardiac Monitoring System
Indications For Use:
Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease
Monitoring of patients in out-of-hospital convalescence settings
Monitoring of patients by physicians, clinics, or skilled care facilities
Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting
The device is not intended to sound real time alarms
This device does not replace physician's care
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. Ragle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number __
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)