(49 days)
Not Found
No
The document describes a multi-functional medical device combining existing technologies (monitoring, ventilation, infusion) into a single platform with a central user interface. There is no mention of AI, ML, image processing, or any data analysis beyond standard physiological monitoring. The description focuses on the integration of hardware components and their control via a central interface.
Yes
The device combines multiple functions like physiological monitoring, infusion pumps, fluid warmer, and ventilator, all of which are used to treat and manage critically ill patients, thus providing therapeutic interventions.
Yes
The device includes "Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate)" which involves measuring and displaying physiological parameters, indicating a diagnostic function.
No
The device description clearly states it is a "portable unit" and combines multiple hardware components like physiological monitoring, infusion pumps, a fluid warmer, and a ventilator into a single platform. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Life Support for Trauma and Transport (LSTAT) G6 Lite System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LSTAT G6 Lite Functionality: The description clearly states that the LSTAT G6 Lite provides intensive care unit (ICU) functionality by combining various medical device capabilities that directly interact with the patient's body (physiological monitoring, ventilation, infusion pumps, fluid warming, oxygen delivery).
- No Mention of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. The monitoring functions are performed on the patient.
Therefore, the LSTAT G6 Lite is a therapeutic and monitoring medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Life Support for Trauma and Transport (I.STAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The G6 Lite may be operated using either battery power or an external power source. The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilitics.
Product codes (comma separated list FDA assigned to the subject device)
DRT, CBK, FRN, MWI
Device Description
The Integrated Medical Systems LSTAT G6 Lite is a portable intensive care unit (ICU) for adult and pediatric patients. The LSTAT G6 Lite combines the medical device capabilities of a physiological monitor, a ventilator, and infusion pumps into a single platform with a central display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilitics.
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)
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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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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a logo with a medical symbol on the left and the letters "IMS" in bold, sans-serif font on the right. The medical symbol appears to be a caduceus, featuring a staff with two snakes coiled around it. The letters "IMS" are large and prominent, suggesting they are the primary identifier of the brand or organization represented by the logo. The image quality is somewhat degraded, with some pixelation and artifacts visible.
2 6 2008
Integrated Medical Systems, Inc. 1984 Obispo Avenue Signal Hill, CA 90755
510(k) SUMMARY
The following summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. All data included in this document and are accurate and complete to the best of Integrated Medical System's knowledge.
| Applicant: | Integrated Medical Systems, Inc.
1984 Obispo Avenue
Signal Hill, CA 90755
(562) 498-1776 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Renate A. MacLaren, Ph.D.
Director, Regulatory Affairs |
| Date: | August 5, 2008 |
| Device Identification: | Common Name:
Intensive Care Unit (ICU) Platform
Physiological Monitor
Ventilator
Infusion Pumps |
| Trade Name: | Life Support for Trauma and Transport (LSTAT) G6 Lite |
| Classification Name(s): | Cardiac Monitor (21 CFR 870.2300, Product Code DRT)
Continuous Ventilator (21 CFR 858.5895, Product Code CBK)
Infusion Pump (21 CFR 880.5725, Product Code FRN) |
The Integrated Medical Systems LSTAT G6 Lite is Substantial Equivalence: substantially equivalent to the Integrated Medical Systems LSTAT 9602 (K965117) since the basic features, design and intended uses are the same or similar. The differences in design, dimensions, and features between the LSTAT G6 Lite and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function, or intended use of the device.
The Integrated Medical Systems LSTAT G6 Lite is a portable intensive Device Description: care unit (ICU) for adult and pediatric patients. The LSTAT G6 Lite combines the medical device capabilities of a physiological monitor, a ventilator, and infusion pumps into a single platform with a central display.
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
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Image /page/1/Picture/0 description: The image shows the logo for IMS, which is a medical services company. To the left of the letters "IMS" is a medical symbol. The medical symbol is a staff with a snake wrapped around it.
Intended Use: The LSTAT G6 Lite is a portable unit intended to supply ICU functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The LSTAT G6 Lite may be operated using either batteries or an external power source. The LSTAT G6 Lite is intended for use in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
Renate A. MacLaren, Ph.D.
Director, Regulatory Affairs
Signed:
082256 72/2
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP 2 6 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integrated Medical Systems, Inc. c/o Renate A. MacLaren, Ph.D. Director, Regulatory Affairs 1984 Obispo Avenue Signal Hill, Ca 90755
Re: K082256
Trade/Device Name: Life Support for Trauma and Transport (LSTAT) G6 Lite Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: August 5, 2008 Reccived: August 8, 2008
Dear Dr. MacLaren:
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 such additional controls. Existing major regulations afficcting 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
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Page 2 - Renate A. MacLaren, Ph.D.
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows a logo with the word "WIMS" in a stylized font. The letters are bold and slightly distorted, giving them a textured appearance. The background is a grid-like pattern, which adds to the overall visual complexity of the logo. The logo is in black and white.
Integrated Medical Systems, Inc. 1984 Obispo Avenue Signal Hill, CA 90755
Indications for Use
510(k) Number (if known):
Life Support for Trauma and Transport (LSTAT) G6 Lite Device Name:
Indications for Use:
The Life Support for Trauma and Transport (I.STAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The G6 Lite may be operated using either battery power or an external power source. The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilitics.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-the-Counter Use (21 CFR 801 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 | K082256 |
|---|---|
| --------------- | --------- |