(49 days)
The Life Support for Trauma and Transport (LSTAT) 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 facilities.
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.
The provided text is a 510(k) summary for the Integrated Medical Systems LSTAT G6 Lite. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document, as it is not a performance study report.
Here's what can be inferred or explicitly stated based on the document's content:
-
A table of acceptance criteria and the reported device performance:
- Information not provided. The document states that "The Integrated Medical Systems LSTAT G6 Lite is substantially equivalent to the Integrated Medical Systems LSTAT 9602 (K965117) since the basic features, design and intended uses are the same or similar." It also says, "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." This implies that the device is expected to meet the same performance standards as its predicate, but specific acceptance criteria (e.g., accuracy, precision, response time for physiological parameters) and detailed performance results are not presented in this summary.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not provided. This summary does not describe a performance study with a test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Information not provided. This summary does not describe a performance study with expert ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not provided. This summary does not describe a performance study with a test set.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The LSTAT G6 Lite is a portable intensive care unit combining physiological monitoring, ventilator, and infusion pump capabilities. It is not an AI-assisted diagnostic device, and therefore an MRMC study with human readers improving with AI assistance is not relevant to its type of submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As the LSTAT G6 Lite is a medical device incorporating multiple functions (monitoring, ventilation, infusion), the concept of "standalone algorithm performance" as typically applied to diagnostic AI is not relevant. Its performance would be evaluated as an integrated system, and the submission relies on substantial equivalence.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information not provided. This summary does not describe a performance study that would establish ground truth in this manner. The "ground truth" for this submission is implicitly the established safety and effectiveness of its predicate device, K965117.
-
The sample size for the training set:
- Information not provided. This summary does not describe the development or training of an algorithm.
-
How the ground truth for the training set was established:
- Information not provided. This summary does not describe the development or training of an algorithm.
In summary, the provided document is a 510(k) summary declaring substantial equivalence for a physical medical device, not a report detailing a clinical performance study with acceptance criteria for an AI or diagnostic algorithm.
{0}------------------------------------------------
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 AvenueSignal 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) PlatformPhysiological MonitorVentilatorInfusion 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
{1}------------------------------------------------
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
{3}------------------------------------------------
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
{4}------------------------------------------------
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 |
|---|---|
| --------------- | --------- |
§ 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).