The Life Support for Trauma and Transport (LSTAT) is a portable system to provide in a single platform, Intensive Care Unit (ICU) functionality for adult patients. Its use is to provide physiological monitoring, upper airway or gastrointestinal drainage suction, automated external defibrillation, IV fluid and drug administration, ventilation and oxygen delivery for use in hospitals, aircraft, ambulances, field hospitals and extended care facilities. It is for use on any adult patient weighing more than 90 pounds. Operating power is applied to unconscious, pulseless and apneic patients from internal rechargeable batteries.

The LSTAT Model 9601 is used to support resuscitation, stabilization, and transport of adult trauma victims or patients needing physiological monitoring and treatment capabilities of a hospital intensive care unit or trauma care unit for pre-operative, intraoperative, and post operative support during pre, intra, and post-transport phases.

The indications for use of selected subsystems/capabilities are dictated by medical protocol, but in general LSTAT use may be anticipated for victims of: combat/civilian casualty, trauma, respiratory distress, pneumothorax, severe fluid loss, cardiac emergency, or unstable clinical presentation.

Device Description

The LSTAT Model 9601 is a portable individualization intensive care unit that incorporates resuscitative and life-sustaining medical devices within a single composite structure assembly.

Physically, the LSTAT Model 9601 is a highly instrumented patient transport platform (interfaced to a NATO litter) with medical devices incorporated within its composite structure assembly. Figure 16-2 shows the appearance of the LSTAT assembly whose unique outer moldline and low profile are defined for military transport compatibility (height = 13.2 inches, length = 86.8 inches, and width = 23.0 inches without patient). Device interfaces are colocated to favor awareness and controls in the "anestheologist position" during intra-operative procedures.

The LSTAT incorporates six portable patient monitoring/treatment subsystems/ capabilities and five utilities/support subsystems as identified below.

The LSTAT Medical Subsystems include:

Physiological Monitoring
a. ECG
b. NIBP
c. Invasive Blood Pressure (BP) (two channels)
d. Temperature
Blood Chemistry Assessment (in vitro)
Suction
Automated External Defibrillator (AED)
IV Fluid Administration (and IV drugs)
Ventilator
a. On-board compressor (for medical air only)
b. Oxygen-air blending
c. Patient ventilation (controllable: mandatory or assist)
d. Ventilation assessment: airway pressure, airway pCO2 and EtCO2, airway flow and tidal volume, and oxygen saturation (pulse oximeter)

The LSTAT Utilities/Support Subsystems include:
7. Structure (including NATO litter)
8. Oxygen
9. Electrical Power
10. Environmental Control Subsystem (ECS)
11. Data Logging and Display Subsystem (DDLS) including a secondary display

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Northrop Grumman Life Support for Trauma and Transport (LSTAT) device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly present a table of numerical acceptance criteria or reported device performance metrics in the format typically seen for algorithm-based devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on the LSTAT's ability to integrate existing, FDA-cleared medical devices and provide a functional ICU platform in severe environments.

The overarching "acceptance criteria" can be inferred as:

Maintaining the safety and efficacy of integrated medical devices.
Providing necessary utilities and support for their operation.
Withstanding severe military/transport environments (vibration, shock, thermal, altitude, EMI/EMS).
Performing continuous data logging and display.
Ensuring structural integrity and patient/component support.
Providing oxygen and power management.

The "device performance" is described through the successful integration of these systems and the extensive testing program designed to validate these aspects.

Acceptance Criterion (Inferred from text)	Reported Device Performance/Study Findings
Integration of existing legally marketed medical devices (without compromising functionality, capability, controls, interfaces).	Explicitly stated as a core design principle. "The LSTAT integration design has not changed any of the supplier's circuitry or patient/operator interfaces."
Provision of utilities and support (power, oxygen, environmental control) meeting device requirements.	"Provision of utilities and support which meet the requirements of each device's operation." Centralized power system supports all devices, provides uninterruptible backup, and stand-alone operation (at least 30 minutes). Compressed and regulated oxygen provided. Environmental control (cooling, temperature, EMI/EMS protection) accommodated.
Continuous data logging and display (patient data, system/device data, alarms, waveforms) for post-treatment analysis and redundant messaging.	"Continuous logging of both patient data and system/device data and alarms for redundant messaging of alarms and for support of post-treatment analysis of any event or observation (24 hours operations before down-load required with continued monitoring during down-load)." A secondary display (portable computer) provides real-time data/alarms at any location.
Aerospace designs for structure, severe environment operations, and airworthiness qualifications.	"Aerospace designs for structure, severe environment operations, and airworthiness qualifications." The structure is lightweight composite, accommodates NATO litter, and designed to accommodate vibration, shock, and rugged environments. Monitoring of tilt, acceleration, humidity, ambient temperature, and altitude. Comprehensive test program includes stress characterization (vibration, shock, thermal, altitude), component/system EMI/EMS. Several incorporated devices have undergone airworthiness qualification testing at USAARL. "The design to operating temperature ranges for many pieces of equipment and parts are -26°C to +49°C."
Safe Design: No created or impacted hazards.	"Aerospace qualified safety engineers provide analysis and acceptance validation...Supplier hazard analyses were included to ensure no modification created or impacted existing device hazard mitigation, and NGC hazard analysis and mitigation assured that no NGC design or implementation produced unacceptable patient or operator hazard."

Study Information

The document describes a comprehensive test program rather than a single, specific clinical study with a defined test set and ground truth in the traditional sense for diagnostic/AI devices. The LSTAT is an integrated system of existing medical devices, and its validation focuses on the system's ability to perform as intended in challenging environments while maintaining the functionality of its components.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "LSTAT #1, LSTAT #2, LSTAT #3, and LSTAT #4" as "completed items ready for government tests" (Figure 16-6). This suggests at least four physical units were part of the final system-level validation. However, the testing also involved individual components and 'brassboard' assemblies before these final units. The specific "data provenance" in terms of patient data is not detailed as this is primarily an engineering and integration validation, rather than a clinical efficacy trial on a patient cohort for a new diagnostic. The test program involves "in vitro subsystem acceptance testing," "stress characterization," "EMI/EMS," "manufacturing acceptance tests," and "usability tests." The document states "U.S. Government Laboratories (WRAIR, USAARL, and Brooks AFB) are participating with Northrop Grumman engineers/technicians in the validation/verification of safety and efficacy." This implies some prospective testing in a controlled environment.
- Data Provenance: United States (U.S. Government Laboratories involved). The testing appears to be prospective in terms of verifying the integrated system's performance and robustness.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The concept of "experts establishing ground truth" for clinical outcomes is not explicitly described in the context of this device, as it is an integration platform. However, the evaluation involved:
  - "Aerospace qualified safety engineers" for hazard analysis and validation of modification designs.
  - "Northrop Grumman engineers/technicians" and "U.S. Government Laboratories (WRAIR, USAARL, and Brooks AFB) personnel" for validation/verification of safety and efficacy.
- The qualifications mentioned are "aerospace qualified safety engineers" and implicitly, the expertise within the U.S. Government Laboratories (Walter Reed Army Institute of Research, U.S. Army Aeromedical Research Laboratory, and Brooks Air Force Base) which would include medical and engineering specialists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the typical sense for a diagnostic device. The validation process appears to be a collaborative effort between Northrop Grumman and government laboratories, implying a consensus-driven approach based on established engineering and medical device testing standards.
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
- No, an MRMC comparative effectiveness study was not done. The LSTAT is a portable ICU platform, not an AI-assisted diagnostic or imaging interpretation device. There is no mention of AI or "human readers" in the context of improving performance with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The LSTAT is a medical device system, not an algorithm. Its operation inherently involves human operators. The emphasis is on how the integrated system supports human medical professionals in delivering care.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device relates to engineering specifications, regulatory compliance, and functional performance objectives under specified environmental conditions, rather than a clinical diagnostic ground truth. This includes:
  - Compliance with supplier's directions for in vitro subsystem acceptance.
  - Meeting stress characterization parameters (vibration, shock, thermal, altitude).
  - Meeting EMI/EMS standards.
  - Verification against hazard analyses.
  - Airworthiness qualifications.
- The "safety and efficacy" of the system as a whole are "asserted by the U.S. Government and tracked with analysis of the extensive data logging capability of each device." This suggests an ongoing monitoring and verification process as part of real-world use.
The sample size for the training set
- Not applicable. The LSTAT is an integrated hardware system, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established
- Not applicable as there is no "training set" for this device.

Summary

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K965117

NORTHROP GRUMMAN

Advanced Technology and Development Center Northrop Grumman Corporation 8900 East Washington Boulevard Pico Rivera, California 90660-0158 Telechone 310 946-9161

SECTION 16 FDA 510(k) SUMMARY

Submitted By

Company:

Northrop Grumman Corporation (NGC) Advanced Technology and Development Center (ATDC) N560/XA 8900 E. Washington Blvd. Pico Rivera, CA 90660

Contact Person:

Louis S. Toth LSTAT Project Engineer (310) 948-6482 (voice) (310) 948-9485 (FAX)

Date:

December 17, 1996

Name of the Device

Life Support for Trauma and Transport (LSTAT) Trade Name: Model 9601

Intensive Care Unit (ICU) Platform Common Name: Portable, Individualized ICU Trauma Pod Medical Evacuation Platform
Classification Name: (This Integrated System Category is Not Listed in 21 CFR Parts 862-892.)

Device Description

The LSTAT Model 9601 is a portable individualization intensive care unit that incorporates resuscitative and life-sustaining medical devices within a single composite structure assembly.

The LSTAT functionality is shown in Figure 16-1 as a well equipped ICU bed.

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Image /page/1/Figure/0 description: This image shows a diagram of a portable intensive care unit (ICU). The diagram lists the functions and features of the ICU, including its ability to provide medical grade air and oxygen, integrate medical devices, and incorporate extensive physiological measurements. The ICU is also packaged for transport, has integrated data logging and communication capabilities, and is compatible with military evacuation vehicles. The diagram also shows the various components of the ICU, such as a ventilator, physiological monitors, a defibrillator, and equipment for IV drug administration.

Figure 16-1. LSTAT Model 9601: General ICU Functionality

The LSTAT incorporates six portable patient monitoring/treatment subsystems/ capabilities and five utilities/support subsystems as identified below.

The LSTAT Medical Subsystems include:

1. Physiological Monitoring
- a. ECG
- b. NIBP
- c. Invasive Blood Pressure (BP) (two channels)
- d. Temperature

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Image /page/2/Picture/0 description: The image shows a flatbed truck with a headboard. The flatbed is long and rectangular, and the headboard is located at the front of the bed. The image also contains the number 96-091-037 in the bottom right corner. The truck appears to be in a well-lit environment.

Image /page/2/Figure/1 description: This image is a figure that shows the LSTAT ICU Platform Model 9601. The figure is labeled as Figure 16-2. The text is in bold font and is centered on the page. The text is black and the background is white.

1. Blood Chemistry Assessment (in vitro)
1. Suction
1. Automated External Defibrillator (AED)
1. IV Fluid Administration (and IV drugs)
1. Ventilator
- On-board compressor (for medical air only) a.
- Oxygen-air blending b.
- Patient ventilation (controllable: mandatory or assist) C.
- Ventilation assessment: airway pressure, airway pCO2 and EtCO2, airway d.
- flow and tidal volume, and oxygen saturation (pulse oximeter)

The LSTAT Utilities/Support Subsystems include:

1. Structure (including NATO litter)
1. Oxygen
1. Electrical Power
1. Environmental Control Subsystem (ECS)
1. Data Logging and Display Subsystem (DDLS) including a secondary display

Figure 16-3 illustrates the anesthesiologist's intra-operative position. Figure 16-4 illustrates the operator-patient interface panel where most of the patient connections to the LSTAT are made.

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Image /page/3/Picture/0 description: The image shows a close-up of three electronic devices. The device on the left is a handheld device with a screen and several buttons. The other two devices are mounted on a panel, and they also have screens. The text "96-091-010" is visible in the bottom right corner of the image.

Figure 16-3. Anesthesiologists Intra-Operative Position (Control and Display Cockpit)

Image /page/3/Picture/2 description: The image shows a piece of equipment with a control panel. The control panel has several gauges, switches, and buttons. The equipment is sitting on a dark surface. The number 96-091-011 is printed in the bottom right corner of the image.

Figure 16-4. Operator-Patient Interface Panel (Patient Connections)

Indications for Use: Medical Applications

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Of course, the LSTAT may be used for transport of less severely injured or traumatized individuals which may not require the use of all the ICU subsystems.

Indications for Use: Transportation Applications

The LSTAT serves as a transportation platform which integrates existing medical devices and the NATO (STANAG) litter into a form-factor small enough to be loaded/carried within the constraints of military evacuation/transport vehicles like:

UH-60 Blackhawk helicopter .
UH-1 Huey helicopter .
CH-47 Chinook helicopter .
. C-9 aircraft
. C-17 aircraft
C-130 aircraft .
C-141 aircraft .
MK-II Humvee ground ambulance .
Carrier, litter wheeled, (US Army). .

Of course, other evacuation/transport vehicles (military or civilian) which do not impose the small (and customized) form factor or which are less densely loaded may also use the LSTAT.

Safety and Efficacy Discussions

The LSTAT provides for the safe transport, physiological monitoring, and treatment of trauma victims/patients without compromising efficacy by integrating FDA cleared medical devices and aerospace developed technologies for operation in severe environments.

The LSTAT is an integrated medical system whose design includes providing ICU functional capabilities, packaging devices for transport, data logging integration, and military evacuation vehicle/environment compatibility. Its safety and efficacy are based on:

1. Integration of existing legally marketed medical devices which have FDA clearance without change to their functionality, capability, controls, operator interfaces, or patient interfaces

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1. Provision of utilities and support which meet the requirements of each device's operation
1. Continuous logging of both patient data and system/device data and alarms for redundant messaging of alarms and for support of post-treatment analysis of any event or observation (24 hours operations before down-load required with continued monitoring during down-load)
1. Aerospace designs for structure, severe environment operations, and airworthiness qualifications.

Device Equivalents

The LSTAT incorporates six patient monitoring/treatment subsystems which contain medical devices which are summarized in Figure 16-5 with their FDA Class type. All devices except the ventilator are currently marketed by their respective suppliers. The ventilator is a customized, integrated subsystem developed for LSTAT. That subsystem incorporates multiple components of devices already legally marketed into its integrated design.

Subsystem	Class
Physiological Monitoring	II
Blood Chemistry	II
Suction	II
Defibrillator	III
IV and Drug Administration	II
Ventilator	II

Figure 16-5. Patient Monitoring/Treatment Subsystem

The listed devices are not just equivalent by predicate reference; they are equivalent by identity. The LSTAT integration design has not changed any of the supplier's circuitry or patient/operator interfaces. The modifications (discussed below) made to the devices have been to accommodate their integration into the low profile structure and to ensure that the devices will be operational in the severe military/transport environments.

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Device Modification Enhancements

Minor repackaging of medical devices for severe operational environments and provisions for on-board utilities are the basic modifications and enhancements for medical devices contained within the LSTAT Model 9601.

The primary modifications made to the marketed devices have been to:

1. Disassemble them
1. Assemble multiple components onto shock mounts
1. Cluster patient connections and operator controls for "cockpit-like" interface
1. Locate components to maintain low profile within the composite EMI-protected structure
1. Provide environmental control
1. Provide centralized power sources, distribution, and support for all components (without preferential supply or denial of resources)
1. Provide communications with devices for data logging, analysis, and alarms.

System Integration Enhancements

The integration approach serves to offer several enhancements as a system:

1. Power: Centralization of power utilities permits all devices to be operated from multiple auxiliary (external) power sources and permits single cabling to their respective interfaces:

115 VAC +/- 10%	60 Hz +/- 5 Hz 1 phase
230 VAC +/- 10%	50 Hz +/- 3 Hz 1 phase
108-118/200 VAC	400 Hz +/- 7 Hz any phase
25 +/- 5 VDC

and to provide un-interruptible backup power capabilities to all devices in the event of loss of auxiliary power. The rechargeable battery source also supports stand-alone operations (at least 30 minutes) during movement between locations while auxiliary power is unavailable. With the centralized subsystem, the need to manage recharge/replacement of each subsystem's batteries individually is eliminated and readiness of all devices concurrently is ensured. No software controls are used in the EPS which could provide power or operations to one

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device preferentially over another. All power switching is under operator control and hardwired/circuit logic.

1. Data Logging and Display: Continuous data logging of patient and system data/status (including all real-time patient parameter waveforms) supports post event analyses of trauma physiology and system operation (flight data recorder equivalency). A secondary display, which is a portable computer, tethered, and capable of displaying any of the subsystems-reported data/alarms via real-time, ethernet communications is provided. This display permits the patient (or system) status to be presented at any location around the LSTAT structure thereby permitting the operator (or observer) to receive information even if the primary device display is not accessible during transport (or operative) scenarios. This secondary display could also include capability for wireless transmission of the data.
1. Environmental Control: Accommodations for equipment cooling and temperature are provided. Electromagnetic interference (EMI) protection is provided for control of emanations and electromagnetic susceptibility (EMS).
1. Structural Support: The structure provides the physical support for the patient and components within a lightweight composite housing which interfaces with the Blackhawk's carousel pan and other military evacuation vehicles identified above. The structure locks the NATO litter (which is assumed to be the way the patient is brought to the LSTAT) in place thereby eliminating the need to move the patient between platforms. The physical mounting of the internal components are designed to accommodate the vibration, shock, and rugged environments anticipated. The structure provides monitoring of tilt, acceleration, humidity, ambient temperature, and altitude and includes this information in the data logging records being generated.
1. Oxygen: Compressed and regulated oxygen (480 liters) is provided for controlled blending with ambient air to administer oxygen enriched air through the ventilator or through a mask/cannula.

Safe Design Analysis

Aerospace qualified safety engineers provide analysis and acceptance validation of the LSTAT modification designs, implementations, and hazard analyses (see Hazard Analysis in Appendix A). Supplier hazard analyses were included to ensure no modification created or impacted existing device hazard mitigation, and NGC hazard

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analysis and mitigation assured that no NGC design or implementation produced unacceptable patient or operator hazard.

Test Program

A comprehensive test program is in place to evaluate devices and total LSTAT assembly for integrated functionality (in vitro subsystem acceptance testing per suppliers directions), stress characterization (vibration, shock, thermal, and altitude), component and system EMI/EMS, manufacturing acceptance tests, usability tests, and airworthiness qualifications.

Image /page/8/Figure/3 description: The image is a flow chart that shows the process of testing and evaluating units for government use. The process starts with breadboard components labeled C #1, C #2, C #3, and C #N, which are disassembled. These components are then assembled into a brassboard, labeled LSTAT BB, which has installed items. The brassboard is then used to create manufacturing articles labeled LSTAT #1, LSTAT #2, LSTAT #3, and LSTAT #4, which are completed items ready for government tests.

Figure 16-6 illustrates the series and sequence of testing addressed in the Test Plan.

Figure 16-6. System Level Validation

The design to operating temperature ranges for many pieces of equipment and parts are -26°C to +49°C. Some medical displays and fluid handling capabilities may be limited at 0°C.

U.S. Government Laboratories (WRAIR, USAARL, and Brooks AFB) are participating with Northrop Grumman engineers/technicians in the validation/verification of safety and efficacy.

Several of the incorporated devices have been through airworthiness qualification testing at USAARL as separate devices: physiological monitor, suction, defibrillator, and IV infusion pump.

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Conclusion

The LSTAT integration of legally marketed medical devices into a portable, individualized, intensive care unit has maintained the safety and efficacy of the existing devices and provided utilities and support for their operations which have passed the rigors of aerospace design and development. The safety and efficacy of the LSTAT system in military and airborne and environments will be asserted by the U.S. Government and tracked with analysis of the extensive data logging capability of each device.

The above 510(k) Summary accurately reflects the information as submitted in other portions of this application.

If you have any questions, please direct them to the undersigned at (310) 948-8628 or Fax at (310) 942-3726.

Sincerely,

Axttitt

Nat F. Piscitelli, Director Business Management and Operations Northrop Grumman Corporation Advanced Technology and Development Center

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Louis S. Toth, Ph.D. Northrop Grumman Corporation Military Aircraft Systems Division Advanced Systems and Technology Department N800/XA 8900 East Washington Boulevard Pico Rivera, CA 90660

Re: K965117 Life Support for Trauma and Transport Requlatory Class: III (three) Product Code: 74 MKJ Dated: April 24, 1998 Received: April 28, 1998

Dear Dr. Toth:

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for

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Page 2 - Louis S. Toth, Ph.D.

devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and ens action of the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993, Federal Register beginning on page 43447.

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 not 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Colloton

Thomas J. Çállahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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USE OR DUPLICATION OF NORTHROP GRUMMAN

PROPRIETARY INFORMATION IS SUBJECT TO THE RESTRICTIONS ON THE TITLE PAGE OF THIS DOCUMENT
NORTHROP GRUMMAN

510(k) Number (If known):

K965117

Device Name: Life Support for Trauma and Transport (LSTAT)

Indications for Use:

The Life Support for Trauma and Transport (LSTAT) is a portable system provide in a since The Life Support for Traditia and Transport (ECTRY) is a porce is to provide in a single Cate Unit (ICO) functionally for adult patients. "Its ass as strontestinal drainage suction, automated plationit. priysiological monitoring, upper annial or gaons, wentilation and oxygen delivery for use in hospitals, aircraft, ambulances, field hospitals and extended care facilities. Je for any of In nospitals, afferan, ambuiances, neid nospitals and oxiended our 90 pounds. Operating power applied to unconoolous pulcolose and appliaternal rechargeable batteries

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Merle Kramer

(Division Sign-Off) Division of Cardiovascular and Neurological Dev 510(k) Number

Prescription Use(Per 21 CFR 801.109)
OR
Over-The-Counter Use

Figure 2-2. Indications for Use (Optional Format)

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.