K Number
K171651
Device Name
EXCELSIUS GPS
Date Cleared
2017-08-16

(72 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
Device Description
The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system. EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.
More Information

StealthStation (K133444), ROSA Spine (K151511)

CREO® (K143633), REVERE® (K133350), REVOLVE® (K111449), QUARTEX™ (K161591), ELLIPSE® (K123783), SI-LOK® (K112028), CAPTIVATE™ (K162825)

No
The summary describes a robotic positioning and navigation system based on image registration and optical tracking, without mentioning AI or ML.

No.
Explanation: The device is intended as an aid for navigation and guidance during surgical procedures, not for treating a condition or disease directly.

No.

The device is described as a "Robotic Positioning System" and is intended as an "aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments." It assists in surgical procedures by providing navigation and guidance based on imaging, rather than diagnosing a condition or disease.

No

The device description explicitly states that the EXCELSIUS GPS™ includes a computer controlled robotic arm, hardware, and software, indicating it is a system with both hardware and software components, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures." This describes a surgical navigation and guidance system used during a surgical procedure on a patient.
  • Device Description: The description details a "Robotic Positioning System" that uses radiological images and optical tracking to assist surgeons in real-time during surgery. It involves a robotic arm, instruments, and software for navigation and guidance.
  • Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are designed for testing biological samples in a laboratory or clinical setting.

The EXCELSIUS GPS™ is a surgical navigation and robotic guidance system, which falls under the category of medical devices used for surgical procedures, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Product codes (comma separated list FDA assigned to the subject device)

OLO

Device Description

The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system.

EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT scans or fluoroscopy

Anatomical Site

Spinal and orthopedic bone screws

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeons in open or percutaneous procedures.

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)

Verification and validation testing was conducted on EXCELSIUS GPS™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:

  • . Non-clinical system, software, and instrument verification and validation
  • Surgical simulations conducted on phantom models ●
  • Human cadaveric quantitative validation under clinically relevant scenarios ●
  • Compliance conformity assessments per: ●
    • o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
    • IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General o
      Requirements for Basic Safety and Essential Performance -Collateral Standard Electromagnetic Compatibility, 2007
  • o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General
  • o Requirements for Basic Safety and Essential Performance Usability

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.

StealthStation (K133444), ROSA Spine (K151511)

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.

CREO® (K143633), REVERE® (K133350), REVOLVE® (K111449), QUARTEX™ (K161591), ELLIPSE® (K123783), SI-LOK® (K112028), CAPTIVATE™ (K162825)

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

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

0

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2017

Image /page/0/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design element resembling an abstract wing or feather above them.

Globus Medical Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K171651

Trade/Device Name: EXCELSIUS GPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2017 Received: August 1, 2017

Dear Dr. Kelly J. Baker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

1

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171651

Device Name EXCELSIUS GPSTM

Indications for Use (Describe)

The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary: EXCELSIUS GPS™

  • Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
  • Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
  • June 1, 2017 Date Prepared:
  • EXCELSIUS GPS™ Device Name:
  • Common Name: Computer-assisted surgical device
  • Per 21 CFR as follows: Classification: §882.4560 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II
  • EXCELSIUS GPS™ Predicates: Primary predicate: StealthStation (K133444) Additional predicate: ROSA Spine (K151511)

EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825)

Purpose:

The purpose of this submission is to request clearance of EXCELSIUS GPS™ and EXCELSIUS GPSTM Instruments.

Device Description:

The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and quidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's

4

anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system.

EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.

Indications for Use:

The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Technological Characteristics:

The EXCELSIUS GPS™ and EXCELSIUS GPS™ Instruments have similar technological characteristics to the predicate devices including the main system

5

components, workflow, user interface, software features, and design. The EXCELSIUS GPS™ System is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation. The table below provides a comparison of technological characteristics and principles of operation for the subject EXCELSIUS GPS™ and the predicate devices.

| Device | Subject
EXCELSIUS™ GPS | Predicate
StealthStation
(K133444) | Predicate
ROSA Spine
(K151511) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Principle of
operation | - Intraoperative/
preoperative images

  • Patient registration
  • Surgical planning
  • Real-time tracking of
    navigated instruments
  • Guidance of instruments | - Intraoperative/
    preoperative images
  • Patient registration
  • Surgical planning
  • Real-time tracking of
    navigated instruments | - Intraoperative images
  • Patient registration
  • Surgical planning
  • Guidance of instruments |
    | Input images | 3D pre-operative exam
    3D intra-operative exam
    2D intra-operative exam | 3D pre-operative exam
    3D intra-operative exam
    2D intra-operative exam | 3D intra-operative exam |
    | Integrated
    planning
    software | EXCELSIUS™ GPS
    Planning and Navigation
    Application software | Synergy Spine software | Rosanna Spine (Medtech) |
    | Save/load
    planning | Yes | Yes | Yes |
    | Merge images
    functionality | Yes | Yes | Yes |
    | Trajectory
    planning
    parameters | Entry point, target point,
    instrument length/diameter | Entry point, target point,
    instrument length/diameter | Entry point, target point,
    instrument length/diameter |
    | Localization
    means | Optical system (infrared
    camera) | Optical (infrared camera)
    or electromagnetic system | Robot arm absolute
    encoders and optical
    system (infrared camera) |
    | Image-guided | Yes | Yes | Yes |
    | Controller | Force-controlled
    movement allowing
    robotic arm positioning | No controller; instruments
    are manually positioned
    by the surgeon. | Axis controller per joint
    Kinematic transformation
    Supervisor module |
    | Patient
    registration
    method | Intra-op CT: Registration
    fixture
    Pre-op CT: Fluoroscopic
    to pre-op CT merge
    Fluoroscopy: Registration
    fixture | Point-to-point registration
    with anatomical markers
    Intra-op CT: Calibrated CT
    gantry to camera merge
    Pre-op CT: Point merge
    Fluoroscopy: Registration
    fixture | 3D registration with X-Ray
    pattern containing
    radiopaque
    markers |
    | Accuracy
    verification on
    anatomical
    landmarks | Yes (probe) | Yes (probe) | Yes (probe) |
    | Real time
    display of
    instrument
    position | Yes | Yes | Yes |
    | Device | Subject
    EXCELSIUS™ GPS | Predicate
    StealthStation
    (K133444) | Predicate
    ROSA Spine
    (K151511) |
    | Provide guide
    for
    instruments | Yes, instruments are used
    through the guide tube on
    the robotic arm or are
    manually positioned by the
    surgeon. | No, instruments are
    manually positioned by the
    surgeon. | Yes, instruments are
    mounted onto the robotic
    arm. |
    | Patient
    fixation | Reference is fixed to
    patient's bony structure
    such as a long bone, iliac
    crest, spinous process,
    vertebra, etc. for tracking
    system | Reference is fixed to the
    patient's iliac crest or
    clamped on the spinous
    for tracking system | Reference is fixed to the
    patient's iliac crest for
    tracking system |

Comparison of Principles of Operation and Technological Characteristics

6

Performance Testing:

Verification and validation testing was conducted on EXCELSIUS GPS™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:

  • . Non-clinical system, software, and instrument verification and validation
  • Surgical simulations conducted on phantom models ●
  • Human cadaveric quantitative validation under clinically relevant scenarios ●
  • Compliance conformity assessments per: ●
    • o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
    • IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General o

Requirements for Basic Safety and Essential Performance -Collateral Standard Electromagnetic Compatibility, 2007

  • o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General
  • o Requirements for Basic Safety and Essential Performance Usability

Biocompatibility:

The biocompatibility evaluation for EXCELSIUS GPS™ has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing", May 1, 1995 and FDA Guidance "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," June 16, 2016. The evaluation confirms that EXCELSIUS GPS meets biocompatibility requirements.

Electrical Safety and Electromagnetic Compatibility:

Testing was performed to assure compliance with recognized safety standards: IEC 60601-1:2012 standard for electrical safety and IEC 60601-1-2:2014 standard for electromagnetic compatibility.

Software Verification and Validation Testing:

Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained

7

in Medical Devices (May 11, 2005) and IEC 62304:2006-05 Medical Device Software - Software life cycle processes. The software for this device is considered a "MAJOR" level of concern.

Basis of Substantial Equivalence:

EXCELSIUS GPS™ has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.