(296 days)
No
The description focuses on image-guided navigation using traditional ultrasound and positional data to build a 3D model and guide a catheter. There is no mention of AI, ML, or any learning algorithms used for image analysis, planning, or guidance. The system appears to be based on established neuronavigation principles using real-time imaging and mechanical guidance.
No
The device aids in the frontal placement of a catheter but does not directly treat a condition or restore function. It is a navigational and localization tool.
No.
The SOLOPASS® System is described as a "neuronavigational system" that provides image-guided localization and navigation to aid in catheter placement. While it uses ultrasound imaging, its primary function is to guide a medical procedure (catheter placement) rather than to diagnose a condition or disease.
No
The device description explicitly lists three main hardware subsystems: the Patient Interface Device (PID), the Ultrasound Probe, and the Workstation. The performance studies also include hardware verification and mechanical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- SOLOPASS® System Function: The SOLOPASS® System is a neuronavigational system that uses ultrasound imaging and positional data to guide the placement of a catheter within the patient's body. It is a tool for surgical guidance and localization, not for analyzing samples taken from the body.
The device's intended use, description, and the type of data it collects (intraoperative ultrasound images and positional data) all point to it being a surgical guidance and navigation system, not an IVD.
N/A
Intended Use / Indications for Use
The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.
Product codes (comma separated list FDA assigned to the subject device)
HAW, IYN
Device Description
The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.
The SOLOPASS® System consists of three main sub-systems:
- The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
- The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
- The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.
The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon or intensivists / Operating Room (OR), Patient Bedside outside of OR
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)
Nonclinical Testing Summary:
- Biocompatibility:
- Tests for in vitro cytotoxicity (ISO 10993-5): Non-cytotoxic
- Tests for irritation and skin sensitization (ISO 10993-10): Non-sensitizing, Non-irritating
- Tests for systemic toxicity (ISO 10993-11): Non-pyrogenic, Negative for acute systemic toxicity
- Bacterial endotoxins test (ANSI/AAMI ST72, USP , USP ): Pass, all samples demonstrated less than 2.15 Eu/device required for devices with cerebrospinal fluid contact
- Thermal, Electrical, Mechanical Safety:
- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1/ANSI AAMI ES 60601-1): Pass
- Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral (IEC 60601-1-2): Pass
- Particular Requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37): Pass
- Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers (AIM 7351731): Pass
- Degrees of protection provided by enclosures (IPX7) (IEC/EN 60529): Pass
- Cleaning, Disinfection, Sterilization:
- Ultrasound Probe Cleaning Validation: Pass
- Ultrasound Probe VHP Sterilization Validation: Pass, SAL 10-6
- Validation of gamma sterilization method for single-use PID (AAMI/ANSI/ISO 11137-1.11137-2): Pass, SAL 10-6
- Ship and Shelf Life Functional Test:
- Verify functional performance of device components following testing per ISTA 3A, ISO 11607-1, and shelf-life aging.
- Results: Pass, PID Shelf life: 12 months
- Verification Bench Testing:
- 2D Imaging Qualification: Verification of ultrasound requirements including imaging depth, image accuracy, active element check and other specifications.
- Results: Pass
- System Targeting Accuracy: Measure targeting accuracy. Acceptance criteria defined based on Reference Device, V-Guide for Ventriculostomies (K141559).
- Results: +/- 3mm target at 6cm
- System Imaging Accuracy: Measure imaging accuracy.
- Results: +/- 2mm target at 4cm-7cm
- Cranial Mounting Mechanical Testing: Verify performance of SOLOPASS® screw and anchor compared to Reference Device Medtronic Navigus Trajectory Guide Kit (K992304). Test methods based on ASTM F543.
- Results: Met acceptance criteria for: mean pullout strength of anchor, mean ratio of yield strength vs. insertion torque.
- Hardware Verification: Verify performance of system electrical design requirements in addition to electrical safety and EMC.
- Results: Pass
- Software Verification and Validation:
- Demonstrate that all software requirements were appropriately implemented in the software. Software development process demonstrates conformity to IEC 62304.
- Results: Pass
- Design Validation:
- Design validation study in simulated use conditions to demonstrate that SOLOPASS® final design met user needs.
- Results: Pass, user needs were successfully validated
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Targeting accuracy: +/- 3mm
- Imaging accuracy: +/- 2mm
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.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 27, 2021
inTRAvent Medical Partners, LP % Connie Qiu Regulatory Consultant M Squared Associates, Inc. 127 West 30th Street. 9th Floor New York, New York 10001
Re: K203251
Trade/Device Name: SOLOPASS System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, IYN Dated: December 3, 2020 Received: December 4, 2020
Dear Connie Qiu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203251
Device Name SOLOPASS® System
Indications for Use (Describe)
The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Sponsor: | inTRAvent Medical Partners, LP
1125 Greenwood Dr.
Hummelstown, PA 17036 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Connie Qiu
M Squared Associates, Inc.
127 West 30th Street, 9th Floor
New York, NY 10001 |
| Date Prepared: | August 27, 2021 |
| Trade Name: | SOLOPASS® System |
| Common Name: | Neurological stereotaxic instrument |
| Classification: | II |
| Product Code: | HAW, 21 CFR 882.4560, Neurological Stereotaxic Instrument
IYN, 21 CFR 892.1550, System, Imaging, Pulsed Doppler, Ultrasonic |
Predicate Devices:
Reference Devices
Description of Device:
The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.
The SOLOPASS® System consists of three main sub-systems:
-
- The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
4
-
- The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
-
- The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.
The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.
Indications for Use:
The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.
Comparison to Predicate Device:
Comparison of intended use and technological characteristics between the SOLOPASS® System to the predicate device, Sonowand Invite System (K083597, K112469), is presented in the following table. The differences between the two devices do not affect the intended use, and do not raise new questions of safety and effectiveness.
| | Subject Device | Predicate Device | Substantial Equivalence
Comparison |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SOLOPASS® System | SonoWand Invite™
K083597, K112469 | N/A |
| Product Codes | HAW, IYN | HAW, IYN | Same |
| Indications for
Use | The SOLOPASS®
System is a tool that
obtains ultrasound
images and
positional data to
provide intra-
procedural, image
guided localization
and navigation, to
aid in the frontal
placement of an
intra-ventricular
catheter. | The SonoWand
Invite™ System is
intended for use as a
tool to aid
intraoperative
ultrasound imaging
and image guided
surgery during
neurosurgery. It is
also intended for use
as a standard
neuronavigation
system and as a
stand-alone
Ultrasound scanner.
The intended use of a
localizer is to enable | Same intended use are
tools used to assist the
surgeon in planning and
guiding the placement of
instruments during
neurosurgical procedures,
such as catheter
placement, with image
guidance provided by
ultrasound or other
imaging modality.
Predicate device has
additional indications
regarding other imaging
modalities. These
differences do not raise |
| | | navigation by
showing the position
of surgical
instruments or
pointers relative to
MR, CT, or
Ultrasound images.
The general purpose
localizers with
adapters are
intended to be used
to attach surgical
tools manufactured
by other vendors.
SonoWand Invite™
System will display
position and
orientation of the
tools in the medical
images on the
screen. | new questions of safety
or effectiveness. |
| Planned Use
Environment | Operating Room
(OR), Patient
Bedside outside of
OR | Operating Room | Similar. Both devices are
intended for use in the
OR. The subject device is
designed as a mobile
workstation to allow for
use at the patient bedside
outside of the OR by
qualified clinicians. While
this adds a use
environment, the
intended use and
qualifications of the
intended users are
equivalent to those of the
predicate device.
Electrical safety and
electromagnetic
compatibility testing using
recognized test standards
support the safety of the
SOLOPASS as a mobile
system. Therefore, these. |
| | | | |
| Planned User | Surgeon or
intensivists | Surgeon | differences do not raise
new questions of safety
and effectiveness.
Similar. Typically this
procedure is performed
by HCP such as a surgeon
or intensivist. |
| Anatomic region
Use for
neurosurgical
catheter/
instrument
placement | Cranial
Yes | Cranial
Yes | Same
Same |
| Main System
Components | Ultrasound Imaging
System;
Skull mounted
mechanical module;
Software Module
for trajectory
planning;
Workstation/
Display;
Cart. | Ultrasound Imaging
System;
Not skull mounted
(Localizer and
Navigation Trackers
on probe);
Radiographic fiducial
markers;
Software module for
instrument tracking;
Workstation/ Display;
Cart. | Similar. Both devices
utilize an ultrasound
imaging system with
custom software module
to aid in instrument (e.g.
catheter) placement, and
consist of a workstation
with display on a cart. The
subject device offers the
benefit of intraoperative
ultrasound images
updated in real-time to
facilitate trajectory
planning and potentially
reduce risks associated
with targeting. There are
differences in how each
system helps track/guide
placement of the
instruments. Verification
testing demonstrates that
the subject device fulfills
its design inputs including
comparable accuracy to
the predicate device. The
differences between the
main system components
do not raise new
questions of safety and
effectiveness. |
| | | | |
| Image guidance | Ultrasound
Intra-op 2D imaging
data with
simultaneously
captured location
data is used to build
3D model of
anatomy | CT: Pre-op
MRI: Pre-op
Ultrasound: Intra-op
(Intra-op MRI only
available if MRI
surgical suite
available)
Provides 2D and 3D
imaging. | Both devices provide
intra-op ultrasound
imaging, and provide 2D
and 3D imaging. The
predicate device offers
additional imaging
modalities not offered by
the subject device. This
difference does not raise
new questions of safety
and effectiveness. |
| Trajectory guide
function | Yes | Yes | Same |
| Patient fixation | Skull-mounted
frame (Patient
Interface Device,
PID) serves as
reference for
instruments and
catheters | No patient fixation
component.
Disposable
radiographic markers
are placed on or near
craniotomy site. | Different. While the
subject device includes a
component that is fixed
to the patient to guide
placement of the
ultrasound probe and
instruments/ catheters,
the predicate device does
not have a patient
fixation component. The
two devices' designs
utilize different methods
of determining the
patient's position for
acquiring imaging and
reference points. Bench
testing of the SOLOPASS® .
System verifies the PID
design and performance
to fulfill its intended use.
These differences do not
raise new questions of
safety and effectiveness. |
| Manually
operated | Yes | Yes | Same |
| Instrument/
Catheter
compatibility | Catheters with
3.4mm or 2.8mm
outer diameter | Does not specify
limitation in
instrument and/or
catheter size
compatibility | Different. The subject
device specifies
compatibility of
instrument/ catheter sizes
based on the design of |
| | | | |
| | | | the fixation component
that limits the size of
these devices. The
predicate device does not
have a similar component
that would restrict the
size of compatible
instruments/ catheters.
This difference does not
impact the shared
intended use and
fundamental technology
comparison between the
subject and predicate
devices. Performance
testing verifies the
compatible device sizes
for the SOLOPASS®.
Therefore, these
differences do not raise
new questions of safety
and effectiveness. |
| Localization
method | Encoders on Patient
Interface Device to
track motion of
instruments/
catheters | Localizers with
adapters that attach
to instruments to
track position.
Adhesive
radiographic markers
placed near
craniotomy site. | Similar. Both devices
include components
designed to track position
of instruments/ catheters
to aid in their placement
to the surgical site during
procedures. The
differences between the
localization methods do
not raise new questions
of safety and
effectiveness. |
| Transducer Type | Phased array probe | Linear array probe,
phased array probe | Same. Both systems offer
phased array probes. The
predicate device provides
an additional linear array
probe. |
| Transducer
Frequency | 5 MHz
1 transducer | 5-10 MHz
Multiple transducers
available | Similar. 5 MHz transducer
frequency is offered in
both systems. Predicate
device provides additional |
| | | | transducers with
additional frequencies.
These differences do not
raise new questions of
safety and effectiveness. |
| Transducer Style | "Burr-hole" style
(craniotomy) | "Burr-hole" style
(craniotomy) | Same |
| Acoustic Output
Display & FDA
Limits | Track 3 | Unknown | The subject device met
acoustic output testing
acceptance criteria and
FDA guidelines. Any
differences in acoustic
output display are not
expected to raise new
questions of safety and
effectiveness. |
| Imaging Mode | B Mode | B Mode | Same |
| General Safety
and
Effectiveness
Information | 1. Total Image
Depth 0-10 cm
-
Optimal Image
Range 2.5 – 8
cm | 1. Total Image
Depth 0-9cm -
Optimal Image
Range 0-5 cm | Similar. Based on
information about the
predicate device available
for comparison, both
systems have similar
parameters with some
differences in range.
Electrical safety, EMC,
acoustic output,
verification, and
validation testing support
the performance of the
subject device, that these
differences do not raise
new questions of safety
or effectiveness. |
| Accuracy | Targeting accuracy:
+/- 3mm
Imaging accuracy:
+/- 2mm | Imaging accuracy:
$±2mm1$ | Similar. The subject and
predicate devices
demonstrate similar
imaging accuracy.
SOLOPASS® has |
| User Interfaces | Graphical touch
screen, Foot switch | Graphical touch
screen, Foot switch | additionally been verified
for targeting accuracy to
aid the surgeon in placing
instruments/ catheters.
This does not raise new
questions of safety and
effectiveness. |
| Electrical Safety | Conformity to
IEC 60601-1
IEC 60601-1-2 | Conformity to
IEC 60601-1
IEC 60601-1-2 | Same |
| Biocompatibility
Patient
Contacting
Components | Conformity to ISO
10993-1
Limited contact (1 Lindseth, Frank et al. "Accuracy evaluation of a 3D ultrasound-based neuronavigation system." Computer aided surgery : official journal of the International Society for Computer Aided Surgery vol. 7,4 (2002): 197-222. doi:10.1002/igs.10046
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11
Nonclinical Testing Summary:
The following performance data are provided in support of the substantial equivalence determination between the proposed device, SOLOPASS® System, and the predicate device, Sonowand Invite System (K083597, K112469).
| Table 1 Summary of Non-Clinical Performance Data | ||
|---|---|---|
| -- | -- | -------------------------------------------------- |
| TEST | TITLE/TEST METHOD SUMMARY | RESULTS |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5 | Biological evaluation of medical devices – | |
| Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | |
| ISO 10993-10 | Biological evaluation of medical devices – | |
| Part 10: Tests for irritation and skin | ||
| sensitization | Non-sensitizing | |
| Non-irritating | ||
| ISO 10993-11 | Biological evaluation of medical devices – | |
| Part 11: Tests for systemic toxicity | Non-pyrogenic | |
| Negative for acute systemic | ||
| toxicity | ||
| ANSI/AAMI ST72, | ||
| USP , USP |
| Bacterial endotoxins test | Pass, all samples demonstrated
less than 2.15 Eu/device
required for devices with
cerebrospinal fluid contact |
| Thermal, Electrical, Mechanical Safety | | |
| IEC 60601-1/
ANSI AAM ES
60601-1 | Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance | Pass |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral | Pass |
| IEC 60601-2-37 | Particular Requirements for the safety of
ultrasonic medical diagnostic and monitoring
equipment. | Pass |
| AIM 7351731 | Medical Electrical Equipment and System
Electromagnetic Immunity Test for Exposure
to Radio Frequency Identification Readers | Pass |
| IEC/EN 60529 | Degrees of protection provided by
enclosures (IPX7) | Pass |
| Cleaning, Disinfection, Sterilization | | |
| Ultrasound Probe
Cleaning Validation | Validation of cleaning and disinfection
method for reusable ultrasound probes. | Pass |
| Ultrasound Probe
VHP Sterilization
Validation | Validation of VHP sterilization method for
reusable ultrasound probes. | Pass, SAL 10-6 |
| AAMI/ANSI/ISO
11137-1.11137-2 | Validation of gamma sterilization method for
single-use PID. | Pass, SAL 10-6 |
| Ship and Shelf Life
Functional Test | Verify functional performance of device
components following testing per ISTA 3A,
ISO 11607-1, and shelf-life aging. | Pass
PID Shelf life: 12 months |
| Verification Bench Testing | | |
| 2D Imaging
Qualification | Verification of ultrasound requirements
including imaging depth, image accuracy,
active element check and other
specifications. | Pass |
| System Targeting
Accuracy | Measure targeting accuracy. Acceptance
criteria defined based on Reference Device,
V-Guide for Ventriculostomies (K141559). | +/- 3mm target at 6cm |
| System Imaging
Accuracy | Measure imaging accuracy. | +/- 2mm target at 4cm-7cm |
| Cranial Mounting
Mechanical Testing | Verify performance of SOLOPASS® screw and
anchor compared to Reference Device
Medtronic Navigus Trajectory Guide Kit
(K992304). Test methods based on ASTM
F543. | Met acceptance criteria for:
mean pullout strength of
anchor, mean ratio of yield
strength vs. insertion torque. |
| Hardware
Verification | Verify performance of system electrical
design requirements in addition to electrical
safety and EMC. | Pass |
| Software Verification and Validation | | |
| Software
Verification and
Validation | Demonstrate that all software requirements
were appropriately implemented in the
software. Software development process
demonstrates conformity to IEC 62304. | Pass |
| Design Validation | | |
| Design validation
study | Validation study in simulated use conditions
to demonstrate that SOLOPASS® final design
met user needs. | Pass, user needs were
successfully validated |
12
Conclusions:
In summary, the SOLOPASS® System and predicate device, Sonowand Invite System (K083597, K112469), are substantially equivalent with respect to intended use. Non-clinical testing results support that the subject and predicate devices are substantially equivalent in function for use as neuro-navigation systems with intraoperative ultrasound imaging. The differences between the two devices do not raise new questions of safety and effectiveness.