(225 days)
Not Found
No
The summary describes needle tip tracking software and image processing, but there is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on bench testing, cadaver testing, and usability, without any indication of training or testing AI/ML models.
Yes.
The device is used to assist physicians in performing regional anesthesia and pain therapy by guiding the injection of local anesthesia or analgesic to target peripheral nerves, which aligns with the definition of a therapeutic device.
No
The device is intended for guiding procedures (regional anesthesia and pain therapy) by tracking a needle tip and performing nerve stimulation, not for diagnosing medical conditions.
No
The device description explicitly states that the system contains "a non-sterile reusable hardware with battery" in addition to the needle tip tracking software.
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 system is used to perform regional anesthesia and pain therapy by tracking a needle tip position during a procedure on a patient. This is an in vivo procedure (performed on a living organism), not an in vitro procedure (performed outside of a living organism, typically on biological samples).
- Device Description: The device components and their functions are described in the context of guiding a needle within a patient's body.
- Input Imaging Modality: Live Ultrasound is used to visualize structures within the patient's body.
- Anatomical Site: The target is peripheral nerves within the patient's body.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological samples.
N/A
Intended Use / Indications for Use
The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.
Product codes (comma separated list FDA assigned to the subject device)
BSP, IYO
Device Description
The proposed Stimuplex® Onvision® system is an add-on device to the Philips Xperius ultrasound system (K182529) that is intended to be used during peripheral nerve block (PNB) procedures. The proposed Stimuplex® Onvision® system consists of:
- a sterile, dedicated single-use Stimuplex® Onvision® needle (manufactured by B. Braun)
- Onvision system (manufactured by Philips) which contains:
- a non-sterile reusable hardware with battery,
- needle tip tracking software
- and a system cable.
The Stimuplex Onvision system is also compatible with the Stimuplex HNS 12 nerve stimulator( K070134).
Mentions image processing
Yes, "use the ultrasound transducer for image processing"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Live Ultrasound
Anatomical Site
peripheral nerves (nerves), nerve bundle, soft tissues (skin, muscle, tendon, fat etc.)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinically trained physicians, Hospitals, surgery centers, clinics: emergency room, examination room, PNB room, operating room.
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
- Bench-top testing was performed in an artificial media to validate user need specification associated with system function and system performance such as: Needletip position, Connectivity, Power indicator, Battery, Boot-up time, System cable clip, Operational, Self-test, Needle tip not shown.
- Preclinical testing on human cadaver was performed with physician (anesthesiologist) in a simulated clinical environment. The participants executed the test in the form of a system workflow to validate the intended use, user needs, and effectiveness of the safety related measure. As part of the validation, the implemented software was evaluated as part of the workflow. Results demonstrated all tests were passed.
- Usability evaluation in accordance with IEC 62366-1 was performed with anesthesiologist in a simulated use environment. Results from the usability evaluation demonstrated the proposed Stimuplex Onvision system is safe and effective for the intended use, users and use environment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing performed on Stimuplex® Onvision® system demonstrates that the device performs as intended, verifies the requirements, as well as the identified risk control measures from risk management and supports substantial equivalence of the proposed device. No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing. Bench-top testing was performed in an artificial media to validate user need specification associated with system function and system performance. Preclinical testing on human cadaver was performed with physician (anesthesiologist) in a simulated clinical environment. The participants executed the test in the form of a system workflow to validate the intended use, user needs, and effectiveness of the safety related measure. Results demonstrated all tests were passed. Usability evaluation demonstrated the proposed Stimuplex Onvision system is safe and effective for the intended use, users and use environment.
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.
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.
Not Found
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
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Philips Medical Systems Nederland B.V. Gert De Vries Senior Regulatory Affairs Manager Veenpluis 4-6 Best, 5684 PC N1
Re: K192914
Trade/Device Name: Stimuplex Onvision System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP, IYO Dated: April 24, 2020 Received: April 27, 2020
Dear Gert De Vries:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192914
Device Name Stimuplex Onvision system
Indications for Use (Describe)
The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.
| 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) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
SUBMITTER INFORMATION:
| Name: | Philips Medical Systems B.V.
Philips Image Guided Therapy – Business Incubation |
|-------------------|------------------------------------------------------------------------------------|
| Address: | Building QG-132, Veenpluis 4-6, 5684 PC Best,
The Netherlands |
| Telephone Number: | +31 (0)6 182 06 281 |
| Contact Person: | Gert de Vries, Senior Regulatory Affairs Manager |
| Telephone Number: | +31 (0)6 182 06 281 |
| Email: | gert.de.vries@philips.com |
| Date Prepared: | April 23rd, 2020 |
| CE NAME: | |
DEVIC
| Device Trade Name: | Stimuplex® Onvision® system |
|---|---|
| Common Name: | Anesthesia Conduction Needle with Ultrasonic Tip |
| Tracking System | |
| Classification Name: | Anesthesia conduction needle 21 CFR §868.5150: |
| Class II, Product code BSP and System, Imaging, | |
| Pulsed Echo, Ultrasonic 21 CFR §892.1560, Class II | |
| Product code IYO |
PREDICATE DEVICES:
- Primary predicate device: SonixGPS Nerve Block Needle Kit, Ultrasonix ● Medical Corporation (K121812)
- Additional predicate devices: ●
DEVICE DESCRIPTION:
The proposed Stimuplex® Onvision® system is an add-on device to the Philips Xperius ultrasound system (K182529) that is intended to be used during peripheral nerve block (PNB) procedures. The proposed Stimuplex® Onvision® system consists of:
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- Onvision® dedicated single-use Stimuplex® • a sterile, needle(manufactured by B. Braun)
- Onvision system (manufactured by Philips) which contains: ●
- o a non-sterile reusable hardware with battery,
- o needle tip tracking software
- o and a system cable.
The Stimuplex Onvision system is also compatible with the Stimuplex HNS 12 nerve stimulator( K070134).
INDICATIONS FOR USE:
The Stimuplex® Onvision® System is intended for clinically trained physicians to perform reqional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaving a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.
TECHNOLOGICAL CHARACTERISTICS:
The Stimuplex® Onvision® system has the same intended use as the primary predicate device of SonixGPS Nerve Block Needle kit (K121812), and an additional predicate device of Stimuplex D Plus Insulated Echogenic Needle(K100241). It also has the same intended use as another additional predicate device of PercuNav Image Fusion and Interventional Navigation (K170716) for the purpose of use during PNB procedures (nerve block and pain management). The predicate device of PercuNav has wider scope of intended use in other procedures.
Both proposed device and primary predicate device of SonixGPS needle kit:
- contain a needle to inject a single dose of anesthetic or analgesic for the ● purpose of regional anesthesia and pain management during PNB procedures
- contain a tracking technology to calculate the position of needle tip and . display the position on live ultrasound image
For the tracking technology, the proposed device and the primary predicate device and an additional predicate device of PercuNav:
- use of an external energy field [ultrasound (acoustic) vs electromagnetic] ● for tracking
- use the ultrasound transducer for image processing
- overlay/fuse image of tracked instrument / needle with live ultrasound ● image
- calculate location of the tracked instrument / needle in 3D and ● visualization in 2D ultrasound image
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- use real-time visualization of Ultrasound during interventional procedure ●
The proposed Stimuplex Onvision needle has fundamentally the same materials of composition as the additional predicate device of Stimuplex D Plus needle. and both the proposed and predicate devices are covered and insulated needles.
There is technological difference between the proposed and predicate devices. Stimuplex® Onvision® system uses ultrasound (acoustic) low energy field while SonixGPS needle and PercuNav employs electromagnetic energy field for tracking the needle. They are all using an external low energy field. The proposed Stimuplex® Onvision® System, SonixGPS needle and PercuNav calculate the positional information of tracked instrument/needle by utilizing the signal converted from external energy field, and overlay/fuse the image of tracked instrument/needle with ultrasound image.
The technological difference does not raise any new questions regarding safety and effectiveness, with the assessment performed in multiple aspects, including electrical safety, EMC evaluation, thermal effect etc.
Based on the information provided above, the Stimuplex Onvision system is considered substantially equivalent to the predicate devices, SonixGPS Nerve Block Needle Kit, PercuNav and Stimuplex D Plus needle, from a technical characteristics perspective.
| Item | Proposed Stimuplex®
Onvision® System | Primary Predicate Device
SonixGPS Nerve Block
Needle Kit (K121812) | Predicate Device
PercuNav Image Fusion
and Interventional
Navigation (K170716) | Predicate Device
B.Braun
Stimuplex® D Plus
Insulated
Echogenic Needle
(K100241) | Analysis and conclusion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Stimuplex®
Onvision® System is
intended for clinically
trained physicians to
perform regional
anesthesia and pain
therapy to target
peripheral nerves by
tracking the B.Braun
Stimuplex®
Onvision® needle tip
position by overlaying
a circle at the given
location using the
Philips Xperius®
Ultrasound and
Onvision® System.
The B. Braun
Stimuplex®
Onvision® needle is
used to inject local
anesthesia or
analgesic to the
targeted nerve bundle
to induce regional
anesthesia for surgical
procedures. The
Stimuplex® HNS 12
can also be used for
nerve stimulation
when connected to
the system cable. | The SonixGPS Nerve
Black Needle Kit is
intended for use in
regional anesthesia and
pain therapy by a trained
physician, to target
peripheral nerves by
visualization at the
needle tip using an
ultrasound imaging
device. The needle is
used to inject local
anesthesia or analgesic
to the targeted nerve
bundle to induce regional
anesthesia for surgical
procedures. | The PercuNav system is a
stereotaxic accessory for
computed tomography
(CT), magnetic resonance
(MR), ultrasound (US),
and positron emission
tomography (PET). CT, Ultrasound, PET, and MR
may be fused in various
combinations, such as CT
with MR, MR with
ultrasound, and so on. It
may include
instrumentation to display
the simulated image of a
tracked insertion tool such
as a biopsy needle or
probe on a computer
monitor screen that shows
images of the target
organs and the current
and the projected future
path of the interventional
instrument. The PercuNav
system is intended for
treatment planning and
guidance for clinical,
interventional, or
diagnostic procedures.
The PercuNav system also
supports an image-free
mode in which the
proximity of the
interventional device is
displayed relative to | The B. Braun
Stimuplex® D Plus
Insulated
Echogenic Needle
is intended for use
in regional
anesthesia and
pain therapy to
target peripheral
nerves by
transferring
electrical impulses
from a nerve
stimulator and for
visualization of an
echogenic
reflective pattern at
the needle tip using
an ultrasound
imaging device.
The needle is used
to inject a single
dose of local
anesthetic or
analgesic to the
targeted nerve
bundle for general
and orthopedic
surgery. | Both devices utilize
ultrasound and electrical
nerve stimulation for
nerve detection while
performing Peripheral
Nerve Blocks.
Both devices are used to
inject a single dose of
anesthetic or analgesic.
The proposed device is
exclusively for the Philips
Onvision system. |
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B|BRAUN | PHILIPS Prem
| narket Notification: Traditional 510(k) | |
|---|---|
| Item | Proposed Stimuplex®
Onvision® System | Primary Predicate Device
SonixGPS Nerve Block
Needle Kit (K121812) | Predicate Device
PercuNav Image Fusion
and Interventional
Navigation (K170716) | Predicate Device
B.Braun
Stimuplex® D Plus
Insulated
Echogenic Needle
(K100241) | Analysis and conclusion |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | another device. The
PercuNav system is
intended to be used in
interventional and
diagnostic procedures in a
clinical setting. The
PercuNav system is also
intended for use in clinical
interventions to determine
the proximity of one device
relative to another.
Example procedures
include, but are not limited
to, the following:
• Image fusion for
diagnostic clinical
examinations and
procedures
• Soft tissue biopsies
(liver, lung, kidney, breast,
pancreas, bladder, adrenal
glands, lymph node,
mesentery, and so on.)
• Soft tissue ablation (liver,
kidney, breast, pancreas,
lung, and so on)
• Bone ablations
• Bone biopsies
• Nerve blocks and pain
management
• Drainage placements
• Tumor resections | | |
| Intended Use | Regional anesthesia
and Pain Therapy | Regional anesthesia and
Pain Therapy | Nerve blocks and pain
management
See part of indication of
use | Regional
anesthesia and
Peripheral Nerve
Blocks | The Intended Use is the
same. However, the
Intended Use for
PercuNav is broader |
| Classification | Class II | Class II | Class II | Class II | Same |
| Product Code | BSP,IYO | BSP | IYO,LLZ | BSP | Same, combination of
the two predicates |
| Ultrasound
Visibility | Shaft identification
and needle tip
tracking in ultrasound
image when
connected to Philips
Onvision System | Shaft identification and
visualization at the
needle tip using an
ultrasound imaging
device | Shaft identification and
visualization at the needle
tip using an ultrasound
imaging device | Needle tip and
shaft identification
in an ultrasound
image | Same |
| Biocompatibility
classification | External
communicating device
bone/tissue/dentin
limited exposure | Information is not
publically
available | N/A | External
communicating
device bone/
tissue/dentin
limited exposure | Same |
| Needle tube | Stainless steel | Information is not
publically
available | see CIVCO needle
information | Needle tube:
Stainless steel | The materials of
construction of the
proposed device and the
predicate devices are
similar. |
| Needle
Dimensions
Needle Gauge /
Outer diameter
x Length] | 22 Ga. X 2in.
22 Ga. X 3 1/8in.
20 Ga. X 4in.
20 Ga. X 4 3/4in.
20 Ga. X 6in. | 19Ga X .55mm | Compatible with CIVCO
needles | 25 Ga. x 1 3/8in.
22 Ga. x 2in.
22 Ga. x 4 3/4in. | The devices offer
clinicians gauge and
length options that do not
affect the safety and
effectiveness of the
devices. |
| Sterilization | Ethylene Oxide | Ethylene Oxide | N/A | Ethylene Oxide | Same |
| Sterility
Assurance
Level (SAL) | 106 | Information is not
publically available | N/A | 106 | Same |
| Shelf Life | 2 years | Information is not
publically
available | N/A | 5 years | Proposed device has a
shelf life of 2 years. The
shelf life does not affect
the safety and
effectiveness of the
proposed device. |
| Item | Proposed Stimuplex®
Onvision® System | Primary Predicate Device
SonixGPS Nerve Block
Needle Kit (K121812) | Predicate Device
PercuNav Image Fusion
and Interventional
Navigation (K170716) | Predicate Device
B.Braun
Stimuplex® D Plus
Insulated
Echogenic Needle
(K100241) | Analysis and conclusion |
| Stimulation
ability | Yes | No | N/A | Yes | Same as Stimuplex D
Plus predicate device
does not affect the safety
and effectiveness of the
proposed device. |
| Connectivity to
Nerve
Stimulator | Direct | N/A | N/A | Direct | Same as Stimuplex D
Plus predicate device
does not affect the safety
and effectiveness of the
proposed device. |
| Tracking
Technology | sensor in needle,
sends signal back to
software which
calculates and
displays on ultrasound
screen | Sensor coil placed in
needle and in transducer
sends signal back to
software which
calculates and displays
on ultrasound screen | Sensor within CNT placed
in needle and in
transducer sends signal
back to software which
calculates and displays on
ultrasound screen | N/A | Equivalent, each tracking
technology make use of
an external energy field
for tracking and displays
on ultrasound screen |
| Sensor | Passive; receives
energy from
ultrasound probe and
uses this to determine
the needle tip position | Passive; receives energy
from an electromagnetic
source and uses this to
determine the sensor
position | Passive; receives energy
from an electromagnetic
source and uses this to
determine the sensor
position | N/A | Equivalent, all sensors
are passive and receive
energy from an external
field to determine the
sensor position |
| Image Modality | Live Ultrasound | Live Ultrasound | Live Ultrasound | N/A | Same |
| Sensor
connection to
tracking
hardware | The lead wires from
the sensor are
connected back to the
Onvision system
(tracking hardware)
through a cable and a
unique connector to
prevent connection to
an incorrect socket. | The lead wires from the
needle sensor are
connected back to the
tracking hardware though
a cable and a unique
connector to prevent
connection to an
incorrect socket. In
addition the sensor within
the ultrasound probe is
connected to the
ultrasound system. | The lead wires from the
sensor are connected
back to the Position
Sensor unit (tracking
hardware) through a cable
and a unique connector to
prevent connection to an
incorrect socket | N/A | Same |
| Software | The software takes
the calculated
positional information
and displays the
positional information
of the tracked device
connected to the
system. | The software takes the
calculated positional
information and predicted
needle trajectory to
display the location
where the needle will
intersect with the
ultrasound beam and
displays the positional
information of the tracked
device connected to the
system. | The software takes the
position data provided by
the hardware and displays
patient imaging data as
well as the location and
orientation of the tracked
instruments connected to
the system. | N/A | Equivalent. Each takes
the position data and
displays the positional
information of the tracked
device. |
| Tracked
Instrumentation/
accessory | Needle tip tracking | Needle tip tracking | Patient tracker
Ultrasound tracker
Coaxial needle tracker
(CNT)
Adaptive needle
tracker (ANT)
Button probes
Biopsy and RFA
Introducers | N/A | Same for primary
predicate device,
equivalent for PercuNav
predicate device |
| Clinical
application | Soft tissues (skin,
muscle, tendon, fat
etc.) | Soft tissues (skin,
muscle, tendon, fat etc.) | Soft tissues (skin,
muscle, tendon, fat etc.) | Soft tissues (skin,
muscle, tendon, fat
etc.) | Same |
| Targeted use
areas | Hospitals, surgery
centers, clinics:
emergency room,
examination room,
PNB room, operating
room. | Hospitals, surgery
centers, clinics:
emergency room,
examination room, PNB
room, operating room. | Hospital operating rooms,
outpatient surgery centers,
ultrasound, CT and other
scanner suites, and
procedure rooms. | Hospitals, surgery
centers, clinics:
emergency room,
examination room,
PNB room,
operating room. | Same. |
7
B BRAUN PHILIPS Premarket Notification: Traditional 510(k)
8
B BRAUN PHILIPS Premarket Notification: Traditional 510(k)
NONCLINICAL TESTING:
Bench testing performed on Stimuplex® Onvision® system demonstrates that the device performs as intended, verifies the requirements, as well as the identified risk control measures from risk management and supports substantial equivalence of the proposed device. No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing. The following testing has been successfully completed for the proposed device:
- Single Use components (Stimuplex® Onvision® needle) .
- o Biocompatibility in accordance with ISO 10993-1
- = Cvtoxicity
- · Sensitization
- · Irritation/Intracutaneous reactivity
- · Material mediated Pyrogenicity
- · Acute Systemic Toxicity
- · Hemocompatibility
- o Sterilization Residual testing in accordance with ISO 10993-7
- o Sterilization Validation in accordance with ISO 11135
- o Testing in accordance with Requirements from, ISO 9626 and ISO 7864 that include:
- · Cannula stiffness
- Tensile load
- · Resistance to breakage
- o Performance and functional testing to internal specifications that include:
- = Flowrate
- · Liquide Tightness
- · Compatibility with Philips Xperius System
- = Shelf Life Testing
- o Biocompatibility in accordance with ISO 10993-1
- Hardware and Software components (Onvision system) ●
- Electrical safety in accordance with ANSI AAMI ES 60601-1 o
- EMC safety in accordance with IEC 60601-1-2 O
- O Software Life Cycle Processes in accordance with IEC 62304
- Non-clinical performance testing to verify the requirements as specified O in the System Requirement Specifications that include:
- Functional requirements
- l Performance requirements
- Service requirements
- l Physical requirements and
- Interface requirements I
Non-clinical validation testing has been performed to validate that the proposed Stimuplex® Onvision® system conforms its intended use and user needs. The
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validation was performed with the following testing:
- Bench-top testing was performed in an artificial media to validate user need specification associated with system function and system performance such as:
- Needle tip position O
- o Connectivity
- Power indicator o
- Battery O
- Boot-up time O
- System cable clip O
- Operational O
- o Self-test
- o Needle tip not shown
- Preclinical testing on human cadaver was performed with physician ● (anesthesiologist) in a simulated clinical environment. The participants executed the test in the form of a system workflow to validate the intended use, user needs, and effectiveness of the safety related measure. As part of the validation, the implemented software was evaluated as part of the workflow. Results demonstrated all tests were passed.
- Usability evaluation in accordance with IEC 62366-1 was performed ● with anesthesiologist in a simulated use environment. Results from the usability evaluation demonstrated the proposed Stimuplex Onvision system is safe and effective for the intended use, users and use environment.
CONCLUSION:
The proposed Stimuplex Onvision system is substantially equivalent to the predicate devices, in terms of intended use, technological characteristics and safety and effectiveness.
Substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. Results of the functional and performance testing conducted on the proposed device demonstrate that the Stimuplex® Onvision® system complies with user need requirements as well as the requirements specified in the international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use. It is considered substantially equivalent to the predicate device in terms of safety and effectiveness. The differences, between proposed device and predicate device, do not raise any new issues of safety and effectiveness. Therefore, proposed Stimuplex® Onvision® system is as safe and effective as predicate devices and substantially equivalent to the predicate devices.