(263 days)
No
The summary describes a stereotaxic image guidance system that fuses real-time camera imaging with medical imagery and navigation data for precise instrument placement. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on image fusion and navigation, not AI-driven analysis or decision-making.
No
The device is an image guidance system used for the spatial positioning and orientation of surgical instruments; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as a "stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments." Its purpose is to aid surgeons in instrument placement during surgery, not to diagnose medical conditions.
No
The device description explicitly states that the system encompasses "non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories," indicating the presence of hardware components beyond just software. The performance studies also mention "Non-Clinical Hardware, Software, and Instrumentation Verification Tests."
Based on the provided information, the Paradigm System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Paradigm System's Function: The Paradigm System is described as a stereotaxic image guidance system used during surgical procedures to assist surgeons with the spatial positioning and orientation of surgical instruments. It uses medical images (CT) and real-time camera imaging to guide instrument placement within the body.
- No Sample Testing: The description does not mention the device performing any tests on samples taken from the patient's body. Its function is entirely focused on guiding surgical actions based on imaging data.
Therefore, the Paradigm System falls under the category of a surgical navigation or image guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Spine, thoracic to sacrum vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, intraoperative (open surgical 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 activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions. Proprio performed the following testing to ensure the safety and effectiveness of the Paradigm System device: Non-Clinical Hardware, Software, and Instrumentation Verification Tests Non-Clinical Design Validation conducted in Cadaveric Model Cadaveric Simulated Workflow Study Assessing Usability Compliance Conformity Assessments
Key results: The Paradigm System intended use, indications for use, and fundamental scientific technology is similar to the predicate device. Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness.
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.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is the Department of Health & Human Services logo. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text to the right of the square.
April 21, 2023
Proprio, Inc. Shannon Eubanks Vice President, HW Engineering and Regulatory 111 W John Street Suite 308 Seattle, Washington 98119
Re: K222291
Trade/Device Name: Paradigm System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 20, 2023 Received: March 22, 2023
Dear Shannon Eubanks:
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
1
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 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 medical devices and radiation-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22291
Device Name Paradigm System
Indications for Use (Describe)
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
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
K222291
2.0 510(k) Summary/Statement
Table 1: 510(k) Summary
| Submitter: | Proprio, Inc |
|---|---|
| Contact Person: | Shannon Eubanks |
| VP of HW Engineering and Regulatory | |
| Phone: (425) 802-6063 | |
| E-mail: seubanks@propriovision.com | |
| Trade Name: | Paradigm System |
| Common Name: | Orthopedic stereotaxic instrument |
| Classification: | Class II |
| Product Code: | OLO |
| Regulation | 21 CFR 882.4650 |
| Predicate Device(s): | The subject device is equivalent to the following device: |
| Envision 3DTM: Image Guidance System (K162375) | |
| Device Description: | The Paradigm System is a stereotaxic image guidance system intended |
| for the spatial positioning and orientation of spinal surgical instruments | |
| used by surgeons. The Paradigm System fuses high-resolution, real-time | |
| camera imaging of the surgical site (such as the spine) with medical | |
| imagery (such as CT) and surgical navigation data, such as | |
| predetermined instrument trajectories for precise instrument placement. | |
| The Paradigm System encompasses non-sterile operating room | |
| equipment components as well as sterilizable, reusable instruments, and | |
| off-the-shelf sterile-packaged, single-use accessories. | |
| The Paradigm System is used with an external monitor. | |
| Indication for Use: | The Paradigm System is a stereotaxic image guidance system intended for |
| the spatial positioning and orientation of spinal surgical instruments used | |
| by surgeons during open surgical procedures with appropriate bone | |
| preparation. The device is indicated for posterior approach spine surgery | |
| where reference to a rigid anatomical structure that can be identified on | |
| CT derived patient images for pedicle screw cannulation of the thoracic to | |
| sacrum vertebrae. |
4
| | Paradigm System
(Subject Device) | Envision 3DTM: Image
Guidance System
(Predicate Device) | Comment |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Device Overview | | | |
| 510(k) Number | To be determined | K162375 | |
| Decision Date | | December 29, 2016 | |
| Manufacturer | Proprio, Inc | 7D Surgical, Inc | |
| Classification | Class II | Class II | Same |
| Product Code | OLO | OLO | Same |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Medical Specialty | Neurology | Neurology | Same |
| Indications for
Use | The Paradigm System is a stereotaxic
image guidance system intended for the
spatial positioning and orientation of
spinal surgical instruments used by
surgeons during open surgical procedures
with appropriate bone preparation. The
device is indicated for posterior approach
spine surgery where reference to a rigid
anatomical structure that can be
identified on CT derived patient images
for pedicle screw cannulation of the
thoracic to sacrum vertebrae. | The Envision 3DTM: Image
Guidance System is a stereotaxic
image guidance system intended
for the spatial positioning and
orientation of neurosurgical
instruments used by surgeons.
The system is also intended to be
used as the primary surgical
luminaire during image guided
surgery. The device is indicated
for posterior approach spine
surgery where reference to a
rigid anatomical structure can be
identified. | Subject device is
not the primary
luminaire. |
5
| | Paradigm System
(Subject Device) | Envision 3DTM: Image
Guidance System
(Predicate Device) | Comment |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
operation | Paradigm System fuses high-
resolution, real-time camera imaging
of the surgical site (such as the spine)
with medical imagery (such as CT)
and surgical navigation data, such as
predetermined instrument trajectories
for precise instrument placement.
The Paradigm System enables surgical
navigation of instruments relative to
the patient spinal anatomy by
combining preoperative imaging
segmentation and intraoperative
registration of the patient's live
anatomy. Preoperative CT data is
uploaded to the console and the system
software generates a 3D model of the
patient's operative vertebrae. The 3D
model is used for preoperative
planning such as implant placements
or instrument trajectories. During the
procedure, once the patient's anatomy
is exposed, the Prism Sensor Array
acquires imaging to match the
topography of the live anatomy to the
3D model. This intraoperative
registration of live anatomy to the 3D
model creates a common coordinate
space between the preoperative CT
data and the patient anatomy. This
enables virtual information to be
overlaid on the live anatomy during
the procedure for intraoperative
guidance. | The Envision 3D system
provides image registration
between preoperative scan data
and data captured
intraoperatively from the
Envision 3DTM integrated
structured light scanner
and/or user selected points. The
system provides guidance data
by displaying the
locations of wireless optically
tracked Envision 3DTM Spinal
Instruments (examples
include pedicle probe and awl)
relative to the patient. Position
and orientation data of
tracked Envision 3DTM Spinal
Instruments are linked to the
preoperative scan data using
the Envision 3DTM workstation. | Subject device
uses light field
where predicate
uses structured
light scanner.
Subject device
segments each
vertebra where the
predicate as if it
were a single
anatomical body. |
| Technical
Comparison | Stereotaxic image guided surgical
navigation system during spine | Stereotaxic image guided
surgical navigation system | Subject device has
option for |
6
| | Paradigm System
(Subject Device) | Envision 3D™: Image
Guidance System
(Predicate Device) | Comment |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | surgery. Preoperative CT data is
segmented and a 3D model is
generated. Preoperative planning can
be performed. Intraoperative image
capture using reflective markers on
spinal instruments and registers the
patient's anatomy to the preoperative
3D model for intraoperative guidance
during the procedure. | during spine surgery.
Preoperative CT data is loaded
onto the cart. Intraoperative
registration of the patient's
anatomy with the preloaded CT
data using 3D structured light
images. Reflective markers on
spinal instruments aid the
surgeon in viewing the position
and orientation of instruments
relative to registered pre-
operative image data while
performing the surgical
procedure. | preoperative
planning. |
| Components | Cart, Arm, Sensor Array, External
Monitor, Surgical Instruments,
Software | Cart, Arm, Head, tracked
surgical Envision 3D™ Spinal
Instruments, Software | Same. |
| Energy Source | 120V | 120V | Same |
| Sterilization
Method -
Surgical
Instruments | Steam | Steam | Same |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| Required
Accessories | Reflective Markers (Northern Digital
K033621) | Reflective Markers | Same |
7
| Functional and Safety
Testing: | Verification and Validation activities have been conducted to provide
assurance that the device meets the performance requirements under the
indications for use conditions. Proprio performed the following testing
to ensure the safety and effectiveness of the Paradigm System device:
Non-Clinical Hardware, Software, and Instrumentation Verification Tests Non-Clinical Design Validation conducted in Cadaveric Model Cadaveric Simulated Workflow Study Assessing Usability Compliance Conformity Assessments |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following standards were used in testing:
IEC 60601-1:2015 Medical electrical equipment. General requirements for basic safety and essential performance IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility IEC 60601-1-6:2010+AMD1:2013 Medical Electrical Equipment - Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements IEC 62366-1: 2015 Ed1Medical Devices – Part 1: Application of Usability Engineering To Medical Devices ISO 10993-1:2003 Biological evaluation of medical devices: Part 1: Evaluation and testing ISO 14971:2019 Medical devices – Application of risk management to medical devices ISO 17665-1:2006 Sterilization of health care products – Moist heat - Part:1 Requirements for the development, validation and routine control of a sterilization process for medical device AAMI / ANSI ST79:2017 Guide to Steam Sterilization ASTM F2554-18 Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems |
| Conclusion: | The Paradigm System intended use, indications for use, and
fundamental scientific technology is similar to the predicate device.
Performance, safety and usability testing demonstrate that the
differences between the subject device and the predicate device do not
raise new risks of safety and effectiveness. |