(389 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on 3D visualization and manipulation, not AI/ML-driven analysis or decision support.
No
The device is described as a software for visualization and orientation of 3D digital models for preoperative planning and heads-up 3D visualization during surgery. It is not intended to provide diagnosis or guide surgical instrumentation, nor is it for stereotactic procedures or surgical navigation. It also does not directly treat or prevent a disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states, "IntraOpVSP is not intended to provide diagnosis."
Yes
The device is explicitly described as a "software device" and its function is to display and manipulate 3D digital models. While it requires "performance-tested hardware" for display, the device itself is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for visualizing and orienting 3D digital models of a patient's anatomy to supplement conventional Virtual Surgical Planning. It is explicitly stated that it is not intended to provide diagnosis.
- Device Description: The device displays 3D objects as holograms to inform operative planning and provide additional information to the surgeon. This is a visualization and planning tool, not a diagnostic tool.
- Input: The input is 3D digital models generated by Virtual Surgical Planning software, typically from CT or MRI data. This is image data, not biological samples or specimens.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a surgical planning and visualization tool, falling under the category of medical devices used in the surgical workflow, but not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.
IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.
IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.
IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IntraOpVSP software displays 3D objects as holograms to inform the user on operative planning. It includes functions for 3D object spatial manipulation and orientation. IntraOpVSP software provides additional information to the surgeon by displaying holograms of the surgical plan, anatomical structures, and guides.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D models that are pre-segmented, typically from CT or MRI data, generated by Virtual Surgical Planning software.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use by surgeons who have been trained to operate IntraOpVSP. For use in healthcare settings, such as hospitals, clinics and operating rooms.
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
Design verification and validation were successfully conducted. Testing performed was simulated use, and actual use in simulated surgery.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Both design verification and design validation were successfully conducted. Design verification was successful in that the design output specifications satisfactorily met the design input requirements. Similarly, design vas successfully completed, and testing met all predetermined acceptance criteria. The testing performed was simulated use, and actual use in simulated surgery. No additional risks to the safety or effectiveness of the device were identified from testing.
- Performance of the augmented reality display was determined suitable for the intended use by characterizing its gamma response, contrast and contrast ratio, resolution, luminance and luminance variation, virtual field of view, display obstructions, and distortion, with testing to IEC 63145-20-10: 2019 and IEC 63145-20-20: 2019 as applicable.
- Validation with intended users: validation of training protocol and validation of trained users' operation of the device in a simulated surgical environment, followed "Guidance for Industry and Food and Drug Administration Staff, February 3, 201" and IEC 62366-1:2015 for Human Factors and Usability testing.
- Hazard analysis was performed following ISO 14971: 2019, and all hazards identified had mitigations implemented and validated through testing, where applicable, to determine acceptable residual risk.
- Software verification and validation was performed according to IEC 62304: 2015: Medical Device Software - Software Lifecycle processes and FDA's guidance on Software as Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff, December 8, 2017.
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.
OpenSight (K172418)
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Xironetic, LLC % Elaine Duncan President Paladin Medical, Inc PO Box 560 STILLWATER MN 55082
Re: K213128
October 21, 2022
Trade/Device Name: IntraOpVSP Software Device Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 15, 2022 Received: September 21, 2022
Dear Elaine Duncan:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213128
Device Name IntraOpVSP software device
Indications for Use (Describe)
IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.
IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.
IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.
IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| SUBMITTER: | Submitted on behalf of: |
|---|---|
| Company Name: | |
| Address: | Xironetic, LLC |
| 712 N. Broadway, Ave. | |
| Oklahoma City, OK 73102, USA | |
| Telephone: | 605-412-3574 |
| by: | Elaine Duncan, M.S.M.E., RAC |
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | September 15, 2022 |
| TRADE NAME: | IntraOpVSP software device |
| COMMON NAME: | Imaging Software; |
| CLASSIFICATION #: | Class II |
| CLASSIFICATION NAME: | System, Image Processing, Radiological |
| REGULATION & PRO CODE: | 21 CFR 892.2050; LLZ |
DEVICE DESCRIPTION:
IntraOpVSP software displays 3D objects as holograms to inform the user on operative planning. It includes functions for 3D object spatial manipulation and orientation. IntraOpVSP software provides additional information to the surgeon by displaying holograms of the surgical plan, anatomical structures, and guides.
INDICATIONS FOR USE:
IntraOpVSP is a software device that is indicated for use with an augmented reality head-mounted display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy. IntraOpVSP software is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.
IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation. IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP. IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
4
SUBSTANTIAL EQUIVALENCE:
The proposed software device, IntraOpVSP, is substantially equivalent to the predicate device, OpenSight (K172418). The intended use of both the proposed device and predicate device is for visualizing 3D patient data using augmented reality for planning purposes; therefore, the devices have the same intended use or general purpose. The two devices have equivalent technological characteristics, with slight differences in software features as described below:
IntraOpVSP software utilizes 3D models that are pre-segmented, typically from CT or MRI data, generated by Virtual Surgical Planning software. OpenSight is intended to enable users to segment previously acquired 3D datasets.
IntraOpVSP's software features are designed for preoperative planning purposes and to evaluate surgical options during surgery. OpenSight's software features are designed for preoperative localization and preoperative planning of surgical options. Neither device is intended for intraoperative use or stereotactic procedures.
When used according to its labeling, IntraOpVSP software raises no questions of safety and effectiveness relative to the predicate device. The table below demonstrates in technological characteristics and software features between IntraOpVSP and the predicate device, OpenSight. Differences are indicated in the table, but the characteristics or features with differences are deemed equivalent if no questions of safety or effectiveness are raised when the proposed device is used according to its labeling.
| ltem | Subject Device:
IntraOpVSP | Predicate Device:
OpenSight (K172418) | Comments |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indications for Use | IntraOpVSP is a software device that
is indicated for use with an
augmented reality head-mounted
display which allows for visualization
and orientation of 3D digital models of
selected structures of a patient's
anatomy.
IntraOpVSP is intended to
supplement conventional Virtual
Surgical Planning (VSP) by facilitating
perception of the shape and scale of
a patient's anatomical targets for use
in preoperative planning and heads-
up 3D visualization during surgery.
IntraOpVSP is not intended to provide
diagnosis or to guide surgical
instrumentation. It is not to be used
for stereotactic procedures or surgical
navigation. | OpenSight is intended to enable users to
display, manipulate, and evaluate 2D,
3D, and 4D digital images acquired from
CR, DX, CT, MR, and PT sources.
It is intended to visualize 3D imaging
holograms of the patient, on the patient,
for pre- operative localization and
preoperative planning of surgical options.
OpenSight is designed for use only with
performance-tested hardware specified
in the user documentation.
OpenSight is intended to enable users to
segment previously acquired 3D
datasets, overlay, and register these
3Dsegmented datasets with the same
anatomy of the patient in order to support
preoperative analysis. | Equivalent - IntraOpVSP
focuses on 3D data from CT,
MR and PT sources. |
| Item | Subject Device:
IntraOpVSP | Predicate Device:
OpenSight (K172418) | Comments |
| | IntraOpVSP is intended for use by
surgeons who have been trained to
operate IntraOpVSP. IntraOpVSP
software is designed for use with
performance-tested hardware
specified in the User Manual. | OpenSight is not intended for
intraoperative use. It is not to be used for
stereotactic procedures.
OpenSight is intended for use by trained
healthcare professionals,
including surgeons, radiologists,
chiropractors, physicians, cardiologists,
technologists, and medical educators.
The device assists doctors to better
understand anatomy and pathology of
patient. | |
| Intended Use
Environment | Not for intraoperative use. For use in
healthcare settings, such as
hospitals, clinics and operating rooms | Not for intraoperative use. For use in
healthcare settings, such as hospitals
and clinics | Equivalent - IntraOpVSP is
also to be used for planning
purposes during surgery. |
| System
Components | Headset with near eye see-through display and tracking camera Software application Optical tracking technology | Headset with near eye see-through display and tracking camera Software application Optical tracking technology | Equivalent. |
| Modes of
Operation | System Set-up Preoperative scan Preoperative planning and planning during surgery VSP Data Import 3D Data Orientation | System Set-up Preoperative scan Preoperative planning Scan Import Patient Registration | Equivalent. |
| Localization
Technology | Mesh surface maps | Mesh surface maps | Equivalent. |
| User Interface | Voice commands Hand gestures Multiple heads-up menu displays | Voice commands Hand gestures Multiple heads-up menu displays | Equivalent. |
| Visualization
Platform | Augmented reality using near-eye
see-through display; data displayed
on patient's anatomy for preoperative
use and as heads-up display during a
surgical procedure | Augmented reality using near-eye see-
through display; data displayed on
patient's anatomy | Equivalent. |
| Display Frame
Rate | 60 fps | 60 fps | Equivalent. |
| Medical Device
Interfaces | Pre-operative planning workstation
Virtual Surgery Planning server | Pre-operative planning workstation
Novarad PACS server | Equivalent - Virtual Surgery
Planning server provides 3D
data to IntraOpVSP instead
of Novarad PACS server. |
| Item | Subject Device:
IntraOpVSP | Predicate Device:
OpenSight (K172418) | Comments |
| Communication
between headset
and
computer/server | Wireless, encrypted | Wireless, encrypted | Equivalent. |
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K213128
6
K213128
SUMMARY of TESTING:
Both design verification and design validation were successfully conducted as part of the testing for the IntraOpVSP software device. Design verification was successful in that the design output specifications satisfactorily met the design input requirements. Similarly, design vas successfully completed, and testing met all predetermined acceptance criteria. The testing performed was simulated use, and actual use in simulated surgery. No additional risks to the safety or effectiveness of the device were identified from testing. The following standards and guidance documents were referenced in conducting this testing:
- Performance of the augmented reality display was determined suitable for the intended use by characterizing its gamma response, contrast and contrast ratio, resolution, luminance and luminance variation, virtual field of view, display obstructions, and distortion, with testing to IEC 63145-20-10: 2019 and IEC 63145-20-20: 2019 as applicable.
- Validation with intended users: validation of training protocol and validation of trained users' operation of the device in a simulated surgical environment, followed "Guidance for Industry and Food and Drug Administration Staff, February 3, 201" and IEC 62366-1:2015 for Human Factors and Usability testing.
- Hazard analysis was performed following ISO 14971: 2019, and all hazards identified had mitigations implemented and validated through testing, where applicable, to determine acceptable residual risk.
- Software verification and validation was performed according to IEC 62304: 2015: Medical Device Software - Software Lifecycle processes and FDA's guidance on Software as Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff, December 8, 2017.
SAFETY AND EFFECTIVENESS CONCLUSION:
Testing demonstrates that IntraOpVSP is at least as safe and effective as the predicate device. Use of IntraOpVSP during surgery provides additional benefits for surgical planning with equivalent safety when used according to its labeling. Based on the documentation submitted in this premarket application, including performance testing and device labeling, along with the benefit-risk analysis, IntraOpVSP is concluded to be substantially equivalent to the predicate device.