(704 days)
Not Found
No
The description focuses on image processing, 3D modeling, and additive manufacturing workflows guided by trained personnel and physician review, with no mention of AI or ML algorithms.
No.
The device is a pre-surgical planning system that creates digital and physical models to aid in maxillofacial surgery. While the outputs (splints, guides) are used during surgery, the device itself is a planning tool and not directly involved in treating a disease or condition. Its purpose is to facilitate the surgical procedure, not to perform a therapeutic function.
No
Explanation: The device is described as a "pre-operative software tool for simulating/evaluating surgical treatment options" and "a software based pre-surgical planning system." It takes imaging information to create models and guides for surgery but does not provide a diagnosis.
No
The device description explicitly states that the system produces "physical outputs including anatomical models, surgical splints, and surgical guides" and describes the manufacturing process for these physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the system processes imaging information from medical scanners (like CT) and produces physical outputs (anatomical models, surgical splints, surgical guides) or digital models. It does not analyze biological samples like blood, urine, or tissue.
- The purpose of this device is pre-operative planning and the creation of patient-specific surgical aids. This falls under the category of medical devices used for diagnosis, planning, and treatment, but not specifically for in vitro diagnostic testing.
The device is a software system that processes medical images and facilitates the creation of physical and digital models for surgical planning and guidance. This is distinct from the function of an IVD, which is to provide information about a patient's health status through the analysis of biological specimens.
N/A
Intended Use / Indications for Use
ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The Immersive View Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
The ImmersiveView Surgical Plan (IVSP®) system is a software based pre-surgical planning system. It is intended for use as a software system for the transfer of imaging information from a medical scanner such as CT based system. Physical outputs include surgical splints, and surgical guides that will be used in maxillofacial surgery. Surgical marking guides and surgical splints are not intended to come in contact with surgical cutting or drilling tools and therefore should not interface with surgical cutting or drilling tools.
ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system. This includes software to extract anatomical areas of interest from 3D medical scan images and create patient-specific physical and digital outputs. Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs.
Physical model outputs include surgical splints, and surgical guides for use in maxillofacial surgery. Surgical splints and surgical guides are designed and manufactured by ImmersiveTouch trained employees. Trained employees utilize the ImmersiveTouch additive manufacturing workflow to design and manufacture surgical guides, and, surgical splints using polymer resin. Surgical splints and surgical guides are provided in a NON-sterile condition and instructions for use provide the steps for cleaning and sterilization prior to use in surgery. Surgical splints and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Prior to use in surgery, the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models are designed and manufactured using similar workflow and materials as the subject devices.
Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel with active support from the surgeon
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)
The performance data indicates that the verification and validation testing performed on the ImmersiveView Surgical Plan (IVSP®) system successfully demonstrates that design outputs meet design inputs.
Device Performance Validation: The performance testing for the device includes processes validation methods such as IQ, OQ, and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, surgical splints and, anatomical models meet production needs. Surgical splints, and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Sterilization Validation: Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10. All test method acceptance criteria were met.
Biocompatibility Validation: Biocompatibility validation was conducted in accordance with international ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the output devices and their intended use.
Mechanical Strength Testing: The subject device was tested for flexural deformation testing. The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria.
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
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June 9, 2020
ImmersiveTouch P. Pat Banerjee CEO 708 Kristin Court Westmont, Illinois 60559
Re: K181813
Trade/Device Name: ImmersiveView Surgical Plan (IVSP®) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 8, 2020 Received: May 13, 2020
Dear P. Pat Banerjee:
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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181813
Device Name ImmersiveView Surgical Plan (IVSP®)
Indications for Use (Describe)
Immersive View Surgical Plan (IVSP®) is intended for use as a software system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The Immersive View Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
| 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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510(K) Summary – K181813
Submitter
| Name: | ImmersiveTouch, Inc. |
|---|---|
| Address: | 910 West Van Buren, Suite 715, Chicago, IL 60607 US |
| Contact Person: | Dr. P. Pat Banerjee |
| Date Prepared: | June 8th , 2020 |
Name of Device and Classification Name
Device Name: ImmersiveView Surgical Plan (IVSP®) Regulation Name: Bone Cutting Instrument and Accessories Regulation Number: 872.4120 Product Code: Primary – DZJ; Secondary – LLZ Classification Panel: Dental
Predicate Device
VSP® System, Medical Modeling, Inc. (K120956).
Indications for Use
ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ImmersiveView Surgical Plan (IVSD®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The ImmersiveView Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
4
Device Description
The ImmersiveView Surgical Plan (IVSP®) system is a software based pre-surgical planning system. It is intended for use as a software system for the transfer of imaging information from a medical scanner such as CT based system. Physical outputs include surgical splints, and surgical guides that will be used in maxillofacial surgery. Surgical marking guides and surgical splints are not intended to come in contact with surgical cutting or drilling tools and therefore should not interface with surgical cutting or drilling tools.
ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system. This includes software to extract anatomical areas of interest from 3D medical scan images and create patient-specific physical and digital outputs. Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs.
Physical model outputs include surgical splints, and surgical guides for use in maxillofacial surgery. Surgical splints and surgical guides are designed and manufactured by ImmersiveTouch trained employees. Trained employees utilize the ImmersiveTouch additive manufacturing workflow to design and manufacture surgical guides, and, surgical splints using polymer resin. Surgical splints and surgical guides are provided in a NON-sterile condition and instructions for use provide the steps for cleaning and sterilization prior to use in surgery. Surgical splints and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Prior to use in surgery, the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models are designed and manufactured using similar workflow and materials as the subject devices.
Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.
Performance Data
The performance data indicates that the verification and validation testing performed on the ImmersiveView Surgical Plan (IVSP®) system successfully demonstrates that design outputs meet design inputs.
Device Performance Validation
The performance testing for the device includes processes validation methods such as IQ, OQ, and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, surgical splints and, anatomical models
5
meet production needs. Surgical splints, and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."
Sterilization Validation
Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10 . All test method acceptance criteria were met.
Biocompatibility Validation
Biocompatibility validation was conducted in accordance with international ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the output devices and their intended use.
Mechanical Strength Testing
The subject device was tested for flexural deformation testing. The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria.
Substantial Equivalence
ImmersiveView Surgical Plan (IVSP®) is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs. Minor differences in the surgical planning and manufacturing processes are verified and validated in the performance data in accordance with the intended use.
The input is medical scanner images such as CT and CBCT. Outputs are physical and digital that include surgical splints and surgical guides. Biocompatible materials are used in the creation of the subject devices.
All devices are intended to aid in maxillofacial surgeries. These systems are intended to be utilized by trained employees with the approval by the physician.
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| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| IVSP® System, | ||
| Immersive | ||
| Touch, Inc. | VSP® System Medical Modeling | |
| Inc. | ||
| 510(k) Number | K181813 | K120956 |
| Clearance Date | TBD | 12/12/2012 |
| Computer | PC Workstation | PC workstation |
| Image Sources | CT | CT |
| Indications for Use | ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The ImmersiveView Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options. | The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating /evaluating surgical treatment options |
| Preoperative software | Yes | Yes |
| Human Intervention for | ||
| Interpretation of images | Yes | Yes |
| Additive manufacturing | ||
| of patient specific | ||
| surgical splints, surgical | ||
| guides and anatomical | ||
| models | Yes | Yes |
| Data inputs | Images from medical scanners | Images from medical scanners |
| Data outputs | Output for surgical splints, surgical | |
| guides and anatomical models | Output for anatomical models, templates, and | |
| surgical guides | ||
| Physical Outputs | Surgical splints, surgical guides, and | |
| anatomical models | Anatomical models, templates, and surgical guides | |
| Materials | Biocompatible polymers | Biocompatible polymers and surgical stainless |
| steel | ||
| Sterilization | Subject device is provided NON- | |
| sterile and is sterilized by the end- | ||
| user | Same |
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Comparison of Technological Characteristics with the Predicate Device
ImmersiveView Surgical Plan (IVSP®) system is substantially equivalent to and it is as safe and effective as its predicate device (VSP® System, Medical Modeling, Inc. -K120956).
Similarities to Predicate
The ImmersiveView Surgical Plan (IVSP®) and VSP® systems utilizes similar technologies as identified by its predicate device including:
- . Software for image transfer, manipulation, and surgical planning. These differences in software were addressed via verification and validation testing of the system.
- . Hardware for additive manufacturing of patient specific surgical splints, surgical guides, and anatomical models. These differences in software were addressed via verification and validation testing of the system
ImmersiveView Surgical Plan (IVSP®) and VSP® systems have similar technological characteristics including:
- . System inputs: Images from medical scanners
- . System Outputs: Physical outputs such as patient specific surgical splints, surgical guides, and anatomical models.
- Software: The subject and predicate devices both use similar software components for the digital workflow. Difference in the software used were addressed via verification and validation testing of the system.
- . Materials: Biocompatible polymers
- Sterility Assurance Level: 1x10-6
The intended use of ImmersiveView Surgical Plan (IVSP®) system and its predicate device is substantially equivalent in the following respect:
- . ImmersiveView Surgical Plan (IVSP®) system and the identified predicate device are intended to be used by trained personnel with active support from the surgeon. ImmersiveView Surgical Plan (IVSP®) system and the identified predicate device are intended for use on surgical candidates undergoing maxillofacial surgeries.
Differences to Predicate
The following technological differences exist between the subject and predicate device:
- . The subject device does not include surgical stainless-steel inserts because the subject devices are not intended to come in contact with surgical cutting or drilling tools.
- . The indications for use statements differ slightly in that the predicate device lists the physical outputs to include "anatomical models, templates, and surgical guides"
8
whereas the subject device includes "anatomical models, surgical guides, and surgical splints" The predicate device includes surgical splints in the device description, but surgical splints were included in the indications for use of the subject device to describe all physical outputs..
- The subject and predicate device both use biocompatible polymers to manufacture system outputs, but the materials used by the predicate device is different from the material used by the subject device.
- . The workflow that both the subject device and predicate device use is different. In order to address the differences IQ, OQ, and PQ testing was conducted along with verification and validation activities.
Conclusion
ImmersiveView Surgical Plan (IVSP®) is substantially equivalent to and is as safe and effective as its predicate device. Both devices incorporate similar inputs, operations, and outputs.