(157 days)
Not Found
No
The description focuses on image manipulation with surgeon input and additive manufacturing, without mentioning AI or ML algorithms for processing or decision support.
No
The device is described as a software system and image segmentation system used for pre-operative planning, creating digital models, templates, and surgical guides for maxillofacial surgery, and for simulating/evaluating surgical treatment options. It provides information and tools to aid surgical decisions and procedures but does not directly treat or diagnose a disease or condition.
No
The device is intended as a software system and image segmentation system for surgical planning, simulation, and producing physical outputs like anatomical models and surgical guides. It processes imaging information but does not diagnose conditions.
No
The device description explicitly states that the system produces "physical outputs including anatomical models, templates, and surgical guides" and "utilizes additive manufacturing to create patient specific guides, and anatomical models." This indicates the system includes hardware components for manufacturing, not just 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 for processing imaging information, creating digital models, and producing physical outputs (anatomical models, templates, surgical guides) for use in maxillofacial surgery. It is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
- Device Description: The description reinforces this by explaining how it uses medical imaging to create surgical plans, inform surgical decisions, and guide surgical procedures. It produces patient-specific outputs for the maxillofacial region.
- Lack of Diagnostic Purpose: An IVD is a medical device that is used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on biological samples. Its purpose is to aid in surgical planning and execution based on imaging data.
The device falls under the category of surgical planning software and patient-specific surgical guides/models, which are typically regulated as medical devices but not as IVDs.
N/A
Intended Use / Indications for Use
The OMF ASP 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 OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP 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 Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input, and to produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides for planning and performing maxillofacial surgeries.
The system utilizes medical imaging, such as CT-based imaging data of the patient's anatomy to create surgical plans with input from the physician to inform surgical decisions and guide the surgical procedure. The system produces a variety of patient specific to the maxillofacial region including anatomic models (physical and digital), physical surgical templates and/or guides, and patient specific case reports. The system utilizes additive manufacturing to create patient specific guides, and anatomical models.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based system
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Design validation was performed to ensure OMF ASP System guide designs conform to user needs and intended use of supporting maxillofacial surgeries. All acceptance criteria for design validation were met.
Process performance testing was completed to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases used for testing were representative of the reconstruction procedures within the subject device's intended use. Both digital and physical outputs from all manufacturing processes were verified against the design specifications. All acceptance criteria for performance testing were met.
Software verification was completed to comply with a Moderate Level of Concern for the subject device. All acceptance criteria for software verification testing were met.
Cleaning validation was performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject devices, bioburden, protein levels, and hemoglobin levels were analyzed. All acceptance criteria for the cleaning validation were met.
Steam sterilization validations were performed for dynamic-air-removal cycle in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10% using the biological indicator (BD) overkill method. All acceptance criteria for the steam sterilization validation were met.
Biocompatibility testing was in compliance to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. All acceptance criteria for biocompatibility were met.
No clinical data were provided in order to demonstrate substantial equivalence.
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
Image /page/0/Picture/0 description: The image contains the logo of 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2022
VHA DEAN % Laura Gilmour Principal Consultant LG Strategies, LLC 2001 Parker Lane #122 Austin, Texas 78741
Re: K220648
Trade/Device Name: OMF ASP System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: June 8, 2022 Received: July 11, 2022
Dear Laura Gilmour:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K220648
Device Name OMF ASP System
Indications for Use (Describe)
The OMF ASP 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 OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary
| 5.1 Applicant/Submitter | |
|---|---|
| Company Name | VHA DEAN |
| Company Street Address | 810 Vermont Avenue, NW |
| City | Washington |
| State | DC |
| Country | United States |
| Zip Code | 20420 |
| 5.2 Contact Person | |
| Full Name | Beth Ripley, MD, PhD |
| Job Title | Deputy Chief |
| beth.ripley@va.gov | |
| 5.3 Correspondent Information | |
| Full Name | Laura Gilmour |
| Job Title | Principal Consultant, Advanced Manufacturing |
| and Regulatory Strategy | |
| Phone | 901-258-3629 |
| laura.gilmour@va.org | |
| 5.4 Date of Preparation | |
| Date of Preparation | August 10, 2022 |
5.5 Device Information
Table 5.1 Device Information
| Trade Name | OMF ASP System |
|---|---|
| Common or Usual Name | Patient specific maxillofacial anatomical models, templates, |
| guides, and surgical plans | |
| Classification Name | Bone cutting Instruments and Accessories. |
| System, Image Processing, Radiological | |
| Classification Regulation | 872.4120 |
| Regulatory Class | Class II |
| Product Code | DZJ |
| Subsequent Product Code | LLZ |
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5.6 Predicate Device(s)
Table 5.2 Predicate Device(s)
| Predicate Type | 510(k) Number | Device Name | Manufacturer |
|---|---|---|---|
| Primary Device | K192192 | VSP 2.0 System | 3D Systems |
The predicate devices have not been subject to a design-related recall.
5.7 Device Description
The Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input, and to produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides for planning and performing maxillofacial surgeries.
The system utilizes medical imaging, such as CT-based imaging data of the patient's anatomy to create surgical plans with input from the physician to inform surgical decisions and guide the surgical procedure. The system produces a variety of patient specific to the maxillofacial region including anatomic models (physical and digital), physical surgical templates and/or guides, and patient specific case reports. The system utilizes additive manufacturing to create patient specific guides, and anatomical models.
The following table provides a list of OMF ASP System outputs by material and function:
| Category | Material | Function |
|---|---|---|
| Marking Guide | Duraform ProX PA | Marking of maxillofacial bone Marking of graft bone |
| Positioning Guide | Duraform ProX PA | Positioning of maxillofacial bone |
| Template/ | ||
| Anatomical Model | Duraform ProX PA | Visualization and fit check of graft anatomy Visualization of anatomy at time of medical scan Visualization of patient specific anatomy modified by established surgical plan |
5.8 Intended Use/Indications for Use
The OMF ASP 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 OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating surgical treatment options.
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5.9 Comparison of Technological Characteristics with Predicate
VHA DEAN believes that the OMF ASP System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar inputs as the devices cleared in K192192. The subject device uses an identical material to a subset of the devices cleared in K192192. The subject device has the same intended use and similar technological characteristics to the devices cleared in K192192. These technological characteristics include image transfer and manipulation via COTS software that is later used for 3D printing of anatomical models and guides for surgical planning. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.
5.10 Summary of Non-Clinical Testing
The following tests were performed to demonstrate safety based on current industry standards:
5.10.1 Design Validation
Design validation was performed to ensure OMF ASP System guide designs conform to user needs and intended use of supporting maxillofacial surgeries. The OMF ASP System has identical indications for use, identical design envelope, and an identical worst-case configuration and post processing conditions to the predicate device. All acceptance criteria for design validation were met.
5.10.2 Performance Testing
Process performance testing was completed to assess the manufacturing process as well as operator repeatability within the digital workflow. Cases used for testing were representative of the reconstruction procedures within the subject device's intended use. Both digital and physical outputs from all manufacturing processes were verified against the design specifications. All acceptance criteria for performance testing were met.
5.10.3 Software Verification
No custom software has been created or included as part of the subject device. All software used in the OMF ASP System process is commercial off-the-shelf (COTS) software. The software verification complied with two FDA guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005 and Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff issued September 9th 2019. Software documentation and software verification were completed to comply with a Moderate Level of Concem for the subject device as described in the aforementioned guidance documents. All acceptance criteria for software verification testing were met.
5.10.4 Cleaning and Sterilization Validation
The OMF ASP System has identical indications for use, identical design envelope, and an identical worstcase configuration and post processing conditions to the predicate device.
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Cleaning validation was performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject devices, bioburden, protein levels, and hemoglobin levels were analyzed. All acceptance criteria for the cleaning validation were met.
Steam sterilization validations were performed for dynamic-air-removal cycle in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10% using the biological indicator (BD) overkill method. All acceptance criteria for the steam sterilization validation were met.
5.10.5 Biocompatibility Testing
The OMF ASP System has identical indications for use, identical design envelope, and an identical worstcase configuration and post processing conditions to the predicate device. All acceptance criteria for biocompatibility were met and the testing adequality addresses biocompatibility for the output devices and their intended use. Biocompatibility testing was in compliance to ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization, and ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
5.11 Clinical Testing
No clinical data were provided in order to demonstrate substantial equivalence.
5.12 Conclusion
Based on the testing performed, including, design validation analysis, performance testing, software verification, biocompatibility testing, cleaning validation, and sterilization it can be concluded that the subject device does not raise any new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed OMF ASP System are assessed to be substantially equivalent to the predicate device.