(90 days)
No
The summary describes a software system for orthodontic planning and design based on 3D models, but it does not mention the use of AI or ML technologies. The description focuses on tools for analysis, simulation, and design based on user input and existing data.
No
Explanation: A therapeutic device directly treats or cures a disease or condition. NemoCast is a software system for orthodontic planning, analysis, and design; it does not directly treat the patient. It provides tools and designs that can be used to create therapeutic devices (like aligners or bracket placement trays), but it is not a therapeutic device itself. Its primary function is diagnostic, planning, and design.
Yes
The "Intended Use" section states that NemoCast provides tools for "systematic inspection, detailed analysis" and can be used for "orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models". These functionalities are directly related to determining the nature of a disease or condition, which is the definition of diagnosis.
Yes
The device description explicitly states "NemoCast is a software system" and describes its functions as software-based tools for managing, analyzing, simulating, and designing based on 3D models. It also states the output is in the form of digital files (STL). There is no mention of accompanying hardware that is part of the regulated device.
Based on the provided information, NemoCast is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NemoCast's Function: NemoCast works with 3D models of the patient's dentition, which are derived from scans (surface scans, CT images). It performs analysis, simulation, and design based on these models. It does not analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's for managing, inspecting, analyzing, simulating, and designing based on 3D models of the dentition. This is related to the physical structure of the teeth and jaw, not the analysis of biological samples.
- Device Description: The description reinforces that it's a software system working with 3D scanned models and has no patient contact.
Therefore, NemoCast falls under the category of a medical device, specifically a software device used in orthodontics, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.
The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Product codes (comma separated list FDA assigned to the subject device)
PNN, LLZ
Device Description
NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan from intra-oral scanner, Surface scan from STL, PLY, OBJ file, CT image data (DICOM), 2D overlay (PNG, JPG, BMP)
Anatomical Site
Maxilla and Mandible
Indicated Patient Age Range
Patients requiring Orthodontic Treatment
Intended User / Care Setting
Dental Professionals
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 testing remains unchanged from the company's own reference device submission, NemoCast K193003. The performance testing for the subject device is being leveraged from the company's own reference device including: design verification and validation testing.
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
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 21, 2023
Software Nemotec S.L. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K232549
Trade/Device Name: NemoCast Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: August 23, 2023 Received: August 23, 2023
Dear Kevin Walls:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
510(k) Number (if known) K232549
Device Name
NemoCast
Indications for Use (Describe)
NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned dectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.
The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
즈 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, lighter blue font. To the right of the text is a circular graphic with a dark blue circle in the center and three light blue segments around it.
510(K) Summary - K232549
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Information:
Software Nemotec S.L.
Av. Juan Caramuel, №1
Leganés, Madrid, Spain, 28919
Submission Correspondent:
Kevin Walls Principal Consultant, Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127
Device Information:
| Trade Name: | NemoCast |
|---|---|
| Common Name: | Orthodontic Software |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification Regulation: | 21CFR 872.5470 |
| Device Class: | II |
| Product Code: | PNN, LLZ |
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Image /page/5/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the "NEMO" in a darker blue and the "TEC" in a lighter blue. Below the name is the text "A BIOTECH DENTAL COMPANY" in a smaller, lighter font. To the right of the name is a circular graphic divided into three sections of varying shades of blue, with a dark blue circle in the center.
Reference Device:
NemoCast, Software Nemotec, K193003
Primary Predicate:
3Shape Ortho System™, 3Shape A/S, K152086
Date Prepared:
Aug 08, 2023
Predicate Device:
The NemoCast Software has the same intended uses and technical characteristics as primary predicate 3Shape Ortho System™ (K152086) from 3Shape A/S and reference predicate NemoCast from Software Nemotec (K193003) as listed in the table below:
Based on the information and supporting documentation provided, the NemoCast Software and the primary predicate (3Shape Ortho System™) have the same intended use.
Both software devices are used by Dental Professionals in orthodontic treatment planning (before, during, after treatment) covering management of patients and models, inspection, 2D and 3D measurement and orthodontic analysis of models, 2D & 3D treatment simulation, as well as virtual appliance preparation, handling and export, and they are both providing device output. Additionally, the indirect bonding functionality of both systems is intended for use with commercially available brackets and wires. Therefore, the NemoCast Software and the primary predicate (3Shape) are found to be similar in their intended use, supported anatomic areas and the majority of the available features and functionalities.
Device Description:
NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.
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Image /page/6/Picture/0 description: The image is a logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first three letters in a darker blue and the last four letters in a lighter blue. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, sans-serif font. To the right of the word "NEMOTEC" is a circular graphic divided into three sections, with a smaller circle in the center.
Indications for Use:
NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.
The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
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Image /page/7/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in large, bold, dark blue letters. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in smaller, light blue letters. To the right of the text is a circular graphic with three sections in different shades of blue and a dark blue circle in the center.
Comparison of Intended Use and Technological Characteristics with the reference Device:
| Substantial Equivalence Table | ||||
|---|---|---|---|---|
| Feature name | SUBJECT | |||
| DEVICE | ||||
| NemoCast | REFERENCE | |||
| DEVICE | ||||
| NemoCast | ||||
| (K193003) | PRIMARY | |||
| PREDICATE | ||||
| 3Shape Ortho | ||||
| System ™, | ||||
| K152086 | Differences | |||
| Product Code | PNN, LLZ | PNN, LLZ | PNN, LLZ | None |
| Common Name | Orthodontic | |||
| Software | Orthodontic | |||
| Software | Orthodontic | |||
| Software | None | |||
| Classification Name | Orthodontic | |||
| Plastic | ||||
| Bracket | Orthodontic | |||
| Plastic Bracket | Orthodontic | |||
| Plastic Bracket | None | |||
| Regulation Number | 21 CFR | |||
| 872.5470 | 21 CFR | |||
| 872.5470 | 21 CFR | |||
| 872.5470 | None | |||
| Supported anatomic areas | Maxilla and | |||
| Mandible | Maxilla and | |||
| Mandible | Maxilla and | |||
| Mandible | None | |||
| Intended Use | ||||
| Use by dental professionals in | ||||
| orthodontic treatment | ||||
| planning (before, during, after | ||||
| treatment). | Yes | Yes | Yes | Reference device |
| NemoCast was | ||||
| used by dental | ||||
| professionals | ||||
| only before | ||||
| treatment. | ||||
| Management of patients and | ||||
| models. | Yes | Yes | Yes | None |
| Inspection, measurement and | ||||
| analysis of orthodontic | ||||
| models. | Yes | Yes | Yes | None |
| Treatment simulation. | Yes | Yes | Yes | None |
| Virtual appliance preparation | ||||
| (including dental casts), | ||||
| handling and export. | Yes | Yes | Yes | None |
| Provide digital file and device | ||||
| output. | Yes | Yes | Yes | All 3 devices |
| output STL files | ||||
| for fabrication of | ||||
| dental casts. | ||||
| The subject | ||||
| Device and | ||||
| predicate Device | ||||
| both additionally | ||||
| output indirect | ||||
| Bonding Transfer | ||||
| Media. | ||||
| Supported PC formats | Windows | Windows | Windows | None |
| Managing patient and case base data: | ||||
| Creating, editing, deleting | ||||
| and copying patient data | Yes | Yes | Yes | None |
| Creating, editing, deleting | ||||
| and copying case data | Yes | Yes | Yes | None |
| Collection of study material | ||||
| Surface scan from | ||||
| intra-oral scanner | Yes | Yes | Yes | None |
| Surface scan from STL, PLY, | ||||
| OBJ file | Yes | No | Yes, only STL | Although |
| predicate device | ||||
| only import STL | ||||
| format, the OBJ | ||||
| and PLY formats | ||||
| are other | ||||
| equivalent | ||||
| formats which do | ||||
| not affect the | ||||
| security and | ||||
| safety of the | ||||
| device. | ||||
| CT image data | DICOM | DICOM | DICOM | None |
| 2D overlay | PNG, JPG, | |||
| BMP | PNG, JPG, | |||
| BMP | PNG, JPG, | |||
| BMP | None | |||
| Alignment of study material | ||||
| Aligning surface scan and | ||||
| CT image | Yes | Yes | Yes | None |
| Aligning cephalometric | ||||
| images | Yes | Yes | Yes | None |
| Alignment of surface scan | ||||
| with 2D overlays | Yes | Yes | Yes | None |
| Ability to check/adjust | ||||
| DICOM visibility | Yes | Yes | Yes | None |
| DICOM scan segmentation | Yes | Yes | Yes | None |
| Occlusal Orientation | Yes | Yes | No | Although the |
| predicate device | ||||
| does not perform | ||||
| occlusal | ||||
| orientation, the | ||||
| reference device | ||||
| contains this | ||||
| Segmenting teeth roots | Yes | Yes | No | option. |
| Although the | ||||
| predicate device | ||||
| does not | ||||
| segment teeth | ||||
| roots, the | ||||
| reference device | ||||
| contains this | ||||
| option. | ||||
| DICOM orientation | Yes | Yes | Yes | None |
| Measuring study material | ||||
| 2D measurement toolbox | Yes | Yes | Yes | None |
| 3D measurement toolbox | Yes | Yes | Yes | None |
| Analyzing study material | ||||
| Arch shape | Yes | Yes | Yes | None |
| Wire length | Yes | Yes | Yes | None |
| Tooth width | Yes | Yes | Yes | None |
| Bolton | Yes | No | Yes | None |
| Space analysis | Yes | Yes | Yes | None |
| Overjet/overbite | Yes | No | Yes | None |
| Occlusion map | Yes | Yes | Yes | None |
| Treatment analysis and | ||||
| report generation | Yes | Yes | Yes | None |
| Treatment simulation | ||||
| 2D & 3D simulation | Yes | Yes | Yes | None |
| Virtual appliance design | ||||
| Orthodontic appliance | ||||
| search | Yes | Yes | Yes | None |
| Orthodontic appliance | Yes | Yes | Yes | None |
| virtual preparation | ||||
| Orthodontic appliance | ||||
| design | Yes | Yes | Yes | None |
| Orthodontic appliance | ||||
| export | Yes | Yes | Yes | None |
| Virtual articulator | Yes | Yes | Yes | None |
| Indications for Use | NemoCast is | NemoCast is | 3Shape Ortho | The indications |
| intended for | intended for | System™ is | for use for the 3 | |
| use as a | supporting the | intended for | devices are the | |
| medical | diagnostic and | use as a | same, with the | |
| front-end | treatment | medical | exception of the | |
| device | plan processes | front-end | virtual design | |
| providing | for | device | options. | |
| tools for | orthodontic | providing | (Compared to the | |
| management | procedures | tools for | reference device, | |
| of | related to | tools for | the Subject | |
| orthodontic | minor anterior | management | Device | |
| models, | tooth | of orthodontic | additionally is | |
| systematic | movements; it | models, | used for design | |
| inspection, | provides tools | systematic | of Indirect | |
| detailed | for | inspection, | Bonding Transfer | |
| analysis, | management | detailed | Media. | |
| treatment | of orthodontic | analysis, | ||
| simulation | models, | treatment | The Subject | |
| and virtual | systemic | simulation and | Device virtual | |
| appliance | inspection, | virtual | design options | |
| design | detailed | appliance | are the same as | |
| options | analysis, | design options | the Virtual design | |
| (Export of | treatment | (Custom Metal | options for the | |
| Models, | simulation | Bands, Export | predicate | |
| Indirect | and virtual | of Models, | Device.) | |
| Bonding | appliance | Indirect | ||
| Transfer | design options | Bonding | ||
| Media) based | (export of | Transfer | ||
| on 3D models | models) based | Media) based | ||
| of the | on 3D models | on 3D models | ||
| patient's | of the | of | ||
| dentition | patient's | the patient's | ||
| before the | dentition | dentition | ||
| start of an | before the | before the start | ||
| orthodontic | start of an | of an | ||
| treatment. It | orthodontic | orthodontic | ||
| can also be | treatment. It | treatment. It | ||
| applied | can also be | can also be | ||
| during the | applied to | applied during | ||
| treatment to | evaluate if the | the treatment | ||
| inspect and | outcome is | to inspect and | ||
| analyze the | consistent | analyze the | ||
| progress of | with | progress of the | ||
| the | the | treatment. It | ||
| treatment. It | planned/desir | can be used at | ||
| can be used | ed treatment | the end of the | ||
| at the end of | objectives. | treatment to | ||
| the treatment | NemoCast | evaluate if the | ||
| to evaluate if | requires the | outcome is | ||
| the outcome | user to have | consistent with | ||
| is consistent | ||||
| with the | ||||
| planned/desir | ||||
| ed treatment | ||||
| objectives. It | ||||
| can also be | ||||
| applied | ||||
| during the | ||||
| treatment to | ||||
| inspect and | ||||
| analyze the | ||||
| progress of | ||||
| the | ||||
| treatment. | ||||
| The use of | ||||
| the | ||||
| NemoCast | ||||
| requires the | ||||
| user to have | ||||
| the necessary | ||||
| training and | ||||
| domain | ||||
| knowledge in | ||||
| the practice | ||||
| of | ||||
| orthodontics, | ||||
| as well as to | ||||
| have received | ||||
| a dedicated | ||||
| training in the | ||||
| use of the | ||||
| software. | the necessary | |||
| training and | ||||
| domain | ||||
| knowledge in | ||||
| the practice of | ||||
| orthodontics, | ||||
| as well | ||||
| as to have | ||||
| received a | ||||
| dedicated | ||||
| training in the | ||||
| use of the | ||||
| software. | the | |||
| planned/desire | ||||
| d treatment | ||||
| objectives. | ||||
| The use of the | ||||
| Ortho | ||||
| SystemTM | ||||
| requires the | ||||
| user to have | ||||
| the necessary | ||||
| training and | ||||
| domain | ||||
| knowledge in | ||||
| the practice of | ||||
| orthodontics, | ||||
| as well as to | ||||
| have received a | ||||
| dedicated | ||||
| training in the | ||||
| use of the | ||||
| software. | ||||
| Intended User | Dental | |||
| Professionals | Dental | |||
| Professionals | Dental | |||
| Professionals | None | |||
| Intended Patient | ||||
| Population | Patients | |||
| requiring | ||||
| Orthodontic | ||||
| Treatment | Adults | |||
| requiring | ||||
| Orthodontic | ||||
| Treatment | Patients | |||
| requiring | ||||
| Orthodontic | ||||
| Treatment | The intended | |||
| patient | ||||
| population for | ||||
| the subject | ||||
| device is the | ||||
| same as the | ||||
| predicate device. | ||||
| The reference | ||||
| device intended | ||||
| patient | ||||
| population was |
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Image /page/8/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first four letters in a darker blue and the last three in a lighter blue. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller font. To the right of the company name is a circular graphic with a dark blue dot in the center and three sections in different shades of blue surrounding the dot.
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Image /page/9/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the company name is the text "A BIOTECH DENTAL COMPANY" in a smaller, lighter font. To the right of the company name is a circular graphic with a dark blue dot in the center.
10
Image /page/10/Picture/0 description: The image shows the word "NEMOTEC" in blue font, with the words "A BIOTECH DENTAL COMPANY" in smaller font underneath. To the right of the word "NEMOTEC" is a circular logo with a blue dot in the center. The logo is made up of three different shades of blue.
Image /page/10/Picture/1 description: The image shows a circular diagram divided into three sections. The sections are colored in varying shades of blue, with the darkest shade at the top right, a medium shade at the bottom, and the lightest shade at the top left. There is a solid dark blue circle in the center of the diagram.
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Image /page/11/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller, lighter blue font. To the right of the company name is a circular graphic with a dark blue circle in the center.
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Image /page/12/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first two letters in a darker blue and the rest in a lighter blue. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller, sans-serif font. To the right of the company name is a circular graphic with three sections in different shades of blue and a white circle in the center with a dark blue dot.
TECHNOLOGICAL CHARACTERISTICS
NemoCast; Software Nemotec, is software for simulating/evaluating orthodontic treatment programmed in C++ language and running on the Windows operating system.
TESTING & VALIDATION
The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users.
The performance testing remains unchanged from the company's own reference device submission, NemoCast K193003. The performance testing for the subject device is being leveraged from the company's own reference device including: design verification and validation testing.
Differences:
The Indications for Use statement between the subject and predicate devices are equivalent; minor differences in wording do not alter the intended use of the subject device. In addition, there are minimum differences in the software functions or technical requirements; none of these differences affect the safety and effectiveness of the subject device relative to the predicate, both can be considered equivalent.