(1 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on physical components and treatment planning software without mentioning AI/ML capabilities.
Yes
The device is described as an "orthodontic appliance system used to correct malocclusions," directly indicating its purpose in treating a medical condition.
Yes
The device description states, "The LFO System consists of...TPS that allows the orthodontist to view, measure, and diagnose cases," indicating a diagnostic capability.
No
The device description explicitly states that the system consists of "patient-specific ceramic brackets, patient-specific placement jigs, and TPS" and includes performance testing on the physical brackets and clips, indicating it is a system with both software and hardware components.
Based on the provided information, the LightForce Orthodontic System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LightForce System Function: The LightForce Orthodontic System is a system of software and physical appliances (brackets and jigs) used to correct malocclusions (misaligned teeth) directly on the patient. It is a treatment system applied to the body, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances." This describes a therapeutic intervention, not a diagnostic process.
- Device Description: The description details physical components like brackets, jigs, and software for treatment planning. There is no mention of analyzing biological samples.
Therefore, the LightForce Orthodontic System falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
Product codes
NJM, PNN
Device Description
The LightForce Orthodontic System (LFO System) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific placement jigs, and TPS that allows the orthodontist to view, measure, and diagnose cases.
The patient-specific brackets are available with slot sizes to orthodontic wires up to 0.022" in height and come in a variety of hook options colors and shades. The patient-specific placement jig is an optional-use lab device to aid orthodontists in bracket placement and bonding and is composed of an FDA cleared, class 1 certification material. The LFO system does not contain commercially available or patient-specific shaped arch wires, ligatures, or adhesives that affix the brackets to the teeth. The LFO system packaging consists of a single product offering box with indirect bonding trays (IDB trays) loaded with brackets as well as a secondary set of individual brackets and, where applicable IDB trays and/or bite turbo indirect bonding travs. The LFO system may also include non-patient-specific brackets for temporary use with predetermined torque, tip, offset and base contour, packaged and labeled separately.
The inclusion of an optional self ligating metal clip is to ligate a wire to the bracket by encapsulating the wire in the slot of the bracket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical performance testing was performed to ensure that the LFO system brackets were similar to the predicate LFO System. Performance testing was carried out to evaluate the features of the design that were different/changed between the LFO system and its predicate. Performance testing consisted of:
-
- Tie-wing fracture strength is the fracture strength of the tie-wing complex when a load is placed directly under the tie wing. The tie wing fracture strength of LFO System brackets is equivalent to the predicate device.
- Wire friction force is the force required to drag a ligated stainless-steel wire through the 2. primary slot of the bracket. The friction force of the LFO System brackets with the inclusion of self-ligating metal clips is substantially better (lower) than the predicate device.
-
- Wire escapement testing is an evaluation of the self ligating clip and bracket's capability to successfully hold a wire in place when subjected to normal orthodontic forces. The LFO system's metal clip is an effective mechanism, in combination with ceramic brackets, to retain a wire in a slot throughout treatment.
No clinical performance testing was conducted on LFO System brackets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LightForce Orthodontic System (K222764)
Reference Device(s)
Dentsply International IN-OVATION C brackets (K060837), CDB Self Ligating Bracket 8F (K160957)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
September 14, 2023
LightForce Orthodontics % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232827
Trade/Device Name: LightForce Orthodontic System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM, PNN Dated: September 13, 2023 Received: September 13, 2023
Dear Prithul Bom:
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.
1
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 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).
Sincerelv.
Michael E. Adjodha -S
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 Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232827
Device Name LightForce Orthodontic System
Indications for Use (Describe)
The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
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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ട്. 510(k) Summary
| 510(k) owner's name: | LightForce Orthodontics |
|---|---|
| Address: | 44 Third Ave. |
| Burlington, MA 01803 | |
| Phone number: | 800-481-0185 |
| Name of contact person: | Jeffrey Roberts |
| Date the summary was prepared: | August 25, 2023 |
| Trade/Proprietary Name of Device: | LightForce Orthodontic System |
| Common or Usual Name: | Orthodontic Ceramic Bracket and Accessory |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification Regulation: | 21 CFR 872.5470 |
| Product Code: | NJM, PNN |
| Regulatory Class: | II |
Predicate Devices:
Primary Predicate: LightForce Orthodontic System (K222764) Reference Predicate: Dentsply International IN-OVATION C brackets (K060837)
Device Description:
The LightForce Orthodontic System (LFO System) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific placement jigs, and TPS that allows the orthodontist to view, measure, and diagnose cases.
The patient-specific brackets are available with slot sizes to orthodontic wires up to 0.022" in height and come in a variety of hook options colors and shades. The patient-specific placement jig is an optional-use lab device to aid orthodontists in bracket placement and bonding and is composed of an FDA cleared, class 1 certification material. The LFO system does not contain commercially available or patient-specific shaped arch wires, ligatures, or adhesives that affix the brackets to the teeth. The LFO system packaging consists of a single product offering box with indirect bonding trays (IDB trays) loaded with brackets as well as a secondary set of individual brackets and, where applicable IDB trays and/or bite turbo indirect bonding travs. The LFO system may also include non-patient-specific brackets for temporary use with predetermined torque, tip, offset and base contour, packaged and labeled separately.
The inclusion of an optional self ligating metal clip is to ligate a wire to the bracket by encapsulating the wire in the slot of the bracket.
4
Intended Use:
The LFO System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
The indications for use are the same as the primary predicate K222764.
Technological Characteristics:
The LFO System brackets, like its primary predicate LFO system (K222764), are composed of a polycrystalline alumina with a bracket design consisting of tie-wings for ligation, a primary archwire slot and auxiliary slots. There are rounded corners and edges along with a rounded hook on the distal-gingival tie wing to accommodate accessories during orthodontic treatment. These design features allow an archwire to move the bonded brackets along a designated path until the desired tooth position is achieved. The brackets have a mechanical locking base design and are built through additive manufacturing methods. The technological characteristics of the LFO System brackets differ from the predicate LFO system in that the updated LFO system offers the inclusion of an optional self ligating nitinol clip. The self ligating nitinol clip included in the LFO system has the same technological characteristics as the reference predicate Dentsply International IN-OVATION C brackets (K060837).
Non-clinical Performance Testing:
Non-clinical performance testing was performed to ensure that the LFO system brackets were similar to the predicate LFO System. Performance testing was carried out to evaluate the features of the design that were different/changed between the LFO system and its predicate. Performance testing consisted of:
-
- Tie-wing fracture strength is the fracture strength of the tie-wing complex when a load is placed directly under the tie wing. The tie wing fracture strength of LFO System brackets is equivalent to the predicate device.
- Wire friction force is the force required to drag a ligated stainless-steel wire through the 2. primary slot of the bracket. The friction force of the LFO System brackets with the inclusion of self-ligating metal clips is substantially better (lower) than the predicate device.
-
- Wire escapement testing is an evaluation of the self ligating clip and bracket's capability to successfully hold a wire in place when subjected to normal orthodontic forces. The LFO system's metal clip is an effective mechanism, in combination with ceramic brackets, to retain a wire in a slot throughout treatment.
5
Clinical Performance Testing:
No clinical performance testing was conducted on LFO System brackets.
Biocompatibility:
A biocompatibility assessment was performed on the proposed modified LFO System to assess the impact of including the nitinol clip to the overall material biocompatibility per ISO 10993-1:2018 and the US FDA's guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." and ANSI/ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry. LFO system brackets are considered mucosal membrane contacting for a duration of greater than 30 days.
The results of the evaluation met the requirements of the standards as identified above.
Substantial Equivalence:
Lightforce Orthodontics claims the LFO System is substantially equivalent to the legally marketed predicate device based on intended use, indication for use, typical clinical use, operational characteristics, and fundamental technological characteristics.
| Characteristic | Proposed | Primary Predicate | Reference Predicate |
|---|---|---|---|
| LFO System | LFO System K222764 | Dentsply International | |
| IN-OVATION C | |||
| brackets K060837 | |||
| Product Codes / | |||
| Regulations | NJM (Orthodontic | ||
| Ceramic Bracket, | |||
| 21CFR 872.5470) | NJM (Orthodontic | ||
| Ceramic Bracket, | |||
| 21CFR 872.5470) | NJM (Orthodontic | ||
| Ceramic Bracket, | |||
| 21CFR 872.5470) | |||
| Indications for | |||
| Use | The LFO System is a | ||
| treatment planning | |||
| software and | |||
| orthodontic appliance | |||
| system used to correct | |||
| malocclusions in | |||
| orthodontic patients | The LFO System is a | ||
| treatment planning | |||
| software and | |||
| orthodontic appliance | |||
| system used to correct | |||
| malocclusions in | |||
| orthodontic patients | The In-Ovation C is an | ||
| orthodontic appliance | |||
| system used to correct | |||
| malocclusions in | |||
| orthodontic patients | |||
| using off-the-shelf | |||
| orthodontic systems. |
| Table 5-1. Side-by-Side Comparison of the LFO System with the Predicate Device |
|---|
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| Characteristic | Proposed | Primary Predicate | Reference Predicate |
|---|---|---|---|
| LFO System | |||
| using patient-matched | |||
| orthodontic appliances. | LFO System K222764 | ||
| using patient-matched | |||
| orthodontic appliances. | Dentsply International | ||
| IN-OVATION C | |||
| brackets K060837 | |||
| Sequence of | |||
| Treatment Plan | |||
| or Mode of Use | LightForce | ||
| Orthodontics (LFO) | |||
| receives the patient's | |||
| digital data via | |||
| commercially available | |||
| communications tools | |||
| from the DDS/DMD. | |||
| LFO prepares a final | |||
| tooth setup and bracket | |||
| placement plan and | |||
| returns the digital data | |||
| back to the DDS/DMD. | |||
| The orthodontist can | |||
| then view, measure and | |||
| modify the case using | |||
| the TPS. Once | |||
| approved, brackets and | |||
| jigs are manufactured | |||
| and shipped to the | |||
| DDS/DMD. | LightForce | ||
| Orthodontics (LFO) | |||
| receives the patient's | |||
| digital data via | |||
| commercially available | |||
| communications tools | |||
| from the DDS/DMD. | |||
| LFO prepares a final | |||
| tooth setup and bracket | |||
| placement plan and | |||
| returns the digital data | |||
| back to the DDS/DMD. | |||
| The orthodontist can | |||
| then view, measure and | |||
| modify the case using | |||
| the TPS. Once | |||
| approved, brackets and | |||
| jigs are manufactured | |||
| and shipped to the | |||
| DDS/DMD. | In-Ovation C brackets | ||
| are manufactured by | |||
| Dentsply International | |||
| and shipped to the | |||
| DDS/DMD or a reseller. | |||
| Bracket Material | Ceramic | Ceramic | Ceramic |
| Clip material | Nickel | ||
| Titanium | N/A | Cobalt chromium, | |
| known to contain | |||
| Nickel | |||
| Clip | |||
| Biocompatibility | |||
| Surface | |||
| Treatment | Electropolished NiTi or | ||
| Gold Rhodium Coating | N/A | Gold Rhodium Coating | |
| Manufacturing | |||
| Method | 3D Printed | 3D printed | Injection molded |
| Analysis | |||
| Methods | N/A | N/A | N/A |
| Characteristic | Proposed | Primary Predicate | Reference Predicate |
| LFO System | LFO System K222764 | Dentsply International | |
| IN-OVATION C | |||
| brackets K060837 | |||
| Non-sterile, | |||
| single use | Yes | Yes | Yes |
| Bracket Base | Mechanical Lock Base | Mechanical Lock Base | Mechanical Lock Base |
| Bracket Design | Arch wire slot, tie | ||
| wings for ligature, and | |||
| identification marks for | |||
| placement. Hooks for | |||
| ligation, for additional | |||
| tooth movement. A | |||
| ceramic body with | |||
| rounded corners and | |||
| edges. Slot to hold | |||
| orthodontic wires. | |||
| Self-ligating metal clip | |||
| to retain orthodontic | |||
| wires. | Arch wire slot, tie | ||
| wings for ligature, and | |||
| identification marks for | |||
| placement. Hooks for | |||
| ligation, for additional | |||
| tooth movement. A | |||
| ceramic body with | |||
| rounded corners and | |||
| edges. Slot to hold | |||
| orthodontic wires. | |||
| Non-self-ligating | Arch wire slot, tie | ||
| wings for ligature, and | |||
| identification marks for | |||
| placement. Hooks for | |||
| ligation, for additional | |||
| tooth movement. A | |||
| ceramic body with | |||
| rounded corners and | |||
| edges. Slot to hold | |||
| orthodontic wires. | |||
| Self-ligating metal clip | |||
| to retain orthodontic | |||
| wires. |
7
Additional reference predicate device with the same chemical composition as the LFO clip material:
- CDB Self Ligating Bracket 8F (K160957) by CDB Corporation. CDB Self Ligating ● Bracket 8F is a self ligating ceramic bracket with a Nickel titanium clip.
Conclusion:
Based on the information provided in Table 5-1 and the results from the nonclinical performance testing and the biocompatibility assessment the LFO System brackets with the inclusion of optional metal clips are substantially equivalent to the listed predicate device in terms of indications for use and technological characteristics and effective. Further, any
8
differences are considered minor and do not raise new issues of safety and effectiveness of the LFO System when compared to the predicate device.