(1 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software for treatment planning and manufacturing patient-specific brackets based on orthodontist input.
Yes.
The device is used to correct "malocclusions in orthodontic patients," which indicates a therapeutic purpose of treating an abnormal dental condition.
No
The device is described as a "treatment planning software and orthodontic appliance system." While the orthodonist uses the TPS to "diagnose the patient, plan treatment, and position the orthodontic brackets," the primary function of the system is treatment planning and correction of malocclusions, not diagnosis itself. The outcome is a prescription for orthodontic brackets, not a diagnostic finding.
No
The device is described as a "treatment planning software and orthodontic appliance system" and explicitly includes "patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates" as components of the system, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- LightForce Orthodontic System Function: The LightForce Orthodontic System is used to correct malocclusions in orthodontic patients. It involves treatment planning software and patient-matched orthodontic appliances (brackets). These devices are applied to the patient's teeth to physically move them.
- Lack of Sample Testing: The description does not mention any testing of samples taken from the patient's body. The input is a "digital impression of the patient," which is a representation of the teeth, not a biological sample.
Therefore, based on the provided information, the LightForce Orthodontic System is a therapeutic device used for orthodontic 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 (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital impression of the patient
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthodontists, DDS/DMD
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
Bench testing was performed to ensure that the patient-specific brackets were similar to the LFO System predicate, Signature Orthodontic System. Performance testing consisted of shear bond strength and torque strength. Tensile testing, wire friction testing and bracket strength (fracture) testing were also completed as comparison tests.
- Shear bond strength is the load per unit area required to remove a bonded bracket from a tooth when a shear force is applied in the occlusal-gingival direction. The shear bond strength of LFO System brackets is equivalent to or better than the predicate device.
- Torque strength is the torque exerted on the bracket at fracture, when subjected to arch wire torsion. The torque strength of LFO System brackets is equivalent to or better than the predicate device.
- Friction (wire draq) force is the force required to drag a ligated stainless-steel wire through the primary slot of the bracket. The friction (wire drag) force of the LFO System brackets is equivalent to the predicate device.
- Tensile bond strength is the load per unit area required to remove a bonded bracket from a tooth when a tensile force is applied to a stainless-steel wire ligated to the primary slot of the bracket. The tensile bond strength of LFO System brackets is equivalent to the predicate device.
- Tie-wing tensile fracture strength is the fracture strength of the tie-wing complex when a tensile load is placed directly under the tie wing. The tie wing tensile fracture strength of LFO System brackets is equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Signature Orthodontics' Signature Orthodontic System (K181271)
Reference Device(s)
Not Found
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). 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 ADMINISTRATION" in blue text.
September 14, 2022
LightForce Orthodontics % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222764
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 12, 2022 Received: September 13, 2022
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 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.
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
2
Indications for Use
510(k) Number (if known) K22764
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 S |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab 5
510(k) Summary
510(k) SUMMARY LightForce Orthodontics' LightForce Orthodontic System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared LightForce Orthodontics 44 Third Ave Burlington, MA 01803
Phone: 800-481-0185 Email: kelsey@lightforceortho.com
Contact Person: Kelsey Fafara
Date Prepared: August 10, 2022
Name of Device and Name/Address of Sponsor
LightForce Orthodontic System
LightForce Orthodontics 44 Third Ave Burlington, MA 01803
Trade/Proprietary Name of Device: LightForce Orthodontic System
Common or Usual Name: Orthodontic Ceramic Bracket and Accessory
Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470
Regulatory Class: II
Product Code: NJM
Predicate Devices:
Primary Predicate: Signature Orthodontics' Signature Orthodontic System (K181271)
Trade/Proprietary Name of Device: Signature Orthodontic System
Common or Usual Name: Orthodontic Ceramic Bracket and Accessory
4
Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470, Product code: NJM
Device Description
The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
Intended Use / Indications for Use
The indications for use are the same between this submission and the primary predicate K181271.
The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
The LightForce Orthodontic System in the primary predicate (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. This current submission provides hardware updates to the hardware delivered in the primary predicate.
Technological Characteristics
LightForce Orthodontic System is similar to other legally marketed devices - while the patient-specific ceramic brackets are equivalent to the Signature Orthdontic Brackets of K181271. Table 6-1 provides a comparison of the LFO System to the predicate devices.
The LFO System patient-specific brackets, like its predicate Signature Orthodontic, are composed of a polycrystalline alumina with a twin bracket design consisting of tie-wings for ligation, a primary arch wire slot and auxiliary slots. There are rounded corners and edges along with a rounded hook on the distal-gingival tie wing of canine brackets to accommodate accessories during orthodontic treatment. These design features allow a ligature wire, in tension, to move the bonded brackets along a designated path until the desired tooth position is
5
achieved. The brackets are non-self-ligating with a mechanical locking base design and built through additive manufacturing methods.
Non-clinical Performance Testing
Bench testing was performed to ensure that the patient-specific brackets were similar to the LFO System predicate, Signature Orthodontic System. Performance testing consisted of shear bond strength and torque strength. Tensile testing, wire friction testing and bracket strength (fracture) testing were also completed as comparison tests.
-
- Shear bond strength is the load per unit area required to remove a bonded bracket from a tooth when a shear force is applied in the occlusal-gingival direction. The shear bond strength of LFO System brackets is equivalent to or better than the predicate device.
-
- Torque strength is the torque exerted on the bracket at fracture, when subjected to arch wire torsion. The torque strength of LFO System brackets is equivalent to or better than the predicate device.
-
- Friction (wire draq) force is the force required to drag a ligated stainless-steel wire through the primary slot of the bracket. The friction (wire drag) force of the LFO System brackets is equivalent to the predicate device.
-
- Tensile bond strength is the load per unit area required to remove a bonded bracket from a tooth when a tensile force is applied to a stainless-steel wire ligated to the primary slot of the bracket. The tensile bond strength of LFO System brackets is equivalent to the predicate device.
-
- Tie-wing tensile fracture strength is the fracture strength of the tie-wing complex when a tensile load is placed directly under the tie wing. The tie wing tensile fracture strength of LFO System brackets is equivalent to the predicate device.
Clinical Performance Testing
No clinical performance testing was conducted on LFO System brackets.
Device Comparison Tables
The following table, Table 5-2, provide a comparison of the device features, functions, and performance characteristics between the LightForce Orthodontic System (LFO System) and its predicate devices.
| Table 5-2: Comparison of LFO System and Predicate Devices | |||
|---|---|---|---|
| ITEM | PRIMARY PREDICATE | ||
| Signature Orthodontic | |||
| System K181271 | LightForce Orthodontic | ||
| System | Similarities | ||
| or | |||
| differences | |||
| Description | The Signature Orthodontic | ||
| System (SO System) is a | |||
| treatment planning software | |||
| (TPS) and orthodontic | |||
| appliance system used to | |||
| correct malocclusions in | |||
| orthodontic patients using | |||
| patient-matched | |||
| orthodontic appliances. | |||
| The SO System | |||
| consists of patient-specific | |||
| ceramic brackets, patient- | |||
| specific bracket placement | |||
| jigs, arch wire templates, and | |||
| a TPS for viewing, measuring, | |||
| and modifying cases. | |||
| Signature | |||
| Orthodontics' (SO) operators | |||
| and the orthodontists use the | |||
| TPS to generate a prescription | |||
| of their choosing. SO then | |||
| manufactures the | |||
| patient-specific brackets and | |||
| placement jigs using | |||
| proprietary additive | |||
| manufacturing techniques. The | |||
| orthodontist then bonds | |||
| the brackets to the teeth using | |||
| the optional placement jig and | |||
| ligates wires to enable tooth | |||
| movement. The SO System | |||
| does not contain | |||
| commercially-available or | |||
| patient-specific shaped arch | |||
| wires, ligatures, or adhesives | |||
| that affixes the brackets to the | |||
| teeth. | The LightForce Orthodontic | ||
| System (LFO System) is a | |||
| treatment planning software | |||
| (TPS) 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 bracket placement | |||
| jigs, arch wire templates, and | |||
| a TPS for viewing, measuring, | |||
| and modifying cases. | |||
| LightForce | |||
| Orthodontics' (LFO) operators | |||
| and the orthodontists use the | |||
| TPS to generate a prescription | |||
| of their choosing. LFO then | |||
| manufactures the | |||
| patient-specific brackets and | |||
| placement jigs using | |||
| proprietary additive | |||
| manufacturing techniques. The | |||
| orthodontist then bonds | |||
| the brackets to the teeth using | |||
| the optional placement jig and | |||
| ligates wires to enable tooth | |||
| movement. The | |||
| LFO System does not contain | |||
| commercially-available or | |||
| patient-specific shaped arch | |||
| wires, ligatures, or adhesives | |||
| that affixes the brackets to the | |||
| teeth. | Identical | ||
| Product | |||
| Codes / | |||
| Regulations | NJM (Orthodontic Ceramic | ||
| Bracket, 21CFR§872.5470) | NJM (Orthodontic Ceramic | ||
| Bracket, 21CFR§872.5470) | Identical | ||
| Indications | |||
| for Use | The Signature Orthodontic | ||
| System is a treatment planning | |||
| software and orthodontic | |||
| appliance system used to | |||
| correct malocclusions in | |||
| orthodontic patients using | The LightForce Orthodontic | ||
| System is a treatment planning | |||
| software and orthodontic | |||
| appliance system used to | |||
| correct malocclusions in | |||
| orthodontic patients using | Identical | ||
| patient-matched orthodontic | |||
| appliances. | patient-matched orthodontic | ||
| appliances. | |||
| Sequence | |||
| of | |||
| Treatment | |||
| Plan or | |||
| Mode of | |||
| Use | Signature Orthodontics (SO) | ||
| receives the patient's digital | |||
| data via commercially | |||
| available communications | |||
| tools from the DDS/DMD. SO | |||
| 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. | Identical | ||
| Bracket | |||
| Material | Polycrystalline Alumina | ||
| Ceramic | Ceramic | Identical | |
| Manufactur | |||
| ing Method | 3D printed | 3D Printed | Identical |
| Analysis | |||
| Methods | N/A | N/A | Identical |
| Non-sterile, | |||
| single use | Yes | Yes | Identical |
| Bracket | |||
| Base | Mechanical Lock Base | Mechanical Lock Base | Identical |
| Bracket | |||
| Design | Arch wire slot, tie wings for | ||
| ligature, and identification | |||
| marks for placement. Hooks | |||
| for ligation, for additional tooth | |||
| movement. Printed 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. Printed ceramic | |||
| body with rounded corners and | |||
| edges. Slot to hold orthodontic | |||
| wires. Non-self-ligating | Identical |
6
7
Substantial Equivalence
The LightForce Orthodontic System (LFO System) is the same as the predicate device; Signature Orthodontic Brackets. The LFO System has the same intended uses/indication for uses, technological characteristics, and principles of operation as its predicate devices. The performance data provided above demonstrates that the LFO System performs at an equivalent
8
or better level compared to Signature Orthodontic Brackets. The minor technological differences between the LFO System and the predicate device, Signature Orthodontic brackets, raise no new issues. There are no alterations in the intended use or the underlying technology or science involved. Thus, the LightForce Orthodontic System is the same as its predicates.
Conclusion
Additionally, the LFO System has the same intended use, composition, design, function, physical properties and performance as its predicate devices. As shown in our performance data, the difference in manufacturing method does not impact the device's intended use and performance. The results from the nonclinical performance testing and the biocompatibility assessment demonstrate that LFO System brackets, along with the appropriate arch wires, constitute standard orthodontic appliances which are equivalent to existing appliances used in the clinical environment.