(376 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on the physical properties and mechanism of the aligners.
Yes
The device is indicated for the treatment of tooth malocclusion, and it positions teeth by way of continuous gentle force, which directly impacts the body to treat a condition.
No
The Byte Aligner System is described as a device that "positions teeth by way of continuous gentle force" and "repositions the teeth," indicating a therapeutic rather than diagnostic function. It is used to treat "tooth malocclusion," which is a condition it corrects, not diagnoses.
No
The device description explicitly states the device is a series of physical dental aligners made of plastic, which are hardware components.
Based on the provided information, the Byte Aligner System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of tooth malocclusion," which is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical appliance used to reposition teeth, not a test or reagent used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The Byte Aligner System does not fit this definition.
N/A
Intended Use / Indications for Use
The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Byte Aligner System is a series of Byte dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Individuals with permanent dentition
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)
Biocompatibility analysis demonstrates that the Byte Aligner System is in compliance with ISO 10993. Testing included:
Cytotoxicity
Sensitization
Information was provided to demonstrate that PETG is commonly used for dental appliances and in other aligners.
Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling.
Straight Smile validated the manufacturing process of the Byte aligners, demonstrating that the process can adequately render the final device as specified by appropriate FDA-cleared design software.
Straight Smile validated the 2-year shelf life of the aligners with real-time testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Straight Smile, LLC % Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda, California 94501
February 19, 2019
Re: K180346
Trade/Device Name: Byte Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 24, 2018 Received: November 26, 2018
Dear Craig Coombs:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.02.19
19:02:26 -05'00'
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180346
Device Name Byte Aligner System
Indications for Use (Describe)
The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.
| 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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K180346: 510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Straight Smile, LLC; dba: Byte |
| 370 Alabama St., Ste K | |
| Redlands, California 92373 | |
| Office phone: 1.818.231.2363 | |
| Fax Number: 1.512.727.0429 | |
| E-mail: sabbasi@byteme.com | |
| Contact: Sepi Abbasi, Managing Member | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Sequential Aligners |
| Device Classification Number: | 21 CFR 872.5470 |
| Device Classification & | |
| Product Code: | Class II, |
| NXC | |
| Device Proprietary Name: | Byte Aligner System |
Predicate Device Information:
| Predicate Device: | ClearCorrect System |
|---|---|
| Predicate Device Manufacturer: | ClearCorrect, Inc |
| Predicate Device Common Name: | Sequential Aligners |
| Predicate Device Premarket Notification # | K113618 |
| Predicate Device Classification: | 21 CFR 872.5470 |
| Predicate Device Classification & | Class 2, |
| Product Code: | NXC |
Reference Device Information:
| Reference Device: | Smart Moves Complete |
|---|---|
| Reference Device Manufacturer: | Great Lakes Orthodontics Ltd |
| Reference Device Common Name: | Sequential Aligners |
| Reference Device Premarket Notification # | K172765 |
| Reference Device Classification: | 21 CFR 872.5470 |
| Reference Device Classification & | |
| Product Code: | Class 2, |
| NXC |
B. Date Summary Prepared
11 February 2019
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C. Description of Device
The Byte Aligner System is a series of Byte dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
D. Indications for Use
The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.
E. Comparison to Predicate/Reference Devices
The Straight Smile Byte Aligner System is substantially equivalent in intended use, indications for use, mode of action, mode of use, design and materials to the predicate ClearCorrect System (K113618).
Both devices have identical Indications for Use, except for the device name, which implies they have the same intended use.
Both devices have the same modes of action and use. Both are a sequential series of rigid aligners that gently pressure the teeth to move in a desired manner. The patient transitions to the next aligner in the series approximately every two weeks. After completing the series, the user's teeth should conform to the desired position.
The application and predicate aligners are made from different base materials. The predicate aligners are made from thermoplastic polyurethane. The Byte aligners are made from thermoplastic PETG. PETG has been used in other dental appliances and aligners, including the reference device Smart Moves Complete sequential aligners (K172765). Straight Smile conducted testing that demonstrated that the PETG material can be manufactured into aligners and meet the same safety and performance criteria as the predicate and reference devices.
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
Straight Smile concludes that the predicate ClearCorrect System (K113618) and the application Byte Aligner System are substantially equivalent.
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Substantial Equivalence Justification Table
| | PREDICATE DEVICE
ClearCorrect System
ClearCorrect, Inc.
K113618 | REFERENCE DEVICE
Smart Moves Complete
Great Lakes Orthodontics Ltd
K172765 | APPLICATION DEVICE
Byte System
Straight Smile, LLC | Substantial Equivalence
Analysis |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Common Name | Sequential Aligner | Sequential Aligner | Sequential Aligner | Identical to both predicate
and reference devices |
| Classification # | 872.5470 | 872.5470 | 872.5470 | Identical to both |
| Product Code | NXC | NXC | NXC | Identical to both |
| Indication for Use | The ClearCorrect System is
indicated for the treatment of
tooth malocclusion in
patients with permanent
dentition (i.e. all second
molars), The ClearCorrect
System positions teeth by
way of continuous gentle
force. | Smart Moves Complete is
indicated for the treatment
of tooth malocclusion in
patients with permanent
dentition (i.e. all second
molars). Smart Moves
Complete positions teeth by
way of continuous gentle
force. | The Byte Aligner System is
indicated for the treatment
of tooth malocclusion in
patients with permanent
dentition (i.e., all second
molars). The Byte Aligner
System positions teeth by
way of continuous gentle
force. | Identical to both, except
for device name |
| Intended Population | Individuals with permanent
dentition | Individuals with permanent
dentition | Individuals with permanent
dentition | Identical to both |
| Mode of Action | Orthodontic tooth movement
occurs through forces applied
by the device to the dentition
as each tooth follows the
programmed displacement
based on a doctor's
prescription. | Orthodontic tooth
movement occurs through
forces applied by the device
to the dentition as each
tooth follows the
programmed displacement
based on a doctor's
prescription. | Orthodontic tooth
movement occurs through
forces applied by the device
to the dentition as each
tooth follows the
programmed displacement
based on a doctor's
prescription. | Identical to both |
| Anatomical Site of Use | Oral cavity | Oral cavity | Oral cavity | Identical to both |
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510(k) Summary K180346: Byte Aligner System
| | PREDICATE DEVICE
ClearCorrect System
ClearCorrect, Inc.
K113618 | REFERENCE DEVICE
Smart Moves Complete
Great Lakes Orthodontics Ltd
K172765 | APPLICATION DEVICE
Byte System
Straight Smile, LLC | Substantial Equivalence
Analysis |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Mode of Use | Each aligner is worn by the
patient as determined by the
treating dental practitioner,
generally for 2 weeks prior to
being replaced by the next
aligner in sequence. This is
repeated for a duration as
prescribed by a Dental
Professional. | Each aligner is worn by the
patient as determined by the
treating dental practitioner,
generally for 2 weeks prior to
being replaced by the next
aligner in sequence. This is
repeated for a duration as
prescribed by a Dental
Professional. | Each aligner is worn by the
patient as determined by the
treating dental practitioner,
generally for 2 weeks prior to
being replaced by the next
aligner in sequence. This is
repeated for a duration as
prescribed by a Dental
Professional. | Identical to both |
| Application | Removable | Removable | Removable | Identical to both |
| Raw Material Used | Thermoplastic polymers
(polyurathane) | Thermoplastic polymers
(polyethylene terephthalate
glycol or PETG) | Thermoplastic polymers
(polyethylene terephthalate
glycol or PETG) | Identical to Reference
device. Used in same way. |
| OTC or Rx | Rx | Rx | Rx | Identical to both |
| Design | Image: ClearCorrect aligner | Image: Smart moves complete aligner | Image: Byte System aligner | Design is developed and
fabricated by similar or
identical processes used by
predicate and reference
devices |
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F. Summary of Supporting Data
Biocompatibility analysis demonstrates that the Byte Aligner System is in compliance with ISO 10993. Testing included:
Cytotoxicity
Sensitization
Information was provided to demonstrate that PETG is commonly used for dental appliances and in other aligners.
Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling.
Straight Smile validated the manufacturing process of the Byte aligners, demonstrating that the process can adequately render the final device as specified by appropriate FDA-cleared design software.
Straight Smile validated the 2-year shelf life of the aligners with real-time testing.
G. Conclusion
The Byte Aligner System is substantially equivalent to the predicate device (ClearCorrect System: K113618) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.