(234 days)
No
The summary describes a physical orthodontic bracket and its mechanical properties, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is described as "intended for orthodontic movement of teeth," which is a therapeutic purpose.
No
The device, an orthodontic sapphire bracket, is described as being used for "orthodontic movement of teeth" and to "control the movement of individual teeth," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is an "orthodontic sapphire bracket," which is a physical hardware component used for orthodontic treatment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic movement of teeth." This is a mechanical function performed directly on the patient's body.
- Device Description: The description focuses on the physical properties and function of the bracket in controlling tooth movement.
- Anatomical Site: The anatomical site is "Teeth," which are part of the human body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
The device described is a medical device used for a therapeutic purpose (orthodontic treatment) directly on the patient, not an IVD used for diagnostic purposes on specimens.
N/A
Intended Use / Indications for Use
The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth.
The bracket is used temporarily and is removed upon completion of orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.
The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use only by professional orthodontists
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)
Two tests were preformed on the Chi Lites Orthodontic Sapphire bracket.
A. Fracture testing. Used to determine the maximum amount of force that can be applied to the product during treatment. The Bracket archwire is placed on a calculated wedge designed to split the bracket at full depth of the archwire. Force is then applied to the base of the bracket until the amount of force fractures/splits the bracket. The results are then recorded.
This process was performed on 20 brackets, 10 of the Chi Lites Orthodontic Sapphire bracket and 10 of the predicate bracket. The results show that the Chi Lites Orthodontic Sapphire bracket was stronger than the predicate bracket by almost 2X. Since the predicate bracket is a cleared bracket, we feel the Chi Lites Orthodontic Sapphire Bracket meets the minimum requirements for strength.
B. Bond/Shear Strength. Used to determine the strength of the bonding surface when adhered to the tooth. A UV curing adhesive is applied to the base of the bracket and mounted to the testing surface i.e. porcelain, ceramic or extracted teeth. The Adhesive is cured and the bracket is then tied to a pull test gauge and force is applied until the bracket separates from the bonding surface. The results are then recorded.
This process was performed on 40 brackets 20 of the Chi Lites Orthodontic Sapphire bracket and 20 of the predicate bracket, both of similar size and orientation. The results show both bracket brands averaged within .005% of each other. The Chi Lites Orthodontic Sapphire bracket range of bond strength was within 40% of the average while the predicate was within 45% of its average bond strength. Chi Lites Orthodontic Sapphire bracket proved to be 5% more consistent than the predicate bracket.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fracture testing: The Chi Lites Orthodontic Sapphire bracket was stronger than the predicate bracket by almost 2X.
Bond/Shear Strength: Both bracket brands averaged within .005% of each other. The Chi Lites Orthodontic Sapphire bracket range of bond strength was within 40% of the average while the predicate was within 45% of its average bond strength. Chi Lites Orthodontic Sapphire bracket proved to be 5% more consistent than the predicate bracket.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Progressive Technology, Inc. Ms. Shannon Rogers President 4130 Citrus Ave #17 Rocklin, California 95677
Re: K142729
Trade/Device Name: Chi Lites Orthodontic Sapphire Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: II Product Code: NJM Dated: April 6, 2015 Received: April 6, 2015
Dear Ms. Rogers:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2. Indications for Use
510 (k) Number: K142729
Device Name: Chi Lites Orthodontic Sapphire Bracket
Indications for use:
The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth.
The bracket is used temporarily and is removed upon completion of orthodontic treatment.
Prescription Use x____________________________________________________________________________________________________________________________________________________
Over-the Counter Use ____________
3
5. 510(K) Summary
Preparation Date: September 22, 2014
Company Information:
Shannon Rogers Progressive Technology, Inc. 4130 Citrus Avenue Rocklin, CA 95677
Contact Information:
Shannon Rogers 4130 Citrus Avenue Rocklin, CA 95677 (916) 632-6715 (Phone) (916) 632-9348 (Fax) (916) 202-3109 (Cell) srogers@prgtech.com
Device Information:
Trade Name: Chi Lites Orthodontic Sapphire Bracket Common Name: Ceramic Brackets Classification Name: Orthodontic Plastic Bracket Classification Code: NJM bracket, ceramic, orthodontic Regulation Number: 872.5470 Device Classification: Class II
Equivalent Legally Marketed Devices Information:
| Predicate | 510(k) | Product Name | Device Manufacturer | |
|---|---|---|---|---|
| Primary | K080749 | Radiance | American Orthodontics | |
| Reference | K060837 | In-Ovation C | Dentsply | |
| Device Name/Manufacturer | ||||
| Product | ||||
| Parameter | Chi Lites | |||
| Orthodontic | ||||
| Sapphire Bracket/ | ||||
| Progressive | ||||
| Technology | Radiance / | |||
| American | ||||
| Orthodontics | In-Ovation C / | |||
| Dentsply | Substantial | |||
| Equivalence | ||||
| Analysis | ||||
| 510(k) number | Pending | Primary K080749 | Reference | |
| K060837 | N/A | |||
| Intended Use | The Progressive | |||
| Technology Inc. | ||||
| Chi Lites | ||||
| Orthodontic | ||||
| Sapphire Bracket | ||||
| is a line of single- | ||||
| use devices | ||||
| intended for | ||||
| orthodontic | ||||
| movement of | ||||
| teeth as diagnosed | ||||
| by an | ||||
| orthodontist. | Orthodontic | |||
| treatment is used | ||||
| to correct dental | ||||
| deficiencies and | ||||
| to improve the | ||||
| appearance of the | ||||
| patient. The | ||||
| brackets, arch | ||||
| wire and elastic o- | ||||
| rings form a force | ||||
| system that is | ||||
| designed to | ||||
| gradually move | ||||
| teeth into a | ||||
| normal alignment. | The In-Ovation C | |||
| is intended for | ||||
| orthodontic | ||||
| movement of | ||||
| natural teeth, | ||||
| excluding the | ||||
| mandibular | ||||
| bicuspid teeth. | Equivalent | |||
| Target Population | Patients in need | |||
| of teeth alignment | ||||
| correction | Patients in need | |||
| of teeth alignment | ||||
| correction | Patients in need | |||
| of teeth alignment | ||||
| correction | Equivalent | |||
| Anatomical Site | Teeth | Teeth | Teeth | Equivalent |
| Location of Use | Use only by | |||
| professional | ||||
| orthodontists | Use only by | |||
| professional | ||||
| orthodontists | Use only by | |||
| professional | ||||
| orthodontists | Equivalent | |||
| Technical | ||||
| Characteristics | Chi Lites | |||
| Orthodontic | ||||
| Sapphire brackets | ||||
| are .019 square | ||||
| inches, 5% larger | ||||
| than other | ||||
| brackets. | .018 square | |||
| inches of area in | ||||
| size | .018 square | |||
| inches of area in | ||||
| size | Difference: | |||
| Chi Lites | ||||
| Orthodontic | ||||
| Sapphire brackets | ||||
| are 5% larger, | ||||
| thus increasing | ||||
| the facture | ||||
| toughness. | ||||
| There are no other | ||||
| differences. | ||||
| Single Use | YES | YES | YES | Equivalent |
| Non-Sterile | ||||
| Packaging | YES | YES | YES | Equivalent |
Description of the Device:
Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.
The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
Indications for Use:
The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth.
The bracket is used temporarily and is removed upon completion of orthodontic treatment.
4
5
Performance Testing
Two tests were preformed on the Chi Lites Orthodontic Sapphire bracket.
-
A. Fracture testing. Used to determine the maximum amount of force that can be applied to the product during treatment. The Bracket archwire is placed on a calculated wedge designed to split the bracket at full depth of the archwire. Force is then applied to the base of the bracket until the amount of force fractures/splits the bracket. The results are then recorded.
This process was performed on 20 brackets, 10 of the Chi Lites Orthodontic Sapphire bracket and 10 of the predicate bracket. The results show that the Chi Lites Orthodontic Sapphire bracket was stronger than the predicate bracket by almost 2X. Since the predicate bracket is a cleared bracket, we feel the Chi Lites Orthodontic Sapphire Bracket meets the minimum requirements for strength. -
B. Bond/Shear Strength. Used to determine the strength of the bonding surface when adhered to the tooth. A UV curing adhesive is applied to the base of the bracket and mounted to the testing surface i.e. porcelain, ceramic or extracted teeth. The Adhesive is cured and the bracket is then tied to a pull test gauge and force is applied until the bracket separates from the bonding surface. The results are then recorded.
This process was performed on 40 brackets 20 of the Chi Lites Orthodontic Sapphire bracket and 20 of the predicate bracket, both of similar size and orientation. The results show both bracket brands averaged within .005% of each other. The Chi Lites Orthodontic Sapphire bracket range of bond strength was within 40% of the average while the predicate was within 45% of its average bond strength. Chi Lites Orthodontic Sapphire bracket proved to be 5% more consistent than the predicate bracket.
Summary:
The function and performance of Chi Lites Orthodontic Sapphire bracket is similar to the predicates. There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in cleared orthodontics devices. Since the subject and predicate are similar in design, function and performance, they are substantially equivalent to the predicate device.