(24 days)
3M Clear Tray Aligner K163689
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and software workflow does not mention any AI/ML components. The software used is described as "standard dental software used for tooth alignment."
Yes
The device is indicated for the "treatment of tooth malocclusions" and "sequentially positions teeth by way of continuous gentle force," which describes a therapeutic action.
No
The device, Blue Sky Bio Aligners, is a medical device used for the treatment of tooth malocclusions, not for diagnosis. The diagnostic process (assessment of the patient's teeth) is performed by a dental health professional using standard dental software, and the aligners are then prescribed based on that assessment.
No
The device description clearly states that the Blue Sky Bio Aligners are "a series of clear plastic aligners," which are physical, thermoformed plastic trays. While software is used in the design and ordering process, the final medical device delivered to the patient is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Blue Sky Bio Aligners are physical devices (plastic trays) used to mechanically move teeth to correct malocclusions. They are applied directly to the patient's teeth.
- Intended Use: The intended use is for the treatment of tooth malocclusions, which is a physical correction, not a diagnostic test performed on a specimen.
- Device Description: The description clearly outlines the process of creating and using physical aligners based on molds of the patient's teeth and software planning.
- Input Imaging Modality: While CT images are used in the planning process, they are used to create a model for designing the physical device, not for analyzing a biological specimen.
- Anatomical Site: The device acts on the teeth, maxilla, and mandible, which are parts of the body, not specimens taken from the body.
The software used in the process (Blue Sky Plan) is a medical device software, but the aligners themselves are physical orthodontic appliances, not IVDs.
N/A
Intended Use / Indications for Use
Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC, LLZ
Device Description
Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars).
Intended User / Care Setting
dental health professional (e.g. orthodontist or dentist)
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)
Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting. The material used for the aligners is Essix from Dentsply which has a 510k clearance as an aligner material (K062828) so no performance tests were done on it.
Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Blue Sky Bio Aligners to support the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. This software in a module which can be installed along with Blue Sky Bio Plan (K090607). The software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan.
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.
3M Clear Tray Aligner K163689
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.
Blue Sky Plan K090607, Dentsply Essix K062828
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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.
Blue Sky Bio LLC % Dave Yungvirt Official Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K180107
Trade/Device Name: Blue Sky Bio Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: January 11, 2018 Received: January 16, 2018
Dear Dave Yungvirt:
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.
February 9, 2018
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); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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.
Mary S. Runner -S
For Tina Kiang, Ph.D Acting Division Director Science and Policy Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 Indications for Use
3
Indications for Use
510(k) Number (if known)
Device Name Blue Sky Bio Aligners
Indications for Use (Describe)
Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
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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4
Section 5 510(k) Summary or Statement
5
510(k) Summary
Blue Sky Bio Aligners
Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake. IL 60030
718-376-0422
www.blueskybio.com
Contact Person: Albert Zickmann
| General Information | |
|---|---|
| Trade Name | Blue Sky Bio Aligners |
| Common Name | Sequential Aligner |
| Predicate 510(k) | 3M Clear Tray Aligner K163689 |
| Reference Predicates | Blue Sky Plan K090607 and Dentsply Essix |
| K062828 | |
| Product Code | NXC, LLZ |
| Regulation No. | 872.5470 Orthodontic Plastic Bracket |
| Classification | Class II |
Device Description:
Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
6
The technology is essentially identical to that used by a number of sequential aligner systems including the predicate device, 3M Clear Tray Aligners.
Indications for Use:
Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
Technological Characteristics:
Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves the teeth to a desired final position is the technological principle for both the subject device and the predicate device. A comparison between the technological characteristics of Blue Sky Bio Aligners and that of 3M Clear Tray aligners has been performed. The results of this comparison demonstrate that the design, technology, materials, and composition of Blue Sky Bio Aligners are substantially equivalent to the predicate devices.
Mechanism of Action:
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied to the teeth by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
Performance Testing:
Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting. The material used for the aligners is Essix from Dentsply which has a 510k clearance as an aligner material (K062828, MQC unclassified) so no performance tests were done on it.
Biocompatibility Testing:
The material used for the Blue Sky Bio aligners has a 510k clearance as an aligner material so no biocompatibility testing was performed.
Software Verification and Validation Testing:
Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Blue Sky Bio Aligners to support the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. This software in a module which can be installed along with Blue Sky Bio Plan (K090607). The software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan.
7
Predicate Device Comparison Table
| | Blue Sky Bio Aligners | 3M Clear Tray Aligners
K163689 | Blue Sky Plan
K090607 | Dentsply Essix
K062828 | | | | hardware using
a Windows
operating
system. | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 870.2050 | unclassified | Mode of
action | Orthodontic tooth
movement
occurs through forces
applied
by the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription.
Imaging software has
added module for
ordering and processing
of aligners. | Orthodontic tooth
movement
occurs through forces
applied
by the appliance to the
dentition as each tooth
follows the
programmed
displacement based on a
doctor's prescription. | Imaging
software | Orthodontic
tooth
movement
occurs
through
forces applied
by the
appliance to
the
dentition as
each tooth
follows the
programmed
displacement
based on a
doctor's
prescription. |
| Device
Classification
Name/Device
Common
Name | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Picture archiving
and
communications
system | Aligner
material | Material | Essix Thermoplastic | Thermoplastic | none | Essix
Thermoplastic |
| Product Code | NXC, LLZ | NXC | LLZ | NXC | Material
Properties | Demonstrates sufficient
tensile strength,
elasticity,
ductility, chemical
resistance,
and clarity for use as a
clear tray aligner.
510k cleared sheet
material for this
indication. | Demonstrates
sufficient
tensile strength,
elasticity,
ductility, chemical
resistance,
and clarity for use as a
clear tray aligner. | | Demonstrates
sufficient
tensile
strength,
elasticity,
ductility,
chemical
resistance,
and clarity for
use as a clear
tray aligner.
510k cleared
sheet
material for
this
indication. |
| Classification | II | II | II | none | Function of
the software | Software used for
ordering workflow.
Ortho module facilitates
ordering and processing
of the aligners.
Blue Sky Plan™ is dental
imaging software which | Software used for
ordering workflow.
Facilitates ordering and
processing of the
aligners. | Blue Sky Plan™ is
dental imaging
software which
loads DICOM
images and
provides 3D
visualization, 2D
image
reformation for | none |
| Indications
for use | Blue Sky Bio Aligners are
a series of clear,
lightweight, plastic
appliances indicated for
the treatment of tooth
malocclusions in patients
with permanent
dentition (i.e., all second
molars). Utilizing a series
of incremental tooth
movements, it
sequentially positions
teeth by way of
continuous gentle force. | The 3M Clear Tray
Aligner System is a
series of clear,
lightweight, plastic
appliances indicated for
the treatment of tooth
malocclusions in
patients with
permanent dentition
(i.e., all second molars).
Utilizing a series of
incremental tooth
movements, it
sequentially positions
teeth by way of
continuous gentle
force. | Blue Sky Plan is
intended to be
used as
conversion
software for
Computed
Tomography
(CT)
generated
DICOM images
into a format
that allows a
dentist to assess
the anatomic
topography of
the maxilla and
mandible as well
as location of
important
structures. It
allows the
information to
be
used for pre-
surgical
treatment
planning of
dental implant
procedures. The
Blue Sky Plan
software
is deployed on
standard
personal
computer | Aligner
materials are
indicated for
the
fabrication of
orthodontic
appliances. | | | | | |
8
9
| | loads DICOM images and
provides 3D
visualization, 2D image
reformation for surgical
implant planning and
stent fabrication, which
allows the virtual
position of implants from
the images supplied by
computerized
tomography. | surgical implant
planning and
stent
fabrication,
which
allows the
virtual position
of implants from
the images
supplied by
computerized
tomography. | |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Design | Image: clear aligner | Image: clear aligner | |
Conclusion:
Blue Sky Bio Aligners have substantially equivalent Indications for Use as the identified predicate and reference devices.
Blue Sky Bio Aligners are as safe, as effective, and are substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility. Blue Sky Bio Aligners are made from reference predicate device Essix from Dentsply so there can be no differences between them.