(99 days)
No
The description focuses on traditional manufacturing processes (thermoforming, 3D printing) based on digital scans and clinician approval, with no mention of AI/ML in the design or planning process.
No
The device corrects dental malocclusion, which is a structural issue, and does not treat or diagnose a disease or condition, which aligns with the definition of a non-therapeutic device.
No
The device is indicated for correcting dental malocclusion, not for diagnosing it.
No
The device description clearly states that the device is comprised of physical aligner trays, which are hardware components. While digital processes are used in the design and manufacturing, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ClearPath Aligner's Function: The ClearPath Aligner is a physical device used to mechanically correct the position of teeth. It does not analyze biological specimens or provide diagnostic information based on such analysis.
- Intended Use: The intended use is for the "correction of dental malocclusion," which is a physical manipulation of teeth, not a diagnostic process.
- Device Description: The description focuses on the physical properties and manufacturing process of the aligners, not on any diagnostic capabilities.
- Input: The input is physical or scanned impressions of the patient's teeth, which are used for creating a physical model for the aligners, not for diagnostic testing.
Therefore, the ClearPath Aligner falls under the category of a medical device used for treatment (orthodontic correction), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The ClearPath clear aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription.
The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked.
The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
physical or scanned impressions of the patient's teeth
Anatomical Site
dental
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars).
Intended User / Care Setting
dental health professional (dentist/orthodontist)
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 performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan.
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.
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/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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
January 5, 2021
ClearPath Orthodontics Ltd % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K202857
Trade/Device Name: ClearPath Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 25, 2020 Received: September 28, 2020
Dear Patsy Trisler:
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.
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
1
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).
Sincerely,
For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202857
Device Name
ClearPath Aligner
Indications for Use (Describe)
The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner 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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K202857
510(k) SUMMARY
| SUBMITTER | |
|---|---|
| Submitter Name: | ClearPath Orthodontics, Ltd |
| Submitter Address: | 6-N Main Boulevard |
| Johar Town | |
| Lahore-Pakistan, 54000 | |
| Contact Person: | Dr. Waqas Wahab, Chief Executive Officer |
| Email: | Waqas.wahab@clearpathortho.com |
| Telephone: | +92 322 491 33 77 |
| Date Prepared: | September 25, 2020 |
| DEVICE | |
| Device Trade Name: | ClearPath Aligner |
| Common Name: | Aligner, Sequential (Clear Braces) |
| Classification Name | |
| Number | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| Product Code | NXC |
| Regulatory Class | 2 |
| Review Panel | Dental |
| PREDICATE DEVICE | Primary Predicate: |
| K162609, ClearPath Aligner, ClearPath Orthodontics | |
| Reference Device: | |
| K180941 Ortho System™, 3Shape A/S | |
| DEVICE | |
| DESCRIPTION | The ClearPath clear aligner is comprised of a series of clear, |
| thin, thermoformed removable aligner trays that are designed to | |
| correct tooth malocclusions without the use of conventional | |
| wire and bracket orthodontic technology. The aligners are | |
| provided non-sterile and are customized for each patient | |
| according to the dental clinician's prescription. |
The dental health professional (dentist/orthodontist) takes
provides physical or scanned impressions of the patient's teeth
to ClearPath. A digital setup of either the scanned impression
or a scan of the physical impression is sent to the clinician for
approval. Upon approval, molds are then created with 3D-
printing technology and the clear aligners are thermoformed on
the molds and laser marked.
The finished, customized aligners are provided to the dental
health care professional who provides them to the patient,
confirming fit and design. The aligner trays are held in place by
pressure and can be removed by the patients at any time. |
| MECHANISM OF
ACTION | Based on a clinician's prescribed treatment plan, each aligner in
the set is used for the specified period of time to exert gentle
force to achieve progressive realignment of the teeth until the
final correction has been achieved. Standard treatment time for
each aligner tray is 2-3 weeks, worn by patient for 22 hours per
day. |
| SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS | The thermoplastic materials used for the manufacture of the
ClearPath aligner is the same material used to make the
predicate ClearPath Aligner. |
| | The software system used is Ortho Analyzer, 2019 ver 1.8.1.0
by 3Shape A/S (Reference device - K180941). It is used for
management of 3D scanned orthodontic models, orthodontic
diagnosis by measuring, analyzing, inspecting and visualizing
3D scanned orthodontic models, virtual planning of orthodontic
treatments by simulating tooth movements, and design of
orthodontic appliances based on 3D scanned orthodontic
models. |
| INDICATIONS FOR
USE STATEMENT | The ClearPath Aligner is a series of clear, lightweight, plastic
appliances indicated for the correction of dental malocclusion in
patients with permanent dentition (i.e. all second molars). The
ClearPath Aligner positions teeth by way of continuous gentle
force. |
| SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable material
used to make the ClearPath Aligner has been provided to FDA
previously. |
| | ISO 10993-5 Cytotoxicity Testing of the finished thermoformed
aligner was provided. |
| PERFORMANCE
TESTING | Bench testing was performed to validate the manufacturing
process: to ensure the accuracy of the final thermoformed
aligner compared to the initial digital scan. |
| | In vivo Animal and Human Clinical performance testing are not
required for this device category. |
| COMPARISON TO
THE PREDICATE
DEVICE | The ClearPath Aligner has the same intended use as the
predicate device. There are no fundamental technological
differences between the Predicate and the modified device.
The difference between the new and predicate devices is in the
use of the referenced software during specified steps in the
manufacturing process. |
| SUBSTANTIAL
EQUIVALENCE
CONCLUSION | The information and data provided in this 510(k) establish that
the ClearPath Aligner is substantially equivalent to the predicate
ClearPath Aligner in the intended use, design, principle of
operation, technology, and thermoformable material used to
make the aligner. Comparison of all key parameters are
presented in the following SE Comparison table |
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5
| | Proposed Device | Predicate Device
K162609 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ClearPath Aligner | ClearPath Aligner |
| Manufacturer | ClearPath Orthodontics, Ltd | ClearPath Orthodontics, Ltd |
| Classification
Regulation Name
Product Code
Class | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 |
| Indications for
Use | The ClearPath Aligner is a series of
clear, lightweight, plastic appliances
indicated for the correction of dental
malocclusion in adult and
adolescent patients with permanent
dentition (i.e. all second molars).
The ClearPath Aligner positions
teeth by way of continuous gentle
force. | The ClearPath Aligner is a series of
clear, lightweight, plastic appliances
indicated for the correction of dental
malocclusion in patients with
permanent dentition (i.e. all second
molars). The ClearPath Aligner
positions teeth by way of continuous
gentle force. |
| Mode of Action | The appliance applies gentle forces
on teeth according to the plan
prescribed by the doctor. | The appliance applies gentle forces
on teeth according to the plan
prescribed by the doctor. |
| Description of
Use | Each removable preformed plastic
tray is worn by the patient as
prescribed by the doctor, usually a
few weeks prior to using the next
sequential aligner tray. | Each removable preformed plastic
tray is worn by the patient as
prescribed by the doctor, usually a
few weeks prior to using the next
sequential aligner tray. |
| Material | Thermoformed plastic | Thermoformed plastic |
| Software Used | Yes, for treatment planning and 3D
printing of models. | No |
| Prescription Use | Rx | Rx |
| Biocompatibility | Yes, shown to meet requirements | Yes, shown to meet requirements |
| Validation
Testing | Yes, performed | Yes, performed. |