(290 days)
No reference devices were included
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the physical properties and use of the aligners.
Yes
Explanation: The device is indicated for the correction of dental malocclusion, which is a therapeutic purpose to improve or correct a medical condition (misaligned teeth).
No
The device description indicates it is a series of plastic appliances for the correction of dental malocclusion, acting by positioning teeth through continuous gentle force. This describes a therapeutic device, not one used for diagnosis.
No
The device description clearly states the device is a physical, thermoformed plastic aligner, not software.
Based on the provided information, the ClearPath Aligner is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ClearPath Aligner Function: The ClearPath Aligner is a physical device worn in the mouth to apply force to teeth and correct their position. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use is for the correction of dental malocclusion, which is a physical manipulation of teeth, not a diagnostic test based on biological samples.
Therefore, the ClearPath Aligner falls under the category of a dental device used for treatment, 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 is intended to position teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.
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
treating dentist or 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)
The reason for this 510(k) was to expand the indication to include realignment of all permanent teeth. The predicate ClearPath Aligner (K123514) is intended "for minor anterior tooth movement".
Clinical case reports were submitted in the 510(k) to demonstrate that the aligners can effectively realign all permanent teeth as indicated.
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.
K123514 ClearPath Aligner, ClearPath Orthodontics
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.
No reference devices were included
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ClearPath Orthodontics Ltd c/o Patsy J Trisler, JD, RAC Qserve Group US, Inc. 5600 Wisconsin Avenue #509 Chevy Chase, Maryland 20815
Re: K162609
Trade/Device Name: ClearPath Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 30, 2017 Received: May 30, 2017
Dear Patsy J Trisler, JD, RAC:
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. Isting 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.
July 6, 2017
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,
Mary S. Runner -A
Lori A. Wiggins, MPT, CLT 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
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
510(k) Number (if known) K162609
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 is intended to position 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
510(k) Summary – K162609
| Submitter Name: | ClearPath Orthodontics Ltd |
|---|---|
| Submitter Address: | 6-N, Main Boulevard, Johar Town, Lahore-Pakistan |
| Phone Number: | +92 42 111 333 276 |
| Contact Person: | Dr. Waqas Wahab, Chief Executive Officer |
| Date Prepared: | 19 September 2016; updated 5 July 2017 |
| Device Trade Name: | ClearPath Aligner |
| Common Name | Clear Braces |
| Classification Name | |
| Number | |
| Product Code | |
| Requlatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Predicate Device: | |
| Reference Device: | K123514 ClearPath Aligner, ClearPath Orthodontics |
| No reference devices were included | |
| Statement of | |
| Intended 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 is intended to position teeth by way of | |
| continuous gentle force. | |
| Device Description | ClearPath Orthodontics uses clear, thin, thermoformed plastic |
| material for the manufacture of its ClearPath Aligner. The aligners | |
| are provided non-sterile and are customized for each patient | |
| according to the molds provided by the treating dentist or | |
| orthodontist. | |
| Depending on the patient need and the treatment plan, a series of | |
| aligners may be used. The duration of use for each aligner is 14 | |
| days and it is to be worn except during meals. | |
| Mechanism of Action | Each ClearPath Aligner exerts gentle force to achieve progressive |
| realignment of the teeth until the final correction has been | |
| attained. | |
| Summary of | |
| Technological | |
| Characteristics | ClearPath Orthodontics manufactures the customized aligners |
| based on standard molds sent to the company by the prescribing | |
| dentist or orthodontist. The molds are made after the clinician has | |
| assessed the patient's teeth, designed a treatment plan, and | |
| taken the impressions. | |
| The plastic used for fabrication of the aligners is a commonly used | |
| thermoformed plastic, used in many dental appliances. It has a | |
| long history of safe and biocompatible use for this purpose. |
5
Performance Testing Bench/Animal Testing
No in vitro or animal testing were required for this product because the identical design and materials compared to the predicate device assure that the preformed aligners are capable of performing similarly to the predicate device for the specified intended use.
Clinical Evaluations
The reason for this 510(k) was to expand the indication to include realignment of all permanent teeth. The predicate ClearPath Aligner (K123514) is intended "for minor anterior tooth movement".
Clinical case reports were submitted in the 510(k) to demonstrate that the aligners can effectively realign all permanent teeth as indicated.
Comparison to The ClearPath Aligner is identical to the predicate device. The Predicate Device: difference is the original ClearPath Aligner (predicate) had the indication, as noted, that was limited to anterior tooth movement. The data submitted in the 510(k) support the broader indications for use.
Substantial Equivalence Conclusion
-
Thus, based on: the same intended use, ●
urvivalce
onclusion -
. the same design,
-
identical materials,
-
identical methods used for fabricating the aligners, and
-
. submission of clinical reports that demonstrate the device performs as intended,
it can be concluded that the ClearPath Aligner is substantially equivalent to the predicate device.