(352 days)
Not Found
No
The document describes a physical dental aligner and its manufacturing process, with no mention of AI or ML technology.
Yes
The ClearPath Aligner is indicated for the correction of dental malocclusion, which is a therapeutic purpose.
No
The ClearPath Aligner is for the correction of dental malocclusion, which is a treatment rather than a diagnostic function.
No
The device description clearly states the device is a physical, thermoformed plastic aligner, not software.
No, based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- ClearPath Aligner Function: The ClearPath Aligner is a physical device used to apply force to teeth for orthodontic correction. It directly interacts with the patient's anatomy (teeth and mouth) and does not involve the examination of biological specimens in vitro.
- Intended Use: The intended use is for the "correction of dental malocclusion," which is a physical treatment, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics of the aligner (material, manufacturing, use) and not on any diagnostic capabilities.
The ClearPath Aligner is a medical device, specifically an orthodontic appliance, but it does not fit the definition of an In Vitro Diagnostic.
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 for minor anterior tooth movement 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
patients with permanent dentition (i.e. all second molars)
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)
No bench testing was warranted for this product because the scientific literature and similarity in design, materials and use to the predicate devices assure that the preformed aligners are safe and effective for the specified intended use.
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.
Not Found
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
ClearPath Aligner Premarket Notification: Traditional 510(k)
510(k) Summary
| Submitter Name: | ClearPath Orthodontics | |
|---|---|---|
| Submitter Address: | 54E/1, D/1, Gulberg III, Lahore, Pakistan, 54000 | |
| Phone Number: | 00 92 42 35752012 | |
| Contact Person: | Dr. Waqas Wahab | |
| Date Prepared: | 09 November 2012; Revised 24 October 2013 | |
| Device Trade Name: | ClearPath Aligner | |
| Common Name | Clear Braces | |
| Classification Name, Number & Product Code: | Orthodontic Plastic Bracket 21 CFR 872.5470 NXC | NOV 0 1 2013 |
| Predicate Devices: | K073121 - NuBrace Invisible Removable Orthodontics (IRO), NuBrace, Inc. K981095 - Align System, Align Technology Inc. | |
| 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 for minor anterior tooth movement 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/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. |
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| Performance
Testing | No bench testing was warranted for this product because the
scientific literature and similarity in design, materials and use to
the predicate devices assure that the preformed aligners are safe
and effective for the specified intended use. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to the
Predicate Devices | The ClearPath Aligner was compared to the two predicate devices
with respect to indications for use, design, material composition,
and the mechanism of action (gentle continuous pressure on
teeth). |
| Substantial
Equivalence
Conclusion | Based upon the same intended use compared to the predicates,
the similar base materials used for fabricating the aligners, the
same basic design, and the same mechanism of action, it can be
concluded that the ClearPath Aligner is substantially equivalent to
the predicate devices. |
| Verifications
regarding this
510(k) Summary | The summary includes only information that is also covered in the
body of the 510(k). The summary does not contain any puffery or
unsubstantiated labeling claims. The summary does not contain
any raw data, i.e., contains only summary data. The summary
does not contain any trade secret or confidential commercial
information. The summary does not contain any patient
identification information. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion 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
November 1, 2013
ClearPath Orthodontics C/O Ms. Patsy J. Trisler, J.D., RAC Vice President, Regulatory and Clinical Affairs Oserve America, Incorporated 1 54 Main Street, Suite 2 CHARLESTOWN NH 03603
Re: K123514
Trade/Device Name: ClearPath Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: October 24, 2013 Received: October 30, 2013
Dear Ms. 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. 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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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,
Mary[S]Bünner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K123514
Device Name: ClearPath Aligner
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 for minor anterior tooth movement by way of continuous gentle force.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen -S 2013.10.31 16:13:12 124
Section 4.0
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