(352 days)
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.
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.
The provided text describes the ClearPath Aligner, a device for correcting dental malocclusion. However, it explicitly states that no performance testing was warranted for this product. Therefore, there is no study described that proves the device meets specific acceptance criteria.
The submission relies on a comparison to predicate devices and asserts substantial equivalence based on similarities in intended use, design, material composition, and mechanism of action.
Given this, I cannot provide a table of acceptance criteria and reported device performance or other details of a study that does not exist for this device.
Here's the information that can be extracted or inferred based on the provided text, along with clarifications for items that are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific acceptance criteria were defined or tested in the provided document. | No device performance data was reported as no bench testing was warranted. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set was used as no performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set was used and therefore no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This product is a physical dental aligner, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established for a performance study. The submission relies on the established safety and efficacy of predicate devices (K073121 - NuBrace Invisible Removable Orthodontics and K981095 - Align System) and scientific literature for the materials used.
8. The sample size for the training set
- Not applicable. No training set was used as no algorithm was developed or tested.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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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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| PerformanceTesting | No bench testing was warranted for this product because thescientific literature and similarity in design, materials and use tothe predicate devices assure that the preformed aligners are safeand effective for the specified intended use. |
|---|---|
| Comparison to thePredicate Devices | The ClearPath Aligner was compared to the two predicate deviceswith respect to indications for use, design, material composition,and the mechanism of action (gentle continuous pressure onteeth). |
| SubstantialEquivalenceConclusion | Based upon the same intended use compared to the predicates,the similar base materials used for fabricating the aligners, thesame basic design, and the same mechanism of action, it can beconcluded that the ClearPath Aligner is substantially equivalent tothe predicate devices. |
| Verificationsregarding this510(k) Summary | The summary includes only information that is also covered in thebody of the 510(k). The summary does not contain any puffery orunsubstantiated labeling claims. The summary does not containany raw data, i.e., contains only summary data. The summarydoes not contain any trade secret or confidential commercialinformation. The summary does not contain any patientidentification 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
Page 1 of 1
§ 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.