(65 days)
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
The provided text describes a 510(k) Pre-market Notification for the "Hyperelastic Archwire." This notification focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, the information typically requested about acceptance criteria and clinical study results for software as a medical device (SaMD) or AI-powered devices is largely not applicable in this context.
Here's an analysis based on the provided text, addressing the requested points where possible, and indicating where information is not available or not relevant for this type of device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Hyperelastic Archwire vs. Predicate) |
|---|---|
| Biocompatibility for intended use (Safety) | Safe for intended use |
| Tensile plateau (Mechanical Property) | Not explicitly quantified, but generally superior |
| Tensile hysteresis (Mechanical Property) | Significantly less stress hysteresis |
| Flexure hysteresis (Mechanical Property) | Not explicitly quantified, but generally superior |
| Binding (Mechanical Property) | Significant reduction in orthodontic binding friction |
| Hardness (Material Property) | Not explicitly quantified |
| Roughness (Material Property) | Not explicitly quantified |
| Set angle after 90° bend (Mechanical Property) | Not explicitly quantified |
| Elastic recovery (Mechanical Property) | Greater superelastic strain recovery |
| Fatigue (Mechanical Property) | Greater fatigue life |
| Corrosion resistance (Material Property) | Equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this submission relies on bench testing of physical properties, traditional "test sets" of patient data are not applicable. The bench tests would have involved specific numbers of archwire samples for each test, but these details are not disclosed.
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)
This information is not applicable as this device does not involve human interpretation of medical images or data. Ground truth here refers to the actual physical and mechanical properties measured by scientific instruments and validated methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical endpoints or interpretation of ambiguous data, which is not the case for bench testing of material properties.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by the AI. The Hyperelastic Archwire is a physical orthodontic device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device does not contain an algorithm. The "performance" here refers to the physical and mechanical characteristics of the archwire itself, measured through bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this device is based on objective measurements of physical and mechanical properties through standardized bench testing methods. This includes measurements of:
- Tensile characteristics (plateau, hysteresis)
- Flexure characteristics (hysteresis)
- Binding force
- Hardness
- Roughness
- Set angle
- Elastic recovery
- Fatigue life
- Biocompatibility (based on established material safety standards)
- Corrosion resistance
8. The sample size for the training set
This information is not applicable. This device is a physical product, not a software or AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
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NOV 1 6 2011
510(k) Summary
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: September 2011
- Trade name HYPERELASTIC ARCHWIRE .
- . Common name - orthodontic appliance & accessories
- ◆ Classification name -- orthodontic wire (21 CFR 872.5410, Product Code DZC)
Devices for Which Substantial Equivalence is Claimed:
CuTiNi Wire, Class I, Exempt, Product Code DZC, Ormco Corporation .
Summary
Device Description
Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
Intended use of the Device
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelastic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
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Technological Characteristics Compared to Predicate
Hyperelastic Archwire functions in a manner similar to and is intended for the same use as CuTiNi Archwire which is currently being marketed by Ormco Corporation. Both products are made of similar materials, must be placed and removed by the dental practitioner, and both have equivalent corrosion resistance.
Hyperelastic Archwire differs from the predicate device, CuTiNi Archwire in that the physical and mechanical property testing of Hyperelastic Archwire demonstrates greater superelastic strain recovery, a significant reduction in orthodontic binding friction, significantly less stress hysteresis in tensile loading, and greater fatigue life.
Non-Clinical Performance Data
Biocompatibility studies have been completed, which demonstrate that the material used to produce Hyperelastic Archwire is safe for its intended use.
The 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Hyperelastic Archwire compared to the predicate device, CuTiNi Archwire. The characteristics evaluated include tensile plateau, tensile hysteresis, flexure hysteresis, binding, hardness, roughness, set angle after 90° bend, elastic recovery and fatigue.
Clinical Testing
Clinical resting has not been conducted on this product.
Conclusion
Based upon the biocompatibility tests and bench testing, the clinical performance of Hyperelastic Archwire is substantially equivalent to the predicate device.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ormco Corporation % Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties. Incorporated 1717 West Collins Avenue Orange, California 92867
NOV 16 2011
Re: K112640
Trade/Device Name: Hyperelastic Archwire Regulation Number: 21 CFR 872.5410 Regulation Name: Orthodontic Appliance and Accessories Regulatory Class: I Product Code: DZC Dated: September 8. 2011 Received: September 12, 2011
Dear Ms. Garman:
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 device-related 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.go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1/11/2640
510(k) Number (if known):
Device Name: Hyperelastic Archwire
Indications For Use:
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
X 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)
| -- | -------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K112440 |
|---|---|
| ---------------- | --------- |
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.