(269 days)
The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed to be immediately used as an anchorage for orthodontic devices. The Storm mini-screw head is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
This 510(k) premarket notification describes the Storm Mini Screw, an orthodontic mini screw. The submission primarily focuses on establishing substantial equivalence to predicate devices based on material, intended use, and mechanical characteristics rather than presenting performance metrics against specific acceptance criteria for a novel device. Therefore, many of the requested sections regarding detailed study design, sample sizes, and ground truth establishment are not applicable or not provided in the document.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific tensile strength value that must be met). Instead, the performance is demonstrated through comparison to predicate devices and general statements about meeting requirements for intended use.
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength (Static Load Resistance) | "Test results concluded that the Storm Micro Screw provides adequate mechanical strength for its intended use in an orthodontic application and has equivalent performance to the predicate devices." |
| Sterilization Validation | "Test for sterilization validation indicated that treatment method reached the established VD Max25 dosage." |
| Sterile Shelf Life | "Test certifications performed after sterilization and accelerated ageing confirmed a 5 year sterile shelf life." |
| Biocompatibility | "Made of biocompatible, medical grade anodized titanium, ISO 10993 compliant." |
| Material Composition | "Grade 5 Titanium ASTM F136-95 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications." (Matches predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "tests for sterilization validation" and "test certifications performed after sterilization and accelerated ageing," but specific sample sizes for these tests are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a physical device, these tests are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the device is a physical orthodontic screw, and its performance is evaluated through mechanical and sterilization testing, not through expert interpretation of data or images.
4. Adjudication Method for the Test Set
This section is not applicable as the device is a physical orthodontic screw and its performance is evaluated through objective physical and chemical tests, not through subjective assessment requiring adjudication.
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
This section is not applicable. The Storm Mini Screw is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The Storm Mini Screw is a physical medical device, not an algorithm, so standalone AI performance is not relevant.
7. The Type of Ground Truth Used
For the specific tests mentioned:
- Mechanical Strength: The "ground truth" would be established by the physical properties of the materials and the design, measured against engineering standards and comparison to predicate devices. It's a direct measurement of physical properties.
- Sterilization Validation: The "ground truth" is achieved when the sterilization process (VD Max25 dosage) effectively renders the device sterile, typically verified through biological indicator testing.
- Sterile Shelf Life: The "ground truth" is established by accelerated aging studies simulating the effects of time on sterility and packaging integrity.
8. The Sample Size for the Training Set
This section is not applicable. The Storm Mini Screw is a physical medical device, not an AI model, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
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R122069
Premarket Notification 510(k) - Storm Mini Screw - Lancer Orthodo
APR 1 1 2013
Image /page/0/Picture/3 description: The image shows the logo for Lancer Orthodontics since 1967. The logo features the word "Lancer" in a bold, stylized font, with the word "Orthodontics" written in a smaller font underneath. There is a graphic of the earth below the text. The logo has a swoosh design element that goes through the word "Lancer".
510(k) Summary
Submitter's name: Address:
Name of contact person:
Date the summary was prepared: Name of the device: Trade or proprietary name: Common or usual name: Regulation description Class Product Code: 21 CFR Regulation Number:
Lancer Orthodontics 2330 Cousteau Court Vista, California 92081 Telephone: 1-800-854-2896 Facsimile: (760) 744-5724
Larry Walker Regulatory & Quality Systems Manager Lancer Orthodontics 2330 Cousteau Court Vista, California 92081 Telephone: (760)-304-2746 Facsimile: (760) 744-5724 Email: gserrano@lancerortho.com
April 4, 2013 Mini screw Storm Mini Screw Orthodontic mini screw Endosseous dental implant. II (two) OAT 872.3640
The legally marketed device to which we are claiming equivalence as per CFR 21 872:3640:
HDC Spider Screw - Temporary Anchorage Device System, 510(k) reference number K071851
T.O.A.D.S., LLC, Orthodontic TAADS (Temporary Anatomical Anchor Device System), 501(k) reference number K063149
The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed
Description of the device:
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placement of orthodontic appliances such as wires.
devices.
springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed.
to be immediately used as an anchorage for orthodontic
The Storm mini-screw head is designed to facilitate
The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage. point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic. treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
Description of Performance Tests:
The Storm Mini Screw has been tested to verify performance characteristics under a static load resistance in order to simulate the geometric conditions to which the device would be subjected to in clinical practice. Static load tests were performed by applying a load at 90° with respect to the axis of the Storm Mini Screw. The test results concluded that the Storm Micro Screw provides adequate mechanical strength for its intended use in an orthodontic application and has equivalent performance to the predicate devices. Tests for sterilization validation indicated that treatment method reached the established VD Max25 dosage. Test certifications performed after sterilization and accelerated ageing confirmed a 5 year sterile shelf life.
Summary of Substantial Equivalence:
Lancer Orthodontics has identified two predicate devices: the Sterile Spider Screw from HDC s.r.l. (ref. K071851) and Orthodontics TAADS from T.O.A.D.S LLC (ref. K063149). The Storm Mini Screw was compared to the two predicate devices in the following areas and was found to have similar or better technological characteristics and was determined to be substantially equivalent
| Storm Mini Screw | Predicate,HDC Spider Screw | Predicate,Orthodontic TAADS | |
|---|---|---|---|
| Intended Use | The Storm Mini Screw is athreaded titanium dental | The HDC sterile SpiderScrew is a threaded titanium | The Orthodontic TAADSScrews are intended to |
| implant screw intended toprovide a fixed anchorage | dental implant screw,intended to serve as a fixed | provide a fixed anchorage | |
| point for the attachment of | anchorage point for | point for the attachment of | |
| orthodontic appliances and | attachment of orthodontic | orthodontic appliance to | |
| facilitate the orthodontic | appliances to facilitate the | facilitate the orthodontic | |
| movement of teeth. It is used | orthodontic movement of the | movement of teeth. They | |
| temporarily and must be | teeth. It is used temporarily | are intended for temporary | |
| removed after orthodontic | and must be removed after | use and should be removed | |
| treatment has been | the orthodontic treatment has | after orthodontic treatmenthas been completed. The | |
| completed. The Storm Mini | been completed. It is | screws are intended for | |
| Screw is provided sterile and | provided sterile and is | single use only. | |
| is intended for single use | intended for single use only. | ||
| only. | |||
| Target | People having orthodontia | People having orthodontia | People having orthodontia |
| Population | work | work. | work |
| Technological | Self-drilling and Self-tapping | Self-drilling and Self-tapping | Not self-drilling (requires |
| Characteristics | pre-drilling), Self-tapping | ||
| Orthodontic head for | Orthodontic head for | Orthodontic head for | |
| appliance placement | appliance placement | appliance placement | |
| Two different diameter | Two different diameter | Two different diameter | |
| bodies: 1.5 mm and 2.0 mm | bodies: 1.5 mm and 1.9 mm | bodies: 1.5 mm and 2.5 mm | |
| Conical thread with | Conical thread with | Conical.thread with | |
| asymmetrical profile | asymmetrical profile | asymmetrical profile | |
| Single use | Single use | Single use | |
| Length 8 mm & 10 mm | Length range: 5 mm - 11 mm | Length (information not | |
| publicly available) | |||
| The neck length of | The neck length of | Neck Length (information | |
| transmucosal portion is | transmucosal portion is | not publicly available) | |
| variable to provide | variable to provide adaptation | ||
| adaptation for different | for different intraoral mucosa | ||
| intraoral mucosa thickness: | thickness: neck length 1 and | ||
| neck lengths: 1.5 and 3 mm | 2 mm | ||
| Materials | Grade 5 Titanium | Grade 5 Titanium | Grade 5 Titanium |
| ASTM F136-95 Standard | ASTM F136-95 Standard | ASTM F136-95 Standard | |
| Specification for Wrought | Specification for Wrought | Specification for Wrought | |
| Titanium-6 Aluminum-4 | Titanium-6 Aluminum-4 | Titanium-6 Aluminum-4 | |
| Vanadium ELI (Extra Low | Vanadium ELI (Extra Low | Vanadium ELI (Extra Low | |
| Interstitial) Alloy for Surgical | Interstitial) Alloy for Surgical | Interstitial) Alloy for Surgical | |
| Implant Applications | Implant Applications | Implant Applications | |
| Storm Mini Screw | Predicate. | Predicate, | |
| HDC Spider Screw | Orthodontic TAADS | ||
| Where Used | Dental and orthodontic | Dental and orthodontic | Dental and orthodontic |
| specialists offices | specialists offices | specialists offices |
Intended Use:
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Premarket Notification 510(k) – Storm Mini Screw - Lancer Orthodonlics
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Premarket Notification 510(k) – Storm Mini Screw - Lancer Orthodontics
| Sterility | Sterile via beta irradiation | Sterile via gamma radiation | Sterile and non-sterile,(Information on method ofsterilization is not publiclyavailable) |
|---|---|---|---|
| 5 year Sterile Shelf Life | Shelf Life of Sterility is notpublicly available information | Shelf Life of Sterility is notpublicly availableinformation | |
| Biocompatibility | Made of biocompatible,medical grade anodizedtitaniumISO 10993 compliant | Made of biocompatible,medical grade titanium | Made of biocompatible,medical grade anodizedtitanium |
| Anatomical Sites | Maxillary edentulousalveolar ridgesMaxillary Buccal/lingualinterradicular areasMandibular edentulousalveolar ridgesMandibular Buccal/lingualinterradicular areasMandibular Buccal shelf atthe oblique areaMandibular retromolar area | Maxillary edentulous alveolarridgesMaxillary Buccal/lingualinterradicular areasMandibular edentulousalveolar ridgesMandibular Buccal/lingualinterradicular areasMandibular Buccal shelf atthe oblique areaMandibular retromolar area | Unknown from publisheddocumentation |
| MechanicalSafety | ASTM F136-95 StandardSpecification for WroughtTitanium-6 Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for SurgicalImplant Applications | ASTM F136-95 StandardSpecification for WroughtTitanium-6 Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for SurgicalImplant Applications | ASTM F136-95 StandardSpecification for WroughtTitanium-6 Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for SurgicalImplant Applications |
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· April 11, 2013
Mr. Larry Walker Regulatory & Quality Systems Manager Lancer Orthodontics 2330 Cousteau Court VISTA CA 92081
Re: K122069
Trade/Device Name: Storm Mini Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: March 8, 2013 Received: March 11. 2013
Dear Mr. Walker:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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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 (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 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.
Image /page/5/Picture/8 description: The image shows the words "Kwame O. Ulmer-S" in a bold, sans-serif font. The letters are arranged in two rows, with "Kwame O." on the top row and "Ulmer-S" on the bottom row. Behind the text is a stylized image of a building or structure, possibly an architectural design. The image is black and white and appears to be a scan or photocopy.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement
510(k) Number (if known):_ K 122069
Device Name: _ Storm Mini Screw
Indications For Use:
The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S 2013.04.09 13:32:42 -04'00'
(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K122064
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§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.