(106 days)
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.
The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.
The provided text is a 510(k) summary for the HDC Spider Screw, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria and detailed statistical analysis.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them because the document does not contain this type of data.
Specifically, the document discusses:
- Device Description: Materials, configurations ("Self Tapping" and "Self Drilling and Self Tapping"), and tip sizes.
- Intended Use: As a temporary fixed anchorage point for orthodontic appliances.
- Basis of Substantial Equivalence: Similarities to predicate devices in intended use, material, design, and function.
- Regulatory Information: Device classification, product code, and predicate devices.
- FDA Clearance Letter: Confirming substantial equivalence based on the submitted information.
There is no mention of:
- Acceptance criteria defined for performance metrics.
- A study designed to test the device against specific performance criteria.
- Sample sizes for test sets or training sets.
- Data provenance or details about a study cohort.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used in a study.
- How ground truth for a training set was established.
The 510(k) pathway for medical device clearance in the US often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with predefined acceptance criteria for novel safety and effectiveness endpoints that are typically found in PMA applications or for devices with entirely new technologies.
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Applicant:
DEC 2 3 2005
KOS2471
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
HDC s.r.l Via dell'Industria, 19 36030 – SARCEDO (Vicenza) - Italy Tel: +39 0445 364148 Fax: +39 0445 383645
Contact Person: Guido Bonapace I.SE.NET. Via Emilia, 418, 40068 - San Lazzaro di Savena (Bologna) - Italy Tel: +39 051 6257315 Fax: +39 051 6284344 Email: gbonapace@alice.it
Date Prepared: September 2, 2005
Device Name
| Proprietary Name : | HDC Spider Screw |
|---|---|
| Common/Usual Name: | Bone Screw |
| Classification Names: | Endosseous dental implant |
| Device Classification: | Class II, 21 CFR 872.3640, Product Code DZI |
Predicate Devices:
| 510 K Number | Device Trade Name | Manufacturer |
|---|---|---|
| K042965 | Tomas-pin | Dentaurum |
| K033767 | Dual Top Anchor System | Jeil Medical |
| K041527 | AARHUS Anchorage System | Medicon |
| K021584 | Replace Scalloped Margin Implant System | Nobel Biocare |
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Device Description:
The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.
Basis of Substantial Equivalence:
HDC Spider Screws are similiar to predicate devices in intended use, material, design, and function. The intended use is identical to K033767 and K041527. The design is substantially equivalent to K033767 and K041527.
Intended Use:
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the tecth. The device is used temporarily and shall be removed after orthodontic treatment.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three trailing lines, representing the department's mission to protect the health of all Americans and provide essential human services.
DEC 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HDC S.R.L. C/O Ms. Millie Lynn Bentley Consultant Alta Consulting 6512 Bannockburn Drive Bethesda, Maryland 20817
Re: K052471
Trade/Device Name: HDC, Spider Screw Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 23, 2005 Received: November 25, 2005
Dear Ms. Bentley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally by the device is substantially equivalent (for the referenced above and have determined ue) to legally marketed predicate devices marketed in indications for use stated in the enclosars, to engines date of the Medical Device merstate connifieree prior to way 20, 1970, career with the provisions of Amenditents, of to devices that nave obsit (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosment . For (Pres) ----------------------------------------------------------------------------------------------------------------------------approval application (1 Mr.). - 1 ou ne), controls provisions of the Act include confors provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for nibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (PMA), it may be subject to such adam first oral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Peaces oncerning your device in the Federal Register.
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Page 2 - Ms. Bentley
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualles of a bassaures complies with other requirements mean that FDA nas made a decemination until your and ministered by other Federal agencies. of the Act of ally receitar statutes and regarants, including, but not limited to: registration You must comply with an the Hotel Stog (21 CFR Part 801); good manufacturing practice and listing (21 CrK Part 607), labeling (21 CFR Pat 820), and if 51 CFR Pat 820), and if requirements as set forum in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin malier and your substantial equivalence of your device to a premiarket notification. The PDF mailing of a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de roo at (240) 276-0115. Also, please note the regulation prease contact the Other or Somphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general mironmational and Consumer Assistance at its toll-free Division of Bintas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suite y. Michael Ows
Chiu Lin, Ph.D. 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
510(k) Number : Koszy71
Device Name: HDC, Spider Screw
Indications for Use:
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.
Prescription Use X (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 (ODF)
Ki Muly for MSR
§ 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.