(77 days)
SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.
SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance.
The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm).
Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times.
SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile.
Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.
Here's an analysis of the provided information regarding the acceptance criteria and study for the SPI® VECTOdrill™ Ceramic Drills:
Crucially, the provided document does not contain detailed information about specific acceptance criteria, a formal study protocol, or quantitative performance metrics typically found in a comprehensive medical device validation study report.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance validation report. Therefore, many of the requested sections will state "Not provided" or explain that the information is not present in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific quantitative acceptance criteria are not explicitly stated in this 510(k) summary. The summary broadly states that "Testing... established their ability to retain their cutting ability under aggressive cutting conditions" and "resulted in the conclusion that the mechanical properties... are appropriate for their safe use." Without specific metrics (e.g., minimum cutting efficiency, maximum wear per use, fracture strength thresholds), it's impossible to create a table with numerical acceptance criteria and corresponding reported performance.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Cutting Ability | (Not explicitly stated in terms of quantifiable metrics) | "established their ability to retain their cutting ability under aggressive cutting conditions" |
| Mechanical Properties | (Not explicitly stated in terms of quantifiable metrics or thresholds) | "appropriate for their safe use" |
| Reuse | Designed for "up to 20 times" | (Implied that testing supports this, but no specific data presented) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Testing of SPI VECTOdrill ceramic drills" but does not give a number of drills tested or the extent of the testing.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given the manufacturer is Thommen Medical AG (Switzerland) and the representative is in the USA, the testing could have occurred in either region, or elsewhere. The nature of the testing (bench testing for mechanical properties and cutting ability) suggests it was likely prospective, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is generally not applicable to a device like a dental drill. Ground truth for a drill's performance would typically be based on objective physical measurements (e.g., torque, force, wear, cutting depth, material analysis) rather than expert interpretation of images or clinical outcomes. Therefore, no experts would be needed to establish "ground truth" in the way described for diagnostic devices.
4. Adjudication Method for the Test Set
- Not applicable, as ground truth typically refers to clinical or diagnostic assessment, not objective mechanical property testing.
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 diagnostic imaging devices involving human interpretation, often with AI assistance. The SPI® VECTOdrill™ Ceramic Drills are surgical instruments, and their performance is assessed through mechanical and material testing, not through human reader interpretation. There is no AI component mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is irrelevant. The performance of the drill itself, without a human operator, cannot be meaningfully assessed, as its function inherently requires human use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" would be established through objective, standardized engineering and material science testing. This would involve:
- Mechanical Property Testing: Measuring tensile strength, bending strength, hardness, fracture toughness, etc., against predefined material specifications.
- Cutting Performance Testing: Assessing cutting speed, efficiency, and wear under simulated clinical conditions (e.g., drilling into bone substitutes).
- Durability/Fatigue Testing: Simulating repeated sterilization and use to evaluate structural integrity and performance over its intended lifespan (up to 20 uses).
- Visual Inspection/Metrology: Checking for physical defects, dimensions, and tolerances.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question does not apply.
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510(k) Summary
1872 SPI® VECTOdrill™ Ceramic Drills
510(k) Summarv
APR 1 7 2007
Thommen Medical AG SPI® VECTOdrill™ Ceramic Drills
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone +41 61 965 90 20 Fax +41 61 965 90 21
Official Contact:
Representative/Consultant:
Orlando Antunes
Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone 1 (858) 792-1235 Fax 1 (858) 792-1236 email: flarson@paxmed.com
DEVICE NAME
Classification Name: Trade/Proprietary Name: Common Name:
Accessories, Implant, Dental, Endosseous SPI® VECTOdrill" Ceramic Drills dental implant drill bit
DEVICE CLASSIFICATION
FDA has classified "Accessories, Implant, Dental, Endosseous" as Class I devices (21 CFR 888.3980), with a product code of NDP.
INDICATIONS FOR USE
SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.
DEVICE DESCRIPTION
SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates
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K070290 a9z
SPI® VECTOdri\l" Ceramic Drills
the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance.
The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm).
Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times.
SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile.
Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.
EQUIVALENCE TO MARKETED DEVICE
Thommen Medical AG submits the following information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SPI VECTOdrill ceramic drills are substantially equivalent in indications and design principles to the following predicate device: Thommen Medical AG, SPI VECTOdrill stainless steel drills which are considered Class I, exempt.
The SPI VECTOdrill ceramic drills have the following similarities to the predicate device:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same design
In summary, the SPI VECTOdrill ceramic drills described in this submission are, in our opinion, substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
APR 1 7 2007
Re: K070290
Trade/Device Name: SPI® VECTOdrill™ Ceramic Drills Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: I Product Code: NDP Dated: January 29, 2007 Received: January 30, 2007
Dear Mr. Larson:
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.
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 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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Page 2 - Mr. Larson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Swifte Y. Michael Omd.
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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510(k) Premarket Notification
SPI® VECTOdrill™ Ceramic Drills
KO70296
Indications for Use
Applicant:
Thommen Medical AG
510(k) Number (if known):
Device Name: SPI® VECTOdrill™ Ceramic Drills
Indications for Use:
SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
moder of therel Hospical. on Conin : " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
*K) Number K070290
Page 15 of 127
§ 872.3980 Endosseous dental implant accessories.
(a)
Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.(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.