(148 days)
No
The device description and performance studies focus on the mechanical properties and performance of surgical drills, with no mention of AI or ML.
No
The device is described as surgical drills intended to cut into bone to create an osteotomy for dental implant placement, which is a preparation step for a procedure, not a therapeutic treatment itself.
No
The device description clearly states its purpose is to "cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement" and to "prepare an osteotomy for a dental implant procedure," which are surgical procedures, not diagnostic ones.
No
The device description clearly states it is a reusable invasive surgical instrument made of surgical grade stainless steel with physical components like drills of various diameters and coatings. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the Surgical Drills are "reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure." They are used directly on the patient's body to cut bone.
- Intended Use: The intended use is to "cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement." This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical instrument used in a dental procedure, not a device used for in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
Product codes
DZI
Device Description
The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks.
The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The Surgical Drills were successfully tested for biocompatibility testing in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes (addition of DLC coating) between the subject and predicate device (K082532).
Performance testing: Simulated osteotomies were created in simulated bone using the subject device and predicate device (K082532). Drilling axial force was recorded and cutting surfaces were assessed visually using SEM images. Results indicate no significant changes in axial drilling thrust forces in all three groups after repeated use and processing. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject and predicate device (K082532).
Corrosion testing: Corrosion testing (ASTM F1089) was successfully undertaken to ensure that Surgical Drills when processed in accordance with the Instructions for Use will not corrode. Worst-case drills were boiled for 30 minutes and allowed to cool and air dry. All tested Surgical Drills showed no sign of corrosion without magnification. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes between the subject and predicate device (K082532).
Cleaning Validation: Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers. The results of the testing were used to address questions related to substantial equivalence based on differences in product use between the subject and predicate device (K082532).
Sterilization: Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10-6. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K082532).
Distribution: The Surgical Drills were subjected to distribution testing to determine any impact distribution would have on the subject device. Worst-case drills were subjected to simulated shipping following ASTM D4169-16. Tests included handling, stacking, loose load vibration, vehicle vibration, concentrated impact, and an additional handling test. All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject and predicate device (K082532).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
June 30, 2020
Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K200265
Trade/Device Name: Surgical Drills Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: March 31, 2020 Received: April 1, 2020
Dear Reina Choi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K200265
Device Name Surgical Drills
Indications for Use (Describe)
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
I. SUBMITTER
Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
Contact Person: Reina Choi, Requlatory Affairs Manager E-mail: reina.choi@implantdirect.com Phone: (818) 444-3306
Date Prepared: March 31, 2020
II. DEVICE
Name of Device: Surgical Drills Common or Usual Name: Endosseous Dental Implant Drills Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120) Requlatory Class: II Product Code: DZI
III.PREDICATE DEVICE
Predicate (primary) Straumann Guided Instruments (K082532)
Predicate (reference) Swiss Plant Dental System (Surgical Drills) (K081396)
IV. DEVICE DESCRIPTION
The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks.
The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.
V. INDICATIONS FOR USE
4
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technological
| characteristics | Subject Device | Predicate (primary) | Predicate (reference) | Comparison | |
|---|---|---|---|---|---|
| Surgical Drills | Straumann Guided | ||||
| Instruments (K082532) | Swiss Plan Dental Implant | ||||
| System Surgical Drills | |||||
| (K081396) | |||||
| Manufacturer | Implant Direct Sybron | ||||
| Manufacturing, LLC | Institute Straumann AG | Implant Direct Sybron | |||
| Manufacturing, LLC | Same as | ||||
| reference | |||||
| predicate | |||||
| Design Characteristic | General design | Multiple cutting edges and | |||
| flutes to create an osteotomy. | |||||
| Shank to fit with hand piece | Multiple cutting edges and | ||||
| flutes to create an osteotomy. | |||||
| Shank to fit with hand piece | Multiple cutting edges and | ||||
| flutes to create an osteotomy. | |||||
| Shank to fit with hand piece | Same | ||||
| Base material | Stainless steel | Stainless steel | Stainless steel | Same | |
| Coating | - No coating |
- DLC (diamond like coating) | No coating | No coating | Addition of DLC |
| | Cutting flutes | 2 and 4 flutes | 2 flutes | 2 and 4 flutes | Same as
reference
predicate |
| | Handpiece
connection shank
type | ISO-1797-1 | ISO-1797-1 | ISO-1797-1 | Same |
| | Irrigation | External only | External only | External only | Same |
| | Packaging | Plastic vial, supported by a
plastic retainer | Loose inside a blister pack | Plastic vial, supported by a
plastic retainer | Same as
reference
predicate |
| | Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| | Reusable or
single use | Reusable | Reusable | Reusable | Same |
| Intended use | | Bone cutting instruments are
intended for use during oral
surgery to drill or cut into the
upper or lower jaw and may be
used to prepare bone to insert | Bone cutting instruments are
intended for use during oral
surgery to drill or cut into the
upper or lower jaw and may be
used to prepare bone to insert | surgical drills used for the
preparation of the surgical site
prior to implantation | Same as primary
predicate |
| Technological
characteristics | Subject Device | Predicate (primary) | Predicate (reference) | Comparison | |
| | Surgical Drills | Straumann Guided
Instruments (K082532) | Swiss Plan Dental Implant
System Surgical Drills
(K081396) | | |
| | a wire, pin or screw. | a wire, pin or screw. | | | |
| Indication for Use | The Surgical Drills are
intended to cut into maxilla or
mandible to create an
osteotomy for endosseous
dental implant placement. | Bone cutting instruments are
intended for use during oral
surgery to drill or cut into the
upper or lower jaw and may be
used to prepare bone to insert
a wire, pin or screw. | The SwissPlant Dental Implant
system consists of two-piece
implants for one or two-stage
surgical procedures that are
intended for use in partially or
fully edentulous mandibles and
maxillae, in support of single -
or multiple-unit restorations
including: cement retained,
screw retained or overdenture
restorations and in terminal or
immediate abutment support
for fixed bridgework. The
SwissPlant dental implants are
intended for immediate
placement and function on
single tooth and/or multiple
tooth applications recognizing
initial implant stability and
appropriate occlusal loading,
to restore normal masticatory
function. | Differences do not
affect substantial
equivalence.
Refer to change
analysis following
this table. | |
6
7
Analysis of Differences Between Subject Device and Predicate
The Surgical Drills are made from the same materials and have the same general design and handpiece connection as both the primary and reference predicates. The Surgical Drills are delivered non-sterile and are intended for multiple use the same as the primary and reference predicates. The Surgical Drills differ from the predicates in the use of a DLC coating. The addition of the DLC coating was validated through the use of biocompatibility, corrosion, and functional wear testing.
The Surgical Drills and primary predicate have the same intended use. Comparison of subject device and predicate device indications for use:
- The name of the device is changed from bone cutting instruments to Surgical l Drills.
- -Creating an osteotomy for the purpose of dental implant placement is a type of oral surgery.
- -The subject Surgical Drills are used in the maxilla or mandible which is the same as the upper or lower jaw.
- -The subject Surgical Drills are used to create osteotomy which is a preparation of the bone.
- The subject Surgical Drills are used to create an osteotomy for the purpose of placing a dental implant. A dental implant is a type of screw.
The above comparison details how the differences between the subject device indications for use and the predicate (K082532) device indications for use do not affect substantial equivalence.
Summary:
The design differences between the subject and predicate device was evaluated through biocompatibility, corrosion, and comparative wear testing. The documentation submitted in the premarket notification demonstrates that the Surgical Drills are substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Biocompatibility
The Surgical Drills were successfully tested for biocompatibility testing in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes (addition of DLC coating) between the subject and predicate device (K082532).
Performance testing
8
Simulated osteotomies were created in simulated bone using the subject device and predicate device (K082532). Drilling axial force was recorded and cutting surfaces were assessed visually using SEM images. Results indicate no significant changes in axial drilling thrust forces in all three groups after repeated use and processing. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject and predicate device (K082532).
Corrosion testing
Corrosion testing (ASTM F1089) was successfully undertaken to ensure that Surgical Drills when processed in accordance with the Instructions for Use will not corrode. Worst-case drills were boiled for 30 minutes and allowed to cool and air dry. All tested Surgical Drills showed no sign of corrosion without magnification. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes between the subject and predicate device (K082532).
Cleaning Validation
Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers. The results of the testing were used to address questions related to substantial equivalence based on differences in product use between the subject and predicate device (K082532).
Sterilization
Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10-°. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K082532).
Distribution
The Surgical Drills were subjected to distribution testing to determine any impact distribution would have on the subject device. Worst-case drills were subjected to simulated shipping following ASTM D4169-16. Tests included handling, stacking, loose load vibration, vehicle vibration, concentrated impact, and an additional handling test. All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject and predicate device (K082532)
VIII. CONCLUSIONS
9
The Surgical Drills were evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the Surgical Drills have been shown to be substantially equivalent to the Straumann Guided Instruments (K082532).