(49 days)
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 Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
This document, K082532, is a 510(k) premarket notification for the Straumann Guided Instruments, specifically drill bits, for use in oral surgery. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove meeting specific performance "acceptance criteria" through a clinical study in the way a novel AI device might. Therefore, the information typically found in an AI device submission regarding acceptance criteria, performance metrics, and clinical study details (like sample sizes, ground truth establishment, or expert reviews for AI model performance) is not applicable or present in this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this 510(k) submission.
510(k) submissions for devices like these typically rely on demonstrating that the new device has the same technological characteristics and intended use as a predicate device and does not raise new questions of safety or effectiveness. There are no explicit performance "acceptance criteria" stated as numerical targets that need to be met by the device's performance, nor is there a report of device performance against such criteria in the context of an efficacy study.
The submission states: "The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "acceptance criteria" for a 510(k) and the "performance" is demonstrated through this comparison.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable.
This submission does not involve a "test set" of data or a study to evaluate a device's performance against ground truth in the way an AI/ML device would. The evaluation is based on engineering and material characteristics compared to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
There is no "ground truth" establishment in the context of a clinical performance study described here, as this is a device based on established technology.
4. Adjudication Method for the Test Set
Not applicable.
No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
This is not an AI/ML device, and therefore, an MRMC comparative effectiveness study is not relevant or described.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
No.
This is not an algorithm-based device.
7. Type of Ground Truth Used
Not applicable.
As this is a 510(k) for surgical instruments, the "ground truth" for showing substantial equivalence generally involves showing that the device meets material specifications, design tolerances, and performs as expected in bench or animal testing (if applicable and novel), rather than clinical outcomes or expert consensus on diagnostic accuracy. No such ground truth data is explicitly presented here.
8. Sample Size for the Training Set
Not applicable.
This is not an AI/ML device, and therefore, no "training set" is used.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
No training set is used.
Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:
The "study" in this 510(k) context is primarily a comparison to a legally marketed predicate device (K894844, Bone Cutting Instruments) rather than a clinical trial with performance metrics. The core argument for acceptance is the demonstration of substantial equivalence to the predicate device.
- Rationale for Equivalence: The submission asserts that the Straumann Guided Instruments (drill bits) are substantially equivalent to the predicate device because:
- They share the identical intended use (bone cutting during oral surgery to drill or cut into the upper or lower jaw to prepare bone for wires, pins, or screws).
- They have the same material composition.
- They have a basic design that is the same.
- They operate on the fundamental operating principles that are the same.
The FDA's decision to clear the device (as indicated by the letter from the FDA) signifies that they agreed with this assessment of substantial equivalence. This type of submission relies on established safety and effectiveness of the predicate device, assuming the new device, by being substantially equivalent, also shares those characteristics.
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OCT 2 1 2008
Section I 510(k) Summary
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: August 29, 2008
2. Name of the Device
| Trade Name: | Straumann Guided Instruments |
|---|---|
| Common Name: | Drill Bits |
| Classification Name: | Bone Cutting Instrument and Accessories |
| Regulation Number: | §872.4120 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Bone Cutting Instruments, K894844
4. Description of the Device
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
5. intended Use of the Device
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.
6. Technological Characteristics
The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 2008
Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K082532
Trade/Device Name: Straumann Guided Instruments Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: August 29, 2008 Received: September 2, 2008
Dear Ms. Alan:
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 - Ms. Alan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours,
J.N. Samuels-Lendry frey
Chiu S. Lin, Ph. D Division 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 Statement
Device Name: Straumann Guided Instruments
Indications for 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 a wire, pin or screw.
× 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)
Page 1 of 1
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081532
510(k) Submission: Straumann Guided Instruments August 29, 2008 Proprietary and Confidential
Straumann US Page 5
§ 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.