(86 days)
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.
The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.
The provided text describes a 510(k) premarket notification for the OSSEOSTAP Microdrill System, focusing on its substantial equivalence to a predicate device. This document does not describe an AI/ML powered device, nor does it contain information typically associated with studies proving acceptance criteria for such devices (e.g., performance metrics like sensitivity, specificity, F1-score, sample sizes for AI models, expert ground truth establishment, MRMC studies, or standalone performance).
The information provided pertains to a traditional surgical drill and its components comparing to an existing drill (the Skeeter Ultra-Lite Oto-Tool Drill). The "acceptance criteria" here are based on demonstrating that the new device is "at least as good" as the predicate device in terms of handling, cutting performance, and noise level, and that it meets established safety and performance standards for medical devices (e.g., sterilization, biocompatibility, electrical safety).
Therefore, I cannot fulfill your request as it's designed for an AI/ML medical device submission. However, I can extract the relevant non-clinical performance data and the general approach to demonstrating "acceptance" within the context of this 510(k) submission for a non-AI device.
Based on the provided text, the device is not an AI/ML powered device. As such, the standard acceptance criteria, study methodologies, and performance metrics typically associated with AI/ML device submissions (e.g., AUROC, sensitivity, specificity, expert readers, ground truth establishment for AI) are not applicable or present in this document.
However, I can describe the non-clinical performance and acceptance criteria for this traditional medical device based on the provided FDA 510(k) summary.
Description of Acceptance Criteria and Study for OSSEOSTAP Microdrill System
The OSSEOSTAP Microdrill System is a traditional surgical device and its acceptance criteria primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device (Skeeter Ultra-Lite Oto-Tool Drill) through non-clinical performance testing, material safety, and adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| Bench Testing Comparison to Predicate: | |
| Handling Performance | At least as good as the predicate (Skeeter) |
| Cutting Performance | At least as good as the predicate (Skeeter) |
| Noise Level | At least as good as the predicate (Skeeter) |
| Material & Durability: | |
| Bur Resistance | Evaluated on basis of repeated running, traction tests, repeated sterilization cycles |
| Handpiece Functionality after Reprocessing | Confirmed with a cycle test after multiple reprocessing cycles |
| Cleaning Validation (Handpiece) | Validated in an external lab using proteins as marker |
| Moist Heat Sterilization Validation (Handpiece) | Validated based on lab validation of 2 related devices sharing similar components but with more complex geometry |
| Cleaning Validation (Reusable Burs) | Validated by an external lab |
| Steam Sterilization Validation (Reusable Burs) | Validated by an external lab |
| Biocompatibility | Evaluated according to ISO 10993-1. Materials (stainless steel for handpiece, stainless steel/diamond/carbide for burs) are suitable for limited direct contact with bone/tissue. |
| Software, Electrical Safety, and EMC: | |
| Software Level of Concern | Classified as minor level of concern (validation documents available) |
| Electrical Safety | Certified through IEC 60601-1 3rd edition |
| EMC Certification | Certified according to IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance:
- This information is not applicable for the type of testing described. The "test set" here refers to specific units of the OSSEOSTAP device and its components (burs, handpiece) being subjected to bench and lab-based performance, durability, and safety assessments. No patient data or imagery is involved. The studies are non-clinical, likely conducted in a lab environment (as indicated by "external lab" for validation).
- Data Provenance: The studies were conducted by the manufacturer (Bien-Air Surgery SA, Switzerland) and external labs. The nature of these tests (e.g., material stress tests, cleaning validation) doesn't typically involve "country of origin of the data" in the same sense as clinical or imaging data; it refers to the location of the test facilities.
- Retrospective/Prospective: These are non-clinical, prospective tests specifically designed to evaluate the manufactured device against pre-defined performance and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as the studies are non-clinical performance tests for a traditional surgical device. There is no "ground truth" to be established by clinical experts in the context of diagnostic interpretation or clinical outcomes. Performance criteria are based on engineering specifications, material standards, and comparative testing against a predicate device.
4. Adjudication Method for the Test Set:
- Not applicable for these non-clinical, objective performance tests. The results are typically quantitative measurements or pass/fail assessments against established standards and predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-powered diagnostic or screening devices involving human readers interpreting clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm-only or AI-powered device.
7. The Type of Ground Truth Used:
- Not applicable in the context of AI/ML. For this device, the "ground truth" or reference for performance is established by:
- Predicate Device Performance: The primary reference is the performance of the Medtronic Xomed Inc. Skeeter Ultra-Lite Oto-Tool Drill (K041523).
- Industry Standards: Compliance with international standards such as ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).
- Engineering Specifications: Internal design specifications for bur resistance, handpiece functionality, rotation speed, etc.
- Laboratory Validation Results: Objective measurements from external lab validations for cleaning and sterilization.
8. The Sample Size for the Training Set:
- Not applicable as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as this is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bien-Air Surgery SA % Mr. Roland Hasler, CEO Rue de l'Ouest 2b 2340 Le Noirmont Switzerland
Re: K143492
Trade/Device Name: OSSEOSTAP Microdrill System (Control Unit, Handpiece and Burs) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric Or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, EQJ Dated: December 3, 2014 Received: December 8, 2014
Dear Mr. Hasler:
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.
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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 devicerelated 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143492
Device Name OSSEOSTAP Microdrill System
Indications for Use (Describe)
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Bien-Air Surgery. The logo is in blue and green, with the words "Bien Air" in a stylized font. Below that, the word "Surgery" is written in a smaller, sans-serif font. There is a green line that runs underneath the word "Bien Air". There is a red cross in a white circle in the upper right corner of the image.
510(k) Summary
| Date prepared: | December 1, 2014 |
|---|---|
| Submitter: | Bien-Air Surgery SARue de l'Ouest 2b2340 Le Noirmont SwitzerlandPhone: +41 32 953 35 35Fax: +41 32 953 35 37 |
| Contact person: | Hugues Froidevaux, Quality and Regulatory Affairs ManagerEmail: hugues.froidevaux@bienair.com |
| Device Name: | |
| Proprietary name: | OSSEOSTAP Microdrill System |
| Common names: | Electrical surgical drill, ENT drillBurs |
| Classification name: | Drill, Surgical, ENT (electric or pneumatic) including handpiece(21 CFR 874.4250, Product code ERL), Class IIBursBur, Ear, Nose and Throat(21 CFR 874.4140, Product code EQJ), Class I |
Predicate device:
Primary predicate device:
| Device | Classification | Manufacturer |
|---|---|---|
| Skeeter Ultra-LiteOto-Tool Drill | 874.4250, ERL, Class 2Drill, Surgical, ENT (electric orpneumatic) including handpiece.Covered by K041523 | Medtronic Xomed Inc. |
Substantial equivalence is claimed to the skeeter OTO-Tool drill, which is an accessory to the XPS3000 console, which is the subject of K041523.
The description of the Skeeter (from the IFU of Medtronic XPS 3000 system), is as follows:
SKEETER® ULTRA-LITE OTO-TOOL -- A slender, lightweight drill handpiece and burs specifically used in middle ear surgical procedures, including stapes footplate procedures. The Skeeter® may be powered from the XPS® 3000 console, XPS® 2000 console, or from a battery powered variable speed foot control.
§5_510(k) summary OSSEOSTAP revised 20150224.doc
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Reference device:
| Fisch Drill System | 874.4250, ERL, Class 2Drill, Surgical, ENT (electric orpneumatic) including handpiece | Jedmed Instrument Co.(original applicant, K792159) |
|---|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------- | -------------------------------------------------------- |
Device Description:
The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.
Intended use of the Device:
The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.
Summary of technological characteristics:
| Characteristic | Skeeter Ultra-LiteOto-Tool DrillMedtronic Xomed Inc.(Accessory of K041523) | Fisch Drill SystemJedmed InstrumentCo.(K792159) | OSSEOSTAPMicrodrillBien-Air Surgery SA |
|---|---|---|---|
| Intended Use | Light drilling of bone | Drilling, cutting andshaping bone | Light drilling of bone |
| Control Unit | Foot pedal | Foot pedal | Foot pedal |
| Energy source | Electrical (batteries) | Electrical (AC) | Electrical (batteries) |
| Rotation speed | Max. 12,000 rpm | Max. 40,000 rpm | Max. 12,000 rpm |
| Steamautoclavablehandpieces | Yes | Yes | Yes |
| Direct patientcontactmaterials | Stainless steel | Stainless steel | Stainless steel |
| Bursbiocompatible | Yes | n.a. | Yes |
The characteristics of the OSSEOSTAP are comparable to those of the predicate device.
The Fisch, Skeeter and OSSEOSTAP drills are all indicated for use in otology (e.g. middle ear) surgical procedures. The maximum rotation speed of the Fisch drill is higher because it can be used for a broader range of indications (including mastoid and plastic surgery).
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Performance Data (non-clinical tests):
The OSSEOSTAP was bench tested in parallel with the predicate device Skeeter to confirm that handling, cutting performance and noise level were at least as good.
The OSSEOSTAP bur resistance has been evaluated on the basis of repeated running, traction tests and repeated sterilization cycles.
Functionality of the OSSOSTAP handpiece after multiple reprocessing has been confirmed with a cycle test.
Cleaning validation of the OSSEOSTAP handpiece has been validated in an external lab using proteins as marker. Moist heat sterilization has been validated based on lab validation of 2 related devices sharing similar components but featuring more complex geometry.
For the dedicated reusable burs, both the cleaning and the steam sterilization have been validated by an external lab.
Biocompatibility of the OSSEOSTAP was evaluated according to ISO 10993-1. The curved tip of the handpiece as well as the burs are in direct contact with bone or tissue for a limited duration. Materials are stainless steel for the handpiece, stainless steel and diamond, respectively carbide for the burs.
The software that controls the micro-controller in the OSSEOSTAP footcontrol has been classified as minor level of concern. All validation documents are available.
The electrical safety of the OSSEOSTAP System has been certified through the standards IEC 60601-1 30 edition, which includes an EMC certification according to IEC 60601-1-2.
No clinical performance data was deemed necessary for this 510(k)
Substantial Equivalence:
The OSSEOSTAP Microdrill System has the same intended use and operating principle as the predicate device. Through comparison of technical and performance characteristics, the OSSEOSTAP is considered to be as safe and effective as the predicate device, and therefore, substantially equivalent.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.