(266 days)
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
The acceptance criteria and study proving the device meets them can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | Demonstrated through extensive comparison of technological characteristics: |
| - Indications for Use | The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures. (Stated as substantially equivalent to predicate devices, expanding on previous indications). |
| - Intended Use | Cutting soft tissue and bone (Similar to predicate devices). |
| - Controller | Console with foot pedal (Similar to predicate devices). |
| - Energy Source | Electrical (Similar to predicate devices). |
| - Speed Indication | Digital (Similar to predicate devices). |
| - Functions | Drill and Microdebrider (Similar to predicate devices). |
| - Drill Motor Speed | Max 80,000 rpm (Similar to predicate devices). |
| - Irrigation | 1 peristaltic pump integrated into console for irrigation (Similar to predicate devices). |
| - Sterilization (Micromotors, Handpieces) | Steam Autoclave, AAMI TIR 12, ISO 17664, ISO 17665 (Similar to predicate devices). |
| - Direct Contact Material (for the proposed device, considering the additional diamond grit) | Stainless Steel / Diamond Grit (Differences in direct contact material related to diamond grit were addressed by biocompatibility testing, demonstrating no impact on safety or effectiveness). |
| Safety and Effectiveness: | |
| - Compliance with Internal Functional Specifications (including software) | Verification/validation testing demonstrated that the device is safe and effective, and performs comparably to and is substantially equivalent to the predicate devices. This included traceability of verification/validation tests to software requirements and software risk hazards. |
| - Operating Temperatures | Testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. |
| - Electrical Safety and Electromagnetic Compatibility (EMC) | Device complies with relevant voluntary safety standards, specifically IEC standards 60601-1 and 60601-1-2. |
| - Biocompatibility (for diamond grit, a new direct contact material) | Cytotoxicity (ISO 10993-5): No cytotoxic potential (MEM Elution method). |
| Irritation/Intracutaneous Reactivity (ISO 10993-10, ISO 10993-12): Not reactive (Intracutaneous Reactivity in Rabbits with two extracts: 0.9% NaCl; sesame oil). | |
| Hemolysis (ISO 10993-4): No hemolytic effect (Material/surface-mediated hemolysis). | |
| Sensitization (ISO 10993-10): No sensitization (Sensitization in Guinea Pigs). | |
| Acute System Toxicity (ISO 10993-11): No evidence of AST observed (Acute System Toxicity in Mice). | |
| - Endotoxin | Met acceptance criterion (< 2.15 EU/device) (Gel-clot-method & Quantitative LAL test). The material-mediated pyrogenicity potential was also adequately evaluated. |
| - Sterilization and Shelf Life (for accessories sold sterile for single use) | Relevant successful sterilizations and shelf life studies have been provided to support the labeled expiration dates. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for a "test set" in the context of clinical data or patient samples. The testing described focuses on engineering verification and validation, biocompatibility, electrical safety, and EMC.
- Engineering Tests (Functional, Software, Operating Temperatures): The "sample size" here would refer to the number of devices or components tested. This is not explicitly specified, but the statement "Test were performed on the OSSEODUO Shaver and Drill System" implies that the relevant device components were subjected to these tests. Given the nature of these tests, it is standard practice to test a representative number of units to ensure compliance.
- Biocompatibility Tests: These tests were performed on "all materials, manufacturing processes and aids used in the manufacture of the patient-contacting device components." The specific number of animals (rabbits, guinea pigs, mice) used for each biocompatibility test is implied by the method (e.g., "Sensitization in Guinea Pigs").
- Data Provenance: The studies are non-clinical, focusing on device performance and safety with respect to its engineering characteristics and material interactions. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective) to report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This is a non-clinical evaluation report for a medical device's engineering and material safety, not a study involving human diagnostic accuracy or clinical outcomes where expert-established ground truth would be required. The "ground truth" here is defined by compliance with established engineering standards, regulatory requirements, and validated test methods.
4. Adjudication Method for the Test Set:
Not applicable. As this is a non-clinical evaluation, there is no need for expert adjudication of results typically found in clinical or image-based studies. Test results are objectively measured against pre-defined acceptance criteria from standards or internal specifications.
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:
Not applicable. This submission is for an electromechanical surgical device (shaver and drill system), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. There is no AI algorithm in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing comprises objective measurements against:
- Established engineering specifications (functional performance, software requirements).
- Voluntary safety standards (IEC 60601-1, IEC 60601-1-2).
- Biocompatibility standards (ISO 10993-4, 5, 10, 11, 12).
- Sterilization standards (AAMI TIR 12, ISO 17664, ISO 17665).
- Regulatory guidance documents (e.g., "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").
8. The sample size for the training set:
Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2018
Bien-Air Surgery SA % Belia Juarez Regulatory Project Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, Texas 75080
Re: K173066
Trade/Device Name: OSSEODUO Shaver and Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, HBE Dated: May 24, 2018 Received: May 25, 2018
Dear Belia Juarez:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173066
Device Name OSSEODUO Shaver and Drill System
Indications for Use (Describe)
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Submitter: | Bien-Air Surgery SARue De l'Ouest 2b2340 Le Noirmont, Switzerland |
|---|---|
| Contact Person: | Bien-Air Surgery SAMr. Adil SlimaniQuality and Regulatory Affairs ManagerRue De l'Ouest 2bCH 2340 Le NoirmontSwitzerlandTEL: +41(0)32 953 35 35FAX: +41(0)32 953 35 37Adil Slimani@Bienair.com |
| Date Prepared: | September 26, 2017 |
| Proposed Device: | Manufacturer: Bien-Air Surgery SACommon Name: Cranial Drill Motor and accessoriesTrade/Device Name: OSSEODUO Shaver and Drill SystemClassification Name: Motor, Drill, ElectricRegulation Number: 21 CFR 882.4360Regulation Name: Electric cranial drill motorRegulatory Class: Class IIProduct Code: HBC, HBE |
| Primary Predicate Device: | Clearance: K083720 March 20, 2009Manufacturer: Bien-Air Surgery SATrade Name: OSSEODUO Shaver and Drill SystemRegulation Number: 21 CFR 874.4250Regulation Name: Ear, nose, and throat electric or pneumatic surgical drillRegulatory Class: Class IIProduct Code: ERL |
| Predicate Device(s): | Clearance: K080802 April 30, 2008Manufacturer: The Anspach Effort, Inc.Trade Name: eMax 2 Plus SystemRegulation Number: 21 CFR 882.4360Regulation Name: Electric cranial drill motorRegulatory Class: IIProduct Code: HBC |
| Predicate Device: | Clearance: K113476 December 16, 2011Manufacturer: The Anspach Effort, Inc.Trade Name: Dissection ToolsRegulation Number: 21 CFR 882.4310Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessoriRegulatory Class: Class II |
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Image /page/4/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo is in blue and green. The word "Bien-Air" is in a stylized font, and the word "Surgery" is in a smaller, sans-serif font. There is a green line under the word "Bien-Air".
Device The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications Description: for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
The OSSEODUO system is intended for shaping bones in spine and cranium surgical Indications for Use Statement: operation. Shaver handpiece is not intended for use in neurosurgical procedures.
Summary of Technological Characteristics:
Both the Bien-Air OSSEODUO Shaver and Drills system and Anspach eMax 2 Plus System feature electrical powered control units that connect with drill motors/handpieces combinations that drive burs in rotation in order to drill bone during surgical interventions. The operating principle and functionality are the same as follows.
| New Device: K173066OSSEODUO(expanded Indications) | OSSEODUOShaver and Drills SystemK083720 | eMax 2 Plus System andDissection ToolsK080802 and K113476 | ||
|---|---|---|---|---|
| Indications forUse | The OSSEODUO systemis intended for shapingbones in spine andcranium surgicaloperation. Shaverhandpiece is notintended for use inneurosurgicalprocedures. | The OSSEODUO is a drill andshaver system that has beendesigned for drilling andshaping bone and for theresection of soft and hardtissues as part of surgicaloperations in the areas ofotorhinolaryngology,otoneurology, maxillofacialsurgery, and head and necksurgery.The shaver handpiece S80 orS120 is designed for cuttingand removal of soft and hardtissue in the fields of:- Endoscopic sinus surgery(such as ethmoidectomy,polypectomy, septoplasty)- Endoscopicdacryocystorhinostomy(DCR)- Nasopharyngeal andlaryngeal procedures (suchas adenoidectomy,polypectomy, tonsillectomy) | The eMax 2 Plus System isintended for Cutting andshaping bone includingspine and cranium. | Similar |
| Intended Use | Cutting soft tissue andbone | Cutting soft tissue and bone | Cutting bone | Similar |
| Controller | Console with foot pedal | Console with foot pedal | Console with foot pedal | Similar |
| Energy Source | Electrical | Electrical | Electrical | Similar |
| SpeedIndication | Digital | Digital | Digital | Similar |
| Functions | Drill and Microdebrider | Drill and Microdebrider | Drill and Microdebrider | Similar |
| Drill MotorSpeed | Max 80,000 rpm | Max 80,000 rpm | Max 80,000 rpm | Similar |
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Image /page/5/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo is in blue and green, with a red cross in the upper right corner. The word "Bien-Air" is in a stylized font, and the word "Surgery" is in a smaller, sans-serif font. A green curved line is underneath the word "Bien-Air".
| Irrigation | 1 peristaltic pumpintegrated into consolefor irrigation | 1 peristaltic pump integratedinto console for irrigation | 1 pump integrated consolefor irrigation | Similar |
|---|---|---|---|---|
| Sterilization(Micromotors)(Handpieces) | Steam AutoclaveAAMI TIR 12, ISO 17664,ISO 17665 | Steam AutoclaveAAMI TIR 12, ISO 17664, ISO17665 | Steam AutoclaveAAMI TIR 12, ISO 17664,ISO 17665 | Similar |
| Direct ContactMaterial | Stainless Steel /Diamond Grit | Stainless Steel | Stainless Steel/ Carbide | Differences |
As with the predicate devices referenced above, the proposed device shares technological characteristics with the predicate devices. The indications for Use statement for the proposed device and the predicate devices are substantially equivalent, and the indications for the proposed device do not introduce any changes to the intended use. The proposed device and predicate devices contain a console and foot pedal and the consoles have 1 peristaltic pump integrated within for irrigation. The functions of the proposed device and predicate devices is a drill and microdebrider and the drill motor speed has a max rotation of 80,000 rpm. The speed indication on the proposed device and predicate device is digital. The proposed device as well as the predicate devices require steam autoclave sterilization for the drills and handpieces and follow AAMI TIR 12, ISO 17664, and ISO 17665. The direct contact material for the proposed device and predicate devices is stainless steel.
The proposed device also has some differences in technological characteristics from those of the predicate devices and any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. A direct contact material of the proposed device is diamond grit whereas the predicate devices do not contain diamond grit. The difference has been addressed by biocompatibility testing.
Test were performed on the OSSEODUO Shaver and Drill System which demonstrated that Summary of Non-Clinical / the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional Test Data: specifications (including software). In addition, testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. Documentation was provided demonstrating compliance of the device to all FDA
requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.
Testing confirmed that the device complies with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2.
Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device.
In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility shown in the table below. The material-mediated pyrogenicity potential has been adequately evaluated for all materials, manufacturing processes and aids used in the manufacture of the patient-contacting device components. See
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the summary table below. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion (< 2.15 EU/device).
| Evaluation Test | Method/Model | Result |
|---|---|---|
| Cytotoxicity [ISO 10993-5] | MEM Elution | No cytotoxic potential |
| Irritation/ Intracutaneous Reactivity[ISO 10993-10] [ISO 10993-12] | Intracutaneous Reactivity in Rabbits(Two extracts: 0.9% NaCl; sesame oil) | Not reactive |
| Hemolysis [ISO 10993-4] | Material/surface-mediated hemolysis | No hemolytic effect |
| Sensitization [ISO 10993-10] | Sensitization in Guinea Pigs | No sensitization |
| Acute System Toxicity [ISO 10993-11] | Acute System Toxicity in Mice | No evidence of AST observed |
| Endotoxin [ISO 10993-5] | Gel-clot-method & Quantitative LAL test | Met acceptance criterion |
For the accessories sold sterile for single use, the relevant successful sterilizations and shelf life studies have been provided to support the labeled expiration dates.
- Conclusion: Bien-Air Surgery SA considers the OSSEODUO Shaver and Drill System to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).