OSSEODUO Shaver and Drill System

K173066 · Bien-Air Surgery SA · HBC · Jun 22, 2018 · Neurology

Device Facts

• Record ID: K173066
• Device Name: OSSEODUO Shaver and Drill System
• Applicant: Bien-Air Surgery SA
• Product Code: HBC · Neurology
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

OSSEODUO Shaver and Drill System is an electrically powered surgical system for bone shaping in spine and cranium procedures. System comprises a control console with integrated peristaltic irrigation pump, foot pedal, and various handpieces (NANO, RAPIDO, PM PERFO; straight and angled models; fixed and rotary craniotomies). System drives burs in rotation to cut/shape bone. Operated by surgeons in clinical settings. Output is mechanical bone resection. Healthcare providers use system to perform surgical bone shaping; device benefits patients by enabling precise bone removal during spine/cranial surgery. Handpieces and motors are reusable, requiring steam autoclave sterilization; burs are single-use and provided sterile.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functional specifications, software requirements, and safety (operating temperatures). Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, irritation, hemolysis, sensitization, acute systemic toxicity, and endotoxin testing (all met acceptance criteria). Sterilization and shelf-life studies provided for single-use accessories.

Technological Characteristics

Electrical powered control unit; stainless steel and diamond grit materials; max speed 80,000 rpm; integrated peristaltic irrigation pump; digital speed indication. Sterilization via steam autoclave per AAMI TIR 12, ISO 17664, and ISO 17665. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for shaping bones in spine and cranium surgical procedures. Shaver handpiece is contraindicated for neurosurgical procedures.

Regulatory Classification

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.

Predicate Devices

• OSSEODUO Shaver and Drills System (K083720)
• eMax 2 Plus System (K080802)
• Dissection Tools (K113476)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 SA<br>Rue De l'Ouest 2b<br>2340 Le Noirmont, Switzerland |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bien-Air Surgery SA<br>Mr. Adil Slimani<br>Quality and Regulatory Affairs Manager<br>Rue De l'Ouest 2b<br>CH 2340 Le Noirmont<br>Switzerland<br>TEL: [phone]<br>FAX: [phone]<br>Adil [e-mail] |
| Date Prepared: | September 26, 2017 |
| Proposed Device: | Manufacturer: Bien-Air Surgery SA<br>Common Name: Cranial Drill Motor and accessories<br>Trade/Device Name: OSSEODUO Shaver and Drill System<br>Classification Name: Motor, Drill, Electric<br>Regulation Number: 21 CFR 882.4360<br>Regulation Name: Electric cranial drill motor<br>Regulatory Class: Class II<br>Product Code: HBC, HBE |
| Primary Predicate Device: | Clearance: K083720 March 20, 2009<br>Manufacturer: Bien-Air Surgery SA<br>Trade Name: OSSEODUO Shaver and Drill System<br>Regulation Number: 21 CFR 874.4250<br>Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill<br>Regulatory Class: Class II<br>Product Code: ERL |
| Predicate Device(s): | Clearance: K080802 April 30, 2008<br>Manufacturer: The Anspach Effort, Inc.<br>Trade Name: eMax 2 Plus System<br>Regulation Number: 21 CFR 882.4360<br>Regulation Name: Electric cranial drill motor<br>Regulatory Class: II<br>Product Code: HBC |
| Predicate Device: | Clearance: K113476 December 16, 2011<br>Manufacturer: The Anspach Effort, Inc.<br>Trade Name: Dissection Tools<br>Regulation Number: 21 CFR 882.4310<br>Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessori<br>Regulatory 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: K173066<br>OSSEODUO<br>(expanded Indications) | OSSEODUO<br>Shaver and Drills System<br>K083720 | eMax 2 Plus System and<br>Dissection Tools<br>K080802 and K113476 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------|
| Indications for<br>Use | The OSSEODUO system<br>is intended for shaping<br>bones in spine and<br>cranium surgical<br>operation. Shaver<br>handpiece is not<br>intended for use in<br>neurosurgical<br>procedures. | The OSSEODUO is a drill and<br>shaver system that has been<br>designed for drilling and<br>shaping bone and for the<br>resection of soft and hard<br>tissues as part of surgical<br>operations in the areas of<br>otorhinolaryngology,<br>otoneurology, maxillofacial<br>surgery, and head and neck<br>surgery.<br>The shaver handpiece S80 or<br>S120 is designed for cutting<br>and removal of soft and hard<br>tissue in the fields of:<br>- Endoscopic sinus surgery<br>(such as ethmoidectomy,<br>polypectomy, septoplasty)<br>- Endoscopic<br>dacryocystorhinostomy<br>(DCR)<br>- Nasopharyngeal and<br>laryngeal procedures (such<br>as adenoidectomy,<br>polypectomy, tonsillectomy) | The eMax 2 Plus System is<br>intended for Cutting and<br>shaping bone including<br>spine and cranium. | Similar |
| Intended Use | Cutting soft tissue and<br>bone | 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 |
| Speed<br>Indication | Digital | Digital | Digital | Similar |
| Functions | Drill and Microdebrider | Drill and Microdebrider | Drill and Microdebrider | Similar |
| Drill Motor<br>Speed | 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 pump<br>integrated into console<br>for irrigation | 1 peristaltic pump integrated<br>into console for irrigation | 1 pump integrated console<br>for irrigation | Similar |
|------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|-------------|
| Sterilization<br>(Micromotors)<br>(Handpieces) | Steam Autoclave<br>AAMI TIR 12, ISO 17664,<br>ISO 17665 | Steam Autoclave<br>AAMI TIR 12, ISO 17664, ISO<br>17665 | Steam Autoclave<br>AAMI TIR 12, ISO 17664,<br>ISO 17665 | Similar |
| Direct Contact<br>Material | Stainless Steel /<br>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<br>[ISO 10993-10] [ISO 10993-12] | Intracutaneous Reactivity in Rabbits<br>(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.