OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece

K143492 · Bien-Air Surgery SA · ERL · Mar 4, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K143492
• Device Name: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
• Applicant: Bien-Air Surgery SA
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

Device Story

OSSEOSTAP Microdrill System comprises a battery-operated foot control unit and a handpiece with an integrated micromotor; drives various burs for light bone drilling. Used by medical professionals in ENT otology procedures (e.g., stapedotomy, ossiculoplasty). Foot control regulates rotation speed via drill cable. Device provides mechanical drilling action to bone tissue. Benefits include precise bone removal in delicate middle ear surgeries. Handpiece and burs are steam autoclavable; stainless steel construction.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via handling, cutting, and noise level comparisons against predicate. Biocompatibility evaluated per ISO 10993-1. Cleaning and sterilization validated via protein marker testing and cycle testing. Electrical safety and EMC certified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Materials: Stainless steel (handpiece), stainless steel/diamond/carbide (burs). Energy: Battery-operated electrical. Max speed: 12,000 rpm. Connectivity: Wired foot control to handpiece. Sterilization: Steam autoclavable. Software: Micro-controller in foot control, minor level of concern.

Indications for Use

Indicated for medical professionals performing light bone drilling during ENT otology surgical procedures, specifically stapedotomy or ossiculoplasty.

Regulatory Classification

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.

Predicate Devices

• Skeeter Ultra-Lite Oto-Tool Drill (K041523)

Reference Devices

• Fisch Drill System (K792159)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 SA<br>Rue de l'Ouest 2b<br>2340 Le Noirmont Switzerland<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | Hugues Froidevaux, Quality and Regulatory Affairs Manager<br>Email: [e-mail] |
| Device Name: | |
| Proprietary name: | OSSEOSTAP Microdrill System |
| Common names: | Electrical surgical drill, ENT drill<br>Burs |
| Classification name: | Drill, Surgical, ENT (electric or pneumatic) including handpiece<br>(21 CFR 874.4250, Product code ERL), Class II<br><br>Burs<br>Bur, Ear, Nose and Throat<br>(21 CFR 874.4140, Product code EQJ), Class I |

# Predicate device:

Primary predicate device:

| Device | Classification | Manufacturer |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------|
| Skeeter Ultra-Lite<br>Oto-Tool Drill | 874.4250, ERL, Class 2<br>Drill, Surgical, ENT (electric or<br>pneumatic) including handpiece.<br>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 2<br>Drill, Surgical, ENT (electric or<br>pneumatic) including handpiece | Jedmed Instrument Co.<br>(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-Lite<br>Oto-Tool Drill<br>Medtronic Xomed Inc.<br>(Accessory of K041523) | Fisch Drill System<br>Jedmed Instrument<br>Co.<br>(K792159) | OSSEOSTAP<br>Microdrill<br>Bien-Air Surgery SA |
|----------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------|
| Intended Use | Light drilling of bone | Drilling, cutting and<br>shaping 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 |
| Steam<br>autoclavable<br>handpieces | Yes | Yes | Yes |
| Direct patient<br>contact<br>materials | Stainless steel | Stainless steel | Stainless steel |
| Burs<br>biocompatible | 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.