← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K083720 # OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (K083720) _Bien-Air Surgery SA · ERL · Mar 20, 2009 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K083720 ## Device Facts - **Applicant:** Bien-Air Surgery SA - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Mar 20, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece 580 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) , - Endoscopic dacryocystorhinostomy (DCR) । - Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy) - Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery) The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery). ## Device Story OSSEODUO is an electric surgical drill and microdebrider system for ENT and maxillofacial procedures. System comprises a control unit with LCD, footswitch, irrigation pump, and interchangeable handpieces (S80/S120 shaver handpieces; 80K micromotor for drills/saws). Inputs include user-defined settings via control unit keys; outputs are mechanical rotation/oscillation of blades/burs. Operated by surgeons in clinical/OR settings. Shaver handpieces support continuous or oscillating modes; micromotor supports up to 80,000 rpm. Irrigation and suction are integrated into shaver blades/handpieces. Device provides precise tissue resection and bone shaping, aiding surgeons in complex ENT/head and neck surgeries. Benefits include improved surgical access and efficiency in tissue removal. ## Clinical Evidence No clinical data. Bench testing only: simulated tissue resection (oyster/scallop flesh, eggshell) and water aspiration trials compared OSSEODUO to predicate systems. Results confirmed equivalent tissue removal rates (grams/minute) and aspiration performance. ## Technological Characteristics Stainless steel construction; autoclavable. Electric motor drive; control unit with LCD and peristaltic irrigation pump. Shaver handpieces (S80/S120) and micromotor (80K) with ISO 3964 Type E coupling. Speed: 400-12,000 rpm (shaver), up to 80,000 rpm (drill). IPX8 waterproof footswitch. Sterile, single-use shaver blades/burs. ## Regulatory 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 - XPS 3000 System ([K041523](/device/K041523.md)) - Diego powered Dissector and Drill System ([K020594](/device/K020594.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ MAR 2 0 2009 Bien Air° Surgery # 510(k) Summary Date prepared : Made by : Bien-Air Surgery SA Rue de l'Ouest 2b 2340 Le Noirmont Switzerland 3rd. December 2008 Submitter (contact): Huques Froidevaux Quality and Regulatory Affairs Manager Bien-Air Surgery SA 2340 Le Noirmont Phone: +41 32 953 35 35 Fax: +41 32 953 35 37 huques.froidevaux@bienair.com Email: ## Device Name: Proprietary name: Common names: OSSEODUO Shaver and Drill System Electrical microresector, microdebrider; shaver Shaver blades, cannulae Electrical surgical drill, ENT drill, straight and angled handpieces, micro-saw handpieces Burs, saw blades ## Classification name: OSSEODUO Shaver and Drill System: Drill, surgical, ent (electric or pneumatic) including handpiece (21 CFR 874.4250, Product code ERL) Class II Shaver blades, burs, rasps and saw blades: Bur, Ear, Nose And Throat (21 CFR 874.4140, Product code EQJ) Class I ## Applicable 510(k) of predicate devices (substantial equivalence): | Device | Manufacturer | FDA Clearance | |---------------------------------------------|----------------------|---------------| | XPS 3000 System | Medtronic Xomed Inc. | K041523 | | Diego powered Dissector and Drill
System | Gyrus ENT L.L. | K020594 | A member of the Bien-Air Group {1}------------------------------------------------ μ083720 #### Device Description: The OSSEODUO Shaver and Drill System consists of a control unit, a footswitch, connection cables, a shaver handpiece (also named microdebrider or microresector) to drive various shaver blades, a drill motor and assorted handpieces to drive various burs, drills, rasps and micro saw. The control unit consists of a closed box with, on its main side, an LCD display screen and various function keys allowing the device to be adjusted according to the planned operation. On the right-hand side of the control unit are the connectors for the shaver handpiece S80 and for the micromotor 80K, while the pedal is connected on the rear panel. A peristaltic pump for irrigation and cooling is mounted on the rear panel which also contains the main power-up switch and the fuse holder. The shaver handpiece includes a micromotor, a gear set, a coupling system for shaver blades and connections for irrigation. Through the control unit it can operate in oscillating modus (reversing after a user-defined number of turns in each direction) or in continuous CW and CCW rotation. Its made of stainless steel and autoclavable. The shaver handpiece is available in two version: the S80 being the basic model and the 5120 with higher rotation speed (up to 12'000 rpm in continuous rotation) and the ability to orient the shaver blade during operation without releasing the chucking mechanism. The micromotor 80K has an ISO 3964 type E standard coupling which connects to a broad range of different handpieces, such as drill, contra-angle, saw, etc. Through the control unit it can achieve speeds of up to 80'000 rpm. All outer surfaces are made of stainless steel and the motor is autoclavable. The footswitch allow a smooth progressive and continuous command of the shaver or drill speed. It is IPX8 waterproof. #### Accessories: Shaver blades are round elonqated stainless steel cutting instruments, with a small cutting window at the distal tip. At the proximal end a coupling part allow the mounting in the handpiece S80 or S120. The shaver blades have built in ways for irrigation and suction. They are available in different diameters, with different geometries and different cutting edges. All shaver blades come in sterile packaging (ETO), most are disposable and for single use only. These accessories are designed to be used with the shaver handpiece S80 or S120 only. Other accessories for the OSSEODUO System include burs, drills and saw blades, which are available sterile or non-sterile, as well as the irrigation lines to be used with the peristaltic pump of the control unit, which are disposable and sterile packaged. {2}------------------------------------------------ **Intended use of the Device:** The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece 580 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) , - Endoscopic dacryocystorhinostomy (DCR) । - Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy) - Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery) The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery). The intended use of the OSSEODUO is substantially equivalent to that of the predicate devices. | Characteristic | XPS 3000 Expanded Indications | Diego Dissector and Drill
System | OSSEODUO Shaver & Drill System | |-----------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Cutting soft tissue and bone | Cutting soft tissue and
bone | Cutting soft tissue and bone | | Driver configuration | Console with separate footswitch | Console with separate
footswitch | Console with separate footswitch | | Energy source | Electric | Electric | Electric | | Speed Indication | Digital | Digital | Digital | | Fonctions | Drill and Microdebrider | Drill and Microdebrider | Drill and Microdebrider | | Drill-Fonctions: | From 10'000 rpm to 80'000 rpm
Forward and reverse | Up to 44'000 rpm
Forward and reverse | From 4000 to 80'000 rpm
Forward and reverse | | Peristaltic pumps | 2 pumps, 1 for irrigation and 1
optional pump for handpiece
cooling | 1 pump integrated into
console for irrigation | 1 pump integrated into console for
irrigation | | Number of
Handpieces supported | 6:
StraightShot Magnum I or II,
Powerforma, Powersculpt, Skeeter,
Xcalibur drill | 4:
Diego, Stapes, Viper Drill
straight and angled | Unlimited: Shaver handpiece S80 or
S120, Drill Micromotor 80K with
standard ISO 3964 Type E coupling
which connects to a number of
different handpieces (straight,
angled, microsaw, etc). | ### Summary of technological characteristics: {3}------------------------------------------------ | Microdebrider
Operating Modes | Forward, Reverse, Oscillate | Forward, Reverse, Oscillate | Forward, Reverse, Oscillate | |-----------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Microdebrider
(Microresector)
FWD / REV speed | Straightshot M4:
From 500 to 12'000 rpm.
Default: 6,000 rpm | Diego:
up to 15'000 rpm | Handpiece S120:
From 400 to 12'000 RPM
Default: 12'000 RPM
Handpiece 580:
From 400 to 8'000 RPM
Default: 8′000 RPM | | Microdebrider
(Microresector)
Oscillation Speed | Straighshot M4:
From 500 to 5000 RPM
Default: 5,000 RPM | Diego:
Up to 5000 rpm | Handpiece S80 & S120:
From 300 to 5,000 RPM
Default: 3,500 RPM | | Duty cycle at full load
oscillating: | Max 60s on
Min 30s off | Max 30s on
Min 1 minute 30s off | Max 3 min 30s on,
Min 6 min off | | Steam autoclavable
handpieces | Yes | Yes | Yes | | Blade sizes (O.D.) | 2.9 mm - 6 mm | 2.9 - 4.6mm | 3.0 mm - 4.0 mm | | Suction Capability
(micro-debrider) | Yes suction port in line with shaver
blade, diameter 3.4mm | Yes suction port in line with
shaver blade | Yes suction port in line with shaver
blade, diameter 3.9mm | | Irrigation Capability | Yes,
Irrigation port on the shaver blade. | Yes,
Irrigation port on the
handpiece | Yes
Irrigation port on the handpiece | | Direct patient
contacting materials
(Burs / Blades) | Stainless Steel and medical
polymer | Stainless Steel and medical
polymer | Stainless Steel and medical
polymer | | Blades / burs
biocompatible | Yes | Yes | Yes | ## Non clinical performance assessment The substantial equivalence of the OSSEODUO to the Xomed XPS 3000 with Straightshot M4 and to the Gyrus Diego has been tested with various experiments. Following trials have been conducted: - i Resection of oyster-flesh mixed with eggshell to simulate the resection of cartilage. - . Resection of scallops flesh - । Aspiration of water By each trial, following points have been watched: weight of removed tissues, frequency of the aspiration system. {4}------------------------------------------------ K0863720 These experiments have confirmed that the OSSEODUO system has a similar rate of tissue removal (grams per minute) to the two reference systems. The aspiration of water with the same vacuum system has also shown equivalent results. Pertaining frequency of clogging, the results vary widely randomly from one measure to the other even with the same system so that comparison between systems are difficult. These experiments have however clearly confirmed that the OSSEODUO system is equivalent in its function and capability to the predicate devices. ## Post Market Surveillance As the OSSEODUO system has been CE-marked and cleared for market in Europe since October 2007, feedback of clinical performance of the OSSEODUO system has been reported by different ENT Surgeons from Italy, Switzerland and China. Following topics have been addressed by the surgeons - Cutting performance of the shaver blades compared to competition - Suction/aspiration capability in shaver mode - Drilling of bone at 40'000 rpm compared to competition The different surgeon's reports confirm the effectiveness and safety of the OSSEODUO system #### Conclusions A comparison of technical features, non clinical testing with the predicate systems as well as post market performance feedback demonstrate that the OSSEODUO system is substantially as safe and effective as the predicate devices. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human services. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 0 2009 Bien Air Surgery SA c/o Hugues Froidevaux Quality & Regulatory Affairs Manager Rue de l'Ouest 2b Le Noirmont Switzerland 2340 Re: K083720 Trade/Device Name: OSSEODUO Shaver and Drill System Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: February 3, 2009 Received: February 18, 2009 Dear Mr. Froidevaux: 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. 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. {6}------------------------------------------------ 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 yours, M. B. Eglinton, mD 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 {7}------------------------------------------------ K083720 # Indications for Use 510(k) Number (if known): K083720 OSSEODUO, Shaver Handpiece S80 and S1.20, Micromotor 80K Device Name: Indications for Use: The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) - - Endoscopic dacryocystorhinostomy (DCR) - - Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy) - Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery) The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery). Prescription Use (Per 21 CFR 801.109) Prescription Use X (Part 21 CFR 801 Subpart D) 510(k) Number AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices Page 1 of 1 BAS / HF /2009-01-27 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K083720](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K083720) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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