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).

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.

AI/ML Overview

The provided 510(k) summary for the OSSEODUO Shaver and Drill System describes non-clinical performance assessments rather than a typical study comparing a device's performance against defined acceptance criteria using a test set and ground truth in the way one might evaluate AI/ML systems.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technical features and informal non-clinical trials. The "acceptance criteria" here are implicitly achieving similar performance to the predicate devices in the specific tests conducted.

Here is an analysis based on the provided text, structured to address your points as much as possible within the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported OSSEODUO Performance
Non-Clinical Performance
Tissue Removal Rate (Oyster-flesh + eggshell)	Similar rate to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594)	Confirmed "similar rate of tissue removal (grams per minute) to the two reference systems."
Tissue Removal Rate (Scallops flesh)	Similar rate to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594)	Confirmed "similar rate of tissue removal (grams per minute) to the two reference systems."
Water Aspiration	Equivalent results to Medtronic XPS 3000 (K041523) and Gyrus Diego (K020594) with the same vacuum system	Confirmed "equivalent results" with the same vacuum system.
Frequency of Clogging	Not definitively quantifiable due to high variability in predicate devices (comparison difficult)	Results "vary widely randomly from one measure to the other even with the same system so that comparison between systems are difficult."
Post-Market Surveillance (Qualitative Feedback)
Cutting Performance (Shaver Blades)	Favorable comparison to competitor products (implied effectiveness)	Surgeons' reports "confirm the effectiveness and safety" of the system, addressing cutting performance compared to competition.
Suction/Aspiration Capability (Shaver Mode)	Satisfactory performance (implied effectiveness)	Surgeons' reports "confirm the effectiveness and safety" of the system, addressing suction/aspiration capability.
Bone Drilling (40,000 rpm)	Favorable comparison to competitor products (implied effectiveness)	Surgeons' reports "confirm the effectiveness and safety" of the system, addressing drilling of bone at 40,000 rpm compared to competition.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not explicitly stated in numerical terms for the non-clinical trials. However, the description implies multiple trials were conducted for each test (oyster-flesh/eggshell, scallops flesh, water aspiration). For post-market surveillance, feedback was gathered from "different ENT Surgeons from Italy, Switzerland and China."
Data Provenance:
- Non-Clinical Trials: Performed by the manufacturer (Bien-Air Surgery SA). The location of these trials is not specified but is presumably Switzerland, where the device was made.
- Post-Market Surveillance: Retrospective collection of feedback (qualitative) from "different ENT Surgeons from Italy, Switzerland and China" after the device had been CE-marked and marketed in Europe since October 2007.

3. Number of Experts and Qualifications for Ground Truth

Non-Clinical Trials: No mention of external experts establishing ground truth for these trials. The "ground truth" was based on direct observation and measurement of physical parameters (weight removed, aspiration frequency) by the testing personnel, comparing directly to the predicate devices.
Post-Market Surveillance: "Different ENT Surgeons" provided feedback. Their number is not specified beyond "different," nor are their specific qualifications (e.g., years of experience), though their role as "ENT Surgeons" implies clinical expertise relevant to the device's use. They served as the "experts" providing real-world feedback.

4. Adjudication Method for Test Set

No formal adjudication method (like 2+1 or 3+1 consensus) is described for either the non-clinical trials or the post-market surveillance.
- In the non-clinical trials, direct measurements were taken and compared.
- For post-market feedback, it appears to be a collection of individual surgeon opinions/experiences, rather than a consensus-driven adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed in the context of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., imaging AI) where human readers interpret results. This submission pertains to a surgical tool, and the "effectiveness" is assessed by physical performance metrics and qualitative surgeon feedback.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the non-clinical trials can be considered a form of "standalone" performance assessment in that they evaluated the device's functional capabilities (tissue removal, aspiration) directly, independent of a specific surgeon's technique or interaction in a clinical setting. The device's operation was tested in a controlled environment to simulate its intended function.

7. Type of Ground Truth Used

Non-Clinical Trials: The ground truth was essentially physical measurements and direct comparison of performance metrics (tissue removal rate, aspiration rate) against the performance of physically existing predicate devices.
Post-Market Surveillance: The ground truth was based on expert clinical opinion/feedback from ENT surgeons regarding the device's real-world performance (cutting, suction, drilling effectiveness and safety).

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device's design and engineering would be refined through traditional R&D processes, prototypes, and testing rather than machine learning training.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" described in the 510(k) submission is a two-pronged approach to demonstrate substantial equivalence:

Non-Clinical Performance Assessment: This involved performing laboratory-based trials using simulated tissues (oyster-flesh/eggshell, scallops flesh) and water aspiration tests. The goal was to compare physical performance metrics (tissue removal rate, aspiration results) of the OSSEODUO system directly against two legally marketed predicate devices (Medtronic XPS 3000 and Gyrus Diego). The conclusion was that the OSSEODUO system has a "similar rate of tissue removal" and "equivalent results" for aspiration, with clogging frequency being too variable for meaningful comparison.
Post-Market Surveillance Feedback: This involved collecting qualitative feedback from "different ENT Surgeons from Italy, Switzerland and China" who had used the OSSEODUO system after its CE-marking in Europe (October 2007). This feedback addressed aspects like cutting performance, suction/aspiration capabilities, and bone drilling, with surgeons reporting confirmation of the system's effectiveness and safety.

Together, these assessments aimed to confirm that the OSSEODUO system is "substantially as safe and effective as the predicate devices," which is the core requirement for 510(k) clearance.

Summary

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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 DrillSystem	Gyrus ENT L.L.	K020594

A member of the Bien-Air Group

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μ083720

Device Description:

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.

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Intended use of the Device:

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 intended use of the OSSEODUO is substantially equivalent to that of the predicate devices.

Characteristic	XPS 3000 Expanded Indications	Diego Dissector and DrillSystem	OSSEODUO Shaver & Drill System
Intended Use	Cutting soft tissue and bone	Cutting soft tissue andbone	Cutting soft tissue and bone
Driver configuration	Console with separate footswitch	Console with separatefootswitch	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 rpmForward and reverse	Up to 44'000 rpmForward and reverse	From 4000 to 80'000 rpmForward and reverse
Peristaltic pumps	2 pumps, 1 for irrigation and 1optional pump for handpiececooling	1 pump integrated intoconsole for irrigation	1 pump integrated into console forirrigation
Number ofHandpieces supported	6:StraightShot Magnum I or II,Powerforma, Powersculpt, Skeeter,Xcalibur drill	4:Diego, Stapes, Viper Drillstraight and angled	Unlimited: Shaver handpiece S80 orS120, Drill Micromotor 80K withstandard ISO 3964 Type E couplingwhich connects to a number ofdifferent handpieces (straight,angled, microsaw, etc).

Summary of technological characteristics:

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MicrodebriderOperating 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 RPMDefault: 12'000 RPMHandpiece 580:From 400 to 8'000 RPMDefault: 8′000 RPM
Microdebrider(Microresector)Oscillation Speed	Straighshot M4:From 500 to 5000 RPMDefault: 5,000 RPM	Diego:Up to 5000 rpm	Handpiece S80 & S120:From 300 to 5,000 RPMDefault: 3,500 RPM
Duty cycle at full loadoscillating:	Max 60s onMin 30s off	Max 30s onMin 1 minute 30s off	Max 3 min 30s on,Min 6 min off
Steam autoclavablehandpieces	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 shaverblade, diameter 3.4mm	Yes suction port in line withshaver blade	Yes suction port in line with shaverblade, diameter 3.9mm
Irrigation Capability	Yes,Irrigation port on the shaver blade.	Yes,Irrigation port on thehandpiece	YesIrrigation port on the handpiece
Direct patientcontacting materials(Burs / Blades)	Stainless Steel and medicalpolymer	Stainless Steel and medicalpolymer	Stainless Steel and medicalpolymer
Blades / bursbiocompatible	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.

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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.

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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.

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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

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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 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)

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

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BAS / HF /2009-01-27

Regulation Number and Section

§ 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.