ORiGO System

• K Number: K221184
• Device Name: ORiGO System
• Manufacturer: Bien-Air Surgery SA
• Date Cleared: 2022-11-02 ( 191 days)
• Product Code: ERL , EQJ , NLY
• Regulation Number: 874.4250
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: K173066 , K083720 , K143492
• Predicate For: N/A

Intended Use

The ORIGO system is a software-controlled motorized system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site.

The ORIGO system is used in the following surgical fields:

· for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.

Device Description

The ORIGO System is a software-controlled electrically-powered surgical system designed to be used in an operating room by a clinician for head & neck, ENT, and maxillofacial surgical procedures in a healthcare facility/hospital setting.

The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible micromotors and motorized handpieces with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.

The ORIGO System transforms electrical energy through micromotors or motorized handpieces and converts it to rotational force to cut bones and resect soft and hard tissues through attached cutting tools.

Four motor subsystems of the ORIGO System include NANO, RAPIDO, OSSEOSTAP, and S120. The NANO and RAPIDO are micromotors. OSSEOSTAP is a motorized microdrill handpiece. S120 is a motorized shaver handpiece that is a microdebrider/microresector.

PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor and used in conjunction with PM2 Burs. The PM2 80K Burs and PM2 50K Burs are used for cutting and shaping bones in ENT surgical procedures.

OSSEPSTAP is intended to be used for cutting and shaping bones in ENT surgical procedures, such as stapedotomy or ossiculoplasty. The OSSEOSTAP is used with OSSEOSTAP Burs and OSSEOSTAP Perforator.

S120 is intended to be used for resecting soft and hard tissues in ENT surgical procedures. The S120 is used with S120 Shaver Blades and S120 Shaver Burs.

The ORIGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORIGO System Irrigation Line.

The ORIGO System is a prescription-only device.

AI/ML Overview

The provided text describes the ORiGO System, a software-controlled motorized surgical system. However, it does not contain information regarding objective acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, or separate training/test set details for AI/algorithm-based performance evaluation.

The document outlines performance testing related to design validation, functional verification, usability, electromagnetic compatibility, electrical safety, software life cycle, and biocompatibility, all in conformance with relevant FDA recognized consensus standards and guidance documents. These tests are described as successfully demonstrating that the device performs as designed and is safe and effective when compared to predicate devices.

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide the detailed study information requested.

The text generally states that the device's performance aligns with relevant standards and shows substantial equivalence to predicate devices, but specific numerical or objective performance criteria and their measured results are not presented in a traditional "acceptance criteria" format.

Here's an overview of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Cannot be generated. The document mentions "functional verification, device performance, and usability" were carried out but does not provide specific acceptance thresholds or quantitative results for these tests. It only states that testing "demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This device is a surgical motor system, not an AI or diagnostic device that typically uses test sets of data (e.g., medical images). The testing described is non-clinical bench testing, and no "test set" in the context of data analysis is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This information pertains to studies involving expert review for establishing ground truth, which is not described for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This pertains to expert review of data, which is not described.

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

• No. The device is a surgical motor system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a surgical motor system, not a standalone AI algorithm. While it is "software-controlled," the performance evaluation described is for the physical device system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable generally. For non-clinical bench testing, "ground truth" typically refers to engineering specifications, physical measurements, and compliance with standards. The document states "conformance of the ORiGO System with applicable international and internal standards was verified" and "successfully demonstrated that the device correctly performs as designed."

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system that undergoes a "training set" of data in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 2, 2022

Bien-Air Surgery SA % Yulia Nikova Regulatory Affairs Manager Ken Block Consulting LLC 800 E. Campbell Road. Suite 202 Richardson, Texas 75081

Re: K221184

Trade/Device Name: ORiGO 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, EQJ, NLY Dated: October 4, 2022 Received: October 4, 2022

Dear Yulia Nikova:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221184

Device Name ORiGO System

Indications for Use (Describe)

The ORIGO system is a software-controlled motorized system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site.

The ORIGO system is used in the following surgical fields:

· for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries."

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo is in blue and green, with the words "Bien Air" in a stylized font. Below the logo, the word "Surgery" is written in a smaller font. The number K221184 is written below the word surgery.

510(k) SUMMARY

Submitter:	Bien-Air Surgery SARue de l'Ouest 2bLe Noirmont, Jura, 2340 Switzerland
Contact Person:	Mr. Jonas GuerdatChief Executive OfficerTEL: [phone]
Date Prepared:	November 2, 2022
Submission Type:	Traditional 510(k)
Subject Device:	Manufacturer: Bien-Air Surgery SATrade Name: ORIGO SystemCommon Name: Electrical Surgery System and AccessoriesRegulation Number: 21 CFR 874.4250Regulation Name: Ear, nose, and throat electric or pneumatic surgical drillRegulatory Class: Class IIClassification Product Code(s): ERLSubsequent Product Code(s): EQJ, NLYClassification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Primary Predicate Device:	Clearance: K083720 dated May 20, 2009Manufacturer: Bien-Air Surgery SATrade Name: OSSEODUO Shaver and Drill SystemCommon Name: Electrical microresector, microdebrider, shaver blades, cannulaeElectrical surgical drill, ENT drill, straight and angled handpieces, micro-saw handpiecesBurs, saw bladesRegulation Number: 21 CFR 874.4250Regulation Name: Ear, nose, and throat electric or pneumatic surgical drillRegulatory Class: Class IIClassification Product Code(s): ERLClassification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Predicate Device:	Clearance: K143492 dated March 4, 2015Manufacturer: Bien-Air Surgery SATrade Name: OSSEOSTAP Microdrill SystemCommon Name: Electrical surgical drill, ENT drill bursRegulation Number: 21 CFR 874.4250Regulation Name: Ear, Nose, and Throat Electric Or Pneumatic Surgical DrillRegulatory Class: Class IIClassification Product Code(s): ERL, EQJ
Offices	Länggasse 56 CH-2504 Bienne Phone [phone] [e-mail]
Registered office & Production	Rue de l'Ouest 2b CH-2340 Le Noirmont Phone [phone] www.bienair.com
	ClassificationName:	Drill, Surgical, Ent (Electric Or Pneumatic) IncludingHandpiece
Reference Device:	Clearance:Manufacturer:Trade Name:Common Name:RegulationNumber:Regulation Name:Regulatory Class:ClassificationProduct Code(s):SubsequentProduct Code(s):ClassificationName:	K173066 dated June 22, 2018Bien-Air Surgery SAOSSEODUO Shaver and Drill SystemCranial Drill Motor and Accessories21 CFR 882.4360Electric cranial drill motorClass IIHBCHBEMotor, Drill, Electric
DeviceDescription:	The ORIGO System is a software-controlled electrically-powered surgical system designed to be used in an operating room by a clinician for head & neck, ENT, and maxillofacial surgical procedures in a healthcare facility/hospital setting.
	The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible micromotors and motorized handpieces with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.
	The ORIGO System transforms electrical energy through micromotors or motorized handpieces and converts it to rotational force to cut bones and resect soft and hard tissues through attached cutting tools.
	Four motor subsystems of the ORIGO System include NANO, RAPIDO, OSSEOSTAP, and S120. The NANO and RAPIDO are micromotors. OSSEOSTAP is a motorized microdrill handpiece. S120 is a motorized shaver handpiece that is a microdebrider/microresector.
	PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor and used in conjunction with PM2 Burs. The PM2 80K Burs and PM2 50K Burs are used for cutting and shaping bones in ENT surgical procedures.
	OSSEPSTAP is intended to be used for cutting and shaping bones in ENT surgical procedures, such as stapedotomy or ossiculoplasty. The OSSEOSTAP is used with OSSEOSTAP Burs and OSSEOSTAP Perforator.
	S120 is intended to be used for resecting soft and hard tissues in ENT surgical procedures. The S120 is used with S120 Shaver Blades and S120 Shaver Burs.
	The ORIGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORIGO System Irrigation Line.
	The ORIGO System is a prescription-only device.

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Image /page/4/Picture/0 description: The image shows the logo for Bien-Air Surgery. The words "Bien Air" are in a stylized blue font, with a green line underneath. The word "Surgery" is in a smaller blue font below the green line.

Offices Registered office & Production Länggasse 56 Rue de l'Ouest 2b CH-2504 Bienne CH-2340 Le Noirmont

Phone [phone] Phone [phone] [e-mail] www.bienair.com

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Image /page/5/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo features the words "Bien Air" in a stylized blue font, with a green line underneath. The word "Surgery" is written in a smaller, sans-serif font below the green line.

Indications for Use:

The ORIGO system is a software-controlled motorized surgical system that includes attachments and tools for cutting soft tissue and bone, and provides irrigation fluid to the surgical site.

The ORIGO system is used in the following surgical fields:

• . for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.
  Summary of The ORiGO System has been designed to combine technical characteristics (or Technological functions) of the previously cleared devices. As such, the OSSEOSTAP has Characteristics: been cleared through [K143492], while the S120 Shaver has been cleared through K083720. Additionally, the S120 reusable shaver blades have initially been cleared under [K083720] as Class I devices under the product code EQJ.

The NANO Micromotor and RAPIDO Micromotor, used with the ORiGO System are identical to those of the OSSEODUO System [K173066], which is why it was selected as the reference device. All handpieces (PM2 Line Handpieces) used in conjunction with the two micromotors (NANO and RAPIDO) and cutting tools for the handpieces (PM2 Burs) from the OSSEODUO System [K173066] are also compatible and intended to be used with the ORiGO System.

Comparison with the predicate devices shows the characteristics of the subject device, the ORiGO System, to be substantially equivalent to the predicate devices. As such, the ORiGO System and predicate devices have the same technological characteristics:

• Method of operation ●
• . Motor subsystems and devices included in the systems

Following technological differences exist between the subject and the predicate devices:

• . Additional cutting tools
• Longer motor cables and irrigation line ●
• Reprocessing instructions .

These differences in the technological characteristics are minor and do not raise different questions of safety and effectiveness.

The following table summarizes the comparison of the subject ORiGO System to the primary predicate and other predicate devices in indications for use. design, operational principle, and technological characteristics.

Bien-Air Surgery SA

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Image /page/6/Picture/0 description: The image shows the logo for Bien Air Surgery. The text "Bien Air" is written in a stylized blue font, with the "Air" portion of the name appearing to be connected in a cursive style. To the right of the name, the word "Surgery" is written in a smaller, simpler font. A green curved line is also present, and a red cross symbol is located above the "Bien" portion of the name.

	Subject Device	Primary Predicate Device	Predicate Device	Reference Device	Substantial Equivalence Rationale
Trade Name	ORIGO System	OSSEODUO Shaver andDrill System	OSSEOSTAP MicrodrillSystem	OSSEODUO Shaver andDrill System	N/A
510(k) Submitter	Bien Air Surgery SA	Bien Air Surgery SA	Bien Air Surgery SA	Bien Air Surgery SA	N/A
[510(k) Number]	[K221184]	[K083720]	[K143492]	[K173066]
Product Code -Primary	ERL	ERL	ERL	HBC	Same as the primarypredicate device
Product Code(s)- Subsequent	EQJ, NLY	N/A	EQJ	HBE	Same as the predicatedevice
Indications forUse	The ORIGO system is asoftware-controlled surgicalsystem that is an activedevice transforming powersupply energy intoelectrical energy toelectronically controlmicromotors or motorizedhandpieces, including theirattachments and tools, forcutting soft tissue and bone,and bringing irrigation fluidto the surgical site.The ORIGO system is usedin the following surgicalfields:• For cutting and shapingbones and resection ofsoft and hard tissues inthe fields of head &neck/ENT (otology,	The OSSEODUO is a drilland shaver system that hasbeen designed for drillingand shaping bone and forthe resection of soft andhard tissues as part ofsurgical operations in theareas ofotorhinolaryngology,otoneurology, maxillofacialsurgery, and head and necksurgery.The shaver handpiece S80or S120 is designed forcutting and removal of softand hard tissue in the fieldsof:- Endoscopic sinus surgery(such as ethmoidectomy,polypectomy, septoplasty)	The OSSEOSTAP systemhas been designed for thelight drilling of bones aspart of surgical operationssuch as stapedotomy orossiculoplasty.	The OSSEODUO system isintended for shaping bonesin spine and craniumsurgical operation. Shaverhandpiece is not intendedfor use in neurosurgicalprocedures.	Substantially equivalent
	Bien-Air Surgery SA
Offices	Länggasse 56CH-2504 Bienne
	Phone [phone]
	[e-mail]
Subject Device	Primary Predicate Device	Predicate Device	Reference Device	Substantial EquivalenceRationale
rhinology, laryngology)and maxillofacialsurgeries.	- Endoscopicdacryocystorhinostomy(DCR)- Nasopharyngeal andlaryngeal procedures (suchas adenoidectomy,polypectomy,tonsillectomy)- Head and neck surgery(such as acoustic-neuromaremoval, tumor removal,rhinoplasty, adipose tissueremoval, plastic,reconstructive and aestheticsurgery)The micromotor 80Kcombines with differentdrill and micro sawhandpieces and is intendedfor cutting, drilling, shapingand sawing bone as part ofvarious surgical proceduresin the areas of ENT andhead and neck surgery suchas otoneurology,otorhinolaryngology andmaxillofacial surgery(facial plastic,reconstructive and aestheticsurgery).

Phone [phone] CH-2340 Le Noirmont CH-2504 Bienne Länggasse 56

Rue de l'Ouest 2b

www.bienair.com

e+41 (0)32 953 353

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CH-2340 Le Noirmont CH-2504 Bienne Rue de l'Ouest 2b Länggasse 56 Registered office & Production Offices

[e-mail] www.bienair.com Phone [phone] Phone [phone]

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rger14

	Subject Device	Primary Predicate Device	Predicate Device	Reference Device	Substantial Equivalence Rationale
Controller	Console with Foot Pedal	Console with Foot Pedal	Foot Controller	Console with Foot Pedal	Same as the primary predicate device and the reference device
Micromotors, Motorized Handpieces, and Handpieces	NANO MicromotorRAPIDO MicromotorOSSEOSTAPS120 ShaverPM2 Line	80K MicromotorS80 ShaverS120 Shaver	OSSEOSTAP	NANO MicromotorRAPIDO Micromotor80K MicromotorPM2 Line	S120 Shaver: same as the primary predicate deviceOSSEOSTAP: same as the predicate deviceNANO Micromotor, RAPIDO Micromotor, amd PM2 Handpieces: same as the reference device
Cutting Instruments	PM2 BursOSSEOSTAP BursS120 Shaver BladesS120 Shaver Burs	S120 Shaver BladesS120 Shaver Burs	OSSEOSTAP Burs	PM2 Burs	S120 Shaver Blades and S120 Shaver Burs: same as the primary predicate deviceOSSEOSTAP Burs: same as the predicate devicePM2 Burs: same as the reference device
Energy Source	Electrical	Electrical	Electrical	Electrical	Same
Speed Indication	Digital	Digital	N/A	Digital	Same as the primary predicate device and the reference device
Function	Drill and microdebrider	Drill and microdebrider	Drill	Drill and microdebrider	Same as the primary predicate device and the reference device
Drill Motor Speed	Max 80,000 rpm	Max 80,000 rpm	Max 12,000 rpm	Max 80,000 rpm	Same as the primary predicate device and the reference device

Offices	Länggasse 56	CH-2504 Bienne	Phone [phone]	[e-mail]
Registered office & Production	Rue de l'Ouest 2b	CH-2340 Le Noirmont	Phone [phone]	www.bienair.com

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rgerC

	Subject Device	Primary Predicate Device	Predicate Device	Reference Device	Substantial Equivalence Rationale
Irrigation	1 peristaltic pumpintegrated into the consolefor irrigation	1 peristaltic pumpintegrated into the consolefor irrigation	N/A	1 peristaltic pumpintegrated into the consolefor irrigation	Same as the primarypredicate device and thereference device
Sterilization	Steam Autoclave	Steam Autoclave	Steam Autoclave	Steam Autoclave	Same
Direct ContactMaterial	Stainless Steel/DiamondGrit, Carbide	Stainless Steel	Stainless Steel/ DiamondGrit	Stainless Steel/DiamondGrit	Substantially equivalent

Bien-Air Surgery SA
Offices	Länggasse 56	CH-2504 Bienne	Phone [phone]	[e-mail]
Registered office & Production	Rue de l'Ouest 2b	CH-2340 Le Noirmont	Phone [phone]	www.bienair.com

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Image /page/10/Picture/0 description: The image shows the logo for Bien-Air Surgery. The words "Bien Air" are in a stylized blue font, with a green curved line underneath. To the right of the words is a red medical cross symbol, and below the line is the word "Surgery" in a smaller blue font.

Summary of Performance Testing:

As required by 21 CFR 820.30(g), the ORiGO System has been successfully subjected to design validation, including software validation. Non-clinical bench testing of the ORiGO System device has been carried out to cover functional verification, device performance, and usability.

The ORiGO System was developed and produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The conformance of the ORiGO System with applicable international and internal standards was verified during non-clinical bench testing and evaluation. Tests were performed on the subject device, which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.

Electromagnetic compatibility and electrical safety of the ORiGO System have been demonstrated in conformity with the FDA recognized consensus standard IEC 60601-1, 60601-1-2, and 60601-1-6 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance".

Software life cycle of the ORiGO System have been demonstrated in conformity with the FDA recognized consensus standard IEC 62304 "Medical device software - Software life cycle processes".

Usability engineering to the ORiGO System has been demonstrated in conformity with the FDA recognized consensus standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices".

Documentation was provided demonstrating compliance of the ORiGO System devices to all FDA expectations stated in the following FDA guidance documents:

• . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,
• . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
• . Pyrogen and Endotoxins Testing: Questions and Answers
• Use of International Standard ISO 10993-1, "Biological evaluation of ● medical devices - Part 1: Evaluation and testing within a risk management process"
• Guidance for the Content of Premarket Submissions for Software . Contained in Medical Devices
• . Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
• Management of Cybersecurity in Medical Devices, and
• . Postmarket Management of Cybersecurity in Medical Devices.

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 devices. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the ORiGO System.

Bien-Air Surgery SA
Offices	Länggasse 56	CH-2504 Bienne	Phone [phone]	[e-mail]
Registered office & Production	Rue de l'Ouest 2b	CH-2340 Le Noirmont	Phone [phone]	www.bienair.com

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Image /page/11/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo is blue and green. The word "Bien-Air" is in a stylized font, and the word "Surgery" is in a smaller, sans-serif font.

BiocompatibilityTesting:	Biocompatibility evaluations of the ORIGO System devices were selected inaccordance with ISO 10993-1 Fifth edition 2018-08 "Biological evaluation ofmedical devices - Part 1: evaluation and testing within a risk managementprocess" and the FDA guidance document Use of International Standard ISO10993-1, "Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process". The testing was conducted on thesubject devices as determined by the risk analysis for the device and included:Cytotoxicity per ISO10993-5 Sensitization per ISO10993-10 Irritation per ISO10993-10 Acute Systemic Toxicity per ISO 10993-11 Material-Mediated Pyrogenicity per ISO 10993-11
Discussion of theClinical Tests:	Clinical testing was not required for a determination of substantial equivalenceof the ORIGO System.
Conclusion:	Bien-Air Surgery SA considers the ORIGO System to be substantiallyequivalent to the predicate devices listed above. This conclusion is based on thesimilarities in the intended use, principles of operation, functional design, andestablished medical use.

Image /page/11/Picture/7 description: The image contains text displaying contact information. The email address "[e-mail]" is listed. The website address "www.bienair.com" is also provided.

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.