ORiGO System

K221184 · Bien-Air Surgery SA · ERL · Nov 2, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K221184
• Device Name: ORiGO System
• Applicant: Bien-Air Surgery SA
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Nov 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

ORiGO System is a software-controlled, electrically-powered surgical system for use in operating rooms by clinicians. System components include a control unit, foot pedal, micromotors (NANO, RAPIDO), motorized handpieces (OSSEOSTAP, S120, PM2 line), irrigation line, and various cutting tools (burs, shaver blades). The system transforms electrical energy into rotational force to cut bone and resect soft/hard tissues; an integrated peristaltic pump delivers saline irrigation to the surgical site. Clinicians operate the system via foot pedal and console controls to perform procedures such as stapedotomy, ossiculoplasty, and sinus surgery. Output includes rotational mechanical action and irrigation flow, which assists the surgeon in tissue removal and bone shaping. The device benefits patients by providing precise, motorized surgical access and tissue resection capabilities in ENT and maxillofacial procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including functional verification, device performance, usability, electromagnetic compatibility (IEC 60601-1 series), software life cycle (IEC 62304), and biocompatibility (ISO 10993-1).

Technological Characteristics

Electrical surgical system; console-controlled micromotors and handpieces. Materials: Stainless steel, diamond grit, carbide. Energy: Electrical. Irrigation: Integrated peristaltic pump. Connectivity: Standalone console. Sterilization: Steam autoclave. Software: IEC 62304 compliant. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 10993-1.

Indications for Use

Indicated for cutting/shaping bone and resection of soft/hard tissue in head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries. Prescription use only.

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

• OSSEODUO Shaver and Drill System (K083720)
• OSSEOSTAP Microdrill System (K143492)

Reference Devices

• OSSEODUO Shaver and Drill System (K173066)

Submission Summary (Full Text)

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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) | |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;"> ☑ </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;"> ☐ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 SA<br>Rue de l'Ouest 2b<br>Le Noirmont, Jura, 2340 Switzerland | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Jonas Guerdat<br>Chief Executive Officer<br>TEL: [phone]<br>[e-mail] | |
| Date Prepared: | November 2, 2022 | |
| Submission Type: | Traditional 510(k) | |
| Subject Device: | Manufacturer: Bien-Air Surgery SA<br>Trade Name: ORIGO System<br>Common Name: Electrical Surgery System and Accessories<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>Classification Product Code(s): ERL<br>Subsequent Product Code(s): EQJ, NLY<br>Classification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | |
| Primary Predicate Device: | Clearance: K083720 dated May 20, 2009<br>Manufacturer: Bien-Air Surgery SA<br>Trade Name: OSSEODUO Shaver and Drill System<br>Common Name: Electrical microresector, microdebrider, shaver blades, cannulae<br>Electrical surgical drill, ENT drill, straight and angled handpieces, micro-saw handpieces<br>Burs, saw blades<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>Classification Product Code(s): ERL<br>Classification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | |
| Predicate Device: | Clearance: K143492 dated March 4, 2015<br>Manufacturer: Bien-Air Surgery SA<br>Trade Name: OSSEOSTAP Microdrill System<br>Common Name: Electrical surgical drill, ENT drill burs<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>Classification 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 | |
| | Classification<br>Name: | Drill, Surgical, Ent (Electric Or Pneumatic) Including<br>Handpiece |
| Reference Device: | Clearance:<br>Manufacturer:<br>Trade Name:<br>Common Name:<br>Regulation<br>Number:<br>Regulation Name:<br>Regulatory Class:<br>Classification<br>Product Code(s):<br>Subsequent<br>Product Code(s):<br>Classification<br>Name: | K173066 dated June 22, 2018<br>Bien-Air Surgery SA<br>OSSEODUO Shaver and Drill System<br>Cranial Drill Motor and Accessories<br>21 CFR 882.4360<br>Electric cranial drill motor<br>Class II<br>HBC<br>HBE<br>Motor, Drill, Electric |
| Device<br>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. | |

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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 and<br>Drill System | OSSEOSTAP Microdrill<br>System | OSSEODUO Shaver and<br>Drill 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 -<br>Primary | ERL | ERL | ERL | HBC | Same as the primary<br>predicate device |
| Product Code(s)<br>- Subsequent | EQJ, NLY | N/A | EQJ | HBE | Same as the predicate<br>device |
| Indications for<br>Use | The ORIGO system is a<br>software-controlled surgical<br>system that is an active<br>device transforming power<br>supply energy into<br>electrical energy to<br>electronically control<br>micromotors or motorized<br>handpieces, including their<br>attachments and tools, for<br>cutting soft tissue and bone,<br>and bringing irrigation fluid<br>to the surgical site.<br><br>The ORIGO system is used<br>in the following surgical<br>fields:<br><br>• For cutting and shaping<br>bones and resection of<br>soft and hard tissues in<br>the fields of head &<br>neck/ENT (otology, | The OSSEODUO is a drill<br>and shaver system that has<br>been designed for drilling<br>and shaping bone and for<br>the resection of soft and<br>hard tissues as part of<br>surgical operations in the<br>areas of<br>otorhinolaryngology,<br>otoneurology, maxillofacial<br>surgery, and head and neck<br>surgery.<br><br>The shaver handpiece S80<br>or S120 is designed for<br>cutting and removal of soft<br>and hard tissue in the fields<br>of:<br><br>- Endoscopic sinus surgery<br>(such as ethmoidectomy,<br>polypectomy, septoplasty) | The OSSEOSTAP system<br>has been designed for the<br>light drilling of bones as<br>part of surgical operations<br>such as stapedotomy or<br>ossiculoplasty. | The OSSEODUO system is<br>intended for shaping bones<br>in spine and cranium<br>surgical operation. Shaver<br>handpiece is not intended<br>for use in neurosurgical<br>procedures. | Substantially equivalent |
| | Bien-Air Surgery SA | | | | |
| Offices | Länggasse 56<br>CH-2504 Bienne | | | | |
| | Phone [phone] | | | | |
| | [e-mail] | | | | |
| Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Substantial Equivalence<br>Rationale | |
| rhinology, laryngology)<br>and maxillofacial<br>surgeries. | - Endoscopic<br>dacryocystorhinostomy<br>(DCR)<br>- Nasopharyngeal and<br>laryngeal procedures (such<br>as adenoidectomy,<br>polypectomy,<br>tonsillectomy)<br>- Head and neck surgery<br>(such as acoustic-neuroma<br>removal, tumor removal,<br>rhinoplasty, adipose tissue<br>removal, plastic,<br>reconstructive and aesthetic<br>surgery)<br>The micromotor 80K<br>combines with different<br>drill and micro saw<br>handpieces and is intended<br>for cutting, drilling, shaping<br>and sawing bone as part of<br>various surgical procedures<br>in the areas of ENT and<br>head and neck surgery such<br>as otoneurology,<br>otorhinolaryngology and<br>maxillofacial surgery<br>(facial plastic,<br>reconstructive and aesthetic<br>surgery). | | | | |

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

Rue de l'Ouest 2b

www.bienair.com

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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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| rger<br>14 |
|------------|
| |

| | 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 Micromotor<br>RAPIDO Micromotor<br>OSSEOSTAP<br>S120 Shaver<br>PM2 Line | 80K Micromotor<br>S80 Shaver<br>S120 Shaver | OSSEOSTAP | NANO Micromotor<br>RAPIDO Micromotor<br>80K Micromotor<br>PM2 Line | S120 Shaver: same as the primary predicate device<br>OSSEOSTAP: same as the predicate device<br>NANO Micromotor, RAPIDO Micromotor, amd PM2 Handpieces: same as the reference device |
| Cutting Instruments | PM2 Burs<br>OSSEOSTAP Burs<br>S120 Shaver Blades<br>S120 Shaver Burs | S120 Shaver Blades<br>S120 Shaver Burs | OSSEOSTAP Burs | PM2 Burs | S120 Shaver Blades and S120 Shaver Burs: same as the primary predicate device<br>OSSEOSTAP Burs: same as the predicate device<br>PM2 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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| rger<br>C |
|-----------|
| |

| | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Substantial Equivalence Rationale |
|----------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Irrigation | 1 peristaltic pump<br>integrated into the console<br>for irrigation | 1 peristaltic pump<br>integrated into the console<br>for irrigation | N/A | 1 peristaltic pump<br>integrated into the console<br>for irrigation | Same as the primary<br>predicate device and the<br>reference device |
| Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave | Same |
| Direct Contact<br>Material | Stainless Steel/Diamond<br>Grit, Carbide | Stainless Steel | Stainless Steel/ Diamond<br>Grit | Stainless Steel/Diamond<br>Grit | 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.

| Biocompatibility<br>Testing: | Biocompatibility evaluations of the ORIGO System devices were selected in<br>accordance with ISO 10993-1 Fifth edition 2018-08 "Biological evaluation of<br>medical devices - Part 1: evaluation and testing within a risk management<br>process" and the FDA guidance document Use of International Standard ISO<br>10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process". The testing was conducted on the<br>subject devices as determined by the risk analysis for the device and included:<br>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 the<br>Clinical Tests: | Clinical testing was not required for a determination of substantial equivalence<br>of the ORIGO System. |
| Conclusion: | Bien-Air Surgery SA considers the ORIGO System to be substantially<br>equivalent to the predicate devices listed above. This conclusion is based on the<br>similarities in the intended use, principles of operation, functional design, and<br>established medical use. |

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