(191 days)
No
The summary describes a software-controlled motorized surgical system with various handpieces and tools for cutting and irrigation. There is no mention of AI, ML, or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
No.
This device is described as a surgical system for cutting and shaping bones and resecting soft and hard tissues, which are operative functions rather than therapeutic ones.
No
The device is described as a surgical system used for cutting soft tissue and bone, providing irrigation, and resecting tissues. Its function is to perform surgical actions, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components including a control unit, foot pedal, micromotors, handpieces, attachments, cutting tools, and an irrigation line. While it is software-controlled, it is not solely software.
Based on the provided information, the ORIGO system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ORIGO System Function: The ORIGO system is a surgical tool used directly on the patient's body during surgical procedures to cut and shape tissue and bone. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states its purpose is for surgical procedures in specific anatomical areas.
- Device Description: The description details its mechanical function of converting electrical energy to rotational force for cutting.
Therefore, the ORIGO system falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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."
Product codes (comma separated list FDA assigned to the subject device)
ERL, EQJ, NLY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room by a clinician in a healthcare facility/hospital setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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". Biocompatibility evaluations of the ORIGO System devices were selected in accordance with ISO 10993-1 Fifth edition 2018-08 "Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process" and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The testing was conducted on the subject 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 SA
Rue de l'Ouest 2b
Le Noirmont, Jura, 2340 Switzerland | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Jonas Guerdat
Chief Executive Officer
TEL: +41 (0)32 953 35 35
jonas.guerdat@bienair.com | |
| Date Prepared: | November 2, 2022 | |
| Submission Type: | Traditional 510(k) | |
| Subject Device: | Manufacturer: Bien-Air Surgery SA
Trade Name: ORIGO System
Common Name: Electrical Surgery System and Accessories
Regulation Number: 21 CFR 874.4250
Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill
Regulatory Class: Class II
Classification Product Code(s): ERL
Subsequent Product Code(s): EQJ, NLY
Classification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | |
| Primary Predicate Device: | Clearance: K083720 dated May 20, 2009
Manufacturer: Bien-Air Surgery SA
Trade Name: OSSEODUO Shaver and Drill System
Common Name: Electrical microresector, microdebrider, shaver blades, cannulae
Electrical surgical drill, ENT drill, straight and angled handpieces, micro-saw handpieces
Burs, saw blades
Regulation Number: 21 CFR 874.4250
Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill
Regulatory Class: Class II
Classification Product Code(s): ERL
Classification Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | |
| Predicate Device: | Clearance: K143492 dated March 4, 2015
Manufacturer: Bien-Air Surgery SA
Trade Name: OSSEOSTAP Microdrill System
Common Name: Electrical surgical drill, ENT drill burs
Regulation Number: 21 CFR 874.4250
Regulation Name: Ear, Nose, and Throat Electric Or Pneumatic Surgical Drill
Regulatory Class: Class II
Classification Product Code(s): ERL, EQJ | |
| Offices | Länggasse 56 CH-2504 Bienne Phone +41 (0)32 344 64 40 surgery@bienair.com | |
| Registered office & Production | Rue de l'Ouest 2b CH-2340 Le Noirmont Phone +41 (0)32 953 35 35 www.bienair.com | |
| | Classification
Name: | Drill, Surgical, Ent (Electric Or Pneumatic) Including
Handpiece |
| Reference Device: | Clearance:
Manufacturer:
Trade Name:
Common Name:
Regulation
Number:
Regulation Name:
Regulatory Class:
Classification
Product Code(s):
Subsequent
Product Code(s):
Classification
Name: | K173066 dated June 22, 2018
Bien-Air Surgery SA
OSSEODUO Shaver and Drill System
Cranial Drill Motor and Accessories
21 CFR 882.4360
Electric cranial drill motor
Class II
HBC
HBE
Motor, Drill, Electric |
| 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. | |
4
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 +41 (0)32 344 64 40 Phone +41 (0)32 953 35 35 surgery@bienair.com www.bienair.com
5
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 | |||
| Drill System | OSSEOSTAP Microdrill | ||||
| System | OSSEODUO Shaver and | ||||
| 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 - | |||||
| Primary | ERL | ERL | ERL | HBC | Same as the primary |
| predicate device | |||||
| Product Code(s) |
- Subsequent | EQJ, NLY | N/A | EQJ | HBE | Same as the predicate
device |
| Indications for
Use | The ORIGO system is a
software-controlled surgical
system that is an active
device transforming power
supply energy into
electrical energy to
electronically control
micromotors or motorized
handpieces, including their
attachments and tools, for
cutting soft tissue and bone,
and bringing 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, | 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) | The OSSEOSTAP system
has been designed for the
light drilling of bones as
part of surgical operations
such as stapedotomy or
ossiculoplasty. | The OSSEODUO system is
intended for shaping bones
in spine and cranium
surgical operation. Shaver
handpiece is not intended
for use in neurosurgical
procedures. | Substantially equivalent |
| | Bien-Air Surgery SA | | | | |
| Offices | Länggasse 56
CH-2504 Bienne | | | | |
| | Phone +41 (0)32 344 64 40 | | | | |
| | surgery@bienair.com | | | | |
| Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Substantial Equivalence
Rationale | |
| rhinology, laryngology)
and maxillofacial
surgeries. | - Endoscopic
dacryocystorhinostomy
(DCR) - Nasopharyngeal and
laryngeal procedures (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). | | | | |
Phone +41 (0)32 953 35 35 CH-2340 Le Noirmont CH-2504 Bienne Länggasse 56
Rue de l'Ouest 2b
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Phone +41
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Phone +41
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Phone +41 (0)32 322 25 35
Phone +4
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Registered office & Production
Phone +41 (0)32 344 64
Dhono +41 (0)32 052 25
Phone +41 (0)32 344 6
Phone +41 (0)32 953 2
Phone +41 (0)
Phone +41 (0)
Phone +41 (0)32 95:
Phone +41 (0)32 344 64 40
Dhana 141 (0)33
Phone +41 (0)32 344 64 40
Phone +41 (0)32 344 6
Phone +41 (0)32 953 3
Phone +41 (0)32 344 6
Bhone 41 (0)32052 2
Phone +41 (0)32 344 64 40
Phone +41 (0)32 344
Phone +41 (0)32
-41(0)32 953 35
phone +41 (0)32 953 35
+41 (0)32 953 35 35
e+41(0)32 953 35
Phone +41 (0)32 953 3
41 (0) 32 344 64 40
41 (0) 32 353 35 35
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surgery
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7
CH-2340 Le Noirmont CH-2504 Bienne Rue de l'Ouest 2b Länggasse 56 Registered office & Production Offices
surgery@bienair.com www.bienair.com Phone +41 (0)32 344 64 40 Phone +41 (0)32 953 35 35
8
| rger
| 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 | ||||
| RAPIDO Micromotor | |||||
| OSSEOSTAP | |||||
| S120 Shaver | |||||
| PM2 Line | 80K Micromotor | ||||
| S80 Shaver | |||||
| S120 Shaver | OSSEOSTAP | NANO Micromotor | |||
| RAPIDO Micromotor | |||||
| 80K Micromotor | |||||
| PM2 Line | S120 Shaver: same as the primary predicate device | ||||
| OSSEOSTAP: same as the predicate device | |||||
| NANO Micromotor, RAPIDO Micromotor, amd PM2 Handpieces: same as the reference device | |||||
| Cutting Instruments | PM2 Burs | ||||
| OSSEOSTAP Burs | |||||
| S120 Shaver Blades | |||||
| S120 Shaver Burs | S120 Shaver Blades | ||||
| S120 Shaver Burs | OSSEOSTAP Burs | PM2 Burs | S120 Shaver Blades and S120 Shaver Burs: same as the primary predicate device | ||
| OSSEOSTAP Burs: same as the predicate device | |||||
| 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 +41 (0)32 344 64 40 | surgery@bienair.com |
|---|---|---|---|---|
| Registered office & Production | Rue de l'Ouest 2b | CH-2340 Le Noirmont | Phone +41 (0)32 953 35 35 | www.bienair.com |
9
| rger
| C |
|---|
| Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Substantial Equivalence Rationale | |
|---|---|---|---|---|---|
| Irrigation | 1 peristaltic pump | ||||
| integrated into the console | |||||
| for irrigation | 1 peristaltic pump | ||||
| integrated into the console | |||||
| for irrigation | N/A | 1 peristaltic pump | |||
| integrated into the console | |||||
| for irrigation | Same as the primary | ||||
| predicate device and the | |||||
| reference device | |||||
| Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave | Same |
| Direct Contact | |||||
| Material | Stainless Steel/Diamond | ||||
| Grit, Carbide | Stainless Steel | Stainless Steel/ Diamond | |||
| Grit | Stainless Steel/Diamond | ||||
| Grit | Substantially equivalent |
| Bien-Air Surgery SA | ||||
|---|---|---|---|---|
| Offices | Länggasse 56 | CH-2504 Bienne | Phone +41 (0)32 344 64 40 | surgery@bienair.com |
| Registered office & Production | Rue de l'Ouest 2b | CH-2340 Le Noirmont | Phone +41 (0)32 953 35 35 | 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 +41 (0)32 344 64 40 | surgery@bienair.com |
| Registered office & Production | Rue de l'Ouest 2b | CH-2340 Le Noirmont | Phone +41 (0)32 953 35 35 | 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
Testing: | Biocompatibility evaluations of the ORIGO System devices were selected in
accordance with ISO 10993-1 Fifth edition 2018-08 "Biological evaluation of
medical devices - Part 1: evaluation and testing within a risk management
process" and the FDA guidance document Use of International Standard ISO
10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process". The testing was conducted on the
subject 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 the
Clinical Tests: | Clinical testing was not required for a determination of substantial equivalence
of the ORIGO System. |
| Conclusion: | Bien-Air Surgery SA considers the ORIGO System to be substantially
equivalent to the predicate devices listed above. This conclusion is based on the
similarities in the intended use, principles of operation, functional design, and
established medical use. |
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