(342 days)
Not Found
No
The description focuses on the mechanical and software control of a motorized surgical system for bone cutting, with no mention of AI or ML capabilities.
No
The device is described as a software-controlled motorized system that cuts bone and provides irrigation fluid during neuro (cranial) and spinal surgeries. It is a surgical tool, not a device intended for therapy or treatment of a disease or condition.
No
Explanation: The device is described as a "software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site." Its intended use is "For cutting bones in neuro (cranial) and spinal surgeries." This describes a surgical tool for performing procedures, not for diagnosing 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 IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the ORiGO System is used for "cutting bones in neuro (cranial) and spinal surgeries." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a system with motors, handpieces, cutting tools, and irrigation for surgical procedures. This aligns with a surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ORiGO System's function is to physically modify bone during surgery.
N/A
Intended Use / Indications for Use
The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site.
The ORiGO System is used in the following surgical fields:
-For cutting bones in neuro (cranial) and spinal surgeries.
Product codes (comma separated list FDA assigned to the subject device)
HBC, HBE
Device Description
The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures.
The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.
The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools.
Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece.
PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures.
PM PERFO is intended to be used for a cranial perforation.
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
bones in neuro (cranial) and spinal
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)
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 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.
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
- Pyrogenicity per ISO 10993-11
- Indirect (extract) Hemolysis per ISO 10993-4 and ASTM F756.
Clinical testing was not required for a determination of substantial equivalence of the ORiGO System.
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.
Not Found
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
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2022
Bien-Air Surgery SA % Akiko Dohi Regulatory Scientist Ken Block Consulting, LLC 800 East Campbell Road, Suite 202 Richardson, Texas 75081
Re: K213697
Trade/Device Name: ORiGO System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE Dated: September 30, 2022 Received: September 30, 2022
Dear Akiko Dohi:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 medical devices and radiation-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.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213697
Device Name ORiGO System
Indications for Use (Describe)
The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site.
The ORiGO System is used in the following surgical fields:
-For cutting bones in neuro (cranial) and spinal 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/1 description: The image shows the logo for Bien-Air Surgery. The text "Bien-Air" is in a stylized blue font, with a green line underneath. The word "Surgery" is written in a smaller blue font below the green line.
510(k) SUMMARY
| Submitter: | Bien-Air Surgery SA
Rue de l'Ouest 2b
Le Noirmont, Jura, 2340 Switzerland | | | Subject Device | Predicate Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jonas Guerdat
Chief Executive Officer
TEL: +41-32-344-64-40
jonas.guerdat@bienair.com | Trade Name | ORIGO System | OSSEODUO Shaver and Drill System | |
| Date Prepared: | September 30, 2022 | 510(k) Submitter | Bien Air Surgery SA | Bien Air Surgery SA | |
| Submission Type: | Traditional 510(k) | [510(k) Number] | [K213697] | [K173066] | |
| Subject Device: | Manufacturer:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Product Code:
Subsequent Product Code:
Classification Name: | Bien-Air Surgery SA
ORIGO System
Electrical Surgery System and Accessories
21 CFR 882.4360
Electric cranial drill motor
Class II
HBC
HBE
Motor, Drill, Electric | Product Code -
Primary | HBC | HBC |
| Predicate Device: | Clearance:
Manufacturer:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Product Code:
Subsequent Product Code:
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 | Product Code -
Subsequent | HBE | HBE |
| Device Description: | The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures.
The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.
The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools.
Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece.
PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures. | | Indications for
Use | The ORIGO System is a software-
controlled motorized surgical system that
includes attachments and
tools for cutting bone, and provides
irrigation fluid to the surgical site.
The ORIGO System is used in the
following surgical fields:
- For cutting bones in neuro (cranial) and
spinal surgeries. | The OSSEODUO system is intended for
shaping bones in spine and cranium
surgical operation. Shaver handpiece is
not intended for use in neurosurgical
procedures. |
| Intended Use | Cutting bone | Cutting bone | | | |
Bien-Air Surgery SA
Länggasse 56 Rue de l'Ouest 2b
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Image /page/4/Picture/1 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. The word "Surgery" is written in a smaller blue font below the green line.
PM PERFO is intended to be used for a cranial perforation.
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.
The ORiGO System is a software-controlled motorized surgical system that Indications for Use: includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site. The ORiGO System is used in the following surgical fields: * For cutting bones in neuro (cranial) and spinal surgeries.
Comparison with the predicate device shows the characteristics of the subject Summary of Technological device, the ORiGO System, to be substantially equivalent to the predicate Characteristics: 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 predicate device in indications for use, design, operational principle, and technological characteristics.
Bien-Air Surgery SA
Offices
Registered office & Production
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Image /page/5/Picture/1 description: The image shows the logo for Bien-Air Surgery. The logo is in blue and green. The word "Bien-Air" is in a stylized font, with a green line underneath. The word "Surgery" is in a smaller, sans-serif font and is also blue. There is a red cross in the upper right corner of the image.
| Subject Device | Predicate Device | |
|---|---|---|
| Controller | Console with Foot Pedal | Console with Foot Pedal |
| Energy Source | Electrical | Electrical |
| Speed Indication | Digital | Digital |
| Function | Drill | Drill and microdebrider |
| Drill Motor Speed | Max 80,000 rpm | Max 80,000 rpm |
| Irrigation | 1 peristaltic pump integrated into the console for irrigation | 1 peristaltic pump integrated into the console for irrigation |
| Sterilization | Steam Autoclave | |
| AAMI TIR 12, ISO 17664, ISO 17665 | Steam Autoclave | |
| AAMI TIR 12, ISO 17664, ISO 17665 | ||
| Direct Contact Material | Stainless Steel, Diamond Grit, Carbide, Full Carbide | Stainless Steel, Diamond Grit |
The ORiGO System was developed and produced under considerations of all Summary of Performance applicable technical standards, internal specifications, and FDA guidance Testing: 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 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 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
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Image /page/6/Picture/1 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. The word "Surgery" is in a smaller blue font below the green line.
Biocompatibility evaluations of the ORiGO System devices were selected in Biocompatibility Testing: 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 Pyrogenicity per ISO 10993-11 ● Indirect (extract) Hemolysis per ISO 10993-4 and ASTM F756 . Clinical testing was not required for a determination of substantial equivalence Discussion of the Clinical Tests: 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 primary intended use, principles of operation, functional design,
and established medical use.
Bien-Air Surgery SA
CH-2340 Le Noirmont
CH-2504 Bienne