(342 days)
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.
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.
The provided text describes a 510(k) premarket notification for the ORiGO System, an electrical surgical system. It details the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the detailed table and answer all the questions regarding acceptance criteria and the study proving the device meets those criteria.
The document focuses on demonstrating that the ORiGO System is substantially equivalent to a legally marketed predicate device (OSSEODUO Shaver and Drill System K173066) based on similarities in intended use, technological characteristics, and performance. The performance testing section primarily lists compliance with various international standards, FDA guidance documents, and biocompatibility tests. It does not provide specific acceptance criteria values with corresponding device performance metrics for the device itself or the study that definitively proves the device meets those criteria in a quantitative sense as might be expected for an AI/software-based device performance study.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it states:
- "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."
- "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."
This broadly states that the device met the required standards for safety and effectiveness and is comparable to the predicate. Specific numerical criteria and results are not provided.
| Acceptance Criteria (Not explicitly stated with values in the document) | Reported Device Performance (General statements from document) |
|---|---|
| Conformity with applicable technical standards (IEC 60601-1, 60601-1-2, 60601-1-6, IEC 62304, IEC 62366-1) | Demonstrated conformity |
| Compliance with FDA guidance documents (e.g., Reprocessing Medical Devices, Sterility Information, ISO 10993-1, Software Content, EMC, Cybersecurity) | Demonstrated compliance |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Indirect Hemolysis) | Testing conducted and devices selected in accordance with ISO 10993-1, implying successful completion. |
| Safety and Effectiveness comparable to predicate device | Tests demonstrated device is safe and effective, performs comparably, and is substantially equivalent. |
| Device performs as designed and validated for intended use | Verification/validation activities demonstrated correct performance. |
| Raises no new questions regarding safety or effectiveness | Verification/validation testing supports this. |
Missing Information/Answers to Specific Questions:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for test units or any 'data sets' in the context of an AI/software performance study. This is a hardware device; thus, the concept of a "test set" as understood for AI performance is not applicable here in the same way. The provenance of any test data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This is a hardware surgical device. The document does not describe any human expert review or ground truth establishment relevant to an AI model's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No mentions of adjudication are present as it's not relevant to the type of device and testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the ORiGO System." Therefore, no MRMC study involving human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. While the device is "software-controlled," the evaluation focuses on the mechanical and electrical safety/performance of the surgical system, not on the standalone performance of an independent algorithm in the context of diagnostic or interpretive tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of AI ground truth. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., electrical safety, software lifecycle, usability, biocompatibility) and its functional performance in cutting bone as designed through bench testing, not through a diagnostic or interpretive ground truth.
8. The sample size for the training set
- Not applicable/Not provided. The device is a hardware surgical system. The concept of a "training set" as used for AI/machine learning models does not apply here.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set mentioned, there is no discussion of establishing ground truth for it.
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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.
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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
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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 SARue de l'Ouest 2bLe Noirmont, Jura, 2340 Switzerland | Subject Device | Predicate Device | ||
|---|---|---|---|---|---|
| Contact Person: | Jonas GuerdatChief Executive OfficerTEL: +41-32-344-64-40jonas.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 SAORIGO SystemElectrical Surgery System and Accessories21 CFR 882.4360Electric cranial drill motorClass IIHBCHBEMotor, 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, 2018Bien-Air Surgery SAOSSEODUO Shaver and Drill SystemCranial Drill Motor and Accessories21 CFR 882.4360Electric cranial drill motorClass IIHBCHBEMotor, 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 forUse | The ORIGO System is a software-controlled motorized surgical system thatincludes attachments andtools for cutting bone, and providesirrigation fluid to the surgical site.The ORIGO System is used in thefollowing surgical fields:* For cutting bones in neuro (cranial) andspinal surgeries. | The OSSEODUO system is intended forshaping bones in spine and craniumsurgical operation. Shaver handpiece isnot intended for use in neurosurgicalprocedures. | |
| 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 AutoclaveAAMI TIR 12, ISO 17664, ISO 17665 | Steam AutoclaveAAMI 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
§ 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).