(266 days)
Not Found
No
The summary describes a mechanical bone shaping system with various handpieces and burs. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on mechanical function, sterilization, and electrical safety.
No
The device is described as being for "shaping bones in spine and cranium surgical operation," which is a surgical tool function, not a therapeutic treatment.
No
The device is described as a "Shaver and Drill System" intended for "shaping bones in spine and cranium surgical operation." Its function is entirely focused on surgical modification (shaping bones), not on gathering information for diagnosis.
No
The device description explicitly mentions physical components like handpieces, motors, and burs, which are hardware. The submission also details hardware-related testing such as operating temperatures, electrical safety, and biocompatibility. While software is mentioned as part of the system and undergoing verification/validation, the device is clearly not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for shaping bones in spine and cranium surgical operation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "Shaver and Drill System" with handpieces and burs used for shaping bone. This is a surgical tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, disease, or condition. This device does not perform such analysis.
The OSSEODUO system is a surgical instrument used during a surgical procedure on a patient.
N/A
Intended Use / Indications for Use
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
Product codes
HBC, HBE
Device Description
The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Tests were performed on the OSSEODUO Shaver and Drill System which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software). In addition, testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. Documentation was provided demonstrating compliance of the device to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.
Testing confirmed that the device complies with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2.
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 device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device.
In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility shown in the table below. The material-mediated pyrogenicity potential has been adequately evaluated for all materials, manufacturing processes and aids used in the manufacture of the patient-contacting device components. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion (
§ 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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2018
Bien-Air Surgery SA % Belia Juarez Regulatory Project Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, Texas 75080
Re: K173066
Trade/Device Name: OSSEODUO Shaver and Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, HBE Dated: May 24, 2018 Received: May 25, 2018
Dear Belia Juarez:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173066
Device Name OSSEODUO Shaver and Drill System
Indications for Use (Describe)
The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| Submitter: | Bien-Air Surgery SA
Rue De l'Ouest 2b
2340 Le Noirmont, Switzerland |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bien-Air Surgery SA
Mr. Adil Slimani
Quality and Regulatory Affairs Manager
Rue De l'Ouest 2b
CH 2340 Le Noirmont
Switzerland
TEL: +41(0)32 953 35 35
FAX: +41(0)32 953 35 37
Adil Slimani@Bienair.com |
| Date Prepared: | September 26, 2017 |
| Proposed Device: | Manufacturer: Bien-Air Surgery SA
Common Name: Cranial Drill Motor and accessories
Trade/Device Name: OSSEODUO Shaver and Drill System
Classification Name: Motor, Drill, Electric
Regulation Number: 21 CFR 882.4360
Regulation Name: Electric cranial drill motor
Regulatory Class: Class II
Product Code: HBC, HBE |
| Primary Predicate Device: | Clearance: K083720 March 20, 2009
Manufacturer: Bien-Air Surgery SA
Trade Name: OSSEODUO Shaver and Drill 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 |
| Predicate Device(s): | Clearance: K080802 April 30, 2008
Manufacturer: The Anspach Effort, Inc.
Trade Name: eMax 2 Plus System
Regulation Number: 21 CFR 882.4360
Regulation Name: Electric cranial drill motor
Regulatory Class: II
Product Code: HBC |
| Predicate Device: | Clearance: K113476 December 16, 2011
Manufacturer: The Anspach Effort, Inc.
Trade Name: Dissection Tools
Regulation Number: 21 CFR 882.4310
Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessori
Regulatory Class: Class II |
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Image /page/4/Picture/0 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, and the word "Surgery" is in a smaller, sans-serif font. There is a green line under the word "Bien-Air".
Device The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications Description: for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.
The OSSEODUO system is intended for shaping bones in spine and cranium surgical Indications for Use Statement: operation. Shaver handpiece is not intended for use in neurosurgical procedures.
Summary of Technological Characteristics:
Both the Bien-Air OSSEODUO Shaver and Drills system and Anspach eMax 2 Plus System feature electrical powered control units that connect with drill motors/handpieces combinations that drive burs in rotation in order to drill bone during surgical interventions. The operating principle and functionality are the same as follows.
| | New Device: K173066
OSSEODUO
(expanded Indications) | OSSEODUO
Shaver and Drills System
K083720 | eMax 2 Plus System and
Dissection Tools
K080802 and K113476 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------|
| Indications for
Use | The OSSEODUO system
is intended for shaping
bones in spine and
cranium surgical
operation. Shaver
handpiece is not
intended for use in
neurosurgical
procedures. | 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) - Endoscopic
dacryocystorhinostomy
(DCR) - Nasopharyngeal and
laryngeal procedures (such
as adenoidectomy,
polypectomy, tonsillectomy) | The eMax 2 Plus System is
intended for Cutting and
shaping bone including
spine and cranium. | Similar |
| Intended Use | Cutting soft tissue and
bone | Cutting soft tissue and bone | Cutting bone | Similar |
| Controller | Console with foot pedal | Console with foot pedal | Console with foot pedal | Similar |
| Energy Source | Electrical | Electrical | Electrical | Similar |
| Speed
Indication | Digital | Digital | Digital | Similar |
| Functions | Drill and Microdebrider | Drill and Microdebrider | Drill and Microdebrider | Similar |
| Drill Motor
Speed | Max 80,000 rpm | Max 80,000 rpm | Max 80,000 rpm | Similar |
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Image /page/5/Picture/0 description: The image shows the logo for Bien-Air Surgery. The logo is in blue and green, with a red cross in the upper right corner. The word "Bien-Air" is in a stylized font, and the word "Surgery" is in a smaller, sans-serif font. A green curved line is underneath the word "Bien-Air".
| Irrigation | 1 peristaltic pump
integrated into console
for irrigation | 1 peristaltic pump integrated
into console for irrigation | 1 pump integrated console
for irrigation | Similar |
|------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|-------------|
| Sterilization
(Micromotors)
(Handpieces) | Steam Autoclave
AAMI TIR 12, ISO 17664,
ISO 17665 | Steam Autoclave
AAMI TIR 12, ISO 17664, ISO
17665 | Steam Autoclave
AAMI TIR 12, ISO 17664,
ISO 17665 | Similar |
| Direct Contact
Material | Stainless Steel /
Diamond Grit | Stainless Steel | Stainless Steel/ Carbide | Differences |
As with the predicate devices referenced above, the proposed device shares technological characteristics with the predicate devices. The indications for Use statement for the proposed device and the predicate devices are substantially equivalent, and the indications for the proposed device do not introduce any changes to the intended use. The proposed device and predicate devices contain a console and foot pedal and the consoles have 1 peristaltic pump integrated within for irrigation. The functions of the proposed device and predicate devices is a drill and microdebrider and the drill motor speed has a max rotation of 80,000 rpm. The speed indication on the proposed device and predicate device is digital. The proposed device as well as the predicate devices require steam autoclave sterilization for the drills and handpieces and follow AAMI TIR 12, ISO 17664, and ISO 17665. The direct contact material for the proposed device and predicate devices is stainless steel.
The proposed device also has some differences in technological characteristics from those of the predicate devices and any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. A direct contact material of the proposed device is diamond grit whereas the predicate devices do not contain diamond grit. The difference has been addressed by biocompatibility testing.
Test were performed on the OSSEODUO Shaver and Drill System which demonstrated that Summary of Non-Clinical / the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional Test Data: specifications (including software). In addition, testing confirmed that the proposed device is equivalent to the predicate device for safety issues such as operating temperatures. Documentation was provided demonstrating compliance of the device to all FDA
requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.
Testing confirmed that the device complies with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2.
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 device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device.
In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility shown in the table below. The material-mediated pyrogenicity potential has been adequately evaluated for all materials, manufacturing processes and aids used in the manufacture of the patient-contacting device components. See
6
the summary table below. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion (