(86 days)
No
The summary describes a mechanical drill system with a foot control and handpiece. There is no mention of AI, ML, image processing, or data-driven decision making. The software mentioned is classified as "minor level of concern," suggesting basic control functions rather than complex AI/ML algorithms.
Yes
This device is intended for the "light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty," which are therapeutic medical procedures.
No
The device is described as a surgical tool for light drilling of bones during surgical operations. It is not intended for diagnosis of a condition or disease.
No
The device description explicitly states it consists of a foot control unit and a handpiece with an integrated micromotor, which are hardware components. While it mentions software controlling the micro-controller, the device itself is a physical drilling system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical system (foot control, handpiece, micromotor, burs) used for physical manipulation (drilling) of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for a physical intervention on the patient.
N/A
Intended Use / Indications for Use
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
Product codes
ERL, EQJ
Device Description
The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bones, middle ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals, surgical ENT otology procedures
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
The OSSEOSTAP was bench tested in parallel with the predicate device Skeeter to confirm that handling, cutting performance and noise level were at least as good. The OSSEOSTAP bur resistance has been evaluated on the basis of repeated running, traction tests and repeated sterilization cycles. Functionality of the OSSOSTAP handpiece after multiple reprocessing has been confirmed with a cycle test. Cleaning validation of the OSSEOSTAP handpiece has been validated in an external lab using proteins as marker. Moist heat sterilization has been validated based on lab validation of 2 related devices sharing similar components but featuring more complex geometry. For the dedicated reusable burs, both the cleaning and the steam sterilization have been validated by an external lab.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bien-Air Surgery SA % Mr. Roland Hasler, CEO Rue de l'Ouest 2b 2340 Le Noirmont Switzerland
Re: K143492
Trade/Device Name: OSSEOSTAP Microdrill System (Control Unit, Handpiece and Burs) 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 Dated: December 3, 2014 Received: December 8, 2014
Dear Mr. Hasler:
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143492
Device Name OSSEOSTAP Microdrill System
Indications for Use (Describe)
The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.
Type of Use (Select one or both, as applicable)
2 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 is a logo for Bien-Air Surgery. The logo is in blue and green, with the words "Bien Air" in a stylized font. Below that, the word "Surgery" is written in a smaller, sans-serif font. There is a green line that runs underneath the word "Bien Air". There is a red cross in a white circle in the upper right corner of the image.
510(k) Summary
| Date prepared: | December 1, 2014 |
|---|---|
| Submitter: | Bien-Air Surgery SA |
| Rue de l'Ouest 2b | |
| 2340 Le Noirmont Switzerland | |
| Phone: +41 32 953 35 35 | |
| Fax: +41 32 953 35 37 | |
| Contact person: | Hugues Froidevaux, Quality and Regulatory Affairs Manager |
| Email: hugues.froidevaux@bienair.com | |
| Device Name: | |
| Proprietary name: | OSSEOSTAP Microdrill System |
| Common names: | Electrical surgical drill, ENT drill |
| Burs | |
| Classification name: | Drill, Surgical, ENT (electric or pneumatic) including handpiece |
| (21 CFR 874.4250, Product code ERL), Class II |
Burs
Bur, Ear, Nose and Throat
(21 CFR 874.4140, Product code EQJ), Class I |
Predicate device:
Primary predicate device:
| Device | Classification | Manufacturer |
|---|---|---|
| Skeeter Ultra-Lite | ||
| Oto-Tool Drill | 874.4250, ERL, Class 2 | |
| Drill, Surgical, ENT (electric or | ||
| pneumatic) including handpiece. | ||
| Covered by K041523 | Medtronic Xomed Inc. |
Substantial equivalence is claimed to the skeeter OTO-Tool drill, which is an accessory to the XPS3000 console, which is the subject of K041523.
The description of the Skeeter (from the IFU of Medtronic XPS 3000 system), is as follows:
SKEETER® ULTRA-LITE OTO-TOOL -- A slender, lightweight drill handpiece and burs specifically used in middle ear surgical procedures, including stapes footplate procedures. The Skeeter® may be powered from the XPS® 3000 console, XPS® 2000 console, or from a battery powered variable speed foot control.
§5_510(k) summary OSSEOSTAP revised 20150224.doc
4
Reference device:
| Fisch Drill System | 874.4250, ERL, Class 2
Drill, Surgical, ENT (electric or
pneumatic) including handpiece | Jedmed Instrument Co.
(original applicant, K792159) |
| -------------------- | ----------------------------------------------------------------------------------------------- | -------------------------------------------------------- |
|---|
Device Description:
The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.
Intended use of the Device:
The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.
Summary of technological characteristics:
| Characteristic | Skeeter Ultra-Lite
Oto-Tool Drill
Medtronic Xomed Inc.
(Accessory of K041523) | Fisch Drill System
Jedmed Instrument
Co.
(K792159) | OSSEOSTAP
Microdrill
Bien-Air Surgery SA |
|----------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------|
| Intended Use | Light drilling of bone | Drilling, cutting and
shaping bone | Light drilling of bone |
| Control Unit | Foot pedal | Foot pedal | Foot pedal |
| Energy source | Electrical (batteries) | Electrical (AC) | Electrical (batteries) |
| Rotation speed | Max. 12,000 rpm | Max. 40,000 rpm | Max. 12,000 rpm |
| Steam
autoclavable
handpieces | Yes | Yes | Yes |
| Direct patient
contact
materials | Stainless steel | Stainless steel | Stainless steel |
| Burs
biocompatible | Yes | n.a. | Yes |
The characteristics of the OSSEOSTAP are comparable to those of the predicate device.
The Fisch, Skeeter and OSSEOSTAP drills are all indicated for use in otology (e.g. middle ear) surgical procedures. The maximum rotation speed of the Fisch drill is higher because it can be used for a broader range of indications (including mastoid and plastic surgery).
5
Performance Data (non-clinical tests):
The OSSEOSTAP was bench tested in parallel with the predicate device Skeeter to confirm that handling, cutting performance and noise level were at least as good.
The OSSEOSTAP bur resistance has been evaluated on the basis of repeated running, traction tests and repeated sterilization cycles.
Functionality of the OSSOSTAP handpiece after multiple reprocessing has been confirmed with a cycle test.
Cleaning validation of the OSSEOSTAP handpiece has been validated in an external lab using proteins as marker. Moist heat sterilization has been validated based on lab validation of 2 related devices sharing similar components but featuring more complex geometry.
For the dedicated reusable burs, both the cleaning and the steam sterilization have been validated by an external lab.
Biocompatibility of the OSSEOSTAP was evaluated according to ISO 10993-1. The curved tip of the handpiece as well as the burs are in direct contact with bone or tissue for a limited duration. Materials are stainless steel for the handpiece, stainless steel and diamond, respectively carbide for the burs.
The software that controls the micro-controller in the OSSEOSTAP footcontrol has been classified as minor level of concern. All validation documents are available.
The electrical safety of the OSSEOSTAP System has been certified through the standards IEC 60601-1 30 edition, which includes an EMC certification according to IEC 60601-1-2.
No clinical performance data was deemed necessary for this 510(k)
Substantial Equivalence:
The OSSEOSTAP Microdrill System has the same intended use and operating principle as the predicate device. Through comparison of technical and performance characteristics, the OSSEOSTAP is considered to be as safe and effective as the predicate device, and therefore, substantially equivalent.