(88 days)
Not Found
No
The description details a mechanical surgical drill system with a foot pedal, motor, handpieces, and irrigation. There is no mention of software, algorithms, or any features that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for surgical procedures such as preparation of intraoral bone for microsurgery and implantology, and for apicoectomies, which are therapeutic interventions.
No
The device is described as a surgical drill system for preparing intraoral bone for microsurgery and implantology, which are therapeutic rather than diagnostic actions. Its function is to perform a physical procedure, not to identify or determine a disease or condition.
No
The device description clearly lists multiple hardware components including a foot pedal control unit, electric micromotor, cable, transformer, handpieces, and an irrigation system with a peristaltic pump.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Bien-Air ORL-E-92 Surgical Drill System is a surgical tool used for physically preparing bone tissue during surgical procedures. It directly interacts with the patient's body during surgery.
- Intended Use: The intended use clearly states it's for "preparation of intraoral bone for microsurgery and implantology and for apicoectomies." This is a surgical function, not a diagnostic one based on analyzing specimens.
The description and intended use clearly indicate this is a surgical device, not a device used for testing or analyzing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.
Product codes
EFB
Device Description
The Bien-Air ORL-E-92 Surgical Drill System is a series of components used in implantology and microsurgery. The system consists of a foot pedal control unit, BASCH electric micromotor and cable and transformer. Several models of straight and contra-angled microsurgery handpieces are available for use with the ORL-E-92 system. A separate irrigation system consisting of peristaltic pump, irrigation tubing and solution supports complements the ORL-E-92 system.
The ORL-E-92 Surgical Drill System consists of a multifunctional foot pedal, electric micromotor and cable and various straight and contra-angled handpieces. There are four speed ranges to select from with the maximum speed being 40,000 rpm. The foot pedal controls all functions of the system and a supporting irrigation system. The ORL-E-92 can accommodate two BASCH electric micromotors with adjustable speed and rotation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral bone
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No formal performance data was submitted for this Class I device. Sterilization certification of the product by steam sterilization was provided within this notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification
Image /page/0/Picture/1 description: The image contains a handwritten string of characters. The string appears to be "K9X4244". The characters are written in a cursive style, with some connections between the letters and numbers. The writing is in black ink on a white background.
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 13:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
13.1 SUBMITTER INFORMATION
| a. Company Name: | Bien-Air USA, Inc. |
|---|---|
| b. Company Address: | 19600 Fairchild Road, Suite 250 |
| Irvine, CA. 92612 | |
| c. Company Phone: | |
| Company Facsimile: | (949) 477-6050 |
| (949) 477-6051 | |
| d. Contact Person: | Arthur Mateen |
| Branch Manager | |
| e. Date Summary Prepared: | February 17, 1999 |
DEVICE IDENTIFICATION 13.2.
| a. Trade/Proprietary Name: | ORL-E-92 Surgical Drill System |
|---|---|
| b. Classification Name: | Dental Handpieces and Accessories |
| 21 CFR 872.4200 |
IDENTIFICATION OF PREDICATE DEVICES 13.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| KaVo America | Intrasept 905 | K934783 | 05/16/94 |
| Jedmed | Fisch Drill System | K792159 | 11/27/79 |
1
Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification
13.4 DEVICE DESCRIPTION
The Bien-Air ORL-E-92 Surgical Drill System is a series of components used in implantology and microsurgery. The system consists of a foot pedal control unit, BASCH electric micromotor and cable and transformer. Several models of straight and contra-angled microsurgery handpieces are available for use with the ORL-E-92 system. A separate irrigation system consisting of peristaltic pump, irrigation tubing and solution supports complements the ORL-E-92 system.
13.5 SUBSTANTIAL EQUIVALENCE
The Bjen-Air ORL-E-92 Surgical Drill System is substantially equivalent to the Intrasept 905 System in commercial distribution by KaVo America and the Fisch Drill System in commercial distribution by Jedmed.
The fundamental technical characteristics of the Bien-Air ORL-E-92 Surgical Drill System are similar to those of the predicate devices. The Bien-Air ORL-E-92 System is equivalent to the Intrasept 905 in design, speed, rotation, irrigation and autoclavablity. Both the ORL-E-92 system and the predicate devices use an electric micromotor which is autoclavable. The range of speed of the system is equivalent with all systems. The ORL-E-92 system and the Intrasept 905 use similar models of straight and contra-angled handpieces. The ORL-E-92 system is identical to the Fisch Drill System with the exception of the indications for use.
INDICATIONS FOR USE 13.6
The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.
CONFIDENTIAL
2
Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification
13.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Bien-Air ORL-E-92 Surgical Drill System with the predicate device is provided within this submission. The ORL-E-92 Surgical Drill System consists of a multifunctional foot pedal, electric micromotor and cable and various straight and contra-angled handpieces. There are four speed ranges to select from with the maximum speed being 40,000 rpm. The foot pedal controls all functions of the system and a supporting irrigation system. The ORL-E-92 can accommodate two BASCH electric micromotors with adjustable speed and rotation.
13.8 PERFORMANCE DATA
No formal performance data was submitted for this Class I device. Sterilization certification of the product by steam sterilization was provided within this notification.
13.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1999
Bien-Air USA, Incorporated C/O Ms. Carol Patterson Consultant Patterson Consulting Group, Incorporated 18140 Smokesignal Drive San Diego, California 92127
Re : K984244 ORL-E-92 Surgical Drill System Trade Name: Requlatory Class: I Product Code: EFB October 28, 1998 Dated: November 27, 1998 Received:
Dear Ms. Patterson
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Patterson
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Rumer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bien-Air ORL-E-92 Surgical Drill System K984244 Altachment }
INDICATION FOR USE
| 510(k) Number: | K984244 |
|---|---|
| Device Name: | Bien-Air ORL-E-92 Surgical Drill System |
| Indications for Use: | The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Rump
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number