The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.

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.

AI/ML Overview

The Bien-Air ORL-E-92 Surgical Drill System is a Class I device and, as such, no formal performance data was submitted to prove the device meets acceptance criteria. The submission indicates that "sterilization certification of the product by steam sterilization was provided." This suggests that the primary acceptance criterion related to performance was likely the successful sterilization of the device by steam.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Sterilization	Sterilization certification by steam sterilization was provided.
Functionality	Not explicitly detailed, but implied to be equivalent to predicate devices (speed, rotation, irrigation, autoclavability).

2. Sample size used for the test set and the data provenance

No formal performance data was submitted, so there is no information regarding a specific test set, its sample size, or data provenance. The submission focuses on substantial equivalence to predicate devices and sterilization certification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no formal performance study with a test set requiring expert ground truth was conducted or submitted.

4. Adjudication method for the test set

Not applicable, as no formal performance study with a test set was conducted or submitted.

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

Not applicable. This device is a surgical drill system, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical drill system, not an algorithm.

7. The type of ground truth used

For sterilization, the "ground truth" would be the successful validation of the sterilization process as per industry standards and regulatory guidelines, and its certification. For the functional aspects, the ground truth for substantial equivalence was the comparison to the existing predicate devices.

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model was developed for this device.

9. How the ground truth for the training set was established

Not applicable, as no algorithm or machine learning model was developed for this device.

Summary

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Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification

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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 250Irvine, CA. 92612
c. Company Phone:Company Facsimile:	(949) 477-6050(949) 477-6051
d. Contact Person:	Arthur MateenBranch 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 Accessories21 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

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Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification

13.4 DEVICE DESCRIPTION

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

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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.

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Susan Rump

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Regulation Number and Section

§ 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.