ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115

• K Number: K014068
• Device Name: ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
• Manufacturer: W & H DENTALWERK BUERMOOS GMBH
• Date Cleared: 2002-05-03 ( 144 days)
• Product Code: EBW
• Regulation Number: 872.4200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Indications are very widespread in the field of oral surgery.

• A. Implant placement, including
  • 1. preparation of the osteotomy site
  • 2. bone reconturing, osteoplasty
• B. Bone grafting
  • 1. granns
  1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
  • 2. harvesting autogen living bone
  • 3. sinus elevation & grafting of alveolar sockets
• C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
• D. Periodontal surgeries
  • 1. bone recontouring & alveoplasty around living teeth
  • 2. removal of exoslosis
• E. Endodontic treatment
  • 1. Intracanal preparations using rotating NiTi-files

Device Description

elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.

AI/ML Overview

The provided 510(k) summary for the elcoMED SA-200 and SA-200 C devices does not contain information related to specific acceptance criteria, performance studies, or AI/ML aspects.

This submission is for a dental surgical unit, which is a physical device, and the information provided focuses on its technical characteristics, intended use, and substantial equivalence to a predicate device (elcomed 100). The typical contents of a 510(k) for such a device do not usually include the kind of detailed performance study data, ground truth establishment, or AI/ML-specific metrics that your request outlines.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the following information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: This document primarily discusses the device's technical specifications and intended use, not performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance: No performance test data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI/ML diagnostic or image analysis device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The submission is a standard 510(k) for substantial equivalence of a physical medical device, not a software or AI/ML-driven device that would require the types of criteria and studies you've asked about.

Summary

{0}------------------------------------------------

K014068

510(k) SUMMARY

W & H Dentalwerk Buermoos GmbH Submitted by: Ignaz-Glaser-Strasse 53 A-5111 Buermoos Austria

Contact person:	Ralf Benda
	Tel.: [phone]
	Fax: [phone]

Date of Preparation:06/12/2001

elcoMED SA-200 and elcoMED SA-200 C Device name: Surgical unit for dental application Common name: Classification name: Controller, foot, handpiece and cord

Predicate device: elcomed 100

Device Description:

elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.

Intended use:

Drive unit for surgical transmission instruments with coupling system according to DIN 13.940/ISO 3964 with the functions "mechanical drive" and "supply with coolant". It is indicated for use in dental, surgical procedures.

Technological Characteristics:

elcoMED SA-200 and elcoMED SA-200 C is the update of elcomed 100 and provides various changes of the design, a calibration function (only type elcoMED SA-200 C) to increase accuracy of torque measurement and a possibility to save data on a card.

Substantial equivalence:

elcoMED SA-200 and elcoMED SA-200 C and the predicate device share the same indication for use and similar technological characteristics.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, stacked vertically.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 3 2002

Mr. Ralf Benda W & H Dentalwerk Buermoos GmbH 53 Ignaz-Glazer-Strasse Buermoos, AUSTRIA 5111

Re: K014068

Trade/Device Name: elcoMed SA-200 115 (110-130 V), elcoMed SA 200 23 (220-240 V), elcoMed SA 200C 115 (100-130 V), elcoMed SA-200C 230 (220-240 V) Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 5, 2002 Received: March 7, 2002

Dear Mr. Benda:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{2}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that I DA has made a decembiations administered by other Federal agencies. of the Act of ally rederal statues and regisments, including, but not limited to: registration You must comply with an the Fee b requirement) and 801); good manufacturing practice allu listing (21 CFR Purt 067), labeling (21 CFR Part 820); and if requirements as set form in the quality by steams (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section I mis letter will anow you to ocelin manating your substantial equivalence of your device to 510(K) premiarket nourieation. The 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 regulation (21 CFR Part 801 If you desire specific at not 10. your in vitro diagnostic devices), please contact the and additionally 21 OF CF [phone]. Additionally, for questions on the promotion and Office of Comphance at [phone] the Office of Compliance at [phone]. advertising or your aregulation entitled, "Misbranding by reference to premarket Also, prease note the regulations of the general information on your responsibilities under nonication (210) It it it it it it is of the Division of Small Manufacturers, International and the Act may be obtained from the Bounber [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K014068

INDICATION FOR USE

Verl 3 - 4/24/96

Applicant: W&H Dentalwerk Buermoos GmbH

510(k) Number (if known): not known yet

elcoMED SA-200 115 (100-130 V),elcoMED SA-200 230 Device Name: (220-240 V), elcoMED SA-200C 115 (100-130 V), elcoMED SA-200C 230 (220-240 V)

Indications For Use:

The Indications are very widespread in the field of oral surgery.

• A. Implant placement, including
  • 1. preparation of the osteotomy site
  • 2. bone reconturing, osteoplasty
• B. Bone grafting
  • 1. granns
  1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
  • 2. harvesting autogen living bone
  • 3. sinus elevation & grafting of alveolar sockets
• C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
• D. Periodontal surgeries
  • 1. bone recontouring & alveoplasty around living teeth
  • 2. removal of exoslosis
• E. Endodontic treatment
  • 1. Intracanal preparations using rotating NiTi-files

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surser Rumper

OR

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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.