(86 days)
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.
The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant from its reservoir via a pump to the motor / handpiece.
This is a 510(k) premarket notification for a medical device called "Private Label Versions of implantMED SI-915/923" (K060287). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided text in the manner typically expected for a performance study of an AI/imaging device.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the "acceptance criteria" for this 510(k) submission are primarily focused on demonstrating substantial equivalence to existing predicate devices (implantMED SI-95 (K002469) and implantMED SI 915/923 (K052741)). The performance is not reported in terms of specific quantitative metrics, but rather in terms of similarity to the predicate.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (based on this 510(k)) |
|---|---|
| Same Intended Use as Predicate Device | The private label versions share the same indication for use as implantMED SI-95. The intended use is: "Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue." |
| Similar Technological Characteristics to Predicate Devices | "The technological characteristics of the private label versions are very similar to the previous implantMED versions." "The comparison of the subject and the predicate device 'implantMED SI-915/923' shows very similar technological characteristics." |
| Same Performance Properties as Predicate Devices | "Performance properties... are the same [as the subject and predicate device 'implantMED SI-915/923']." |
| Same Biocompatibility as Predicate Devices | "Biocompatibility are the same [as the subject and predicate device 'implantMED SI-915/923']." |
| Minor Differences from Predicate Devices | Differences "result from the modification of the Intended Use and become manifest in programs and factory settings." Also, "an alternative foot control" is offered. These differences are deemed not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This document does not describe a performance study with a test set of data. It's a regulatory submission demonstrating substantial equivalence based on comparing device specifications and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. No ground truth establishment activity for a test set is described.
4. Adjudication Method for the Test Set:
- Not Applicable. No test set or adjudication method is described.
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 mechanical dental surgical unit, not an AI or imaging device with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device contains a mechanical motor and control unit, not an algorithm in the sense of AI or image processing.
7. The type of ground truth used:
- Not Applicable. No explicit "ground truth" in the context of diagnostic accuracy or AI performance is used or described. The "ground truth," in a regulatory sense for this submission, is the established safety and effectiveness of the predicate devices to which this device is compared.
8. The sample size for the training set:
- Not Applicable. This document does not describe the development of an algorithm or model that would require a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As no training set is described, no ground truth for it was established in this context.
Summary of what the document does provide:
- Predicate Devices: implantMED SI-95 (K002469) and implantMED SI 915/923 (K052741).
- Basis for Substantial Equivalence: The new private label versions share the same indication for use, very similar technological characteristics, and the same performance properties and biocompatibility as the predicate devices. Differences are minor (modification of intended use interpretation and factory settings, alternative foot control).
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for W&H Dentalwerk. The logo consists of the letters "W&H" inside of a hexagon on the left, and the word "DENTALWERK" on the right. The text is in bold, sans-serif font.
3 2006 MAY 510(k) Section 5
abel Versions of "implantMED Si-915/923"
510(k) SUMMARY
| Submitted by: | W & H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustria |
|---|---|
| Contact person: | Gabriele WienbeckTel.: +43-6274-6236-397Fax: +43-6274-6236-234 |
| Date of Preparation: | 01/20/2006 |
| Device name: | Private Label Versions of "implantMED SI-915/923"Such as "DrillTech", "Ism", " Implant Unit" and "ZimmerSurgical Motor Unit" |
| Common Name: | Surgical motor unit for implantology and maxillosurgery |
| Classification Name: | Controller, foot, handpiece and cord |
| Predicate devices: | implantMED SI-95 (K002469)implantmed SI 915/923 ( K052741) |
Device Description:
The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant from its reservoir via a pump to the motor / handpiece.
Intended use:
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964.
The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.
Technological Characteristics:
The technological characteristics of the private label versions are very similar to the previous implantMED versions. Differences result from the modification of the Intended Use and become manifest in programs and factory settings. Furthermore we offer an alternative foot control.
Substantial equivalence:
The private label versions and the predicate device "implantMED SI-95" share the same indication for use.
{1}------------------------------------------------
The comparison of the subject and the predicate device "implantMED SI-915/923" shows very similar technological characteristics. Performance properties and biocompatibility are the same.
The private label versions are substantially equivalent to those devices it was modified from.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three parallel lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 2006
Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Büermoos GmbH Ignaz Glaser Strasse 53 Büermoos, Austria A-5111
Re: K060287
Trade/Device Name: Private Label Versions of implantMED SI-915/923 including accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" Regulation Number: 872.4200
Regulation Name: Dental Handpiece and Accessories Regulatory Class: I
Product Code: EBW Dated: February 2, 2006
Received: February 7, 2006
Dear Ms. Wienbeck:
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.
{3}------------------------------------------------
Page 2 - Ms. Wienbeck
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clue
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
| W&H | DENTALWERK |
|---|---|
| ----- | ------------ |
INDICATION FOR USE
510(k) (if known):____________________________________________________________________________________________________________________________________________________________ Device Name: Private Label Versions of implantMED SI-915/923 incl. accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" Indication for Use: Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
X
AND/OR
Over- The -Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roe Muler for MCR
Technology, General Hospital,
Control, Luminal Devices
§ 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.