(117 days)
Not Found
No
The device description focuses on mechanical transmission of rotational movement and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as surgical handpieces used to transmit rotational movement for cutting dental hard tissue. This is an operative device, not a therapeutic one that treats disease.
No
Explanation: The device is described as surgical handpieces and mikro saw handpieces designed for transmitting rotational movement for surgical treatment, not for diagnosing conditions.
No
The device description explicitly states it is a surgical handpiece and Mikro saw handpiece, which are physical hardware devices used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Surgical treatment of dental hard tissue in oral and maxillo-facial surgery." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details surgical handpieces and saw handpieces that transmit rotational movement for cutting or shaping tissue. This is a mechanical surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
Product codes
KMW
Device Description
Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece. They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964. The user manual points out the recommendations for the different handpiece types covered by this application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue in oral and maxillo-facial
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
Bench testing results demonstrate substantially equivalence
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters 'W', '&', and 'H' inside of a hexagon. The letters are all capitalized and in a bold, sans-serif font. The hexagon is outlined in black, and the letters are also black. The logo is simple and easy to read.
Koyoa39
510(k) SUMMARY
| Applicant and Owner | W & H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
A - 5111 Buermoos
Austria
Tel.: +43-6274-6236-397
Fax: +43-6274-6236-234
JUL 29 2008 |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Gabriele Wienbeck |
| Date of Preparation | 21.03.2008 |
| Device Name | Surgical straight handpiece SI-11 LED G
Surgical contra-angle handpiece WI-75 LED
Mikro saw handpieces S-8 R, S-8 O, S-8 S |
| Classification Name | Handpiece, rotary bone cutting |
| Regulation Number | 21 CFR872.4120 |
| Product Code | KMW |
| Predicate Device | Surgical contra-angle handpieces, K011061
Saw handpieces K052741 |
| Device Description | Surgical handpieces and Mikro saw handpieces have
been designed to transmit the rotational movement of the
motor axle to the shank of a bur or a saw blade which
will be inserted into the output end of the handpiece.
They fit all surgical drive units and surgical motors with a
coupling system according to ISO 3964.
The user manual points out the recommendations for the
different handpiece types covered by this application. |
| Intended Use: | Surgical treatment of dental hard tissue in oral and
maxillo-facial surgery |
| Technological
Characteristics | The Surgical contra-angle handpieces represents
revised versions of the predicate device. The main
technical characteristics have been retained unchanged.
New : The redesigned handpieces contain their own
integrated generator to provide LED light to the operating
area. |
| Comparison of the
device to the
predicate device | The intended use, technological characteristics,
performance parameter and material are very similar to
the predicate device.
The devices are substancially equivalent to the predicate
devices. |
| Performance Testing | Bench testing results demonstrate substancially
equivalence |
| Clinical Testing | Clinical data were not needed for this modification. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Straße 53 P.O. Box 1, 5111 Bürmoos AUSTRIA
JUL 2 9 2008
Re: K080939
Trade/Device Name: Surgical Handpieces and Mikro Saw Handpieces Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: KMW Dated: June 25, 2008 Received: July 21, 2008
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.
2
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Khmuele-Lending for //
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
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Image /page/3/Picture/0 description: The image shows a logo with the letters 'W&H' inside of a horizontally oriented hexagon. The letters are in a simple, sans-serif font and are all capitalized. The logo is black and white, with the letters and the hexagon outline in black.
INDICATION FOR USE
510(k) (if known): K080939
Device Name: Surgical handpieces and Mikro saw handpieces
Indication for Use:
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over- The -Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Roane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080939