(174 days)
Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
The Planmeca Promax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
This 510(k) summary for the Planmeca Promax 3D Max does not include information about specific acceptance criteria or a study that directly proves the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K060328 Planmeca ProMax 3D). This means the manufacturer is asserting that the new device is as safe and effective as a previously cleared device, rather than providing a new, standalone study against specific performance metrics/acceptance criteria.
Therefore, many of the requested details (sample sizes, expert qualifications, ground truth methods, MRMC studies) are not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., image resolution, contrast-to-noise ratio, diagnostic accuracy). The acceptance basis is substantial equivalence to the predicate device.
- Reported Device Performance:
- Intended Use: To produce three-dimensional images of the human teeth, jaw and skull.
- Function: Uses a cone-shaped x-ray beam projected onto a flat panel detector; produces a 3D reconstructed volume image viewable in 3D stations.
- Claim: "Planmeca Promax 3D Max is as safe and effective as the predicate device."
2. Sample size used for the test set and the data provenance:
- Not applicable as no specific performance study with a test set is described. The submission relies on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific performance study with a ground truth established by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific performance study with a test set requiring adjudication 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:
- No MRMC comparative effectiveness study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an imaging system. Its "performance" is implicitly tied to image quality for human interpretation. There is no description of a standalone algorithm performance study independent of image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific performance study requiring ground truth is described.
8. The sample size for the training set:
- Not applicable as this is not a machine learning/AI device requiring a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Approach:
The manufacturer, Planmeca, used the substantial equivalence pathway to demonstrate the safety and effectiveness of the Planmeca Promax 3D Max. This means they compared their new device to a previously cleared predicate device (K060328 Planmeca ProMax 3D) and asserted that it is similar in design, composition, and function, and therefore "as safe and effective." This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, and expert review as one might find for novel diagnostic algorithms.
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PLANMECA
ENCLOSURE 12
P. 12-1
K0935590
510K) SUMMARY
DATE
November 13, 2009
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca Promax 3D Max Common name: Tomography x-ray system Classification: 76 EHD, Class II Regulation number: 872.1800
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT) Planmeca USA Inc. 100 North Gary Avenue, Suite A
Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planneca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
PRODUCT DESCRIPTION
The Planmeca Promax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
MAY 1 2 2010
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Image /page/1/Picture/0 description: The image shows the words PLANMECA in large, bold letters. Below that, the words ENCLOSURE 12 are printed in a smaller font. The text P. 12-2 is printed below that in the same font size.
SUBSTANTIAL EQUIVALENCE
We consider this product modification to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
K060328 Planmeca ProMax 3D
The comparison of characteristics supports substantial equivalence. Planmeca Promax 3D Max is as safe and effective as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 2 2010
Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 FI-00880 Helsinki FINLAND
Re: K093590
Trade/Device Name: Planmeca Promax 3D Max Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 9, 2010 Received: April 12, 2010
Dear Mr. Moring:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 dry ice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket -notification''-(21-CFR-Part-807-97)--For-questions-regarding-the-reporting-of-adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K 093590
Device Name:
Planmeca Promax 3D Max
Indications For Use:
Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) F. 11-1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Off)
(Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K693590 Page 1 of 1
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.