(86 days)
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No
The document describes a standard CBCT and tomosynthesis imaging system with 3D reconstruction software. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is described as producing X-ray images for diagnostic support, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is intended to produce digital X-ray images "as diagnostic support".
No
The device description explicitly states it is an "x-ray unit" that "uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images". This indicates a hardware component (the X-ray unit) is integral to the device's function, making it a hardware-based medical device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- This device is an X-ray system that produces images of anatomical structures within the body. It uses cone beam computed tomography (CBCT) and tomosynthesis to create 2D and 3D images.
- The intended use is for diagnostic support based on imaging, not on the analysis of biological samples.
Therefore, the Planmeca ProMax 3D Max or Maximity falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions, maxillofacial and ENT anatomies
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The performance testing for ENT imaging applications was carried out taking clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae. The images were reviewed by a specialist and were deemed to be of a clinically usable diagnostic quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing for ENT imaging applications was carried out taking clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae. The images were reviewed by a specialist and were deemed to be of a clinically usable diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Planmeca Oy % Lars Moring Regulatory Affairs Manager Asentaiankatu 6 Helsinki, 00880 FINLAND
Re: K160506
Trade/Device Name: Planmeca ProMax 3D Max, Planmeca Maximity Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 2, 2016 Received: May 5, 2016
Dear Lars 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K160506 |
|---|---|
| Device Name | Planmeca ProMax 3D Max |
| Planmeca Maximity | |
| Indications for Use (Describe) | The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "PLANMECA" in white letters against a black background. The letters are bold and sans-serif. The word appears to be a logo or brand name.
510K) SUMMARY
DATE
May 2, 2016
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca ProMax 3D Max or Planmeca Maximity Common name: Computed tomography x-ray system Classification: OAS, Class II Regulation number: 892.1750
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
The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
PRODUCT DESCRIPTION
The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.
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Image /page/4/Picture/0 description: The image shows the word "PLANMECA" in bold, white letters against a black background. The font is sans-serif and appears to be a custom or stylized typeface. The letters are closely spaced, creating a solid block of text. The overall impression is clean and modern.
PREDICATE DEVICE
We consider this product modification to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:
Planmeca ProMax 3D Max # K093590 # K103659 Carestream CS 9300
SUBSTANTIAL EQUIVALENCE
The product is principally just the same as in the previous 510(k) #K093590. The indications for use are expanded to include the ENT area.
The expanded intended use of the Planmeca ProMax 3D Max and the predicate device #K103659 is identical. The compared technical features for imaging technology, FOV, imaging parameters, resolution, and other basic characteristics are matching very closely, and the differences are so small that they do not have any effect on performance in practice. Both devices conform to given international performance standards.
The performance testing for ENT imaging applications was carried out taking clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae. The images were reviewed by a specialist and were deemed to be of a clinically usable diagnostic quality.
CONCLUSION
The comparison of characteristics supports substantial equivalence. Planmeca ProMax 3D Max is as safe and effective as the predicate device.