(210 days)
K 033849
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image segmentation and planning software without mentioning AI/ML capabilities.
No
The device description states it is a software device used for planning and simulation, not for direct treatment or therapy. It does not make contact with the patient and is solely intended to assist physicians in surgical planning.
No
The device is described as software for transferring imaging information and for planning and simulation of surgical treatment. It assists in planning surgical treatments but does not diagnose conditions.
Yes
The device description explicitly states "The device is a software device". While it interacts with imaging hardware (CT scanner), the device itself is described as software and does not appear to include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Maxilim is for planning and simulation of surgical treatment, specifically maxillofacial procedures, and as a software interface for transferring imaging information. This falls under the category of medical image processing and surgical planning software, not diagnostic testing performed on samples taken from the human body.
- Device Description: The description emphasizes its role in assisting physicians in surgical planning and its lack of contact with the patient. This aligns with a surgical planning tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions based on such analysis, or providing diagnostic information derived from in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Maxilim's function is to process medical images and aid in surgical planning, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Maxilim is indicated for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial treatment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The device is a software device (minor level of concern) with minimal risk to the patient. The device does not make contact with the patient. The device is used to assist physicians in the planning of surgical treatments, but is not meant to replace the professional judgment of the physician.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 033849
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.
Not Found
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).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
MAR 3 1 2006
510(k) Notification
Maxilim
510(k) Summary
(1) Contact Information
This 510(k) is being submitted by Joseph Azary on behalf of Medicim NV.
Submitter / Regulatory Consultant: Joseph Azary, 543 Long Hill Avenue, Shelton, CT 06484, Tel: 203-944-9320, Fax: 203-944-9317
Applicant / Sponsor: Medicim NV, Callaertstraat 49, B-9100 Sint-Niklaas, Belgium. FDA Establishment Registration pending.
(2) Device Information
Trade or Proprietary Name: Maxilim
Common, Usual, and Classification Name: Image Processing System, Preoperative Software, System, Image Processing
(3) Predicate Devices:
The predicate devices are identified as the following: Simplant System by Materialise NV, 510(k) K 033849. The subject device and predicate device have the same indications for use (planning for surgical treatment), similar technology, and both are 3-D and utilize CT images.
(4) Intended Use:
Maxilim is indicated for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial procedures.
- (5) Technological Characteristics: The device is a software device (minor level of concern) with minimal risk to the patient. The device does not make contact with the patient. The device is used to assist physicians in the planning of surgical treatments, but is not meant to replace the professional judgment of the physician. The device is substantially equivalent to the predicate device.
- (6) Conclusion: We believe the differences are minor and conclude that the subject device is as safe and effective as the predicate devices.
1
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The logo is black and white and appears to be of low resolution.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
Medicim NV % Mr. Joseph Azary Azary Technologies, LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K052424
Trade/Device Name: Maxilim Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 8, 2006 Received: March 10, 2006
Dear Mr. Azary:
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 (Premarket Approval), 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.
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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your to be finding of substantial equivalence of your device to a legally premarket nothloadon: "Thesults 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 rryou desire apourie at need of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 11100, from the rise the regeneral information on your responsibilities under the Act from the 00 : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Bugdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enelosure
3
Indications for Use
510(k) Number (if known): K052424
Maxilim Device Name:
Indications For Use:
Maxilim is indicated for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Beagdon Page 1 of __
(Division Sign-Off Division of Reproductive, Abdomine and Radiological Devices 510(k) Number