MAXILIM

K052424 · Medicim NV · LLZ · Mar 31, 2006 · Radiology

Device Facts

• Record ID: K052424
• Device Name: MAXILIM
• Applicant: Medicim NV
• Product Code: LLZ · Radiology
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Maxilim is a software-based image processing system used by physicians for preoperative planning and simulation of maxillofacial surgical procedures. The device accepts medical imaging data (e.g., CT scans) as input. It functions as a software interface and image segmentation tool, allowing clinicians to visualize and manipulate anatomical data to assist in surgical planning. The device does not make physical contact with the patient and is not intended to replace professional clinical judgment. It produces outputs that aid the physician in determining surgical strategy. The device is intended for use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only device; minor level of concern. Functions as an image processing and segmentation system for CT data. No patient contact. No specific hardware, materials, or connectivity standards mentioned.

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring CT scan data and as planning/simulation software for maxillofacial surgical treatment. No specific patient population age or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Simplant System by Materialise NV (K033849)

Submission Summary (Full Text)

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MAR 3 1 2006

510(k) Notification
Maxilim

K052424

# 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: [phone], Fax: [phone]

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.

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#### 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.

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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 [phone] 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

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## 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