IMPLANT 3D

K153091 · Media Lab S.R.L. · LLZ · Feb 25, 2016 · Radiology

Device Facts

• Record ID: K153091
• Device Name: IMPLANT 3D
• Applicant: Media Lab S.R.L.
• Product Code: LLZ · Radiology
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner. It is also intended as pre-planning software for dental implant placement.

Device Story

Software for dental implant pre-operative planning; processes axial images from medical scanners (e.g., CAT). Enables 3D implant simulation, mandibular canal identification, and bone model visualization; provides qualitative bone density indication. Used by clinicians on PC (Windows/MAC OS) to generate overviews, sections, and 3D bone models. Output supports surgical template design and fabrication. Facilitates precise implant positioning; aids clinical decision-making for dental surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included unit, integration, IR, smoke, formal, acceptance, alpha, and beta testing to confirm device functionality and conformance to design requirements.

Technological Characteristics

Software-based image processing system; operates on Windows or MAC OS (via Parallel Desktop). Functions include image segmentation, 3D model generation, and dental implant library management. Connectivity via standard medical scanner image transfer. No specific hardware requirements; software-only device.

Indications for Use

Indicated for dental implant pre-planning and image segmentation of medical scanner (CAT) data for patients requiring dental implant procedures.

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 2011 (K110300)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

Media Lab S.r.l. % Mr. Massimo Ivani CEO Via Trieste 4 Follo, La Spezia 19020 ITALY

Re: K153091

Trade/Device Name: IMPLANT 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2016 Received: February 23, 2016

Dear Mr. Ivani:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K153091

Device Name

IMPLANT 3D

Indications for Use (Describe)

Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner.

It is also intended as pre-planning software for dental implant placement.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510 (K)SUMMARY

#### SUBMITTER/510(K) HOLDER:

| Company Name: | MEDIA LAB S.R.L. |
|------------------------|--------------------------------------|
| Company Address: | Via Trieste 4<br>19020 Follo - Italy |
| Company Phone: | 039- 0187517775 |
| Company Fax: | 039- 0187511833 |
| Company e-mail: | [e-mail] |
| Contact person: | Mr. Massimo Ivani |
| | CEO |
| Date Summary Prepared: | October 19, 2015 |

#### DEVICE IDENTIFICATION

| Common Usual Name: | Image processing system and software for<br>evaluating dental implant placement |
|-------------------------|---------------------------------------------------------------------------------|
| Trade/Proprietary Name: | IMPLANT 3D |
| Classification: | Class II |
| Product Code: | LLZ |
| Classification Panel: | 892 Radiology Devices |
| Regulation Number: | 892.2050 |

#### LEGALLY MARKETED PREDICATE DEVICE

| Predicate device | 510 (k) Holder | 510 (k) No. |
|------------------|-----------------------|-------------|
| SIMPLANT 2011 | MATERIALISE DENTAL NV | K110300 |

# DEVICE DESCRIPTION

Implant 3D is a software that allows to perform three-dimensional implant simulation directly on the PC. It enables to simulate the position of the implants in bi-dimensional and three-dimensional models. It also consent to identify the mandibular canal and to draw overviews and sections of the bone mode. Implant 3D enables to view the three

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dimensional bone model with the possibility to provide a qualitative indication of bone density.

Implant 3D generates the overview, the sections and the three-dimensional bone model by reading the axial images.

### INDICATIONS FOR USE STATEMENT

Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner. It is also intended as pre-planning software for dental implant placement.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

MEDIA LAB S.R.L. claims substantial equivalence of IMPLANT 3D to the predicate device based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of IMPLANT 3D and the cited predicate device is included below.

| ATTRIBUTE /<br>CHARACTERISTICS | IMPLANT 3D<br>(Submitted Device) | LEGALLY MARKETED<br>PREDICATE DEVICES OF<br>Materialised Dental NV |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | NA | K110300 |
| Device Name | IMPLANT 3D | SIMPLANT 2011 |
| CFR Section | 892.2050 | 892.2050 |
| Pro-code | LLZ | LLZ |
| Device Class | II | II |
| Classification panel | Radiology | Radiology |
| Intended / Indications<br>For Use | Implant 3D is intended for use as a<br>software interface and image<br>segmentation system for the transfer<br>of imaging information from a<br>medical scanner such as a CAT<br>scanner.<br>It is also intended as pre-planning<br>software for dental implant. | SimPlant 2011 is intended for use as<br>a software interface and image<br>segmentation system for the transfer<br>of imaging information from a<br>medical scanner such as a CT<br>scanner or a Magnetic Resonance<br>scanner. It is also intended as pre-<br>planning software for dental implant<br>placement and surgical treatment. |
| Materials | Software - Magnetic Media | Software - Magnetic Media |
| Design | Software for use in pre-operative<br>planning. | Software for use in pre-operative<br>planning. |
| Functions | IMPLANT 3D provides a means for<br>transferring patient images from a<br>medical scanner to an output file. | SimPlant 2011 provides a means for<br>transferring patient images from a<br>medical scanner to an output file. |
| | IMPLANT 3D is used to provide a<br>means for advanced pre-operative<br>planning of dental implant<br>placements. | SimPlant 2011 is used to provide a<br>means for advanced pre-operative<br>planning of dental implant<br>placements and orthognatic<br>treatment. |
| | IMPLANT 3D contains a library of<br>dental implants | SimPlant 2011 contains a library of |

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| | | dental implants |
|------------------|---------------------------------------|---------------------------------------|
| | Surgical templates may be designed | |
| | and fabricated based on the output of | Surgical templates may be designed |
| | the pre-operative planning. | and fabricated based on the output of |
| | | the pre-operative planning. |
| Operating System | Windows , MAC OS with Parallel | Windows |
| | Desktop | |
| Hardware testing | N/A | N/A |
| Software testing | • Unit testing | • Unit testing |
| | • Integration testing | • Integration testing |
| | • IR testing | • IR testing |
| | • Smoke testing | • Smoke testing |
| | • Formal testing. | • Formal testing. |
| | • Acceptance testing | • Acceptance testing |
| | • Alpha testing | • Alpha testing |
| | • Beta testing | • Beta testing |

#### PERFORMANCE DATA

MEDIA LAB S.R.L. has conducted laboratory testing and determined device functionality and conformance to design input requirements.

The device has been designed and validated in such a way that, when used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people, provided that any risk which may be associated with its use constitute acceptable risks when weighed against the benefits to the patient and is compatible with a high level of protection of health and safety.

### CONCLUSION

Based on the foregoing, IMPLANT 3D is substantially equivalent to the legally marketed, claimed predicate device for the purposes of this 510 (k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.