SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

K103136 · Materialise NV · JEY · Mar 18, 2011 · Dental

Device Facts

• Record ID: K103136
• Device Name: SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
• Applicant: Materialise NV
• Product Code: JEY · Dental
• Decision Date: Mar 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2

Intended Use

SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. SurgiCase Guides are intended for single use only.

Device Story

SurgiCase Guides are patient-specific templates designed to transfer pre-operative surgical plans to the patient's anatomy. Input data consists of medical imaging (CT or MRI) processed via SurgiCase software (K073449) to create a patient-specific design. The guides are manufactured to fit the specific patient's bone structure, assisting surgeons in mandibular and maxillofacial procedures by guiding bone marking or surgical instruments. Used in clinical settings by surgeons; the guides are single-use devices. The output is a physical template that ensures the surgical execution matches the pre-operative plan, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data. Performance was assessed via non-clinical testing, including quantitative validation using bone models and cadaveric specimens, biocompatibility testing, sterilization, dimensional stability, and packaging/shipment testing.

Technological Characteristics

Patient-specific templates designed from CT/MRI imaging data. Manufactured via standardized processes to fit specific patient anatomy. Single-use. Biocompatible materials. Performance verified through dimensional stability and mechanical testing on bone models.

Indications for Use

Indicated for use as surgical tools to transfer pre-operative plans to the surgical site by guiding bone marking or surgical instruments during mandibular and maxillofacial surgical procedures. For prescription use only.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Zimmer Patient Specific Instruments System 2.0 (K093533)
• Smith and Nephew Patient Matched Cutting Blocks (K082358)

Submission Summary (Full Text)

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K103.136

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MAR 1 8 20i1

# 510(k) Summary

# Submitter information

| Company name | Materialise N.V. |
|-----------------------------------|-------------------------------------|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory affairs officer |
| Contact e-mail address | [e-mail] |

### Submission date

The date of the Traditional 510(k) submission is 215 October 2010.

### Submission information

| Trade Name | SurgiCase Guides |
|---------------------|----------------------------|
| Common Name | Bone plate |
| Classification Name | Bone plate |
| Product code | JEY, MQN (21 CFR 872.4760) |

# Predicate devices

Manufacturer

| Trade or proprietary or model name | Zimmer Patient Specific Instruments System 2.0 |
|------------------------------------|-------------------------------------------------|
| 510(k) number | K093533 |
| Decision date | 2010/02/17 |
| Product code | MBH, JWH |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Smith and Nephew Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 2008/11/25 |
| Product code | JWH, MBH |

Smith and Nephew, Inc.

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### Device Information

### Description and functioning of the device

The SurgiCase Guides are patient specific devices or templates that are based on a preoperative software planning and are designed to fit a specific patient. These templates are used to assist a surgeon in transferring this pre-operative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments.A standardized design and manufacturing process with detailed procedures and work instructions allows manufacturing patient-specific templates that consistently perform in a safe and effective way during surgery.

The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).

SurgiCase is software for pre-operative simulation and evaluation of implant placement and surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner. The SurgiCase software was previously reviewed under K073449 and is not submitted for review in this 510k submission. References to the software are included to give a complete overview on the guide design process.

#### Intended use

SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.

SurgiCase Guides are intended for single use only.

#### Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.

### Performance data

#### Non-clinical tests

Non-clinical tests such as quantitative validation using bone models and cadaveric specimens, biocompatibility test, sterilization dimensional stability test and packaging and shipment test were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.

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

Mr. Alexandra Razzhivina Regulatory Affairs Officer Materialise NV Technologielaan 15 Leuven, Belgium 3001

MAR 1 8 2011

Re: K103136

Trade/Device Name: SurgiCase Guides Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 10, 2011 Received: March 16, 2011

Dear Mr. Razzhivina:

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.

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Page Mr. Razzhivina

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K103136

181

# Indications for Use

510(k) Number (if known): K103136

Device Name: SurgiCase Guides

Indications for Use:

SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.

SurgiCase Guides are intended for single use only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pusser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K103136