(144 days)
No
The summary describes patient-specific surgical guides based on pre-operative software planning, but there is no mention of AI or ML being used in the planning or guide design process. The software referenced (K073449) is described as for "pre-operative simulation and evaluation," which doesn't inherently imply AI/ML.
No.
The device is described as a surgical tool intended to guide the marking of bone and/or surgical instruments, not to provide therapy or treatment itself.
No
The device description clearly states its purpose is to "guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures" and to "assist a surgeon in transferring this pre-operative plan to the surgery". It is a surgical tool/template, not a device used for diagnosis.
No
The device description explicitly states that the SurgiCase Guides are "patient specific devices or templates" and mentions "manufacturing patient-specific templates," indicating a physical, manufactured product, not solely software. While the guides are based on software planning, the device itself is a physical guide.
Based on the provided text, the SurgiCase Guides are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the SurgiCase Guides are "surgical tools to transfer a pre-operative plan to the surgery" and "to guide the marking of bone and/or guide surgical instruments". This describes a device used during a surgical procedure on a patient, not a device used to examine specimens outside of the body to provide diagnostic information.
- Device Description: The description reinforces this by stating they are "patient specific devices or templates" used to "assist a surgeon in transferring this pre-operative plan to the surgery".
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SurgiCase Guides do not fit this definition. They are surgical planning and guidance tools.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY, MQN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner or a Magnetic Resonance Imaging (MRI) scanner
Anatomical Site
Mandibular and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
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.
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.
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.
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
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.
0
K103.136
p
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 | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory affairs officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and head turned to the left.
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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