(337 days)
Not Found
No
The document describes software for pre-surgical simulation and planning and patient-specific guides, but there is no mention of AI or ML in the description of the technology or its function. The validation studies focus on software functionality and guide performance, not on the performance of an AI/ML algorithm.
No.
The device is a surgical instrument for pre-operative planning and guiding surgical procedures, not for treating a disease or condition.
No
The device is described as a surgical instrument for pre-operative planning and guiding surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the SurgiCase Orthopaedics system is composed of two components: SurgiCase Connect (software) and SurgiCase Guides (hardware). The performance studies also include validation of the hardware component (SurgiCase Guides).
Based on the provided information, the SurgiCase Orthopaedics system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SurgiCase Intended Use: The SurgiCase system is intended for surgical planning and guidance during orthopedic procedures. It assists the surgeon in marking bone and guiding surgical instruments based on pre-surgical plans derived from medical imaging.
- Device Components: The system consists of software for planning and patient-specific guides used during surgery. Neither of these components directly analyzes biological specimens.
- Lack of Specimen Analysis: There is no mention of the system analyzing any biological samples from the patient. Its function is based on processing medical imaging data and providing physical guides for surgical intervention.
In summary, the SurgiCase Orthopaedics system is a surgical planning and guidance tool used in vivo (within the body during surgery), not an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures.
The system is to be used for adult patients.
SurgiCase Guides are intended for single use only.
Product codes
PBE, PBF
Device Description
The SurgiCase Orthopaedics system is composed of two components: SurgiCase Connect (software) and SurgiCase Guides (hardware).
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the lower and upper extremity during orthopaedic surgical procedures.
SurgiCase Connect is a medical device for Materialise and a surgeon for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing, measuring, annotating and editing medical data.
The SurgiCase Guides are patient specific templates that are based on a pre-surgical software plan and are designed to fit a specific patient. All guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee guides that consistently perform in a safe and effective way. In surgery these guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments according to the pre-surgical plan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower and upper extremity
Indicated Patient Age Range
adult patients
Intended User / Care Setting
surgeon
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
The SurgiCase Connect software has been validated for its intended use to determine substantial equivalence to the predicate devices.
SurgiCase Guides were validated through non-clinical studies using bone models and cadaver specimens. Biocompatibility test, sterilization dimensional stability test, debris test and packaging and shipment test and cleaning validation test were performed to assess the safety and effectiveness of the SurgiCase Guides. Testing verified that the accuracy and performance of the device is adequate to perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
JUL 2002012
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 officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
Submission date
The date of the Traditional 510(k) submission is 16th of August, 2011.
Submission information
| Trade Name | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides |
|---|---|
| Common Name | Image processing system and software for simulating/evaluating implant placement and surgical treatment options |
| Classification Name | Radiological image processing system |
| Product code | PBE |
Predicate devices
Manufacturer
.
| Trade or proprietary or model name | SurgiCase |
|---|---|
| 510(k) number | K073449 |
| Decision date | 2008/04/16 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | SurgiCase Guide |
| 510(k) number | K103136 |
| Decision date | 2011/04/18 |
| Product code | JEY, MON |
Materialise N.V.
1
Device Information
Description and functioning of the device
The SurgiCase Orthopaedics system is composed of two components: SurgiCase Connect (software) and SurgiCase Guides (hardware).
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the lower and upper extremity during orthopaedic surgical procedures.
SurgiCase Connect is a medical device for Materialise and a surgeon for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing, measuring, annotating and editing medical data.
The SurgiCase Guides are patient specific templates that are based on a pre-surgical software plan and are designed to fit a specific patient. All guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee guides that consistently perform in a safe and effective way. In surgery these guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments according to the pre-surgical plan.
Intended use
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures.
The system is to be used for adult patients.
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 devices.
Performance data
Non-clinical tests
The SurgiCase Connect software has been validated for its intended use to determine substantial equivalence to the predicate devices.
SurgiCase Guides were validated through non-clinical studies using bone models and cadaver specimens. Biocompatibility test, sterilization dimensional stability test, debris test and packaging and shipment test and cleaning validation test were performed to assess the safety and effectiveness of the SurgiCase Guides. Testing verified that the accuracy and performance of the device 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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise N.V. % Ms. Alexandra Razzhivina Technologielaan 15 Leuven, Belgium 3001
JUL 30 2012
Re: K112389 Trade/Device Name: Surgicase Connect, Surgicase Guide Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: PBF Dated: July 06, 2012
Received: July 09, 2012
Dear Ms. Razzhivina:
This letter corrects our substantially equivalent letter of July 20, 2012 for the product code and regulation number for your medical device. We have reviewed your Section 510(k) and regulation namber 10. Jour 10 market the device referenced above and have determined premarket hourseantially equivalent (for the indications for use stated in the enclosure) to the device is substantially of a ransmarketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been the onatined in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general market as wisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your (1 wire), it thay of babyer. 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 I vactar agencies: "10 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical
3
Page 2 - Ms. Alexandra Razzhivina
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/ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K112389
Device Name: The SurgiCase Orthopaedics system
Indications for Use:
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in rrie Surgicales Online and/or in guiding the marking of bone and/or guide surgical instruments pre operative planning of replacing osteotomies for upper extremity orthopedic surgical procedures.
The system is to be used for adult patients.
SurgiCase Guides are intended for single use only.
Pete. Rums
(Division Sign-(Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K112381
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)
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