(298 days)
No
The summary describes patient-specific surgical guides based on pre-operative software planning, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software used (K073449) is also a previously cleared predicate, and there's no indication it incorporates AI/ML.
No.
The device acts as a surgical tool to guide instruments and marking, not to treat or cure a disease or condition itself.
No
The device is a surgical tool designed to guide surgical instruments and transfer a pre-operative plan to the surgery. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device description explicitly states that the SurgiCase Guides are "patient specific devices or templates" and mentions "manufacturing process" and "finished device" in the performance studies, indicating a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SurgiCase Guides' Intended Use: The intended use of SurgiCase Guides is to be used as surgical tools to transfer a pre-operative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments during craniofacial osteotomies.
- Mechanism of Action: The device works by physically guiding surgical actions based on a pre-operative plan derived from imaging data. It does not analyze biological specimens.
The device is a surgical guide used during a surgical procedure, not a diagnostic tool used to analyze samples outside the body.
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 during craniofacial osteotomies.
SurgiCase Guides are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The SurgiCase Guides are patient specific devices or templates that are based on a pre-operative 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. Guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee templates that consistently perform in a safe and effective way.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SurgiCase is software for pre-operative simulation 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.
Anatomical Site
craniofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 included to assess the safety and effectiveness of the device:
-
. Quantitative validation using bone models and cadaveric specimens to validate the accuracy the guides obtain in transferring a surgical planning to the actual surgery during craniofacial osteotomies. Qualitative validation to evaluate the fit and stability of the guides.
The guides meet the predefined acceptance criteria. -
Biocompatibility testing: According to the results of biocompatibility testing on the finished device, the biocompatibility requirements have been met. Cytotoxicity testing was also performed on the finished device after sterilization. The finished product was determined to be non-cytotoxic.
-
Sterility testing: A sterilization dimensional stability test was performed to verify the device does not deform more than the predefined production tolerance after two sterilization cycles. A sterility test demonstrates that the device can be successfully sterilized with the recommended sterilization parameters.
-
. A packaging and shipment test was performed to demonstrate the device can be safely shipped without
Conclusion: Testing verified that the accuracy and performance of the system is adequate to perform as intended.
No clinical testing was performed to support this submission.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
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 Officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
Submission date
The date of the Traditional 510(k) submission is March 27th, 2012.
Submission information
| Trade Name | SurgiCase Guide |
|---|---|
| Common Name | Craniofacial Osteotomy Guide |
| Classification Name | Stereotaxic Instrument |
| Product code | HAW (21 CFR 882.4560) |
Predicate devices
| Trade or proprietary or model name | SurgiCase Guides |
|---|---|
| 510(k) number | K103136 |
| Decision date | 2011/03/18 |
| Product code | JEY, MQN |
| Manufacturer | Materialise N.V. |
Device Information
Description and functioning of the device
The SurgiCase Guides are patient specific devices or templates that are based on a pre-operative 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. Guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee templates that consistently perform in a safe and effective way.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text "K111558" is on the top line, and "P.2 of 3" is on the bottom line. The handwriting is clear and legible, and the text is centered on the page.
SurgiCase is software for pre-operative simulation 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 during craniofacial osteotomies.
The principal difference between the subject and predicate device is with respect to the anatomical region where the guides will be applied -- craniofacial for the subject guides versus mandibular and maxillary for the predicate guides.
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, material and performance characteristics to the predicate device.
The proposed device has the same principles of operation as the predicate device: Each guide, made from polyamide, consists of a basic shape that fits the patient's anatomy and serves as an anatomical reference to position the guide on the surgical site. For each planned drill location, a functional element for drilling is added to the base shape and for each planned bone cut, a functional element for cutting is added.
Performance data
Non-clinical tests
Non-clinical tests included to assess the safety and effectiveness of the device:
-
. Quantitative validation using bone models and cadaveric specimens to validate the accuracy the guides obtain in transferring a surgical planning to the actual surgery during craniofacial osteotomies. Qualitative validation to evaluate the fit and stability of the guides.
The guides meet the predefined acceptance criteria. -
Biocompatibility testing: According to the results of biocompatibility testing on the finished device, the biocompatibility requirements have been met. Cytotoxicity testing was also performed on the finished device after sterilization. The finished product was determined to be non-cytotoxic.
-
Sterility testing: A sterilization dimensional stability test was performed to verify the device does not deform more than the predefined production tolerance after two sterilization cycles. A sterility test demonstrates that the device can be successfully sterilized with the recommended sterilization parameters.
-
. A packaging and shipment test was performed to demonstrate the device can be safely shipped without
Conclusion: Testing verified that the accuracy and performance of the system is adequate to perform as intended.
2
Image /page/2/Picture/0 description: The image shows the text "K111558 p. 3 of 3 Clinical tests". The text appears to be handwritten, with the exception of the words "Clinical tests", which are printed in a bold font. The text is arranged in three lines, with the first line containing the code "K111558", the second line containing the page number "p. 3 of 3", and the third line containing the words "Clinical tests".
No clinical testing was performed to support this submission.
Substantial equivalence to predicate devices
In conclusion, the SurgiCase Guides have similar intended use, principles of operation and performance characteristics compared to the predicate device. The only difference in intended use is the surgical region where the guides will be applied: cranial for the subject guides versus mandibular and maxillary for the predicate device.
Non-clinical testing data demonstrates that the accuracy and performance of the system is adequate to perform as intended during craniofacial osteotomies. The information presented supports substantial equivalence of these SurgiCase Guides to the predicate device for this new indication.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise NV c/o Mr. Oliver Clemens, Quality and Regulatory Officer Technologielaan 15 3001 Leuven Belgium
MAR 2 7 2012
Re: K111558
Trade/Device Name: Surgicase Guides Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 7, 2012 Received: March 9, 2012
Dear Mr. Clemens:
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.
4
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/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,
Malvina B Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111558
Device Name: SurgiCase Guides (for cranial application)
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 during craniofacial osteotomies.
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)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic, Neurological and Ear, | |
| Nose and Throat Devices | |
| 510(k) Number | K111558 |
| Page | 1 of 1 |
| Prescription Use | X |
| (Per 21 CFR 801.109) |