(435 days)
Not Found
No
The summary describes image processing and surgical planning software, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on image segmentation, data processing, and additive manufacturing for creating physical models and guides.
No
The device is a pre-operative software tool used for surgical planning and creating physical models/guides; it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as a software system and image segmentation system for surgical planning and simulating/evaluating surgical treatment options. It produces physical and digital outputs for pre-surgical treatment planning, rather than diagnosing a disease or condition.
No
The device description explicitly states it is a "combination of software design and additive manufacturing" and produces "physical products (surgical guides, anatomical models)" manufactured using additive manufacturing. This indicates the device includes hardware components and manufacturing processes beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The primary function of this device is to process medical imaging data (CT scans) and create surgical plans, guides, and anatomical models. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for surgical planning and guidance. The system is designed to assist surgeons in planning and executing Maxillofacial reconstructive surgeries based on patient imaging data. This is a clinical application, not a diagnostic one performed on in vitro samples.
- The outputs are physical models, surgical guides, and digital planning reports. These are tools for surgical intervention and planning, not diagnostic results derived from analyzing biological specimens.
The device falls under the category of medical devices used for surgical planning and guidance, likely regulated as a Class II or Class III medical device depending on the specific risks associated with its use.
N/A
Intended Use / Indications for Use
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
PBF, LLZ
Device Description
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in Maxillofacial reconstructive surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides for harvesting bone grafts from the Fibula or Ilium, anatomical models of the Fibula and Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. The physical products (surgical guides, anatomical models) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based system, CT, DICOM images
Anatomical Site
Fibula and Ilium (for harvesting bone grafts), Maxillofacial reconstructive surgeries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians (not for use by patients), well-trained engineers (operate software systems), surgeon or relevant hospital staff (sterilize surgical guides and anatomical models before use in the operating room)
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 performance testing was performed:
- Mechanical testing: The results showed that the sterilized and aged test specimens met the pre-defined acceptance criteria: maintain 85% of initial bending strength and 85% of initial tensile strength.
- Dimensional testing: The results showed that the dimensional changes were within the predefined acceptance criteria.
- Wear debris testing: The results showed that the average material loss was within the predefined acceptance criteria.
- Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic toxicity, Pyrogenicity): All tests showed no evidence of adverse effects and met requirements.
- Sterilization testing: The results demonstrated the assurance of sterility of 10-6 SAL (sterility assurance level) for surgical guides and anatomical models individually packaged.
- Software validation: All the COTS software applications for image segmentation and manipulation are FDA cleared. Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to the system requirements. Testing required as a result of risk analysis (level of concern) and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and the system performs as intended based on the user requirements and specifications.
Clinical performance data and animal studies data were not deemed necessary.
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.
Not Found
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
§ 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
August 4, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CenterMed, Inc. Jash Bhayani Chief Operating Officer 226 N Wiget Ln Walnut Creek, California 94598
Re: K211614
Trade/Device Name: CenterMed Patient Matched Assisted Surgical Planning (ASP) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF, LLZ Dated: July 29, 2022 Received: August 1, 2022
Dear Mr. Bhayani:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211614
Device Name CenterMed Patient Matched Assisted Surgical Planning (ASP) System
Indications for Use (Describe)
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K211614 Page 1 of 13
centermed
510(k) Summary
| Submitter Information | |
|---|---|
| Submitter: | CenterMed, Inc. |
| Submitter Address: | 226 N Wiget Ln, |
| Walnut Creek, CA 94598 | |
| Contact Person: | Jash Bhayani |
| Contact Title: | Chief Operating Officer |
| Phone number: | 855-840-8823 |
| E-mail address: | Jash.bhayani@CenterMed.com |
| Date Prepared: | July 29, 2022 |
| The content is prepared based on the requirements of 21 | |
| CFR 807.92 | |
| Submission Information | |
| Trade Name: | CenterMed Patient Matched Assisted Surgical Planning |
| (ASP) System | |
| Common Name: | System for the creation of patient specific anatomical |
| models, surgical guides and surgical planning case reports | |
| Classification Name: | Orthopedic Surgical Planning and Instrument Guides (21 |
| CFR 888.3030) (Primary) | |
| System, Image Processing, Radiological (21 CFR 892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | PBF, LLZ |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS) Planning |
| System (K192979) | |
| Device Description: | CenterMed Patient Matched Assisted Surgical Planning |
| (ASP) System is a combination of software design and | |
| additive manufacturing for customized virtual pre-surgical | |
| treatment planning in Maxillofacial reconstructive surgeries. | |
| The system processes patients' imaging data files obtained | |
| from the surgeons for treatment planning and outputs various | |
| patient-specific products (both physical and digital), | |
| including surgical guides for harvesting bone grafts from the | |
| Fibula or Ilium, anatomical models of the Fibula and Ilium, | |
| and surgical planning case reports for use in Maxillofacial | |
| reconstructive surgeries. The physical products (surgical | |
| guides, anatomical models) are manufactured with | |
| biocompatible polyamide (PA-12) using additive | |
| manufacturing (Selective Laser Sintering). |
4
centermed
Indications for Use: CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
1 Abbreviations
| Abbreviation | Definition |
|---|---|
| ASP | Assisted Surgical Planning |
| COTS | Commercially off-the-shelf |
| CT | Computer Tomography |
| DICOM | File Format; Digital Imaging and Communications in Medicine |
| IPS | Individual Patient Solutions |
| PA-12 | Polyamide 12 |
| SAL | Sterility Assurance Level |
| SLA | Stereolithography |
| SLS | Selective Laser Sintering |
| STL | File format used in 3D printing |
5
510(k) Summary
2 General Workflow
The general workflow of CenterMed Patient Matched Assisted Surgical Planning System begins with software simulation of patients' imaging data files obtained from the surgeon for treatment planning. Products (surgical guides and anatomical models) are designed and approved by the surgeon based on these imaging data files and converted to 3D STL files. Simultaneously, a surgical planning case report is created based on the same imaging data files as well as the STLs of the designed products. Receiving signed approval from the surgeon, the STL files of the product are sent to manufacturing to be pre-processed, 3D-printed, and post-processed. The completed output of the system includes the surgical planning case report, anatomical models, and corresponding surgical guides. These are packaged, labeled, and sent to the surgeon clean and non-sterile. The surgeon or relevant hospital staff will sterilize the surgical guides and anatomical models before use in the operating room. The workflow is shown in Figure 1.
Image /page/5/Figure/3 description: This image is a flowchart that outlines the process of creating anatomical models and surgical guides from CT/DICOM images. The process begins with inputting CT/DICOM images, followed by surgical treatment planning using software like MIMICS and 3-Matic. The next steps include data preparation using software like Magics and PSW, material preparation involving polyamide powder mixing, 3D printing using SLS printing technique, post-processing steps like cooling down, unpacking, sieving, sandblasting, packaging, and labeling, and finally, the output of anatomical models, surgical guides, and surgical planning case reports, which are then sterilized by the end user.
Figure 1: General Workflow of CenterMed Patient Matched ASP System
Image /page/5/Picture/6 description: The image contains the word "Centermed" in a bold, sans-serif font. The word is colored in a dark red or maroon hue. A horizontal line is placed above the text, spanning the entire length of the word, and is also in the same dark red color.
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3 Technological Characteristics / Substantial Equivalence Discussion
Both the subject device and predicate device have similar indications for use.
Indications for use of the subject device
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs, including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. The subject device and predicate device are also both intended as a pre-operative software tool for simulating/ evaluating surgical treatment options.
Indications for use of the predicate device:
The KLS Marin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that mav then be provided as digital models or used in an additive manufacturing portion of the system that produces physical outputs including anatomical models, guides and case reports for use in thoracic (excluding spine) and reconstructive surgeries. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
4 Similarities to Predicate
Both the subject device and predicate device fit the same premarket regulation and are identical in conditions of use.
Both the subject device and predicate device share the same fundamental technologies. They both use a combination of software and hardware. Commercially off-the-shelf (COTS) software systems are used for image transfer, manipulation, surgical simulation as well as digital model creation of patient specific anatomical models, and surgical guides. These software systems are intended to be operated by well-trained engineers and the outputs are evaluated by physicians. The additive manufacturing hardware is used to manufacture the physical models from the digital models.
Both the subject device and predicate device share the same fundamental technologies as follows:
- Both use medical imaging data, such as CT scans, in DICOM format as input data file;
- Both have the same system outputs, including anatomical models, and surgical guides; ●
7
- Both generate digital models and surgical planning case reports to assist physicians in . how to use the products during clinical operation;
- . Both use the same materials for surgical guides (Polyamide-12);
- Both use additive manufacturing techniques for product manufacturing;
- Both use the same manufacturing methods for printing surgical guides (Selective Laser ● Sintering (SLS));
- Both are passive medical devices; ●
- Both are patient-specific devices;
- Both are provided for single-use;
- Both are provided non-sterile with an end-user sterilization method of steam sterilization . with the validated assurance level of 10-6 SAL;
- Both use temporary screws for surgical guide fixation to temporarily fix the surgical . guide to the target bone surface for more precise guidance of the osteotomy position;
- . Both devices require trained employees/engineers who utilize the software applications to manage data and work with the physician to create the virtual surgical plan;
- . Both devices need the physician to provide input for surgical planning and give feedback of the system outputs by viewing digital models modified by trained employees/engineers during the planning session.
5 Differences from Predicate
- The predicate device indicates the thoracic region in their indications for use which is . not present in the subject device. The subject device is indicated for the fibula and ilium regions of the body.
- Subject device creates anatomical models using Polyamide-12 (PA-12) material with a . SLS manufacturing process, whereas the predicate device uses resin material with an SLA manufacturing process.
- For the predicate device, manufacturing materials include epoxy/resin and acrylic for . anatomical models, and polyamide, Titanium Alloy (Ti-6A1-4V) and CP Titanium for guides. The subject device only uses PA-12 to manufacture all anatomical models, and surgical guides.
- . The predicate device provides two kinds of surgical guides, one made with polyamide and the other made with Titanium Alloy (Ti-6Al-4V) and CP Titanium. The subject device only uses surgical guides made of polyamide, along with medical grade 316L stainless steel sleeves.
8
centermed
- The predicate device uses previously cleared fixation screws which range from 2.3mm -. 3.2mm diameter, with length of 7mm - 17mm. The subject device recommends a range of standard screw sizes to the doctor (diameter 1.5mm - 2.1mm, length 5mm - 22mm) (Standard screw sizes determined by manufacturer catalogs of medical grade screws for maxillofacial surgeries).
- Both the predicate and subject device utilize Materialise Mimics for image segmentation . and processing, but the predicate and subject device use different additional commercially off-the-shelf (COTS) software applications for image segmentation and processing. Additionally, the subject device utilizes two (2) commercially off-the-shelf (COTS) software for manufacturing.
- The predicate device has one contraindication that is not present in the subject device, . "Bone tumors located in the implant base region". The subject device does not include implants and therefore this contraindication is not relevant to the subject device. All other contraindications are identical to the predicate device.
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Image /page/9/Picture/1 description: The image features the word "entermed" in a stylized, red font. The word is presented in a bold, italicized typeface, giving it a dynamic and modern appearance. A registered trademark symbol is located to the right of the word.
K211614 Page 7 of 13
Table 1: Subject and Predicate Device Comparison
| Subject Device | Predicate Device | |
|---|---|---|
| Characteristics | CenterMed Patient Matched Assisted Surgical | |
| Planning (ASP) System | KLS Martin IPS Planning System (K192979) | |
| Product Code | LLZ, PBF | LLZ, PBF |
| Classification | 21 CFR 892.2050, Class II | |
| 21 CFR 888.3030, Class II | 21 CFR 892.2050, Class II | |
| 21 CFR 888.3030, Class II | ||
| Common Name | System for the creation of patient specific anatomical | |
| models, surgical guides and surgical planning case | ||
| reports | System for the creation of patient specific anatomical | |
| models, cutting/marking guides, and case reports | ||
| Indications for use | CenterMed Patient Matched Assisted Surgical Planning | |
| (ASP) System is intended for use as a software system | ||
| and image segmentation system for the transfer of | ||
| imaging information from a medical scanner such as a | ||
| CT based system. The input data file is processed by | ||
| the ASP system and the result is an output data file. | ||
| This file may then be provided as digital models or | ||
| used as input to a rapid prototyping portion of the | ||
| system that produces physical outputs including | ||
| anatomical models of the Fibula and Ilium, surgical | ||
| guides for harvesting bone grafts from the Fibula or | ||
| Ilium, and surgical planning case reports for use in | ||
| Maxillofacial reconstructive surgeries. CenterMed | ||
| Patient Matched ASP System is also intended as a pre- | ||
| operative software tool for simulating/evaluating | ||
| surgical treatment options. | The KLS Martin Individual Patient Solutions (IPS) | |
| Planning System is intended for use as a software system | ||
| and image segmentation system for the transfer of | ||
| imaging information from a medical scanner such as a CT | ||
| based system. The input data file is processed by the IPS | ||
| Planning System and the result is an output data file that | ||
| may then be provided as digital models or used in an | ||
| additive manufacturing portion of the system that | ||
| produces physical outputs including anatomical models, | ||
| guides, and case reports for use in thoracic (excluding | ||
| spine) and reconstructive surgeries. The IPS Planning | ||
| System is also intended as a pre-operative software tool | ||
| for simulating / evaluating surgical treatment options. | ||
| Contraindications | 1. Active infections (obvious, or clinically apparent). |
- Hypersensitivity to foreign bodies.
- Circulatory problems, systematic diseases, or
metabolic disorders. - Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative processes
that may have negative influences. - Interventions carried out in a non-sterile
environment - Regions exposed to inappropriate forces or excessive
weight loads - Patients unwilling to follow instructions during the
postoperative phase due to their mental,
neurological, or physical condition. - Obvious drug or alcohol abuse
- Significant changes to the patient's anatomy have
occurred since the medical scan used for planning
purposes was obtained. | 1. Obvious infections. - Hypersensitivity to foreign bodies.
- Circulatory problems, systemic diseases, and metabolic
disorders. - Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative processes that
may negatively influence the healing process. - Interventions carried out in a non-sterile environment.
- Regions exposed to inappropriate forces or excessive
weight loads. - Patients unwilling or unable to follow instructions
during the postoperative phase due to their mental,
neurological, or physical condition. - Bone tumors located in the implant base region.
- Obvious drug or alcohol abuse.
- Significant changes to the patient's anatomy has
occurred since the medical scan used for planning
purposes was obtained. |
| Clinical
Application | Maxillofacial reconstructive surgeries | Thoracic (excluding spine) and reconstructive surgeries |
| Prescription Use | Yes, intended to be used by physicians, not for use by
patients. | Yes, intended to be used by physicians, not for use by
patients. |
| Energy
used/delivered | Passive | Passive |
| System Inputs | CT, DICOM images,
Anatomical models, | CT, DICOM images
Anatomical models, |
| System Outputs | Surgical guides, Surgical planning case reports | Guides, Case reports |
| Materials | Anatomical models: Medical Grade Polyamide (PA-12) | Anatomical models: Epoxy/Resin, Acrylic |
| 510(k) Summary | | |
| | Surgical guides:
3D printed part: Medical Grade polyamide (PA-12)
Sleeve: Medical Grade Stainless Steel 316L | Cutting/Marking guides: Polyamide, Titanium Alloy (Ti-
6Al-4V), CP Titanium |
| Manufacturing
Method | Medical Grade Polyamide (PA-12):
3D (Additive; Selective Laser Sintering (SLS))
Medical Grade Stainless Steel 316L:
Traditional (Subtractive) | Epoxy/Resin, Acrylic:
3D (Additive; Stereolithography (SLA))
CP Titanium: Traditional (Subtractive)
Ti-6Al-4V: 3D (Additive; Selective Laser Melting)
Polyamide: 3D (Additive; Selective Laser Sintering) |
| Patient-specific
configuration? | Yes | Yes |
| Provided for single-
use? | Yes | Yes |
| Provide sterile? | No | No |
| Sterilization
Method | Steam Sterilization | Steam Sterilization |
| Recommended
Temporary Screw
Diameter | 1.5mm-2.1mm | 2.3mm - 3.2mm |
| Recommended
Temporary Screw
Length | 5mm-22mm | 7mm -17 mm |
| Recommended
Temporary Screw
Style | Drill-Free, Tapping-Free | MaxDrive (Drill-Free,
non-locking, locking) |
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K211614 Page 8 of 13
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11
Image /page/11/Picture/1 description: The image contains the word "centermed" in a stylized, sans-serif font. The word is in a dark red color. There is a horizontal line above the word, and the registered trademark symbol is to the right of the word.
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6 Device Types and Functions
Table 2 lays out the types, materials, and functions of the various devices offered in the CenterMed Patient Matched ASP System.
| Table 2: Types and Functions of CenterMed Patient Matched Devices | |||||
|---|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------------- | -- | -- | -- |
| Category | Material | Function |
|---|---|---|
| Anatomical Models | • PA-12 | • Visual representation of patient's |
| bone pre and/or post-op | ||
| Cutting Guide | • PA-12 | |
| • 316L Stainless Steel | • Cutting reconstructive bone |
7 Non-clinical Performance Data
The following non-clinical performance testing was performed as supportive evidence to demonstrate substantial equivalence:
- Mechanical testing .
- Dimensional testing .
- . Wear debris testing
- Biocompatibility testing .
- Sterilization testing ●
- Software validation ●
Table 3 shows an overview of the testing performed on surgical guides, and validation testing performed on the COTS software.
| Test performed | Test
description/Guidelines | Conclusion | Safety and Efficacy
Confirmed | |
|------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------|
| Mechanical testing | ISO 178:2019 | The results showed that the
sterilized and aged test
specimens met the pre-
defined acceptance criteria:
maintain 85% of initial
bending strength. The test
specimens used for bending
testing were designed and | Yes | |
| 510(k) Summary | | | | |
| | ISO 20753:2018 | tested according to these ISO
standards.
The smaller test specimens
used for tensile testing were
designed according to this
ISO standard. | Yes | |
| | ASTM D638 | The larger test specimens
used for tensile testing were
designed according to this
ASTM standard. | Yes | |
| | ISO 527-2:2012 | The results showed that the
sterilized and aged test
specimens can reach the pre-
defined criteria: maintain 85%
of initial tensile strength. | Yes | |
| Dimensional testing | Pre-defined
dimensional tolerance
limits | The results showed that the
dimensional changes were
within the predefined
acceptance criteria. | Yes | |
| Wear debris testing | Pre-defined average
amount of material loss | The results showed that the
average material loss was
within the predefined
acceptance criteria. | Yes | |
| Cytotoxicity | ISO 10993-5, GB/T
16886.5-2017 | The results showed no
evidence of the test specimen
causing cell lysis or toxicity. | Yes | |
| Sensitization | ISO 10993-10, GB/T
16886.10-2017 | The test specimen extracts
showed no evidence of
causing delayed dermal
contact sensitization. | Yes | |
| Intracutaneous
reactivity | ISO 10993-10, GB/T
16886.10-2017 | The results showed no
evidence of intra-cutaneous
reactivity. | Yes | |
| Acute Systemic
toxicity | ISO 10993-11, GB/T
16886.11 2011 | The results showed no
mortality or evidence of
systemic toxicity. | Yes | |
| 510(k) Summary | | | | Centermed |
| Pyrogenicity | USP , ISO
10993-11 | The results met the
requirements for the absence
of pyrogens. | Yes | |
| Sterilization
validation | ANSI/AAMI/ISO
17665-1 | The results demonstrated the
assurance of sterility of 10-6
SAL (sterility assurance level)
for surgical guides and
anatomical models
individually packaged in a
single-pouched or wrapped
sterilization configuration. | Yes | |
| Software validation | Pre-defined
requirement
specifications | All the COTS software
applications for image
segmentation and
manipulation are FDA
cleared.
Quality and on-site user
acceptance testing provide
objective evidence that all
software requirements and
specifications were
implemented correctly and
completely and are traceable
to the system requirements.
Testing required as a result of
risk analysis (level of
concern) and impact
assessments showed
conformity with pre-defined
specifications and acceptance
criteria. Software
documentation demonstrates
all appropriate steps have
been taken to ensure
mitigation of any potential
risks and the system performs
as intended based on the user
requirements and
specifications | Yes | |
Table 3: Summary of Non-Clinical Performance Data
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510(k) Summary
8 Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence, or safety and effectiveness of the CenterMed ASP System. The predicate device did not perform clinical testing for their products (surgical guides, anatomical models, case reports), and since there are no significant technological differences, or significant indications for use differences between the subject device products (surgical guides, anatomical models, surgical planning case reports) and the predicate device, clinical testing is not needed for the subject device.
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9 Animal Studies Data
Animal testing was not necessary for the determination of substantial equivalence, or safety and effectiveness of the CenterMed ASP System. The predicate device did not perform animal testing for their products (surgical guides, anatomical models, case reports), and since there are no significant technological differences, or significant indications for use differences between the subject device products (surgical guides, anatomical models, surgical planning case reports) and the predicate device, animal testing is not needed for the subject device.
10 Conclusions
The predicate device chosen was KLS Martin Individual Patient Solutions System. It was shown that the subject device, CenterMed Patient-Matched Assisted Surgical Planning System is substantially equivalent to the predicate device. Both have the same indications for use as a software and image segmentation system for the transfer of imaging information from a medical scanner, and both result in creation of outputs such as anatomical models, surgical guides, and surgical planning case reports for use in reconstructive surgery. Both create physical outputs using rapid prototyping. They are both intended for use as a pre-operative software tool for simulating and evaluating surgical treatment options.
Any differences between the predicate device and the subject device have been thoroughly analyzed to conclude no safety or efficacy issues in the subject device. A full risk analysis was performed to determine the safety of the device, and any residual risk has been justified. Additionally, mechanical, biocompatibility, and sterilization tests have been performed to analyze the safety and effectiveness of the subject device. All tests passed their respective test criteria. Software risk analysis and validation was also performed to confirm the safety and effectiveness of the COTS software used to design and manufacture the subject device.
Based on the comparisons and analyses detailed above in this summary, we believe that the information and performance test reports of the subject device provided in this 510(k) submission are sufficient to demonstrate the safety and effectiveness of the CenterMed Patient Matched ASP System. Additionally, the information and performance test reports provided support the conclusion of Substantial Equivalence to the predicate device.