(435 days)
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.
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).
The provided text is a 510(k) Summary for the CenterMed Patient Matched Assisted Surgical Planning (ASP) System. This document focuses on demonstrating substantial equivalence to a predicate device (KLS Martin Individual Patient Solutions (IPS) Planning System).
Crucially, this type of submission (510(k)) does not typically involve clinical performance studies to establish "acceptance criteria" through a traditional clinical trial or MRMC study in the way medical AI/imaging devices often do. Instead, the focus is on a comparison to a legally marketed predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" in terms of clinical performance (like sensitivity, specificity, reader performance, etc.) are not applicable to this 510(k) summary. The "acceptance criteria" here are primarily around demonstrating engineering performance, biocompatibility, sterilization, and software validation to ensure the device performs as intended and is as safe and effective as the predicate.
Here's a breakdown based on the provided document and the nature of a 510(k) submission for this type of device:
1. A table of acceptance criteria and the reported device performance
The provided document details non-clinical performance data and their conclusions. These serve as the "acceptance criteria" for demonstrating the device's functional and safety characteristics.
| Test Category | Acceptance Criteria / Guidelines | Reported Device Performance / Conclusion | Safety and Efficacy Confirmed |
|---|---|---|---|
| Mechanical Testing | ISO 178:2019 (bending strength), ISO 20753:2018 (tensile testing with smaller specimens), ASTM D638 (tensile testing with larger specimens), ISO 527-2:2012 (tensile strength) - Pre-defined criteria: maintain 85% of initial bending/tensile strength. | The results showed that the sterilized and aged test specimens met the pre-defined acceptance criteria: maintain 85% of initial bending strength. The smaller test specimens used for tensile testing were designed according to ISO 20753:2018. The larger test specimens used for tensile testing were designed according to ASTM D638. 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 - No evidence of cell lysis or toxicity. | The results showed no evidence of the test specimen causing cell lysis or toxicity. | Yes |
| Sensitization | ISO 10993-10, GB/T 16886.10-2017 - No evidence of delayed dermal contact sensitization. | The test specimen extracts showed no evidence of causing delayed dermal contact sensitization. | Yes |
| Intracutaneous Reactivity | ISO 10993-10, GB/T 16886.10-2017 - No evidence of intra-cutaneous reactivity. | The results showed no evidence of intra-cutaneous reactivity. | Yes |
| Acute Systemic Toxicity | ISO 10993-11, GB/T 16886.11 2011 - No mortality or evidence of systemic toxicity. | The results showed no mortality or evidence of systemic toxicity. | Yes |
| Pyrogenicity | USP <151>, ISO 10993-11 - Meet requirements for absence of pyrogens. | The results met the requirements for the absence of pyrogens. | Yes |
| Sterilization Validation | ANSI/AAMI/ISO 17665-1 - Assurance of sterility of 10-6 SAL. | 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 - Conformity with specifications and acceptance criteria. | 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 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No clinical test set was used for this 510(k) submission. The submission relies on non-clinical (mechanical, biocompatibility, sterilization) and software validation testing.
- The raw material for the device (patient CT scans) would be prospective in real-world use, but for the purpose of this submission, no patient data was used to "test" the device's diagnostic performance. The software processes existing DICOM data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No clinical ground truth was established as no clinical performance study was conducted. The "ground truth" for the device's outputs (models, guides, plans) is established through the surgeon's approval of the digital models and plans, as described in the workflow.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was performed. The device is an "Assisted Surgical Planning System" that produces physical and digital outputs for Maxillofacial reconstructive surgeries, not a diagnostic AI that assists human readers in interpreting images. It is used by "well-trained engineers" and "evaluated by physicians" for surgical planning. The submission explicitly states "Clinical testing was not necessary for the determination of substantial equivalence, or safety and effectiveness."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable for a typical AI performance metric. The device is described as an "Assisted Surgical Planning System" where "well-trained engineers" use "COTS software systems" for image transfer, manipulation, and simulation, with outputs "evaluated by physicians." This implies a human-in-the-loop system for the actual planning process, not a standalone diagnostic algorithm. The software validation detailed in the report is for the underlying software's functionality and adherence to specifications, not its stand-alone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (mechanical, biocompatibility, sterilization), the "ground truth" is adherence to established international and industry standards (ISO, ASTM, USP) and pre-defined internal acceptance criteria.
- For the software, the "ground truth" is adherence to "pre-defined requirement specifications" and "traceable to the system requirements," validated through "Quality and on-site user acceptance testing."
- There is no clinical ground truth in terms of patient outcomes or expert pathological diagnosis as this was not a clinical performance study for image interpretation.
8. The sample size for the training set
- Not applicable. The document does not describe a machine learning model that requires a "training set" in the context of deep learning. The software uses "Commercially off-the-shelf (COTS) software systems" for image processing and simulation, which would have been developed and validated by their respective vendors, not developed from scratch by CenterMed using a large training dataset for a novel AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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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
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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
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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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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 21CFR 807.92 | |
| Submission Information | |
| Trade Name: | CenterMed Patient Matched Assisted Surgical Planning(ASP) System |
| Common Name: | System for the creation of patient specific anatomicalmodels, surgical guides and surgical planning case reports |
| Classification Name: | Orthopedic Surgical Planning and Instrument Guides (21CFR 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) PlanningSystem (K192979) |
| Device Description: | CenterMed Patient Matched Assisted Surgical Planning(ASP) System is a combination of software design andadditive manufacturing for customized virtual pre-surgicaltreatment planning in Maxillofacial reconstructive surgeries.The system processes patients' imaging data files obtainedfrom the surgeons for treatment planning and outputs variouspatient-specific products (both physical and digital),including surgical guides for harvesting bone grafts from theFibula or Ilium, anatomical models of the Fibula and Ilium,and surgical planning case reports for use in Maxillofacialreconstructive surgeries. The physical products (surgicalguides, anatomical models) are manufactured withbiocompatible polyamide (PA-12) using additivemanufacturing (Selective Laser Sintering). |
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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 |
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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; ●
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- 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.
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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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K211614 Page 7 of 13
Table 1: Subject and Predicate Device Comparison
| Subject Device | Predicate Device | |
|---|---|---|
| Characteristics | CenterMed Patient Matched Assisted SurgicalPlanning (ASP) System | KLS Martin IPS Planning System (K192979) |
| Product Code | LLZ, PBF | LLZ, PBF |
| Classification | 21 CFR 892.2050, Class II21 CFR 888.3030, Class II | 21 CFR 892.2050, Class II21 CFR 888.3030, Class II |
| Common Name | System for the creation of patient specific anatomicalmodels, surgical guides and surgical planning casereports | System for the creation of patient specific anatomicalmodels, cutting/marking guides, and case reports |
| Indications for use | CenterMed Patient Matched Assisted Surgical Planning(ASP) System is intended for use as a software systemand image segmentation system for the transfer ofimaging information from a medical scanner such as aCT based system. The input data file is processed bythe ASP system and the result is an output data file.This file may then be provided as digital models orused as input to a rapid prototyping portion of thesystem that produces physical outputs includinganatomical models of the Fibula and Ilium, surgicalguides for harvesting bone grafts from the Fibula orIlium, and surgical planning case reports for use inMaxillofacial reconstructive surgeries. CenterMedPatient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluatingsurgical treatment options. | The KLS Martin Individual Patient Solutions (IPS)Planning System is intended for use as a software systemand image segmentation system for the transfer ofimaging information from a medical scanner such as a CTbased system. The input data file is processed by the IPSPlanning System and the result is an output data file thatmay then be provided as digital models or used in anadditive manufacturing portion of the system thatproduces physical outputs including anatomical models,guides, and case reports for use in thoracic (excludingspine) and reconstructive surgeries. The IPS PlanningSystem is also intended as a pre-operative software toolfor simulating / evaluating surgical treatment options. |
| Contraindications | 1. Active infections (obvious, or clinically apparent).2. Hypersensitivity to foreign bodies.3. Circulatory problems, systematic diseases, ormetabolic disorders.4. Insufficient or inadequate bone tissue.5. Secondary diseases such as degenerative processesthat may have negative influences.6. Interventions carried out in a non-sterileenvironment7. Regions exposed to inappropriate forces or excessiveweight loads8. Patients unwilling to follow instructions during thepostoperative phase due to their mental,neurological, or physical condition.9. Obvious drug or alcohol abuse10. Significant changes to the patient's anatomy haveoccurred since the medical scan used for planningpurposes was obtained. | 1. Obvious infections.2. Hypersensitivity to foreign bodies.3. Circulatory problems, systemic diseases, and metabolicdisorders.4. Insufficient or inadequate bone tissue.5. Secondary diseases such as degenerative processes thatmay negatively influence the healing process.6. Interventions carried out in a non-sterile environment.7. Regions exposed to inappropriate forces or excessiveweight loads.8. Patients unwilling or unable to follow instructionsduring the postoperative phase due to their mental,neurological, or physical condition.9. Bone tumors located in the implant base region.10. Obvious drug or alcohol abuse.11. Significant changes to the patient's anatomy hasoccurred since the medical scan used for planningpurposes was obtained. |
| ClinicalApplication | Maxillofacial reconstructive surgeries | Thoracic (excluding spine) and reconstructive surgeries |
| Prescription Use | Yes, intended to be used by physicians, not for use bypatients. | Yes, intended to be used by physicians, not for use bypatients. |
| Energyused/delivered | Passive | Passive |
| System Inputs | CT, DICOM images,Anatomical models, | CT, DICOM imagesAnatomical 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 | |
| ManufacturingMethod | 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-specificconfiguration? | Yes | Yes |
| Provided for single-use? | Yes | Yes |
| Provide sterile? | No | No |
| SterilizationMethod | Steam Sterilization | Steam Sterilization |
| RecommendedTemporary ScrewDiameter | 1.5mm-2.1mm | 2.3mm - 3.2mm |
| RecommendedTemporary ScrewLength | 5mm-22mm | 7mm -17 mm |
| RecommendedTemporary ScrewStyle | Drill-Free, Tapping-Free | MaxDrive (Drill-Free,non-locking, locking) |
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K211614 Page 8 of 13
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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'sbone 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 | Testdescription/Guidelines | Conclusion | Safety and EfficacyConfirmed | |
|---|---|---|---|---|
| Mechanical testing | ISO 178:2019 | The results showed that thesterilized and aged testspecimens met the pre-defined acceptance criteria:maintain 85% of initialbending strength. The testspecimens used for bendingtesting were designed and | Yes | |
| 510(k) Summary | ||||
| ISO 20753:2018 | tested according to these ISOstandards.The smaller test specimensused for tensile testing weredesigned according to thisISO standard. | Yes | ||
| ASTM D638 | The larger test specimensused for tensile testing weredesigned according to thisASTM standard. | Yes | ||
| ISO 527-2:2012 | The results showed that thesterilized and aged testspecimens can reach the pre-defined criteria: maintain 85%of initial tensile strength. | Yes | ||
| Dimensional testing | Pre-defineddimensional tolerancelimits | The results showed that thedimensional changes werewithin the predefinedacceptance criteria. | Yes | |
| Wear debris testing | Pre-defined averageamount of material loss | The results showed that theaverage material loss waswithin the predefinedacceptance criteria. | Yes | |
| Cytotoxicity | ISO 10993-5, GB/T16886.5-2017 | The results showed noevidence of the test specimencausing cell lysis or toxicity. | Yes | |
| Sensitization | ISO 10993-10, GB/T16886.10-2017 | The test specimen extractsshowed no evidence ofcausing delayed dermalcontact sensitization. | Yes | |
| Intracutaneousreactivity | ISO 10993-10, GB/T16886.10-2017 | The results showed noevidence of intra-cutaneousreactivity. | Yes | |
| Acute Systemictoxicity | ISO 10993-11, GB/T16886.11 2011 | The results showed nomortality or evidence ofsystemic toxicity. | Yes | |
| 510(k) Summary | Centermed | |||
| Pyrogenicity | USP <151>, ISO10993-11 | The results met therequirements for the absenceof pyrogens. | Yes | |
| Sterilizationvalidation | ANSI/AAMI/ISO17665-1 | The results demonstrated theassurance of sterility of 10-6SAL (sterility assurance level)for surgical guides andanatomical modelsindividually packaged in asingle-pouched or wrappedsterilization configuration. | Yes | |
| Software validation | Pre-definedrequirementspecifications | All the COTS softwareapplications for imagesegmentation andmanipulation are FDAcleared.Quality and on-site useracceptance testing provideobjective evidence that allsoftware requirements andspecifications wereimplemented correctly andcompletely and are traceableto the system requirements.Testing required as a result ofrisk analysis (level ofconcern) and impactassessments showedconformity with pre-definedspecifications and acceptancecriteria. Softwaredocumentation demonstratesall appropriate steps havebeen taken to ensuremitigation of any potentialrisks and the system performsas intended based on the userrequirements andspecifications | Yes |
Table 3: Summary of Non-Clinical Performance Data
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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.
§ 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.