(403 days)
Not Found
No
The summary describes image processing and software validation but does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development.
No.
The sole purpose of this device is for surgical planning and visualization; it does not directly treat or diagnose a disease or condition.
No
The device aids in surgical planning and creates models/splints based on existing imaging data, but it does not diagnose a medical condition itself.
No
The device description explicitly states it is a "combination of software design and additive manufacturing" and outputs "physical products (surgical guides, anatomical models and surgical splints)" which are manufactured using additive manufacturing. This indicates the device includes hardware components and manufacturing processes beyond just software.
Based on the provided information, the CenterMed Patient Matched Assisted Surgical Planning (ASP) System 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 an IVD is to provide information about a patient's health status through the analysis of biological samples like blood, urine, tissue, etc.
- The CenterMed ASP System processes medical imaging data (CT, CBCT DICOM images). It uses this data for surgical planning, creating physical models and guides, and simulating surgical options. It does not analyze biological specimens.
- The intended use and device description clearly focus on surgical planning and the creation of patient-specific surgical aids. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the CenterMed Patient Matched Assisted Surgical Planning (ASP) System falls under the category of a medical device used for surgical planning and guidance, not an In Vitro Diagnostic.
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, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Product codes
DZJ, 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 reconstruction and orthognathic 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, anatomical models, surgical splints, and surgical planning case reports. The physical products (surgical guides, anatomical models and surgical splints) 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, CBCT DICOM images, Teeth models (stone models, STL file or CBCT of mouth/teeth) if applicable, Patients' digital photos if applicable
Anatomical Site
maxillofacial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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
Non-clinical performance testing was performed:
- Mechanical testing: Tested according to ISO 178:2019, ISO 20795-2:2013, ISO 20753:2018, ASTM D638, ISO 527-2:2012. Results showed sterilized and aged test specimens met pre-defined acceptance criteria, maintaining 85% of initial bending strength and tensile strength.
- Biocompatibility testing:
- Cytotoxicity: Tested according to ISO 10993-5, GB/T 16886.5-2017. Results showed no evidence of causing cell lysis or toxicity.
- Sensitization: Tested according to ISO 10993-10, GB/T 16886.10-2017. Results showed no evidence of causing delayed dermal contact sensitization.
- Intracutaneous reactivity: Tested according to ISO 10993-10, GB/T 16886.10-2017. Results showed no evidence of intra-cutaneous reactivity.
- Acute Systemic toxicity: Tested according to ISO 10993-11, GB/T 16886.11 2011. Results showed no mortality or evidence of systemic toxicity.
- Pyrogenicity: Tested according to USP , ISO 10993-11. Results met requirements for the absence of pyrogens.
- Sterilization testing: Tested according to ANSI/AAMI/ISO 17665-1. Results demonstrated sterility assurance level of 10-6 SAL for surgical guides, surgical splints and anatomical models.
- Software validation: All COTS software applications for image segmentation and manipulation are FDA cleared. Quality and on-site user acceptance testing provided 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 for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
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June 28, 2021
CenterMed, Inc. % Jash Bhayani Director of Design 226 N Wiget Ln Walnut Creek, California 94598
Re: K201353
Trade/Device Name: CenterMed Patient Matched Assisted Surgical Planning (ASP) System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 25, 2021 Received: May 26, 2021
Dear Jash 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 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
1
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 (QS) 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.
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201353
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, surgical splints and surgical planning case reports for use in maxillofacial surgery. 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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| K201353 | |
|---|---|
| Submitter Information | |
| Submitter: | CenterMed, Inc. |
| Submitter Address: | 226 N Wiget Ln, |
| Walnut Creek, CA 94598 | |
| Contact Person: | Jash Bhayani |
| Contact Title: | Director of Design |
| Phone number: | 855-840-8823 |
| E-mail address: | Jash.Bhayani@centermed.com |
| Date Prepared: | May 25, 2021 |
| 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 splints, surgical guides and surgical | |
| planning case reports | |
| Classification Name: | Bone Cutting Instruments and Accessories |
| (21 CFR 872.4120); | |
| Regulatory Class: | Class II |
| Product Code: | DZJ, LLZ |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS) Planning |
| System (K181241) | |
| 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 reconstruction and | |
| orthognathic 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, anatomical | |
| models, surgical splints, and surgical planning case reports. | |
| The physical products (surgical guides, anatomical models | |
| and surgical splints) are manufactured with | |
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biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).
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, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
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Image /page/5/Picture/0 description: The image shows the Centermed logo in a dark red color. The logo features a stylized font with a horizontal line above the letters. A registered trademark symbol is located to the right of the word.
| 1 Abbreviations | ||
|---|---|---|
| Abbreviation | Definition | |
| ASP | Assisted Surgical Planning | |
| CBCT | Cone Beam Computed Tomography | |
| 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 |
2 General Workflow
The general workflow of CenterMed Patient Matched Surgical Planning System begins with software simulation of patients' imaging data files obtained from the surgeon for treatment planning. Products (surgical guides, surgical splints and anatomical models) are designed based on these imaging data files, converted to 3D STL files, and sent to manufacturing to be preprocessed, printed, and post-processed. Simultaneously, a surgical planning case report is created based on the same imaging data files as well as the STLs of the designed products. The completed output of the system includes the surgical planning case report, anatomical models, and corresponding surgical guides and/or surgical splints. These are packaged, labeled, and sent to the surgeon clean and non-sterile. The surgeon or relevant hospital staff will sterilize the surgical guides, surgical splints and anatomical models before use in the operating room. The workflow is shown in Figure 1.
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Image /page/6/Picture/1 description: The image shows the logo for Centermed. The logo is in a dark red color and features a stylized font. There is a line above the word "Centermed" and a registered trademark symbol to the right of the word.
Image /page/6/Figure/2 description: This image is a flowchart that outlines the steps involved in a surgical treatment planning process. The process begins with input, which includes CT, CBCT, DICOM images, teeth models, and patient's digital photos. The next steps are design, pre-processing, printing, post-processing, and output, which leads to the end user sterilization.
Figure 1: General Workflow of CenterMed Patient Matched ASP System
3 Technological Characteristics / Substantial Equivalence Discussion
Both the subject device and predicate device have the same indications for use. The subject and predicate devices are 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 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, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. The subject device and predicate device are also both intended as a pre-operative software tool for simulating/ evaluating surgical treatment options.
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Image /page/7/Picture/1 description: The image shows the logo for Centermed. The logo is in a dark red color and features a stylized font. A horizontal line runs above the text. A registered trademark symbol is located in the upper right corner of the logo.
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, surgical splints 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 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, surgical splints and . surgical guides;
- 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 10to 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/repositioning 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 interactive . feedback through viewing the digital models of system outputs that are modified by the trained employee/engineer during the planning session.
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5 Differences from Predicate
- 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.
- . Compared to that of the predicate device, the subject device's input data also includes patients' teeth models (either physical or digital models) and patients' digital photos.
- For the predicate device, manufacturing materials include epoxy/resin and acrylic for . anatomical models, methacrylate for splints, and polyamide, Titanium Alloy (Ti-6A1-4V) and CP Titanium for guides. The subject device only uses PA-12 to manufacture all anatomical models, surgical guides, and surgical splints.
- . 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. Surgical splints of the subject device are made with the same manufacturing process as the surgical guides, both using polyamide as the raw material.
- . The predicate device guides are used for bone cutting or marking, while those of the subject device are provided in three types: bone cutting, bone marking, and bone repositioning.
- . The predicate device uses previously cleared fixation screws which range from 1.5mm -2.7mm diameter, with length of 4mm - 22mm. 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).
- The predicate device utilizes four (4) commercially off-the-shelf (COTS) software . applications for image segmentation and processing, whereas the subject device utilizes three (3) commercially off-the-shelf (COTS) software applications for image segmentation and processing, and 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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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 (K181241) | |
| Product Code | DZJ, LLZ | DZJ, LLZ |
| Classification | 21 CFR 872.4120, Class II | |
| 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II | |
| 21 CFR 892.2050, Class II | ||
| Common Name | System for the creation of patient specific | |
| anatomical models, surgical splints, surgical | ||
| guides and surgical planning case reports | System for the creation of patient specific | |
| anatomical models, cutting/marking guides, | ||
| splints, 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, surgical guides, surgical | ||
| splints and surgical planning case reports for use | ||
| in maxillofacial surgery. 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 as | ||
| input to a rapid prototyping portion of the system | ||
| that produces physical outputs including | ||
| anatomical models, guides, splints, and case | ||
| reports for use in maxillofacial surgery. 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 (e.g. paranasal sinuses). - 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 have occurred since the medical
scan used for planning purposes was
obtained. |
| Clinical
Application | Maxillofacial surgeries | Maxillofacial 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 |
| 10(k) Summary | | |
| System Inputs | CT, CBCT DICOM images,
Teeth models (stone models, STL file or CBCT
of mouth/teeth) if applicable, Patients' digital
photos if applicable | CT, CBCT DICOM images |
| System Outputs | Anatomical models, Surgical splints, Surgical
guides, Surgical planning case reports | Anatomical models, Splints,
Guides, Case reports |
| Materials | Anatomical models: Medical Grade Polyamide
(PA-12)
Surgical splints: Medical Grade Polyamide (PA-
Surgical guides:
3D Printed Part: Medical Grade Polyamide (PA-
12)
Sleeve: Medical Grade Stainless Steel 316L | Anatomical models: Epoxy/Resin, Acrylic
Splints: Methacrylate
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 |
| 10(k) Summary | | |
| Recommended
Temporary Screw
Diameter | 1.5mm - 2.1mm | 1.5mm - 2.7mm |
| Recommended
Temporary Screw
Length | 5mm - 22 mm | 4mm -22 mm |
| Recommended
Temporary Screw
Style | Drill-Free, Tapping-Free | MaxDrive & CrossDrive
(Drill-Free, locking [ThreadLock Taper Screw - TLTS]) |
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Image /page/11/Picture/0 description: The image contains the word "Centermed" in a stylized, red font. The letters are connected and have a modern, slightly rounded appearance. A registered trademark symbol is located to the right of the word.
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Image /page/13/Picture/0 description: The image shows the logo for Centermed. The logo is in a dark red color and features a stylized, sans-serif font. A horizontal line extends over the top of the letters 'enter' in the word. A registered trademark symbol is located in the upper right corner of the logo.
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.
| Category | Material | Function |
|---|---|---|
| Splint | • PA-12 | • Maintaining occlusion |
| • Positioning maxillofacial bone to intermediate or final occlusions | ||
| Marking Guide | • PA-12 | • Marking of maxillofacial bone |
| • 316L Stainless Steel | ||
| Cutting Guide | • PA-12 | • Cutting/drilling maxillofacial bone |
| • 316L Stainless Steel | ||
| Repositioning Guide | • PA-12 | • Positioning maxillofacial bone |
| • 316L Stainless Steel |
Table 2: Types and Functions of CenterMed Patient Matched Devices
7 Non-clinical Performance Data
The following non-clinical performance testing was performed as supportive evidence to demonstrate substantial equivalence:
- Mechanical testing
- Biocompatibility testing .
- Sterilization testing .
- . Software validation
Table 3 shows an overview of the testing performed on surgical guides, surgical splints and validation testing performed on the COTS software.
| Table 3: Summarv of Non-Clinical Performance Data | ||||
|---|---|---|---|---|
| Test performed | Test
description/Guidelines | Conclusion | Safety and Efficacy
Confirmed |
|------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Mechanical testing | ISO 178:2019, ISO
20795-2:2013 | 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 | Yes |
| | | | |
| | | 510(k) Summary | |
| | ISO 20753:2018 | 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 |
| 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 |
| 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, surgical
splints and anatomical models | Yes |
| 510(k) Summary | | | |
| | | individually packaged in a
single-pouched or wrapped
sterilization configuration. | |
| 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 |
14
Image /page/14/Picture/1 description: The image shows the logo for "Centermed". The logo is in a dark red color. There is a line above the letters "ent" in the logo. There is a registered trademark symbol to the right of the logo.
15
Image /page/15/Picture/1 description: The image shows the word "Centermed" in a stylized, maroon-colored font. A horizontal line extends above the word, and a circled "R" symbol is present to the right of the word, indicating a registered trademark. The font is bold and slightly italicized, giving the word a dynamic and modern appearance.
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, splints, 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, surgical splints, anatomical models, surgical planning case reports) and the predicate device, clinical testing is not needed for the subject device.
16
Image /page/16/Picture/1 description: The image shows the logo for Centermed. The logo is in a dark red color and features a stylized font. A horizontal line runs above the text. A registered trademark symbol is located in the upper right corner of the logo.
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, splints, 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, surgical splints, 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 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, surgical splints and surgical planning case reports for use in maxillofacial 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. All tests passed their respective test criteria. Software risk analysis and validation was also performed 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 and provided support the conclusion of Substantial Equivalence to the predicate device.