(179 days)
No
The description focuses on image processing, segmentation, and computer-aided modeling with physician input, but does not mention AI or ML technologies. The performance studies also do not indicate the use of AI/ML.
No.
The device is a software system and image segmentation system used for surgical planning, creating anatomical models, and producing splints. It assists physicians in planning maxillofacial surgeries and thus operates as a diagnostic and planning tool rather than directly treating a disease or condition. While the outputs (splints) are used during surgery, the system itself does not provide therapy.
No
The device is intended for planning complex maxillofacial surgeries, producing anatomical models and splints, and simulating/evaluating surgical treatment options. It processes imaging information for surgical planning and manufacturing, rather than directly diagnosing conditions.
No
While the system includes software for image processing and surgical planning, it also explicitly describes the production of physical outputs (anatomic models and splints) using additive manufacturing, which are integral components of the system's intended use and outputs.
Based on the provided information, the OsteoPlan™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OsteoPlan™ System's Function: The OsteoPlan™ System processes medical images (CT and CBCT) of the patient's anatomy to create digital models, physical models, and surgical splints. It is a pre-operative planning tool and a system for producing physical aids for surgery.
- No Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its input is imaging data, not biological samples.
- Intended Use: The intended use clearly states it's for transferring imaging information, processing it into digital models, and using those models for additive manufacturing of physical outputs (anatomic models and splints) for use in maxillofacial surgery. It's also a pre-operative software tool for simulating/evaluating surgical treatment options. None of these activities fall under the definition of an IVD.
Therefore, the OsteoPlan™ System is a medical device, but it is not an In Vitro Diagnostic device. It falls under the category of surgical planning software and patient-specific surgical guides/models.
N/A
Intended Use / Indications for Use
The OsteoPlan™ 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 OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan 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)
DZJ, LLZ
Device Description
OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs.
The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning.
The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes.
Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery.
Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT based system. (CT and CBCT)
Anatomical Site
maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Equipment/Process Qualification (IQ/OQ/PQ) was performed in accordance with the OsteoMed quality management system with all validations meeting acceptance criteria.
- Software Validation and documentation for software of moderate level of concern was provided per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Off-The-Shelf Software Use in Medical Devices." All software verification/validation passed.
- Cleaning Validations were performed in accordance with FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. All testing passed.
- Steam Sterilization Validation was conducted using both pouches and rigid sterilization containers in accordance with ANSI/AAMI/ISO 17665-1 "Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- Biocompatibility testing for the worst-case splint and anatomical model was conducted per its contact classification according to the FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Testing included: cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, subchronic toxicity, and implantation. All biocompatibility testing passed.
- Packaging Validation was conducted to confirm that the packaging for the OsteoPlan System protects and retains the splints and models during normal shipping and handling. All testing passed.
- Shelf Life was established with functional testing to confirm the specified requirements were met. All testing passed.
- A Cadaver Study was conducted to verify the functionality of the design of the OsteoPlan system via simulated use with all acceptance criteria being met.
Performance equivalence was shown through the verification comparison to the predicate device.
Clinical testing is not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
February 11, 2022
OsteoMed Diane Rutherford Regulatory Affairs Manager 3885 Arapaho Road Addison, Texas 75001
Re: K212570
Trade/Device Name: OsteoPlan System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: November 12, 2021 Received: November 15, 2021
Dear Diane Rutherford:
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,
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) K212570
Device Name OsteoPlan System
Indications for Use (Describe)
The OsteoPlan™ 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 OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan 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 K212570
I. SUBMITTER
OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA Phone: 972-677-4795 Fax: 972-677-4601 Email: diane.rutherford(@acumed.net Contact Person: Diane Rutherford Date Prepared: February 9, 2022
II. DEVICE
| Name of the Device: | OsteoPlan™ System |
|---|---|
| Common or Usual Name: | Patient specific maxillofacial anatomical models, splints, and surgical plans |
| Classification Name: | Bone Cutting Instrument and Accessories |
| Classification: | Class II, 21 CFR 872.4120 |
| Product Code: | DZJ, LLZ |
III. PREDICATE DEVICES
Predicate Device: VSP® System, Medical Modeling, Inc (K133907, K120956)
Reference Device: Surgicase Guides, Materialise (K103136)
IV. DEVICE DESCRIPTION
OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs.
The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning.
The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes.
Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery.
Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.
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V. INDICATIONS FOR USE
The OsteoPlan™ 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 OsteoPlan System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The principles of operation and technological characteristics are substantially equivalent between the subject device and the primary predicate, VSP System. Specifically, the predicate device includes patient specific anatomic models and splints produced through 3D printing. The only difference in the Technological Characteristics is found in the materials of the outputs. The OsteoPlan System uses photopolymers for splints while the VSP System uses photopolymers (with stainless-steel inserts) in the cutting guides of the system. The OsteoPlan System uses Polyamide anatomic models (Polyamide 12) produced through an SLS printing process equivalent to the reference device. SurgiCase Guides (K103136), which includes outputs for the same anatomic region, made out of identical material (Polyamide 12) and printing process (SLS). The subject device contains a subset of the outputs of the predicate and reference device.
| New Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Trade Name | OsteoMed OsteoPlan™ | ||
| System K212570 | Medical Modeling VSP | ||
| System K133907, K120956 | Materialise Surgicase | ||
| Guides K103136 | |||
| Indication for Use | The OsteoPlan™ 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 | |||
| OsteoPlan System and the result is | |||
| an output data file that may then be | |||
| provided as digital models or used | |||
| as input to the additive | |||
| manufacturing portion of the system | |||
| that produces physical outputs | |||
| including anatomical models and | |||
| splints for use in maxillofacial | |||
| surgery. The OsteoPlan System is | |||
| also intended as a pre-operative | |||
| software tool for simulating / | |||
| evaluating surgical treatment | |||
| options. | The Medical Modeling VSP | ||
| 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 VSP | |||
| 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, | |||
| templates, and surgical guides for | |||
| use in maxillofacial surgery. The | |||
| VSP System is also intended as a | |||
| pre-operative software tool for | |||
| simulating / evaluating surgical | |||
| treatment options. | SurgiCase Guides are | ||
| intended to be used as | |||
| surgical tools to transfer a | |||
| pre-operative plan to | |||
| the surgery. The devices are | |||
| intended to guide the | |||
| marking of bone and/or | |||
| guide surgical | |||
| instruments in mandibular | |||
| and maxillofacial surgical | |||
| procedures. | |||
| SurgiCase Guides are | |||
| intended for single use only. | |||
| Outputs | Anatomic Models | ||
| Surgical Positioning Templates | |||
| (splints) | |||
| Patient Specific Case Reports | Anatomical Models | ||
| Surgical Positioning | |||
| Templates/Guides | |||
| Osteotomy Templates/Guides | |||
| Patient Specific Case Reports | |||
| Plate Bending Templates/Guides | |||
| Stainless Steel Culling and Drill | |||
| Inserts | Surgical Positioning | ||
| Templates/Guides | |||
| Osteotomy Templates/Guides | |||
| Patient Specific Case Reports | |||
| Plate Bending | |||
| Templates/Guides |
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OsteoMed OsteoPlan™ System Traditional 510(k)
| New Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Trade Name | OsteoMed OsteoPlanTM | ||
| System K212570 | Medical Modeling VSP | ||
| System K133907, K120956 | Materialise Surgicase | ||
| Guides K103136 | |||
| Additive | |||
| Manufacturing | Yes | Yes | Yes |
| Biocompatible | |||
| Materials | Yes | Yes | Yes |
| Patient-Contacting | |||
| External | |||
| Communicating | |||
| Tissue/Bone/Dentin | Limited ( |