(30 days)
No
The summary describes a system for patient-specific surgical instrumentation based on CT scans and pre-operative planning, but there is no mention of AI or ML being used in the process. The validation study focuses on the manufacturing process and substantial equivalence, not on the performance of an AI/ML algorithm.
No.
Explanation: The device is described as patient-specific surgical instrumentation intended to assist in the positioning of total ankle replacement components and guiding bone marking. It is not designed to treat, prevent, or diagnose a disease or condition itself, but rather to facilitate a surgical procedure.
No
The device is described as "patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting." It is also stated to "assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery". This indicates the device is used for surgical planning and guidance, not for diagnosing a disease or condition.
No
The device description explicitly states that the system contains "several physical and digital outputs including patient-specific anatomical models and guides (physical outputs)". This indicates the device includes physical components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MAVEN™ Patient-Specific Instrumentation System is described as patient-specific surgical instrumentation used intraoperatively to assist in positioning total ankle replacement components and guiding bone marking during surgery. It uses pre-operative CT scans to create physical guides and digital reports for surgical planning and execution.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on processing imaging data (CT scans) and creating physical tools and digital plans for surgical use.
Therefore, the MAVEN™ Patient-Specific Instrumentation System falls under the category of surgical instrumentation or planning tools, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAVEN™ Patient-Specific Instrumentation System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The MAVEN™ Patient- Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient-Specific Instrumentation System is intended for single use only. The Paragon 28® TAR Patient- Specific Case Reports are intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Product codes
HSN, OYK
Device Description
The Paragon 28® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in total ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output).
The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperatively
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)
The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument. The validation successfully demonstrated the minor changes made to the subject device are substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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November 17, 2022
Paragon 28, Inc. % Jan Triani Regulatory Affairs Consultant Triani Consulting, LLC 14445 Grasslands Drive Englewood, Colorado 80112
Re: K223227
Trade/Device Name: MAVENTM Patient-Specific Instrumentation Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN. OYK Dated: October 17, 2022 Received: October 18, 2022
Dear Jan Triani:
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
1
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 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 medical devices and radiation-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,
Ting Song -S
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K223227
Device Name MAVEN™ Patient Specific Instrumentation
Indications for Use (Describe)
The MAVEN™ Patient-Specific Instrumentation System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The MAVEN™ Patient- Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landment and positioning of the implant are identifiable on patient imaging CT scans. The MAVEN™ Patient-Specific Instrumentation System is intended for single use only. The Paragon 28® TAR Patient- Specific Case Reports are intended for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Paragon 28, Inc. MAVEN Patient Specific Instrumentation
| Manufacturer: | Paragon 28, Inc
14445 Grasslands, Dr.
Englewood, CO 80112
Phone: 855-786-2525 |
|---------------------|----------------------------------------------------------------------------------------|
| Official Contact: | Jan Triani
Regulatory Consultant
Patient Specific, Paragon 28, Inc. |
| Date Prepared: | October 11 ,2022 |
| Device Trade Name: | Paragon 28 MAVEN™ Patient-Specific Instrumentation |
| Device Common Name: | Patient Specific Guide |
| Classification: | 21 CFR 888.3110 |
| Product Code: | HSN, OYK |
Purpose of the Special 510(k) notice:
The modification to the subject device is to allow an additional material and supplier to make the subject device.
Intended Use
The intended use and indication are the same as the main predicate device. K202019. Indications are:
The MAVEN™ Patient-Specific Instrumentation System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the MAVEN™ marking of bone before cutting. The Patient-Specific Instrumentation System is intended for use with the Paragon 28® APEX 3D™ Replacement System indications Total Ankle and its cleared for use, provided that anatomic landmarks necessary for alignment and positioning of the MAVEN™ implant are identifiable on patient imaging CT scans. The Patient-Specific Instrumentation System is intended for single use only. The 286 TAR Patient-Specific Case Reports are intended Paragon for use with the Paragon 28® APEX 3D™ Total Ankle Replacement System and its that anatomic landmarks necessary cleared indications for use, provided for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Device Description
The Paragon 28® MAVEN™ Patient Specific Instrumentation (PSI) system is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in total
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ankle replacement procedures. The system contains several physical and digital outputs including patient-specific anatomical models and guides (physical outputs); and a patient-specific case report (digital or documentation output).
The MAVEN™ PSI System is for use with the APEX 3D™ Total Ankle Replacement System.
Performance Data
The company conducted a design and manufacturing process validation, to demonstrate that the changes presented within this premarket submission, did not change the outputs, which is the creation of a patient specific instrument. The validation successfully demonstrated the minor changes made to the subject device are substantially equivalent to the predicate.
Substantial Equivalence
The modification made to the MAVEN Patient Specific Instrumentation are minor. The subject device has the same intended use and same indications, and principles of operation, as the primary predicate (K202019). The minor differences in the grade of nylon and OTS design software do not raise any new questions of safety or effectiveness. The subject device is made by the same supplier, from the same nylon material and manufacturing methods, and uses the same software as the secondary predicate (K211076). Performance data demonstrates that the subject device is as safe and effective as the predicate devices. Thus, the subject device is substantially equivalent to its predicate devices.
Conclusions
In summary, the company's modified MAVEN Patient Specific Instrumentation has the same intended use as all of the previously cleared MAVEN Patient Specific Instrumentation (K202019). In addition, the modified device has the same indications, technological characteristics, and principles of operation as its primary predicate. Although there are minor differences between the subject and its primary predicate device, namely the grade of nylon material and the OTS software used by the design engineers, those differences do not raise new questions of safety or efficacy, and data provided in this and previous 510(k)s establish equivalence. Thus, the subject device is substantially equivalent.