(25 days)
None
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as a re-write for efficiency and bug fixing, with new functionality focused on frame identification and treatment planning based on surgeon feedback, not AI/ML algorithms.
Yes
The device is used for fracture fixation, limb lengthening, and deformity correction, which are therapeutic interventions.
No
The device is described as an external fixation system used for treatment planning, fracture fixation, limb lengthening, and deformity correction. While it uses software that helps in treatment planning based on X-rays, its primary function is therapeutic and corrective (external fixation), not diagnostic identification or characterization of a disease or condition. The software aids in planning the treatment of an already identified condition (fracture, deformity), rather than diagnosing the condition itself.
No
The device description explicitly states that the system consists of both "MAXFRAME Hardware (schanz screws, pins, struts, rings)" and "MAXFRAME Web Software". While the submission focuses on a software re-write, the overall system includes hardware components.
Based on the provided information, the DePuy Synthes MAXFRAME™ Multi-Axial Correction System 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.
- Device Function: The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is an external fixation system used for surgical procedures on bones. It involves hardware (screws, pins, struts, rings) and software for treatment planning based on radiographic images.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is related to the mechanical support and correction of bones, guided by imaging and software planning.
Therefore, the device falls under the category of a surgical device or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects
Product codes
OSN, KTT
Device Description
The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an external ring fixation system that consists of MAXFRAME Hardware (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used in treatment of soft tissue and bone deformities.
The subject device MAXFRAME 3D II Software (Moderate Software Level of Concern) is a software re-write of the MAXFRAME Web Software to make it more efficient, simplify software upgrades for functionality and fixing of software anomalies or bugs. Additionally, based on surgeon feedbacks and voice of customer, new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.
Mentions image processing
new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Rays/radiographic images
Anatomical Site
long bones and bones of the foot
Indicated Patient Age Range
The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware
Intended User / Care Setting
surgeons
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 performance of the subject MAXFRAME 3D II Software has been evaluated by confirming that the outputs meet the input requirements and conform to the user needs and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
None
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
May 25, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Synthes (USA) Products, LLC Suchitra Basu Associate Director, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K211313
Trade/Device Name: MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: OSN, KTT Dated: April 29, 2021 Received: April 30, 2021
Dear Suchitra Basu:
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
1
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 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,
Ting Song, PhD 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
2
Indications for Use
510(k) Number (if known) K211313
Device Name
MaxFrame™ Multi-Axial Correction System
Indications for Use (Describe)
The DePuy Synthes MaxFrame™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for DePuy Synthes Trauma. The logo consists of a circular design on the left, followed by the text "DePuy Synthes" in a bold, sans-serif font. Below "DePuy Synthes" is the word "TRAUMA" in a smaller, sans-serif font. Underneath the word "TRAUMA" is the text "COMPANIES OF Johnson & Johnson" in a smaller font.
6 510(k) Summary
K211313
| Sponsor | Synthes | Address |
|---|---|---|
| Primary Contact | Suchitra Basu, PhD, RAC | |
| Associate Director, Regulatory Affairs | ||
| DePuy Synthes | 1301 Goshen Parkway | |
| West Chester, PA USA | ||
| T: 610-719-5448 | ||
| Email: sbasu23@its.jnj.com | ||
| Secondary Contact | Thomas Shea | |
| Regulatory Affairs Manager | ||
| DePuy Synthes | 1301 Goshen Parkway | |
| West Chester, PA USA | ||
| T: 610-719-5679 | ||
| Email: tshea@its.jnj.com | ||
| Date Prepared | April 27, 2021 | |
| Proprietary Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Device Name | MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) | |
| Common Name | Software for Diagnosis/Treatment; Single/multiple component metallic bone | |
| fixation appliances | ||
| Classification | Class II | |
| Product Code(s): OSN (Software for Diagnosis/Treatment), | ||
| KTT (Appliance, fixation, nail/blade/plate combination, multiple components) | ||
| Predicate | ||
| Device(s) | DePuy Synthes MAXFRAME™ Multi-Axial Correction System (K161417) | |
| Reference | ||
| Device(s) | None | |
| Reason for | ||
| Submission | To introduce MAXFRAME 3D II Software (software re-write of MaxFrame Web | |
| Software) compatible with existing MaxFrame Hardware cleared as a part of the | ||
| MAXFRAME Multi Axial Correction System in K161417 | ||
| Device | ||
| Description | The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an | |
| external ring fixation system that consists of MAXFRAME Hardware | ||
| (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used | ||
| in treatment of soft tissue and bone deformities. |
The subject device MAXFRAME 3D II Software (Moderate Software
Level of Concern) is a software re-write of the MAXFRAME Web
Software to make it more efficient, simplify software upgrades for
functionality and fixing of software anomalies or bugs. Additionally, based
on surgeon feedbacks and voice of customer, new functionality has been
added around how frames are identified on X-Rays/radiographic images
and how the treatment of the deformity can be planned. | |
| Intended Use | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is intended | |
| Indications for
Use | for external fixation of fractured long bones and bones of the foot, limb
lengthening, and deformity correction in adult, children* (3-12), and adolescent*
(12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial
Correction System utilizes software for assisting surgeons in treatment planning.
*in which the growth plates have fused or will not be crossed. | |
| | The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated
for the following treatments in adults, and in both children (3-12) and adolescents
(12-21) in which the growth plates have fused or will not be crossed with hardware:
• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities
• correction of segmental defects. | |
| Comparison to
Predicate | The DePuy Synthes MAXFRAME 3D II Software has the same indications for
use and design (fundamental software architecture) as the MAXFRAME Web
Software. It utilizes the existing MAXFRAME hardware, creates a similar patient
treatment plan, and has highly comparable functionality and usability to the
predicate MAXFRAME Web Software. | |
| Non-clinical
Performance
Testing | The performance of the subject MAXFRAME 3D II Software has been evaluated
by confirming that the outputs meet the input requirements and conform to the
user needs and intended uses. | |
| Clinical
Performance Data | Clinical data was not necessary for the determination of substantial equivalence. | |
| Substantial
Equivalence | The subject device has the same intended use, indications for use, and
fundamental principles as the predicate device. It has been adequately compared
to the predicate device to demonstrate substantial equivalence | |
| Conclusion | The results of non-clinical performance data in terms of software verification and
validation demonstrate that the subject device is substantially equivalent to the
predicate device. | |
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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Trauma, a company that is part of Johnson & Johnson. The logo consists of a geometric design on the left, followed by the company name in bold, blue letters. Below the company name is the word "TRAUMA" in smaller, black letters. At the bottom of the image, the words "COMPANIES OF Johnson & Johnson" are printed in a smaller font.