(27 days)
No
The 510(k) summary describes a mechanical system with software for controlling length-adjustable struts. It explicitly states the submission is for the sterile struts and mentions the control system and software were cleared under a separate K number (K202810). There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation within this summary.
Yes
The device is indicated for various medical treatments such as fracture fixation, limb lengthening, and correction of deformities, which directly address a health condition.
No
The provided text describes the MAXFRAME AUTOSTRUT System as being used for various surgical treatments such as fracture fixation, limb lengthening, and correction of deformities. This indicates a therapeutic or interventional purpose rather than a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description explicitly states that the system is comprised of a control system, software, and six length-adjustable struts powered by a motor, and this submission is specifically for the clearance of the sterile struts, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on bones (fracture fixation, limb lengthening, deformity correction, etc.). This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is described as a mechanical system with struts, a control system, and software used in conjunction with an external fixation system. This is consistent with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on such testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on the mechanical manipulation and stabilization of bone structures.
N/A
Intended Use / Indications for Use
The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which 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
KTT
Device Description
The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts.
This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long.
The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware
Intended User / Care Setting
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)
Non-Clinical Performance Testing was performed and included Mechanical Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation and Biocompatibility Evaluation. The data was used for the determination of substantial equivalence.
Clinical Performance Data was not necessary for the determination of substantial equivalence.
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
§ 888.3030 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 26, 2023
Depuy Synthes Mitchel Bartko Regulatory Affairs Specialist III 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K231922
Trade/Device Name: DEPUY SYNTHES MAXFRAME AUTOSTRUT System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 29, 2023 Received: June 29, 2023
Dear Mitchel Bartko:
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.
1
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 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.
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231922
Device Name
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
Indications for Use (Describe)
The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Sponsor | DePuy Synthes | Address |
|---|---|---|
| Primary Contact | Mitchel Bartko | |
| Regulatory Affairs Specialist III | ||
| DePuy Synthes | 1301 Goshen Parkway | |
| West Chester, PA USA | ||
| T: 908-808-6541 | ||
| Email: mbartko1@its.jnj.com | ||
| Secondary Contact | Silvia De La Barra | |
| Manager, Regulatory Affairs | ||
| DePuy Synthes | 1301 Goshen Parkway | |
| West Chester, PA USA | ||
| T: 385-258-9397 | ||
| Email: sdelabar@its.jnj.com | ||
| Date Prepared | June 29, 2023 | |
| Device Trade Name | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | |
| Common Name | External Fixation System | |
| Classification | Class II | |
| Product Code | KTT (Appliance, fixation, nail/blade/plate combination, multiple components) | |
| Regulation Number | 888.3030 : Single/multiple component metallic bone fixation appliances and | |
| accessories | ||
| Predicate Device(s) | K202810 - Autostrut G2 | |
| Device Description | ||
| Summary | The MAXFRAME AUTOSTRUT System is comprised of a control system, | |
| software, and six length-adjustable struts powered by a motor. The devices are | ||
| used in conjunction with the DePuy Synthes MAXFRAME multi axial | ||
| correction system (K161417), including all its parts and software, except that the | ||
| MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT | ||
| Hexapod Struts. | ||
| This submission is solely for the clearance of a sterile version of the | ||
| MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME | ||
| AUTOSTRUT Hexapod Struts are provided sterile and are comprised of | ||
| telescopic rods made of stainless steel and aluminum and a motor adapter made | ||
| from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are | ||
| available in three lengths - short, medium, and long. | ||
| The MAXFRAME AUTOSTRUT Control System and Software have been | ||
| cleared under K202810. | ||
| Intended Use | ||
| Indications for Use | The MAXFRAME AUTOSTRUT System is indicated for the following | |
| treatments in adults, and in both children (3-12) and adolescents (12-21) in | ||
| which 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. | ||
| Indications for Use | ||
| Comparison | The MAXFRAME AUTOSTRUT System has the same indications for use as the | |
| predicate device (AutoStrut G2 [K202810]). | ||
| Technological | ||
| Comparison | The DePuy Synthes MAXFRAME AUTOSTRUT System has similar | |
| technological characteristics (design, material and chemical composition) as the | ||
| predicate device AutoStrut G2 (K202810). The only differences between the | ||
| predicate and subject device is that the subject device struts are provided | ||
| ethylene oxide sterilized and packaged within sterile barrier packaging. The | ||
| predicate device struts are provided non-sterile and are end user steam sterilized. | ||
| Non-clinical | ||
| Performance | ||
| Testing | Non-Clinical Performance Testing was performed and included Mechanical | |
| Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation | ||
| and Biocompatibility Evaluation. The data was used for the determination of | ||
| substantial equivalence. | ||
| Clinical | ||
| Performance Data | Clinical Performance Data was not necessary for the determination of substantial | |
| equivalence. | ||
| Conclusion | These minor differences in the technological characteristics compared to the | |
| predicate do not raise different questions of safety or effectiveness. Bench | ||
| testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as | ||
| safe and effective as its predicate device. Therefore, MaxFrame AutoStrut | ||
| System is substantially equivalent to its predicate. | ||
| The purpose of this 510(k) submission is to clear the sterile version of the | ||
| MAXFRAME AUTOSTRUT Hexapod Strut only. The MAXFRAME | ||
| AUTOSTRUT Control System and Software have been cleared under K202810. |
4