(98 days)
No
The summary describes a motorized strut system with a control system and software, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on mechanical and electrical safety, software validation, and comparison to the predicate device's adjustment speed and accuracy, not on AI/ML performance metrics.
Yes
The device is indicated for various medical treatments such as fracture fixation, limb lengthening, and correction of deformities, which are all therapeutic interventions.
No
The device description and intended use indicate that AutoStrut is used for treatment (e.g., fracture fixation, limb lengthening, correction of deformities), not for diagnosing medical conditions.
No
The device description explicitly states that AutoStrut is comprised of "six length-adjustable struts powered by a motor, a control system and software," indicating the presence of hardware components beyond just software.
Based on the provided information, the AutoStrut device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- AutoStrut's Intended Use: The intended use of AutoStrut is for surgical procedures involving bone fixation, lengthening, and correction of deformities. This is a direct intervention on the body, not a test performed on a sample outside the body.
- Device Description: The device description details a mechanical system with struts, a motor, and a control system, all designed for external fixation and manipulation of bones. This aligns with a surgical device, not an IVD.
- Lack of IVD-related information: The document does not mention any testing of biological samples, analysis of bodily fluids, or any other activities typically associated with IVD devices.
Therefore, AutoStrut is a surgical device used for orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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
AutoStrut is comprised of six length-adiustable struts powered by a motor, a control system and software. The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.
The predicate MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the control box which will then automatically extend the motorized Autostruts the predetermined amount at the prespecified times.
The struts are supplied sterile via EtO.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones
Indicated Patient Age Range
adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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)
- Sterilization validation per ISO 11135
- Cytotoxicity testing per ISO 10993-5
- Software characterization and validation
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2
- Static compression, static torsion, static cantilever bending, and dynamic compression/tension testing per ASTM F1541
- Extension speed and resolution testing
Speed and accuracy tests of AutoStrut vs MAXFRAME have verified that the accuracy and speed of adjustment is similar or better than the MAXFRAME strut. The additional motors and components inside the struts add 540 gr weight to the entire fixation system. Construct testing per ASTM 1541 show that the AutoStrut performs at least as well as the MAXFRAME multi axial correction system.
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
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August 14, 2019
OrthoSpin % Janice Hogan Partner Hogan Lovells US LPP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103
Re: K191241
Trade/Device Name: AutoStrut 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: July 12, 2019 Received: July 12, 2019
Dear Janice Hogan:
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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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)
Device Name AutoStrut
Indications for Use (Describe)
AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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):
| Regulatory Use (Part 21 CFR 884 Subpart B) | |
|---|---|
| In-Vitro Diagnostic Use (21 CFR 809 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
OrthoSpin's AutoStrut
OrthoSpin, Ltd.
17 Techelet Street, Misgav, Israel Phone: 972 722607075 Facsimile: +972.72.260.7222
Contact Person: Oren Cohen
Date Prepared: May 8, 2019
Name of Device: AutoStrut
Common or Usual Name: External ring fixation system
Classification Name: Single/ multiple component metallic bone fixation appliance
Predicate Devices
K161417 DePuy Synthes MAXFRAME multi axial correction system
Reference device:
K981423 Autogenesis Automator 2000
Intended Use / Indications for Use
AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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.
4
Technological Characteristics
AutoStrut is comprised of six length-adiustable struts powered by a motor, a control system and software. The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.
The predicate MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the control box which will then automatically extend the motorized Autostruts the predetermined amount at the prespecified times.
The struts are supplied sterile via EtO.
Performance Data
- Sterilization validation per ISO 11135
- Cytotoxicity testing per ISO 10993-5 ●
- Software characterization and validation
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2
- . Static compression, static torsion, static cantilever bending, and dynamic compression/tension testing per ASTM F1541
- Extension speed and resolution testing
Substantial Equivalence
No changes, aside from replacing the struts, are being made to the predicate MAXFRAME components or its software. Similarly, the indications for the system are not being changed. Therefore, the substantial equivalence review is limited to the struts.
The most significant difference between the subject and predicate struts is that the predicate struts are adjusted manually, while the subject struts are automatically adjusted via motorized control. Motor controlled fixation systems have been previously cleared, such as the Autogenesis Automator (K981423) (reference device). Thus, replacing manual adjustment with a motorized adjustment does not raise different questions of safety or efficacy as the question remains if the clinically correct adjustment is received. As the motorized adjustment simply carries out the treatment plan generated by the same software as the predicate device, there is no change to the delivered treatment. The motorized struts of AutoStrut generate the same adjustment steps of a manual adjustment as per the MAXFRAME multi axial correction system treatment software.
Speed and accuracy tests of AutoStrut vs MAXFRAME have verified that the accuracy and speed of adjustment is similar or better than the MAXFRAME strut. The additional motors and components inside the struts add 540 gr weight to the entire fixation system. Construct testing per ASTM 1541 show that the AutoStrut performs at least as well as the MAXFRAME multi axial correction system.
Conclusions
The AutoStrut is substantially equivalent to its predicate.