(105 days)
No
The device description explicitly states that the software generates a "treatment plan" with "predetermined amount[s]" and "prespecified times," which are then automatically executed by the motorized struts. This indicates a rule-based or pre-programmed system, not one that learns or adapts using AI/ML. The "Mentions AI, DNN, or ML" section also states "Not Found".
Yes
The device is indicated for various medical treatments, including fracture fixation, limb lengthening, and correction of deformities, which are therapeutic medical interventions.
No
This device is designed for therapeutic purposes, such as fracture fixation, limb lengthening, and deformity correction, rather than for diagnosing medical conditions. It carries out a predetermined treatment plan generated by separate software.
No
The device description explicitly states that the AutoStrut G2 is comprised of a control system, software, and six length-adjustable struts powered by a motor, indicating it includes hardware components.
Based on the provided information, the AutoStrut G2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AutoStrut G2 Function: The AutoStrut G2 is a mechanical device used for external fixation and correction of bone deformities and fractures. It directly interacts with the patient's skeletal system to apply forces and adjust bone position.
- Intended Use: The intended uses listed (fracture fixation, limb lengthening, joint arthrodesis, etc.) are all surgical or orthopedic procedures performed directly on the patient's body.
- Device Description: The description details a mechanical system with struts, motors, and software for controlling the movement of these struts. There is no mention of analyzing biological specimens.
Therefore, the AutoStrut G2 falls under the category of a surgical or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AutoStrut G2 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, OSN
Device Description
The AutoStrut G2 is comprised of 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 AutoStrut G2 motorized struts.
The 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 AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.
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 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)
- Static compression, static torsion, static cantilever bending, and dynamic compression/tension testing per ASTM F1541
- Electrical safety testing per IEC 60601-1 and IEC 60601-1-11
- EMC testing per IEC 60601-1-2
- Software characterization and validation
- Sterilization validation per ISO 17665-1, ISO 17665-2, ISO 11737-1 and ISO 11737-2
- Cytotoxicity testing per ISO 10993-5
- Speed and accuracy evaluation
- Reliability, force and accuracy test
- Corrosion Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
January 6, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OrthoSpin Ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K202810
Trade/Device Name: AutoStrut G2 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: November 27, 2020 Received: November 27, 2020
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 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,
Ting Song, Ph.D., R.A.C. 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
510(k) Number (if known) K202810
Device Name
AutoStrut G2
Indications for Use (Describe)
AutoStrut G2 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)
凶 Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K202810 page 1 of 2 510(k) SUMMARY OrthoSpin's AutoStrut G2
OrthoSpin, Ltd.
13 Hayezira Street, Yokneam, Israel
Phone: +972.54.334.2651 Facsimile: +972.46886054
Contact Person: Oren Cohen
Date Prepared: January 5, 2021
Name of Device: AutoStrut G2
Common or Usual Name: External ring fixation system
Product Codes: KTT, OSN
Regulation Name: 21 CFR 888.3030 Single / multiple component metallic bone fixation appliances and accessories
Predicate Devices
K191241 AutoStrut, OrthoSpin Ltd.
Intended Use / Indications for Use
AutoStrut G2 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
The AutoStrut G2 is comprised of 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 AutoStrut G2 motorized struts.
The 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 AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.
Performance Data
· Static compression, static torsion, static cantilever bending, and dynamic compression/tension testing per ASTM F1541
- · Electrical safety testing per IEC 60601-1 and IEC 60601-1-11
- · EMC testing per IEC 60601-1-2
- Software characterization and validation
- · Sterilization validation per ISO 17665-1, ISO 17665-2, ISO 11737-1 and ISO 11737-2
- · Cytotoxicity testing per ISO 10993-5
- Speed and accuracy evaluation
- Reliability, force and accuracy test
- Corrosion Test
Substantial Equivalence
AutoStrut G2 is substantially equivalent to OrthoSpin's AutoStrut (K191241). AutoStrut G2 has the exact same indications as the AutoStrut (K191241). Furthermore, it has the same principles of operation and similar technological characteristics as the previously cleared predicate AutoStrut. The primary differences between AutoStrut G2 and AutoStrut are: the motors are assembled separately from the telescopic rods, control box modifications, addition of short strut length to existing medium and long lengths, and software modification to enable more increments per day of rod expansion. In addition, the sterilization method was changed from EtO to steam sterilization by the end user.
These minor differences in the technological characteristics compared to the predicate do not raise different questions of safety or efficacy. Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.
Conclusions
The AutoStrut G2 is substantially equivalent to its predicate.