(234 days)
Not Found
No
The document describes a mechanical fixation device (screws) and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "fixation device for small bones, bone fragments, and osteotomies" and is intended for use in "fusions, fractures, or osteotomies." These uses directly address the treatment and healing of injuries and conditions, aligning with the definition of a therapeutic device.
No
Explanation: The device is described as a "fixation device for small bones, bone fragments, and osteotomies" and is intended to "provide fixation of various fractures and osteotomies while they heal." It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description explicitly states the device is manufactured from Titanium alloy and includes instruments and sterilization trays, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Acutrak and Acutrak 2 screws as fixation devices intended to be implanted in the body to stabilize bones during healing. They are used in surgical procedures.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.
Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The purpose of this Traditional 510(k) is to add the MR conditional safety information to the labeling and provide performance data for Acutrak and Acutrak 2 Screw Systems. The intended use, technological characteristics, function and operating principles and anatomical site for implantation of the devices remain unchanged. No modification has been made to the ilization, packaging, and the manufacturing processes of the currently marketed devices.
The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.
Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, bone fragments, and osteotomies, clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons with orthopedic training, sterile operating room setting.
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 testing to support MR Conditional labeling was conducted per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014, and the standards listed below:
- Magnetically induced displacement force (ASTM F2052)
- Magnetically induced torque (ASTM F2213)
- Radiofrequency (RF) induced heating (ASTM F2182)
- MR image artifact (ASTM F2119) include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
- Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment (ASTM F2503)
Performance data demonstrate that the Acutrak and Acutrak 2 screws, when used in the MR environment using specified MR parameters and instructions, are not adversely affected by magnetically induced displacement force and frequency (RF) heating, and image artifacts.
Mechanical performance testing (Torsional Yield Strength, Insertion Torque, and Axial Pullout Force) was conducted on the subject screws per ASTM F543-17 (Standard Specification and Testing Methods for Metallic Medical Bone Screws passed acceptance criteria and demonstrated substantially equivalent mechanical performance to their corresponding predicate screws.
Clinical testing was not necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K930834, K944330, K110658, K123890, K163303, K202680
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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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December 29, 2022
Acumed LLC Saleh Amirriyazi Regulatory Affairs Specialist 5885 NE Cornelius Pass Rd. Hillsboro, Oregon 97124
Re: K221333
Trade/Device Name: Acumed Acutrak System, Acumed Acturak 2 System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 5, 2022 Received: May 9, 2022
Dear Saleh Amirriyazi:
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 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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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
Submission Number (if known)
Device Name
Acumed Acutrak System Acumed Acturak 2 System
Indications for Use (Describe)
Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.
Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
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| K221333 (Page 1 of 2) | 510(k) Summary | Prepared on: 2022-12-28 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Acumed LLC | |||
| Applicant Address | 5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States | |||
| Applicant Contact Telephone | 925-353-7073 | |||
| Applicant Contact | Mr. Saleh Amirriyazi | |||
| Applicant Contact Email | saleh.Amirriyazi@acumed.net | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Acumed Acutrak System | |||
| Acumed Acturak 2 System | ||||
| Common Name | Smooth or threaded metallic bone fixation fastener | |||
| Classification Name | Screw, Fixation, Bone | |||
| Regulation Number | 888.3040 | |||
| Product Code | HWC | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K930834 | Acutrak Fixation System | HWC | ||
| K944330 | Acutrak Plus Fixation System | HWC | ||
| K110658 | APTUS Cannulated Compression Screws | HWC | ||
| K123890 | Acumed Cannulated Screw System | HWC | ||
| K163303 | OsteoMed ExtremiFix Mid and Large Screw System | HWC | ||
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | HWC | ||
| Device Description Summary | ||||
| 21 CFR 807.92(a)(4) |
Device Description Summary
The purpose of this Traditional 510(k) is to add the MR conditional safety information to the labeling and provide performance data for Acutrak and Acutrak 2 Screw Systems. The intended use, technological characteristics, function and operating principles and anatomical site for implantation of the devices remain unchanged. No modification has been made to the ilization, packaging, and the manufacturing processes of the currently marketed devices.
The Acutrak and Acutrak 2 Screw Systems - MR Conditional (subject devices) are being compared to the existing on market Acutrak and Acutrak 2 Screw Systems (predicate devices). Mechanical performance of Acutrak 2 screws were compared to other comparable on market screws (other predicates).
The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These
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K221333 (Page 2 of 2)
systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.
Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.
Intended Use/Indications for Use
Acutrak Fusion, Standard and Mini, Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not interference or soft tissue fixation.
Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, or osteotomies of the clavice, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Indications for Use Comparison
The subject devices, Acutrak and Acutrak 2 Screw Systems, have the same indications for use as their corresponding predicate devices. The basis of substantial equivalence for the similarities in intended use, material, technology, operating principle, anatomical site for implantation, performance and design.
Technological Comparison
The technological characteristics, operating principles and anatomical site for implantation of the subject devices remain unchanged. Both subject and predicate devices are bone screws intended for fracture fixation of bones appropriate for their sizes. The subject and predicate screws achieve their intended use through a variety of diameters and lengths of screw size offerings.
No modification has been made to the device material, sterilization, packaging, and the manufacturing processes of the currently marketed devices.
While some differences exist in the basic shape, design and technology; however, the performance evaluation demonstrates that the subject screws are equivalent to their predicate screws.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical testing to support MR Conditional labeling was conducted per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014, and the standards listed below:
- · Magnetically induced displacement force (ASTM F2052)
- · Magnetically induced torque (ASTM F2213)
- · Radiofrequency (RF) induced heating (ASTM F2182)
- MR image artifact (ASTM F2119) include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.
- Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment (ASTM F2503)
Performance data demonstrate that the Acutrak and Acutrak 2 screws, when used in the MR environment using specified MR parameters and instructions, are not adversely affected by magnetically induced displacement force and frequency (RF) heating, and image artifacts.
Mechanical performance testing (Torsional Yield Strength, Insertion Torque, and Axial Pullout Force) was conducted on the subject screws per ASTM F543-17 (Standard Specification and Testing Methods for Metallic Medical Bone Screws passed acceptance criteria and demonstrated substantially equivalent mechanical performance to their corresponding predicate screws.
Clinical testing was not necessary.
Based on the results of the nonclinical testing described above, it was concluded that the subject and predicate devices are substantially equivalent in performance specifically for the intended use, hence the subject devices were proven to be safe and effective for the indications.