(84 days)
No
The device description and performance testing focus solely on the mechanical properties and physical design of the screws and instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is a system of screws and instruments for fracture repair and fixation, not a therapeutic device in itself designed to provide treatment or therapy. It is used in surgical procedures that facilitate healing, but the screws themselves are mechanical aids.
No
This device is a surgical implant (screws) used for bone reconstruction, fracture repair, and other orthopedic procedures, not for diagnosis.
No
The device description clearly states it is a set of screws and instruments made of Titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones." These are all surgical procedures performed directly on the patient's body.
- Device Description: The description details a system of screws and instruments used for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.
Product codes
HWC
Device Description
Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.
Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides 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.
The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.
Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also 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
bones appropriate for the size of the device
Indicated Patient Age Range
Not Found
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
Non-Clinical testing to support performance was conducted per FDA's Guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, December 11, 2020, and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment- Guidance for Industry and Food and Drug Administration Staff, May 20, 2021.
Safety and Performance evaluation conducted for the subject devices:
- Torsional Yield Strength (ASTM F543 Annex A1)
- Driving Torque (ASTM F543 Annex 2)
- Axial Pullout Force (ASTM F543 Annex 3)
- Self-Tapping Performance (ASTM F543-17 Annex 4)
- Sterilization (ISO 17665-1)
- Sterilization (ISO 11137-1)
- Packaging (ISO 11607-1)
- Biocompatibility (ISO 10993-1)
- Screw Lifetime Verification Testing
- Self-Drilling Verification Testing
- Magnetically Induced Displacement Force (ASTM F2052)
- Magnetically Induced Torque (ASTM F2213)
- MR Image Artifact (ASTM F2119)
- MRI Safety Labelling (ASTM F2503)
Performance data demonstrate that the Acutrak 3 Headless Compression Screws are equivalent to the designated predicate devices when used as intended.
Clinical testing was not necessary.
Based on the results of the non-clinical testing described above, it was concluded that the subject and predicate devices are substantially equivalent when used as intended. Therefore, the subject devices were proven to be safe and effective for the indications.
Key Metrics
Not Found
Predicate Device(s)
K202680, K163303, K063298, K110658
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 9, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
Acumed LLC Phillip Saddik Regulatory Affairs Specialist 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124
Re: K230744
Trade/Device Name: Acumed Acutrak 3 Headless Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 15, 2023 Received: March 17, 2023
Dear Mr. Phillip Saddik:
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,
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
2
Indications for Use
510(k) Number (if known) K230744
Device Name Acutrak 3 Headless Compression Screws
Indications for Use (Describe)
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K230744
Date prepared: May 16th 2023
l. Contact Details
Applicant Name: Acumed LLC Applicant Address: 5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States Applicant Contact Name: Mr. Philip Saddik Applicant Telephone: 917-586-5641 Applicant Contact Email: Philip.saddik@acumed.net
II. Device Name
Device Trade Name: Acumed Acutrak 3 Headless Compression Screw System Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Requlation Number: 21 CFR 888.3040 Product Code: HWC
lll. Leqally Marketed Primary Predicate Devices
Primary Predicate Device: OsteoMed ExtremiFix Mini & Small Cannulated Screws Screw System K202680 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040
Product Code: HWC
Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K163303 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC
Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K063298 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC
Predicate Device: Medartis Aptus SpeedTip Cannulated Compression Screw System, K110658 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC
Reference Device: Acumed Acutrak/Acutrak 2 System, K221333 Common Name: Screw. Fixation. Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC
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IV. Device Description Summary
Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.
Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides 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.
The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.
Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.
V. Intended Use/ Indications for Use
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screws are not intended for interference or soft tissue fixation.
VI. Indications for Use Comparison
The subject devices, Acutrak 3 Headless Compression Screws, have the same indications for use as the predicate devices.
Technological Comparison VII.
The technological characteristics, operating principles and anatomical site for implantation of the subject device is identical to the predicates.
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 the use of variety of sizes, in terms of diameters and lengths.
While some differences exist in the basic shape and design of the performance evaluation demonstrates that the subject devices are equivalent to the predicate devices.
5
VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions
Non-Clinical testing to support performance was conducted per FDA's Guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, December 11, 2020, and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment- Guidance for Industry and Food and Drug Administration Staff, May 20, 2021.
Safety and Performance evaluation conducted for the subject devices:
- Torsional Yield Strength (ASTM F543 Annex A1) ●
- . Driving Torque (ASTM F543 Annex 2)
- Axial Pullout Force (ASTM F543 Annex 3) ●
- Self-Tapping Performance (ASTM F543-17 Annex 4) .
- Sterilization (ISO 17665-1)
- Sterilization (ISO 11137-1) ●
- . Packaging (ISO 11607-1)
- . Biocompatibility (ISO 10993-1)
- . Screw Lifetime Verification Testing
- Self-Drilling Verification Testing
- Magnetically Induced Displacement Force (ASTM F2052) ●
- Magnetically Induced Torque (ASTM F2213)
- . MR Image Artifact (ASTM F2119)
- MRI Safety Labelling (ASTM F2503) ●
Performance data demonstrate that the Acutrak 3 Headless Compression Screws are equivalent to the designated predicate devices when used as intended.
Clinical testing was not necessary.
Based on the results of the non-clinical testing described above, it was concluded that the subject and predicate devices are substantially equivalent when used as intended. Therefore, the subject devices were proven to be safe and effective for the indications.