(206 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of bone plates and screws, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device provides fixation for fractures, fusions, or osteotomies, which is a structural support function rather than a therapeutic treatment.
No
The device is described as a system of plates, screws, and instruments intended for fixation of fractures, fusions, or osteotomies of the distal radius and ulna, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a set of plates, screws, and instruments, which are physical hardware components used for surgical fixation. The performance studies also focus on the mechanical properties and biocompatibility of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation for fractures, fusions, or osteotomies of the distal radius and ulna." This describes a surgical procedure to stabilize bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as a "set of plates, screws and instruments." These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on mechanical properties (strength, torque, pullout force), sterilization, packaging, biocompatibility, and MRI compatibility. These are relevant to surgical implants, not diagnostic tests.
In summary, the Acumed Wrist Plating System is a surgical device used for bone fixation, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.
Product codes
HRS, HWC
Device Description
Acumed Wrist Plating System is a set of plates, 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 Congruent Bone Plate Systems, per K012655, K120903 and K102998.
Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile.
The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only.
Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-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
distal radius and ulna
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 Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, April 11, 2022
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
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:
- Safety and Performance evaluation conducted for the subject devices (ASTM F382-17)
- 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 demonstrates that the Acumed Wrist Plating System plates and 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.
Key Metrics
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
April 22, 2024
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Acumed LLC Anusha Gedala Regulatory Affairs Specialist 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124
Re: K233311
Trade/Device Name: Acumed Wrist Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 19, 2024 Received: March 20, 2024
Dear Anusha Gedala:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, MPH 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
2
Indications for Use
510(k) Number (if known)
Device Name Acumed Wrist Plating System
Indications for Use (Describe)
Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.
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)
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
Image /page/3/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in black on the right. The plus sign is made up of two intersecting rectangles. The word "acumed" is in a sans-serif font. There is a registered trademark symbol to the upper right of the word "acumed".
510(k) Summary
Date prepared: April 15, 2024
l. Contact Details
Applicant Name: Acumed LLC Applicant Address: 5885 NE Cornelius Pass Rd. Hillsboro OR 97124 United States Applicant Contact Name: Ms. Anusha Gedala Applicant Telephone: 503-207-1638 Applicant Contact Email: anusha.gedala@acumed.net
II. Device Name
Device Trade Name: Acumed Wrist Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3030 21 CFR 888.3040
Product Code: HRS, HWC
III. Legally Marketed Primary Predicate Devices
Primary Predicate Device: Congruent Bone Plate System, K012655 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HRS
Predicate Device: Congruent Bone Plate System - Acu-Loc 2 Plate, K120903 / K102998 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3030 21 CFR 888.3040
Product Code: HRS, HWC
Reference Device: Acumed Hand Plating System, K132769 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030
4
Image /page/4/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in dark gray on the right. The plus sign is made up of two intersecting rectangles. There is a registered trademark symbol next to the "d" in "acumed".
Product Code: HRS, HWC
Reference Device: Frag-Loc System, K130986 Common Name: Washer, Bolt, Nut Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HTN, HWC
IV. Device Description Summary
Acumed Wrist Plating System is a set of plates, 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 Congruent Bone Plate Systems, per K012655, K120903 and K102998.
Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile.
The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only.
Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-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
The Acumed Wrist Plating System provides fixation for fractures, fusions, of the distal radius and ulna.
VI. Indications for Use Comparison
The subject device system, Acumed Wrist Plating System includications for use of the primary predicate device, Congruent Bone Plate System (K012665).
VII. Technological Comparison
The operating principles and anatomical site for implantation of the subject device are identical to the predicate devices. Both subject and predicate devices are bone plates and screws intended to provide fixation for fractures, fusions and osteotomies. There are some differences in basic shape, design, and size between the subject and predicate.
5
Image /page/5/Picture/0 description: The image shows the Acumed logo. The logo consists of a blue plus sign on the left and the word "acumed" in black on the right. There is a registered trademark symbol next to the "d" in "acumed."
Non-Clinical and/or Clinical Tests Summary & Conclusions VIII.
Non-Clinical testing to support performance was conducted per FDA's Guidance:
Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff, April 11, 2022
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
Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment- Guidance for Industry and Food and Drug Administration Staff, May 20, 2021.
Safety and Performance evaluation conducted for the subject devices:
- Safety and Performance evaluation conducted for the subject devices (ASTM F382-17) ●
- 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 demonstrates that the Acumed Wrist Plating System plates and 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.