(112 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of screws and plates for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as a "Thoracic Fixation System" that consists of screws and plates intended for the stabilization and fixation of fractures in the chest wall. This function directly aims to treat and improve a medical condition, qualifying it as a therapeutic device.
No
The Valkyrie Thoracic Fixation System is described as a system of screws and plates used for stabilization and fixation of fractures in the chest wall, which indicates it is a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly states it consists of "a variety of screws and plates" made from PEEK and Ti-6Al-4V, which are physical hardware components. The performance studies also detail testing on these physical components (displacement force, torque, image artifact, heating, torsional strength, axial pullout strength, driving torque).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the stabilization of fractures in the chest wall, including sternal procedures. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of screws and plates made from materials like PEEK and Ti-6Al-4V, designed for physical fixation within the body.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Valkyrie Thoracic Fixation System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in diameters from 2.5mm to 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall, sternal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To support the inclusion of MR Conditional labeling, the following tests were completed:
Magnetically induced displacement force per ASTM F2052
Magnetically induced torque per ASTM F2213
MR Image artifact per ASTM F2119
Radio frequency induced heating per ASTM F2182
To support the inclusion of additional screw sizes, the following tests were completed:
Screw torsional strength testing per ASTM F543
Screw axial pullout strength testing per ASTM F543
Screw driving torque testing per ASTM F543
All testing has met the documented acceptance criteria.
Clinical testing was not necessary for the determination of substantial equivalence.
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.
K202889 Valkyrie Thoracic Fixation System, K221412 JEIL Medical ARIX Rib System
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
§ 888.3030 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
December 8, 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 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.
JM Longyear Manufacturing, LLC d/b/a Able Medical Devices Katie Barron Project Manager 512 4th Street Gwinn, Michigan 49841
Re: K232515
Trade/Device Name: Valkyrie Thoracic Fixation 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: August 18, 2023 Received: August 18, 2023
Dear Katie Barron:
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) K232515
Device Name Valkyrie Thoracic Fixation System
Indications for Use (Describe)
The Valkyrie Thoracic Fixation System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
| 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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3
K232515 510(k) Summary
| Date Prepared: | August 18, 2023 |
|---|---|
| 510(k) Owner / | |
| Manufacturer: | JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
| 512 4th Street | |
| Gwinn, MI 49841 | |
| Contact Person: | Katie Barron |
| Able Medical Devices | |
| Phone: (906) 372-3213 | |
| Email: KatieB@abledev.us | |
| Trade or Proprietary | |
| Name: | Valkyrie Thoracic Fixation System |
| Common or Usual | |
| Name: | Bone Plate |
| Classification: | Class II per 21 CFR §888.3030 (primary) and 21 CFR §888.3040 |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and accessories |
| (primary); Screw, Fixation, Bone | |
| Product Code: | HRS (primary), HWC |
| Classification Panel: | Panel Code 87: Orthopedics |
| Primary Predicate | K202889 Valkyrie Thoracic Fixation System |
| Additional Predicate | K221412 JEIL Medical ARIX Rib System |
| Description | The Valkyrie Thoracic Fixation System consists of a variety of screws and plates |
| intended for use in the stabilization and fixation of fractures in the chest wall | |
| including sternal reconstructive surgical procedures, trauma, or planned | |
| osteotomies. The system is intended for use in patients with normal and/or poor | |
| bone quality. |
To accommodate varying patient anatomy and surgeon preference, the Valkyrie
Thoracic Fixation System includes screws in diameters from 2.5mm to 3.5mm
diameters and lengths from 7-20mm. The system also includes various styles of
plates. The Valkyrie Thoracic Fixation System plates are made from PEEK per
ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136. |
| Indications for Use | The Valkyrie Thoracic Fixation System is indicated for use in the stabilization and
fixation of fractures in the chest wall including sternal reconstructive surgical
procedures, trauma, or planned osteotomies. The system is intended for use in
patients with normal and/or poor bone quality |
4
| Summary of | The subject Valkyrie Thoracic Fixation System has nearly identical technological | ||||
|---|---|---|---|---|---|
| Technological | characteristics as the primary predicate device cleared for use in stabilization and | ||||
| Characteristics | fixation of fractures in the chest wall. Similarities to the predicate device include: | ||||
| Identical indications for use while clarifying the term "indicated for" | |||||
| Identical principles of operation and fundamental technology: intended | |||||
| to stabilize and fixate fractures of the anterior chest wall through the | |||||
| use of plates and screws | |||||
| Identical implant materials and manufacturing processes | |||||
| ● | |||||
| ● | Identical sterilization processes | ||||
| Able Medical Devices | |||||
| Valkyrie Thoracic Fixation | PRIMARY PREDICATE: | ||||
| Able Medical Devices | |||||
| System | Valkyrie Thoracic Fixation | ||||
| (Subject Device) | System | ||||
| (K202889, K211695) | |||||
| The Valkyrie Thoracic | The Valkyrie Thoracic | ||||
| Fixation System is indicated | Fixation System is intended | ||||
| for use in the stabilization and | for use in the stabilization and | ||||
| fixation of fractures in the | fixation of fractures in the | ||||
| chest wall including sternal | chest wall including sternal | ||||
| Indications for Use: | reconstructive surgical | reconstructive surgical | |||
| procedures, trauma, or | procedures, trauma, or | ||||
| planned osteotomies. The | planned osteotomies. The | ||||
| system is intended for use in | system is intended for use in | ||||
| patients with normal and/or | patients with normal and/or | ||||
| poor bone quality. | poor bone quality. | ||||
| Sterility: | Provided Sterile | Provided Sterile | |||
| Rib Plate | Rib Plate, V-Plate, Box Plate, | ||||
| Configurations: | X-Plate, M-Plate, T-Plate, | ||||
| Plate | Ladder Plate | ||||
| Features: | # Screw Holes: | 8 to 16 | 4 to 16 | ||
| Material: | PEEK per ASTM F2026 | PEEK per ASTM F2026 | |||
| Screw | Diameter: | Ø2.5mm, Ø2.8mm | Ø3.0mm, Ø3.5mm | ||
| Features: | Length: | 7mm – 15mm | 7mm - 20mm | ||
| Material: | Ti-6Al-4V per ASTM F136 | Ti-6Al-4V per ASTM F136 | |||
| The differences of the subject devices as compared to the primary predicate | |||||
| device are as follows: | |||||
| Updated labeling to include MR conditional | |||||
| ● | |||||
| Inclusion of additional plate and screw sizes | |||||
| O | Additional predicate K212412 is included to leverage the | ||||
| technological characteristics of the smaller screw sizes | |||||
5
| Discussion of
Supporting Non-
Clinical Testing | To support the inclusion of MR Conditional labeling, the following tests were
completed:
Magnetically induced displacement force per ASTM F2052 Magnetically induced torque per ASTM F2213 MR Image artifact per ASTM F2119 Radio frequency induced heating per ASTM F2182 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | To support the inclusion of additional screw sizes, the following tests were
completed:
Screw torsional strength testing per ASTM F543 Screw axial pullout strength testing per ASTM F543 Screw driving torque testing per ASTM F543 |
| | All testing has met the documented acceptance criteria. |
| Clinical Performance
Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
Equivalence | The subject device is substantially equivalent to the Valkyrie Thoracic Fixation
System (K202889) in terms of material composition, manufacturing process,
sterilization, and packaging and both are manufactured in the same facility. |
| | The subject device and the predicate device have the same intended uses, the
same product classification and produce code and have identical Indications for
Use statements. The subject device and the predicate incorporate the same basic
design, same materials, have identical manufacturing processes, and are both
provided sterile for single-patient and single-use. |
| Conclusion | The overall technological similarities to the predicate and non-clinical performance
data lead to the conclusion that the Valkyrie Thoracic Fixation System is
substantially equivalent to the predicate system. The devices are determined to be
MR Conditional based on the results of testing completed. |