(21 days)
Not Found
No
The device description focuses on the physical components (screws and plates) and materials used for surgical fixation, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "stabilization and fixation" system for fractures in the chest wall, which points to a therapeutic function.
No
Explanation: The device is described as a "Thoracic Fixation System" intended for stabilizing fractures, indicating a therapeutic or reconstructive purpose rather than a diagnostic one. It does not mention analyzing data, identifying conditions, or providing information for diagnosis.
No
The device description explicitly states it consists of "a variety of screws and plates" made from PEEK-Optima and Ti-6Al-4V, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description: The Valkyrie Thoracic Fixation System is described as a system of screws and plates intended for the stabilization and fixation of fractures in the chest wall. This is a surgical implant used within the body to physically support and repair bone.
- Intended Use: The intended use clearly states its purpose is for "stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies." This is a structural and mechanical function, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Valkyrie Thoracic Fixation System is intended 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
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 3.0mm and 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-Optima 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)
The following nonclinical tests were submitted and relied upon in this premarket notification submission for a determination of substantial equivalence. Testing identified in Design Control Activities Summary has all met acceptance criteria established by the associated recognized standards: Biocompatibility Cytotoxicity (ISO 10993-5:2009) Sensitization (ISO 10993-10:2010) Irritation or Intracutaneous Reactivity (ISO 10993-10:2010) Acute Systemic toxicity (ISO 10993-11:2017) Material-Mediated Pyrogenicity (ISO 10993-11:2017). The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K202889 Valkyrie Thoracic Fixation System
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
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June 23, 2021
JM Longyear Manufacturing, LLC d/b/a Able Medical Devices Wade Depas Director, Quality & Product Development 512 4th Street Gwinn, Michigan 49841
Re: K211695
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: June 2, 2021 Received: June 2, 2021
Dear Wade Depas:
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
1
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 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 medical devices and radiation-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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211695
Device Name Valkyrie Thoracic Fixation System
Indications for Use (Describe)
The Valkyrie Thoracic Fixation System is intended 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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510(k) SUMMARY
| Date Prepared: | June 2nd, 2021 |
|---|---|
| 510(k) Owner / | |
| Manufacturer: | JM Longyear Manufacturing, LLC d/b/a Able Medical Devices |
| 512 4th Street, Gwinn, MI 49841 | |
| http://www.ablemedicaldevices.com | |
| Establishment Registration #3014680795 | |
| Contact Person: | Wade DePas Director, Quality & Product Development |
| Able Medical Devices | |
| Phone: (906) 360-4670 | |
| Email: WadeD@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 |
| 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 3.0mm and | |
| 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-Optima™ per ASTM F2026, and the screws are | |
| made from Ti-6Al-4V per ASTM F136. | |
| Purpose of | |
| Submission | Obtain clearance for the following modification to the predicate |
| K202889 Valkyrie Thoracic Fixation System: addition of Caddy Guide | |
| Instrument (Device specific Instrument). | |
| Indications for Use | This Valkyrie Thoracic Fixation System is 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 |
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| Summary of
Technological
Characteristics | The subject Valkyrie Thoracic Fixation System has similar
technological characteristics as the predicate K202889 devices cleared
for use in closure of the sternum. Similarities to the predicate device
include:
Identical indications for use Identical principles of operation and fundamental
technology: intended to stabilize and fixate fractures of the
anterior chest wall (e.g., sternal fixation) through the use of
plates and screws. Identical sterilization/cleaning Identical packaging/expiration dating Identical implant components The addition of the Caddy Guide instrument is supported by nonclinical testing listed below. |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion of
Supporting Non-
Clinical Testing | The following nonclinical tests were submitted and relied upon in this
premarket notification submission for a determination of substantial
equivalence. Testing identified in Design Control Activities Summary
has all met acceptance criteria established by the associated recognized
standards:
Biocompatibility Cytotoxicity (ISO 10993-5:2009) Sensitization (ISO 10993-10:2010) Irritation or Intracutaneous Reactivity (ISO 10993-10:2010) Acute Systemic toxicity (ISO 10993-11:2017) Material-Mediated Pyrogenicity (ISO 10993-11:2017) |
| Conclusion | The results demonstrate that the acceptance criteria defined in the Design
Control Activities Summary were met. The Valkyrie Thoracic Fixation
System is shown to be substantially equivalent to the predicate system.
The subject device is as safe, as effective, as the predicate device. |