(155 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the fixation system components (screws and plates), with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Thoracic Fixation System" intended for "stabilization and fixation of fractures in the chest wall," which directly addresses a medical condition (fractures) and is used to restore normal function or structure (fixation), aligning with the definition of a therapeutic device.
No
The device is described as a "Thoracic Fixation System" consisting of screws and plates for stabilizing and fixing fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of "a variety of screws and plates" made from materials like PEEK-Optima and Ti-6Al-4V, which are physical hardware components.
Based on the provided information, the Valkyrie Thoracic Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Valkyrie Thoracic Fixation System is a surgical implant used to physically stabilize and fix fractures in the chest wall. It is a medical device used in vivo (within the body) for structural support and repair.
The description clearly indicates its purpose is mechanical fixation of bone, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The 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.
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 (including sternum/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
The Valkyrie Thoracic Fixation System has been tested in the following test modes:
- Static construct tension
- Dynamic construct tension
- Biocompatibility
- Cytotoxicity (ISO 10993-5:2009)
- Systemic toxicity (ISO 10993-11:2017)
- Genotoxicity (ISO 10993-3:2014)
- Intracutaneous irritation (ISO 10993-10:2010)
- Pyrogenicity (ISO 10993-11:2017)
- Sensitization (ISO 10993-10:2010)
- Chemical characterization (ISO 10993-18:2020)
- Sterilization validation (ISO 11137-1:2006)
- Packaging Shelf-life (ASTM 1980)
- Packing Peel Strength (ASTM F88)
- Packaging integrity validation (ASTM F1886, ASTM F1929, ASTM F2096)
The results of this non-clinical testing show that the Valkyrie Thoracic Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K163007, K151019, K121302, K110574
Reference Device(s)
K193468, K133785, K151983, K170767
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
March 2, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K202889
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 Dated: January 25, 2021 Received: January 26, 2021
Dear Nathan Wright:
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,
For; 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number ( if known )
K202889 | |
| Device Name | |
| Valkyrie Thoracic Fixation System | |
| Indications for Use ( Describe ) | |
The 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.
| 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.
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FORM FDA 3881 (7/17)
3
510(K) SUMMARY - K202889
| Submitter's Name: | Able Medical Devices |
|---|---|
| Submitter's Address: | 512 4th Street |
| Gwinn, MI 49841 | |
| Submitter's Telephone: | 906-372-3213 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | September 25, 2020 |
| 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: | Orthopedics |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
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.
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.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
4
- Indications for Use ●
- Materials of manufacture ●
- Structural support mechanism ●
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K163007, K151019, | |||
| K121302, K110574 | Biomet Microfixation | ||
| Sternalock 360 Sternal | |||
| Closure System | Biomet Microfixation | Primary | |
| K193468, K133785 | Tritium Sternal Cable Plate | ||
| System | Pioneer Surgical | ||
| Technology, Inc. | Additional | ||
| K151983 | KLS Martin LSS Plating | ||
| System | KLS Martin L.P. | Additional | |
| K170767 | Stainless Steel Suture | Ethicon Incorporated | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Valkyrie Thoracic Fixation System has been tested in the following test modes:
- Static construct tension ●
- Dynamic construct tension
- Biocompatibility ●
- Cytotoxicity (ISO 10993-5:2009) o
- Systemic toxicity (ISO 10993-11:2017) o
- Genotoxicity (ISO 10993-3:2014) O
- Intracutaneous irritation (ISO 10993-10:2010) O
- Pyrogenicity (ISO 10993-11:2017) o
- Sensitization (ISO 10993-10:2010) o
- o Chemical characterization (ISO 10993-18:2020)
- Sterilization validation (ISO 11137-1:2006) .
- Packaging Shelf-life (ASTM 1980) .
- Packing Peel Strength (ASTM F88)
- Packaging integrity validation (ASTM F1886, ASTM F1929, ASTM F2096) .
The results of this non-clinical testing show that the Valkyrie Thoracic Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Valkyrie Thoracic Fixation System is substantially equivalent to the predicate device.