(21 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is available within the document. It's important to note that this 510(k) summary is for a modification (addition of an instrument) to an already cleared device, so extensive clinical studies with AI components are not expected or detailed here.
This document describes a submission for a medical device (Valkyrie Thoracic Fixation System) which is a physical bone fixation system, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific criteria (such as AI assistance, standalone algorithm performance, training/test set data, expert ground truth for AI, etc.) are not applicable to this submission. The "acceptance criteria" and "study" described herein refer to non-clinical testing for the physical device components and their materials.
Acceptance Criteria and Device Performance (for the physical device, not AI)
This submission is for the addition of a "Caddy Guide Instrument" to an existing Thoracic Fixation System. The acceptance criteria primarily revolve around the safety and performance of the device materials and the new instrument.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria Met (Reported Device Performance) |
|---|---|
| Biocompatibility - Cytotoxicity | Met acceptance criteria per ISO 10993-5:2009 |
| Biocompatibility - Sensitization | Met acceptance criteria per ISO 10993-10:2010 |
| Biocompatibility - Irritation or Intracutaneous Reactivity | Met acceptance criteria per ISO 10993-10:2010 |
| Biocompatibility - Acute Systemic Toxicity | Met acceptance criteria per ISO 10993-11:2017 |
| Biocompatibility - Material-Mediated Pyrogenicity | Met acceptance criteria per ISO 10993-11:2017 |
| Design Control Activities Summary | All criteria met |
| Performance of Caddy Guide instrument | Supported by nonclinical testing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The document mentions "nonclinical tests" and "Design Control Activities Summary," which would involve material testing and instrument functionality tests. The sample sizes for these tests (e.g., number of material samples tested, number of instrument prototypes tested) are not specified.
- Data Provenance: Not specified. Standard medical device testing is typically conducted in controlled laboratory environments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not explicitly stated. For material and instrument testing, "ground truth" is typically established by engineering specifications, recognized standards (like ISO and ASTM), and validated test methodologies rather than expert human interpretation in the way it would be for an AI diagnostic device. Experts involved would be engineers and material scientists specialized in medical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used for clinical studies involving subjective human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This is not relevant for non-clinical material and mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical thoracic fixation system and associated instrument. It is not an AI-powered device, so an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: The ground truth is established by the pass/fail criteria defined in the specific ISO standards (e.g., ISO 10993-5 for cytotoxicity).
- For instrument performance: The ground truth is established by engineering specifications and performance criteria derived from risk analysis and intended use of the instrument, verified through nonclinical functional testing.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI/machine learning.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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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
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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 Devices512 4th Street, Gwinn, MI 49841http://www.ablemedicaldevices.comEstablishment Registration #3014680795 |
| Contact Person: | Wade DePas Director, Quality & Product DevelopmentAble Medical DevicesPhone: (906) 360-4670Email: WadeD@abledev.us |
| Trade or ProprietaryName: | Valkyrie™ Thoracic Fixation System |
| Common or UsualName: | 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 andaccessories (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 screwsand plates intended for use in the stabilization and fixation of fracturesin the chest wall including sternal reconstructive surgical procedures,trauma, or planned osteotomies. The system is intended for use inpatients with normal and/or poor bone quality.To accommodate varying patient anatomy and surgeon preference, theValkyrie Thoracic Fixation System includes screws in 3.0mm and3.5mm diameters and lengths from 7-20mm. The system also includesvarious styles of plates. The Valkyrie Thoracic Fixation System platesare made from PEEK-Optima™ per ASTM F2026, and the screws aremade from Ti-6Al-4V per ASTM F136. |
| Purpose ofSubmission | Obtain clearance for the following modification to the predicateK202889 Valkyrie Thoracic Fixation System: addition of Caddy GuideInstrument (Device specific Instrument). |
| Indications for Use | This Valkyrie Thoracic Fixation System is intended for use in thestabilization and fixation of fractures in the chest wall including sternalreconstructive surgical procedures, trauma, or planned osteotomies. Thesystem is intended for use in patients with normal and/or poor bonequality |
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| Summary ofTechnologicalCharacteristics | The subject Valkyrie Thoracic Fixation System has similartechnological characteristics as the predicate K202889 devices clearedfor use in closure of the sternum. Similarities to the predicate deviceinclude:Identical indications for use Identical principles of operation and fundamentaltechnology: intended to stabilize and fixate fractures of theanterior chest wall (e.g., sternal fixation) through the use ofplates 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 ofSupporting Non-Clinical Testing | The following nonclinical tests were submitted and relied upon in thispremarket notification submission for a determination of substantialequivalence. Testing identified in Design Control Activities Summaryhas all met acceptance criteria established by the associated recognizedstandards: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 DesignControl Activities Summary were met. The Valkyrie Thoracic FixationSystem is shown to be substantially equivalent to the predicate system.The subject device is as safe, as effective, as the predicate device. |
§ 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.