(87 days)
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
The devices covered by this submission include cables, beaded cables, cable sleeves, trochanteric grips, trochanteric grip plates, and mini cleat. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Dall-Miles Cable System components are manufactured from stainless steel or cobalt chromium alloy (Vitallium®) materials.
The purpose of this submission is to modify the labeling of the Dall-Miles Cable System to add MR Conditional labeling.
This document is a 510(k) premarket notification for the Dall-Miles® Cable System, focusing on adding MR Conditional labeling. It does not describe an AI/ML-driven medical device requiring human performance studies for its acceptance criteria. Therefore, most of the requested information (sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this submission.
However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet them, specifically for its MR Conditional labeling.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them for its MR Conditional labeling:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MR Conditional Labeling, based on FDA Guidance and ASTM Standards) | Reported Device Performance (Summary of Testing) |
|---|---|
| Magnetically Induced Displacement Force: Must be acceptable for patient safety in the MR environment. | Testing performed per ASTM F2052-15. (Implied acceptable performance to support MR Conditional labeling) |
| Magnetically Induced Torque: Must be acceptable for patient safety in the MR environment. | Testing performed per ASTM F2213-17. (Implied acceptable performance to support MR Conditional labeling) |
| Image Artifact: Must not produce excessive artifacts that compromise diagnostic image quality within the MR environment. | Testing performed per ASTM F2119-07 (Reapproved 2013). (Implied acceptable performance to support MR Conditional labeling) |
| Radiofrequency (RF) Induced Heating: Must not cause clinically significant heating of the implant or surrounding tissue during MR imaging within specified parameters. | Testing performed per ASTM F2182-19. (Implied acceptable performance to support MR Conditional labeling. The labeling will provide safe scanning parameters.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical 'sample size' of patients or data points in the clinical sense. Instead, the "test set" pertains to the physical Dall-Miles Cable System components themselves, tested in a laboratory setting. The typical approach for device material testing like this involves testing a sufficient number of representative samples of each device configuration to ensure robust and reproducible results according to the specified ASTM standards. The document doesn't specify the exact number of physical samples tested.
- Data Provenance: This was non-clinical laboratory testing conducted to characterize the compatibility of the device in the MR environment. The document does not specify a country of origin for the data; it would be generated in a lab setting where the physical tests are performed. It is analogous to "prospective" testing as it's specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for MR compatibility is established by adherence to recognized engineering standards (ASTM) and FDA guidance documents. These standards define the methodologies and acceptable limits for MR environments.
- Qualifications of Experts: The work is implicitly performed by engineers, physicists, and technicians with expertise in medical device testing, MR physics, and relevant ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a human reader study requiring adjudication of interpretations. The tests are objective measurements against defined standards.
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:
- MRMC Study: No. This submission does not involve an AI/ML-driven device or a human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for MR Compatibility in this context is defined by scientific principles, relevant engineering standards (ASTM), and FDA guidance documents that specify the acceptable parameters and methodologies for evaluating device behavior in an MR environment. It's essentially "physical laws and established engineering standards."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. There is no AI/ML model or training set involved.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. There is no training set involved.
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October 16, 2020
Howmedica Osteonics Corp., dba Stryker Orthopaedics Margaret Klippel Senior Principal RA Project Manager 325 Corporate Drive Mahwah, New Jersey 07430
Re: K202016
Trade/Device Name: Dall-Miles® Cable System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDO, HRS, LYT, LRN Dated: July 20, 2020 Received: July 21, 2020
Dear Margaret Klippel:
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.
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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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202016
Device Name Dall-Miles® Cable System
Indications for Use (Describe)
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
| 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
| Sponsor | Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430 |
|---|---|
| Contact Person | Margaret KlippelSenior Principal Regulatory Affairs Project ManagerStryker Orthopaedics325 Corporate DriveMahwah, NJ 07430Telephone: 201-831-5559Fax: 201-831-4559 |
| Date Prepared: | October 14, 2020 |
| Proprietary Name: | Dall-Miles® Cable System |
| Common Name: | Bone fixation accessories |
| Regulatory Class: | Class II |
| Regulation: | Single/multiple component metallic bone fixation appliances andaccessories (888.3030)Bone fixation cerclage (888.3010) |
| Product Codes: | HRS, JDQ, LYT, LRN |
Predicate Devices
Primary Predicate Device: K070170
Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926
| Product Name | Previous PremarketNotifications |
|---|---|
| Dall-Miles Stainless Steel CableDall-Miles Cable and Sleeve Set | K971741 |
| Dall-Miles Cable Sleeve | K900926 |
| Dall-Miles Trochanteric Grip (Stainless Steel) | K070170 |
| Dall-Miles Trochanteric Grip Plate (Stainless Steel) | |
| Dall-Miles Trochanteric Grip with 2 cables (CoCr) | |
| Dall-Miles Trochanteric Grip Plate with 2 cables (CoCr) |
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| Product Name | Previous PremarketNotifications |
|---|---|
| Dall-Miles CoCr Cable | K945294K961283 |
| Dall-Miles Cable Sleeve | K900926 |
| Dall-Miles Cable Grip | |
| Dall-Miles Cable and Sleeve Set | K945294K953818 |
| Dall-Miles Cable Set Cable Grip | K945294 |
| Dall-Miles Mini-Cleat | K934058 |
Device Description:
The devices covered by this submission include cables, beaded cables, cable sleeves, trochanteric grips, trochanteric grip plates, and mini cleat. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Dall-Miles Cable System components are manufactured from stainless steel or cobalt chromium alloy (Vitallium®) materials.
The purpose of this submission is to modify the labeling of the Dall-Miles Cable System to add MR Conditional labeling.
Indication for Use:
The indications for the subject components are as follows:
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Summary of Technological Characteristics: There have been no changes to the technological characteristics of the subject cable system devices as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices.
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Non-Clinical Testing:
The following non-clinical laboratory testing was performed to determine substantial equivalence:
Non-clinical testing as outlined in the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and FDA Staff", dated December 11, 2014 was conducted to characterize the compatibility of Stryker Orthopaedics Dall-Miles Cable System in the MR environment. FDA guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Guidance for Industry and FDA Staff", dated March 22, 2016 was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- Magnetically Inducted Displacement Force - performed per ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- Magnetically Induced Torque performed per ASTM F2213-17. Standard Test Method 0 for Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- . Image Artifact - performed per ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from passive Implants
- Heating by RF Fields per ASTM F2182-19. Standard Test Method for Measurement of . Radio Frequency Induced Heating near Passive Implants during MR Imaging
The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Dall-Miles Cable System components are substantially equivalent to the predicate devices identified in this premarket notification.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.