(18 days)
The Drive Rail System is intended to be used on adult or pediatric patients in the treatment of conditions of the long bones of the arms and legs including limb lengthening, acute or gradual multiplanar correction of long bone deformities, fractures and diseases which generally may result in joint contractures or loss of range of motion, fractures requiring distraction, open or closed fractures, non- unions, and infected fractures or non-unions.
The Drive Rail System is a unilateral external fixation system that consists of various components used in the management of lower extremity bone fractures and reconstructive, as well as corrective, orthopedic surgery. The system consists of 316LVM stainless steel half pins along with frame components including rail segments, pin clamps, distraction/compression devices and associated accessories made from aluminum and stainless-steel materials. These components should be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided nonsterile.
The worm gear component in the Drive Rail System is made of 17-4 stainless steel, which is ferromagnetic. Since the worm gear component is magnetic and is within each external rail construct, the Drive Rail System is MR unsafe.
Here's a summary of the acceptance criteria and study information based on the provided text:
Executive Summary:
The provided document describes a Special 510(k) submission (K220809) for the OrthoPediatrics Drive Rail System. The primary purpose of this submission is to change the device's labeling regarding its Magnetic Resonance (MR) safety status from "Safety in MR environment not evaluated" to "MR Unsafe." This change is based on a determination that a component within the Drive Rail System (the worm gear) is made of ferromagnetic material. No new performance data was generated or required to support this labeling change, as per FDA guidance for MR unsafe labeling. Therefore, traditional acceptance criteria related to a device's functional performance are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Related to MR Safety Labeling) | Reported Device Performance |
|---|---|
| Presence of ferromagnetic materials: The device contains one or more ferromagnetic materials. | Confirmed: The worm gear component in the Drive Rail System is made of 17-4 stainless steel, which is ferromagnetic. |
| MR Safety Status: Labeling states that the device is "MR Unsafe." | Proposed: The proposed labeling for the subject device is "The Drive Rail System is MR Unsafe." |
| Compliance with FDA Guidance: The determination to label as "MR Unsafe" is in accordance with FDA guidance for medical devices in the MR environment. | Confirmed: The submission explicitly references FDA guidance documents ("Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and "The Special 510(k) Program") to support that no performance data is needed for "MR Unsafe" labeling based on scientific rationale of ferromagnetic materials. |
2. Sample Size Used for the Test Set and Data Provenance:
No explicit test set with a sample size was used for this FDA submission as it was a Special 510(k) focused on a labeling change based on material composition.
- Test Set Sample Size: Not applicable. The change is based on a review of device design specifications and material composition.
- Data Provenance: The determination of ferromagnetic material was based on the "OrthoPediatrics Corp reviewed drawings and conducted test to determine of component in the system contains ferromagnetic materials and is magnetic." This implies internal material specification data and potentially simple magnetic testing. No external "data provenance" like country of origin or retrospective/prospective study is relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. Ground truth for a test set is not relevant here as no traditional performance study was conducted. The determination was based on the material properties of the worm gear component. The implicit "experts" would be the engineers responsible for material selection and design at OrthoPediatrics Corp.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication was utilized for this specific submission.
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:
Not applicable. This submission is for a physical medical device (an external fixation system) and not for an AI/software device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the material composition of the device's worm gear, which was identified as 17-4 stainless steel, a known ferromagnetic material. This was established through design review and material testing by the manufacturer (OrthoPediatrics Corp.).
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set.
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April 8, 2022
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.
OrthoPediatrics Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K220809
Trade/Device Name: Drive Rail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: March 18, 2022 Received: March 21, 2022
Dear Yan Li:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K220809
Device Name Drive Rail System
Indications for Use (Describe)
The Drive Rail System is intended to be used on adult or pediatric patients in the treatment of conditions of the long bones of the arms and legs including limb lengthening, acute or gradual multiplanar correction of long bone deformities, fractures and diseases which generally may result in joint contractures or loss of range of motion, fractures requiring distraction, open or closed fractures, non- unions, and infected fractures or non-unions.
| 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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OrthoPediatrics, Corp. Drive Rail System Special 510(k)
Image /page/3/Picture/3 description: The image shows the logo for OrthoPediatrics. The logo is made up of a cartoon drawing of a child's face and body, with the word "Ortho" written in blue above the child's head. The word "Pediatrics" is written in red to the right of the child's head. The logo is simple and colorful, and it is likely intended to appeal to children and their parents.
3.0 510(k) Summary
I. Submitter
| Submission: | Special 510(k) Premarket Notification |
|---|---|
| Applicant: | OrthoPediatrics Corp. |
| Applicant Address: | 2850 Frontier Drive, Warsaw, IN 46582 |
| Establishment Registration Number: | 3006460162 |
| Contact: | Yan Li |
| Contact Phone: | (574) 267-0864 |
| Date Prepared: | March 18, 2022 |
II. Device
| Device Trade Name: | Drive Rail System |
|---|---|
| Regulation Number: | 21 CFR 888.3030 |
| Product Code and Common Name: | KTT: Appliance, Fixation, Nail/Blade/PlateCombination, Multiple ComponentJDW: Pin, Fixation, Threaded |
| Device Classification: | II |
| Classification Panel: | Orthopedic |
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices:
Predicate: Drive Rail System, K140822, OrthoPediatrics Corp.
Note: K140822 was submitted by Devise Ortho Inc. in 2014, however, Devise Ortho Inc. was purchased by OrthoPediatrics Corp on April 20, 2021. OrthoPediatrics is the owner of K 140822 and the manufacturer of the Drive Rail System.
IV. Device Description
The Drive Rail System is a unilateral external fixation system that consists of various components used in the management of lower extremity bone fractures and reconstructive, as well as corrective, orthopedic surgery. The system consists of 316LVM stainless steel half pins along with frame components including rail segments, pin clamps, distraction/compression
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OrthoPediatrics, Corp. Drive Rail System Special 510(k)
Image /page/4/Picture/1 description: The image shows the text "K220809 - Page 2 of 3" at the top, followed by a logo for OrthoPediatrics. The logo features a stick figure with a smiley face and the company name in a stylized font. The stick figure is drawn in blue and green, while the company name is in blue and red.
devices and associated accessories made from aluminum and stainless-steel materials. These components should be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided nonsterile.
The worm gear component in the Drive Rail System is made of 17-4 stainless steel, which is ferromagnetic. Since the worm gear component is magnetic and is within each external rail construct, the Drive Rail System is MR unsafe.
V. Indications for Use
The Drive Rail System is intended to be used on adult or pediatric patients in the treatment of conditions of the long bones of the arms and legs including limb lengthening, acute or gradual multiplanar correction of long bone deformities, fractures and diseases which generally may result in joint contractures or loss of range of motion, fractures requiring distraction, open or closed fractures, non-unions, and infected fractures or non-unions.
VI. Comparison of Technological Characteristics
The OrthoPediatrics Drive Rail System and predicate devices share identical indications for use, device classification, product code. They are used in the same anatomical sites and have the same principle of operation, materials, sterilization, packaging, design and fundamental technological characteristics. The difference between the predicate device and the subject device is that the predicate device labeling states that "The Drive Rail System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment.", and the proposed labeling for the subject device is that "The Drive Rail System is MR Unsafe." as the component in the Drive Rail System contains ferromagnetic material.
VII. Performance Data
The purpose of this submission is to obtain clearance to label the Drive Rail System as "The Drive Rail System is MR Unsafe". When the Drive Rail System was cleared under K140822, the system has the labeling "The Drive Rail System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment."
According to page 23 and 24 of FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff' issued on May 20, 2021. If the medical device contains ferromagnetic material(s), manufacturers cannot use the labeling of "Safety in MR environment not evaluated".
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Image /page/5/Picture/1 description: The image shows the text 'K220809 - Page 3 of 3'. The text is in a simple, sans-serif font and is left-aligned. The text indicates a document identifier and page number within a larger document.
Image /page/5/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child's face with a smiling expression. The word "Ortho" is written in blue and is integrated into the cartoon drawing. The word "Pediatrics" is written in red and is located to the right of the word "Ortho".
According to page 10 of 36 of the FDA guidance "The Special 510(k) Program, Guidance for Industry and Food and Drug Administration Staff" issued on September 13, 2019, when addressing the question of Are performance data needed to evaluate the change? It states that "Verification and validation testing, however, may not be necessary to support SE. For example, FDA may receive a 510(k) from a manufacturer requesting clearance to label their device as Magnetic Resonance (MR) Unsafe after previously labeling their device as 'Safety in MR Imaging Not Evaluated.' As discussed in the FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, MR Unsafe labeling is based on a scientific rationale and does not involve any performance data."
Therefore, OrthoPediatrics Corp reviewed drawings and conducted test to determine of component in the system contains ferromagnetic materials and is magnetic.
VIII. Conclusion
The information provided above supports that the Drive Rail System is as safe and effective as the predicate device. Information provided within the submission support the differences between the subject and predicate devices and support the labeling change. Therefore, it is concluded that the Drive Rail System is substantially equivalent to the predicate devices.
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