(142 days)
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This is a 510(k) premarket notification for the Revolution Radial Head, a medical device for radial head replacement. The provided document is a clearance letter from the FDA, a 510(k) summary, and indications for use. It details the device's characteristics and its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | Bending stress analysis demonstrated that the strength of the worst-case Revolution Radial Head is greater than the strength of the worst-case predicate device and is adequate for its intended use. |
| Endotoxin Level | Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of <20 EU/device. |
| Packaging Integrity | Packaging integrity testing met requirements per ASTM D4169 Distribution Cycle 13, Assurance Level 1. |
| Package Shelf Life | One-year accelerated aging was conducted according to ASTM F1980-16 to determine Package Shelf Life. (The document states it was conducted to determine shelf life, implying it met the criteria, though the specific result value for shelf life isn't explicitly given here, but rather the method used to establish it.) |
| Sterility Assurance Level | Sterilization validations were completed using the VDmax method specified in ISO 11137-1:2006/A1:2013, achieving a Sterility Assurance Level (SAL) of 10-6. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for each test set beyond mentioning "worst-case samples" for endotoxin testing. The testing described is non-clinical (mechanical, sterilization, packaging) and does not involve human data. Therefore, there's no information on data provenance related to human subjects or retrospective/prospective studies.
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. The tests performed are non-clinical and do not involve expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical device submission based on bench testing, not a clinical study requiring adjudication of results.
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. No clinical or comparative effectiveness study involving human readers or AI assistance was conducted for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests (mechanical strength, endotoxin, packaging, sterility) is based on established engineering principles, international standards (e.g., ASTM F1537, ASTM D4169, ASTM F1980-16, ISO 11137-1:2006/A1:2013), and validated laboratory methods. There is no expert consensus, pathology, or outcomes data used for these types of tests in this submission.
8. The sample size for the training set
Not applicable. This device is a mechanical implant and does not involve a training set as would be used in machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Ignite Orthopedics, Inc. Russ Parrott VP of Research and Development 210 North Buffalo Street Warsaw, Indiana 46580
Re: K183618
Trade/Device Name: Revolution Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: December 21, 2018 Received: December 26, 2018
Dear Russ Parrott:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
May 17, 2019
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Raquel Peat, PhD, MPH, USPHS For: Director Office of Health Technology 6 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) K183618
Device Name Revolution Radial Head
Indications for Use (Describe)
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary - K183618 | |
|---|---|
| Prepared: | December 21, 2018 |
| Submitter: | Ignite Orthopedics, Inc.210 North Buffalo StreetWarsaw, IN 46580 |
| Contact: | Russ ParrottVP of Research and DevelopmentPhone: 574.527.2864russ.parrott@igniteorthopedics.com |
| Proprietary Name: | Revolution Radial Head |
| Common Name: | Radial Head |
| Classification: | 21 CFR §888.3170: Elbow joint radial (hemi elbow) polymer prosthesis;Class II |
| Product Code: | KWI |
| Predicate Device: | Wright Medical Evolve Modular Radial Head, K060731 |
Device Description:
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
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Intended Use / Indications:
The Ignite Orthopedics Revolution Radial Head is indicated for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting ● pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- resistance to conservative treatment. o
- Primary replacement after fracture of the radial head. ●
- Symptomatic sequelae after radial head resection. ●
- Revision following failed radial head arthroplasty. ●
Summary of Technologies/Substantial Equivalence:
The Revolution Radial Head is substantially equivalent to the predicate devices in regards to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
Bending stress analysis was used to compare the strength of the Revolution Radial Heads with the strength of the predicate device. This analysis confirmed that the strength of the worst case Revolution Radial Head is greater than the strength of the worst case predicate device and is adequate for its intended use. Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of <20 EU/device. Packaging integrity testing met requirements per ASTM D4169 Distribution Cycle 13, Assurance Level 1. One Year accelerated aging was conducted according to ASTM F1980-16 to determine Package Shelf Life. Sterilization validations were completed using the VDmax method specified in ISO 11137-1:2006/A1:2013. The Sterility Assurance Level (SAL) is 10-6.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Revolution Radial Head to the predicate device.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.