(19 days)
The ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular fractures and non-unions of small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metatarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The purpose of this Special 510(k) is to add additional sizes to INnate™ Cannulated Screw System. The InFrame™ Cannulated Fixation System includes cannulated stainless screws with a diameter of 2.0 mm and lengths ranging from 10 mm to 50 mm.
The provided text describes the regulatory clearance for the ExsoMed InFrame™ Cannulated Fixation System, a metallic bone fixation fastener. However, it does not include information about AI/ML device performance or studies related to AI/ML.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI/ML device, as the provided document pertains to a traditional medical device (a screw system for bone fixation).
The document mainly focuses on:
- Regulatory Clearance: A 510(k) premarket notification for a traditional medical device.
- Device Description: Cannulated stainless screws for bone fixation.
- Predicate Devices: Comparison to other similar, legally marketed screw systems.
- Performance Testing (Non-Clinical): References testing according to ASTM F543 and engineering analysis for mechanical strength, screw fixation, and usability. This is standard for mechanical devices, not AI/ML.
In summary, none of the requested information (AI/ML acceptance criteria, study details, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/ML component) is present in the provided text.
{0}------------------------------------------------
June 20, 2020
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 the FDA logo, which 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.
ExsoMed, Corp. % Patricia Kontoudis Specialist, Regulatory Affairs Regulatory and Quality Solutions, LLC 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K201430
Trade/Device Name: InFrame™ Cannulated Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 28, 2020 Received: June 1, 2020
Dear Patricia Kontoudis:
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.
{1}------------------------------------------------
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 (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 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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201430
Device Name
InFrame™ Cannulated Fixation System
Indications for Use (Describe)
The ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular fractures and non-unions of small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metatarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
4. 510(k) Summary
| Manufacturer: | ExsoMed, Corp. |
|---|---|
| 135 Columbia | |
| Aliso Viejo, CA 92656 | |
| Contact: | Mr. Jung Chang |
| Director of Engineering | |
| Phone: (619) 823-5775 | |
| jchang@exsomed.com | |
| Prepared By: | Ms. Patricia Kontoudis |
| Specialist, Regulatory Affairs | |
| Regulatory and Quality Solutions LLC | |
| 2790 Mosside Blvd, Suite 800 | |
| Monroeville, PA 15146 | |
| Phone: (443) 722-0126 | |
| pkontoudis@rqteam.com | |
| Date Prepared: | May 28, 2020 |
| Device Trade Name: | InFrame™ Cannulated Fixation System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 - Smooth or Threaded Metallic Bone Fixation |
| Fastener | |
| Class II | |
| Product Codes: | HWC |
| Indications for Use: | The ExsoMed InFrame™ Cannulated Fixation System is intendedfor fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis ofsmall joints; bunionectomies and osteotomies, including scaphoidand other carpal bones, metacarpals, tarsals, metatarsals, patella,ulnar styloid, capitellum, radial head and radial styloid. |
| Device Description: | The purpose of this Special 510(k) is to add additional sizes toINnate™ Cannulated Screw System. The InFrame™ Cannulated |
| Fixation System includes cannulated stainless screws with adiameter of 2.0 mm and lengths ranging from 10 mm to 50 mm. | |
| Predicate Devices: | ExsoMed ITN Cannulated Screw System (K171558) (Primary)INnate Cannulated Screw System (K183603)GEO Bone Screw System (K161904) |
| Technology Comparisonand Non-ClinicalPerformance Testing: | The ExsoMed InFrame™ Cannulated Fixation System hasdiffering specific geometry from the predicates but ismanufactured from similar materials and has similar lengths,diameters and thread profiles as the predicate bone screws. Theinformation summarized in the Design Control ActivitiesSummary demonstrates that the additional sizes meet the pre-determined acceptance criteria for the verification activities.Testing, according to ASTM F543, and engineering analysis wereused to evaluate the mechanical strength, screw fixationperformance, and screw usability performance of the InFrame™Cannulated Fixation System implants. |
{4}------------------------------------------------
InFrame™ Cannulated Fixation System is equivalent to the Conclusion: predicate devices with respect to intended use, materials, design, method of fixation, and performance characteristics. demonstrated that the the ExsoMed InFrame™ All Cannulated Fixation System performs similarly to the predicate device and is substantially equivalent.
N/A