(55 days)
No
The device description and performance studies focus on the material properties and mechanical function of a polymer-based implant, with no mention of AI/ML algorithms or data processing.
Yes
Rotium® is indicated for the management and protection of tendon injuries, functioning as a protective layer and promoting healing, which are therapeutic actions.
No
Rotium® is described as a protective layer for tendon injuries, used for management and protection, not for diagnosing conditions. Its description focuses on its material composition and physical function as a barrier, and the performance studies evaluate biocompatibility and physical properties, not diagnostic accuracy.
No
The device description clearly states that Rotium® is composed of polymer fibers and is a physical implant designed to function as a protective layer. It is a material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management and protection of tendon injuries." This describes a therapeutic or protective function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of polymer fibers designed to be placed between tissues. This is consistent with a medical device used for treatment or support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Rotium® does not fit this description.
N/A
Intended Use / Indications for Use
Rotium® is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Product codes
OWW
Device Description
Rotium® is composed of two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Rotium® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. Rotium® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. Rotium® is designed for stand-alone use. At the discretion of the surgeon, Rotium® may be hydrated with sterile isotonic solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tendon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Rotium® has been tested according to ISO 10993, Biological Evaluation of Medical Devices. The following testing was conducted: Cytotoxicity, Intracutaneous Reactivity. Sensitization, Acute Systemic Toxicity, 20 Week Systemic Toxicity, 4-Week Implantation, 8-Week Implantation, 20-Week Implantation, Genotoxicity and Pyrogenicity. Rotium® was found to be non-cytotoxic, nonirritating and non-sensitizing. Rotium® exhibited no systemic toxicity. It was non-pyrogenic and non-mutagenic.
Bench Testing: The following tests were conducted to demonstrate substantial equivalence to the predicate device: dimensional analysis, density, tensile strength, strain at break, flexibility, and suture retention strength.
Animal Testing: Rotium® was evaluated in a rabbit calcaneal tendon injury model. Histological analysis confirmed that the use of Rotium® did not introduce any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TAPESTRY Biointegrative Implant (K201572)
Reference Device(s)
Rotium Bioresorbable Wick (K183236, K201414, K231641)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
February 27, 2025
Nanofiber Solutions, LLC Jason Chakroff QA/RA Manager 5164 Blazer Parkway Dublin, Ohio 43017
Re: K250021
Trade/Device Name: Rotium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWW Dated: January 2, 2025 Received: January 3, 2025
Dear Jason Chakroff:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Thomas Mcnamara -S
Christopher Ferreira, MS 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
3
Indications for Use
510(k) Number (if known) K250021
Device Name Rotium®
Indications for Use (Describe)
Rotium® is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
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)
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."
4
Image /page/4/Picture/2 description: The image shows the logo for Nanofiber Solutions. The logo consists of a purple square with white curved lines inside, followed by the word "Nanofiber" in a serif font, also in purple. Below "Nanofiber" is the word "SOLUTIONS" in a smaller, sans-serif font, also in purple.
SUBMITTER'S INFORMATION
| Owner: | Nanofiber Solutions, LLC |
|---|---|
| Address: | 5164 Blazer Parkway |
| Dublin, OH 43017 | |
| Official Correspondent: | Jason T. Chakroff |
| 614-565-4161 | |
| jason.chakroff@nanofibersolutions.com | |
| Date Summary Prepared: | February 27, 2025 |
DEVICE INFORMATION
| Name of Device: | Rotium® |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh (21 CFR 878.3300) |
| Regulatory Class: | Class II |
| Product Code: | OWW |
| Predicate Device(s): | TAPESTRY Biointegrative Implant (K201572) |
| Reference Device(s): | Rotium Bioresorbable Wick (K183236, K201414, K231641) |
| Reason for Submission: | New Device |
| Indication for Use: | Rotium® is indicated for the management and protection of |
| tendon injuries in which there has been no substantial loss of | |
| tendon tissue. | |
| Device Description: | Rotium® is composed of two types of polymer fibers: |
| Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid | |
| (PGA). It is designed to function as a non-constricting, | |
| protective layer between the tendon and surrounding tissues. | |
| Rotium® is conformable and designed for easy placement | |
| between the tendon and surrounding tissue and may be | |
| secured in place using standard fixation techniques. Rotium® | |
| is provided sterile, non-pyrogenic, for single-use only, in a | |
| variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. | |
| Rotium® is designed for stand-alone use. At the discretion of | |
| the surgeon, Rotium® may be hydrated with sterile isotonic | |
| Technological | |
| Characteristics: | solution. |
| Rotium® has very similar technological characteristics compared | |
| to the predicate, TAPESTRY Biointegrative Implant (K201572). | |
| Physical and mechanical properties such as materials, | |
| construction, size, thickness, and suture retention are similar | |
| between the products. |
5
Performance Data: Biocompatability
Rotium® has been tested according to ISO 10993, Biological Evaluation of Medical Devices. The following testing was conducted: Cytotoxicity, Intracutaneous Reactivity. Sensitization, Acute Systemic Toxicity, 20 Week Systemic Toxicity, 4-Week Implantation, 8-Week Implantation, 20-Week Implantation, Genotoxicity and Pyrogenicity. Rotium® was found to be non-cytotoxic, nonirritating and non-sensitizing. Rotium® exhibited no systemic toxicity. It was non-pyrogenic and non-mutagenic.
Bench Testing
The following tests were conducted to demonstrate substantial equivalence to the predicate device: dimensional analysis, density, tensile strength, strain at break, flexibility, and suture retention strength.
Animal Testing
Rotium® was evaluated in a rabbit calcaneal tendon injury model. Histological analysis confirmed that the use of Rotium® did not introduce any new safety or effectiveness issues.
- Substantial Equivalence: Rotium® is substantially equivalent to the TAPESTRY Biointegrative Implant (K201572). Rotium® raises no new questions of safety or effectiveness as compared to the predicate devices. Rotium® has the same intended use and indications for use, technological characteristics, and principles of operation as the predicate devices. There are no new novel features as compared to the Tapestry predicate device.
- Conclusion: The information in this submission demonstrates that the subject device is substantially equivalent to the cited predicate device. The non-clinical data support the safety and effectiveness of the device and demonstrate that Rotium® should perform as intended in the specified use conditions.