(27 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on material properties and mechanical function.
Yes
The device is used for the "reattachment of tendon to bone in rotator cuff repairs" and is designed to "facilitate tendon-bone attachment," which are therapeutic actions to treat a medical condition.
No
The device description clearly states its purpose is to "facilitate tendon-bone attachment" as an accessory for rotator cuff repair, not to diagnose any condition.
No
The device description clearly indicates it is a physical, bioresorbable wick made of polymer fibers, intended for surgical implantation. It is 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 reattachment of tendon to bone in rotator cuff repairs. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a physical implant (a wick) made of polymers, designed to be placed between bone and tendon.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo as a surgical aid.
N/A
Intended Use / Indications for Use
The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
Product codes
MAI
Device Description
The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed between the bone and the tendon and is designed to facilitate tendon-bone attachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff
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)
Performance Data: No new performance data is required because the labeling changes made to the device will have no impact on the Biocompatibility, Bench Testing, or Animal Testing results the predicate (K183236). Material mediated of pyrogenicity testing has demonstrated that the device is non-pyrogenic. The Rotium™ Bioresorbable Wick was also tested for the presence of endotoxin via the LAL kinetic chromogenic method. Test results indicate the endotoxin levels were below the recommended limit of 20 EU/device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
June 25, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Nanofiber Solutions, LLC Jason Chakroff Project Engineer 4389 Weaver Ct. N. Hilliard, Ohio 43026
Re: K201414
Trade/Device Name: Rotium™ Bioresorbable Wick Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: May 27, 2020 Received: May 29, 2020
Dear Mr. 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 (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
1
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,
for
Laura Rose, Ph.D. Acting 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K201414 |
| Device Name | Rotium ™ Bioresorbable Wick |
| Indications for Use (Describe) | The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs. |
| 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) |
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.
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collection of information. Send comments regarding this burden estimate or any other aspect of this information collection,
including suggestions for reducing this burden, to:
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Page 1 of 1
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3
Image /page/3/Picture/2 description: The image shows the logo for Nanofiber Solutions. The logo consists of a square with a pattern of curved lines inside, followed by the text "Nanofiber" in a large, serif font. Below "Nanofiber" is the word "SOLUTIONS" in a smaller, sans-serif font. The logo is purple.
SUBMITTER'S INFORMATION
| Owner: | Nanofiber Solutions, LLC |
|---|---|
| Address: | 4389 Weaver Court North |
| Hilliard, OH 43026 | |
| Official Correspondent: | Jason T. Chakroff |
| 614-565-4161 | |
| jason.chakroff@nanofibersolutions.com | |
| Date Summary Prepared: | June 12, 2020 |
DEVICE INFORMATION
| Name of Device: | Rotium™ Bioresorbable Wick |
|---|---|
| Common/Usual Name: | Bioresorbable Wick Accessory |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue fixation |
| appliances and accessories (21 CFR 888.3030) | |
| Regulatory Class: | Class II |
| Product Code: | MAI |
| Primary Predicate Device: | Rotium™ Bioresorbable Wick, K183236 |
| Reason for Submission: | Updating the list of suture and anchor devices that are |
| compatible with the wick accessory. | |
| Indication for Use: | The Rotium™ Bioresorbable Wick is intended to be used in |
| conjunction with suture anchors for the reattachment of | |
| tendon to bone in rotator cuff repairs. | |
| Device Description: | The Rotium™ Bioresorbable Wick is an accessory to be used |
| in conjunction with suture anchors for rotator cuff repair. | |
| The wick is placed between the bone and the tendon and is | |
| designed to facilitate tendon-bone attachment. The wick is | |
| an electrospun, non-woven, microporous, microfiber matrix. | |
| The wick is made from two types of polymer fibers: | |
| Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid | |
| (PGA). The wick is packaged in a primary foil pouch with a | |
| desiccant pouch, sealed within a secondary Tyvek pouch. | |
| The device is supplied gamma-sterilized. The device is | |
| single use only. | |
| Technological | |
| Characteristics: | No changes have been made to the technological |
| characteristics of the device. |
4
- Performance Data: No new performance data is required because the labeling changes made to the device will have no impact on the Biocompatibility, Bench Testing, or Animal Testing results the predicate (K183236). Material mediated of pyrogenicity testing has demonstrated that the device is non-pyrogenic. The Rotium™ Bioresorbable Wick was also tested for the presence of endotoxin via the LAL kinetic chromogenic method. Test results indicate the endotoxin levels were below the recommended limit of 20 EU/device.
- Substantial Equivalence: The Rotium™ Bioresorbable Wick accessory is identical to the predicate, Rotium™ Bioresorbable Wick (K183236). The labeling changes raise no new safety or effectiveness questions.
- Conclusion: The Rotium™ Bioresorbable Wick accessory is substantially equivalent to the primary predicate device.