(30 days)
No
The description focuses on the material composition and physical function of a bioresorbable wick, with no mention of AI or ML.
No.
A therapeutic device is typically characterized by a direct active treatment or intervention to cure, mitigate, treat, or prevent disease. This device is an accessory intended to facilitate reattachment, not to directly treat or cure.
No
The device description clearly states its purpose is for "reattachment of tendon to bone in rotator cuff repairs" and "to facilitate tendon-bone reattachment." It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states 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 directly on the patient's body.
- Device Description: The device is a physical implant (a wick) made of bioresorbable polymers, designed to facilitate tissue repair in vivo.
- 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) 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 (inside the body) during surgery.
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 over the tendon and is designed to facilitate tendon-bone reattachment. 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 repairs (tendon to bone)
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
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 of the predicate (K183236, K201414).
Key Metrics
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.
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July 5, 2023
Nanofiber Solutions, LLC Jason Chakroff QA/RA Manager 5164 Blazer Parkway Dublin, Ohio 43017
Re: K231641
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 31, 2023 Received: June 5, 2023
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 (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.
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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 (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.
Jesse Muir -S
Jesse Muir, Ph.D. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K231641
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the logo for Nanofiber Solutions. The logo consists of a square graphic to the left of the company name. The graphic is a purple square with white lines inside that create a web-like pattern. The company name is written in a large, purple font, with the word "SOLUTIONS" written in a smaller font below.
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: | May 31, 2023 |
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, K201414 |
| Reason for Submission: | Updating labeling to allow for placement on top of the rotator |
| cuff tendon. | |
| 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 over the tendon and is designed to facilitate | |
| tendon-bone reattachment. 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. |
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510(K) Summary
Technological No changes have been made to the technological Characteristics: characteristics of the device.
- 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 of the predicate (K183236, K201414).
- Substantial Equivalence: The Rotium™ Bioresorbable Wick accessory is identical to the predicate, Rotium™ Bioresorbable Wick (K183236, K201414). The labeling changes raise no new safety or effectiveness questions.
- Conclusion: The Rotium™ Bioresorbable Wick accessory is substantially equivalent to the primary predicate device.