(111 days)
BioWick™ X Implant with Driver, K172186
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a bioresorbable wick, with no mention of AI or ML technology.
Yes
The device is intended to facilitate tendon-bone reattachment in rotator cuff repairs, which is a therapeutic intervention.
No
Explanation: The device is an accessory used in rotator cuff repairs to facilitate tendon-bone reattachment, not to diagnose a condition.
No
The device description clearly states it is a physical, bioresorbable wick made of polymer fibers, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Rotium Bioresorbable Wick is a physical implant used during surgery to facilitate the reattachment of tendon to bone. It is a surgical accessory, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the Rotium Bioresorbable Wick is a surgical implant, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 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
tendon to bone (in rotator cuff repairs)
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: Biocompatibility
The Rotium™ Bioresorbable Wick has been tested according to ISO 10993, Biological Evaluation of Medical Devices. The following testing was conducted: Cytotoxicity. Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, 12 Week Systemic Toxicity, 4-Week Muscle Implantation, 8-Week Muscle Implantation, 12-Week Muscle Implantation, Genotoxicity and Pyrogenicity. The Rotium™ Bioresorbable Wick was found to be non-cytotoxic, nonirritating and nonsensitizing. The Rotium™ Bioresorbable Wick exhibited no systemic toxicity. It was non-pyrogenic and non-mutagenic. 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.
Bench Testing
The following test were conducted to demonstrate substantial equivalence to the predicate device's wick: dimensional analysis, density, tensile strength, strain at break, flexibility, suturability, cannula compatibility and wick retention strength.
Animal Testing
Bioresorbable Wick accessory used in The Rotium™ conjunction with suture anchors was evaluated in an ovine rotator cuff model. Biomechanical testing and histological analysis confirmed that the use of the Rotium™ bioresorbable wick did not introduce any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioWick™ X Implant with Driver, K172186
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 11, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized eagle. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nanofiber Solutions, LLC Ronald L. Bracken Chief Operating Officer 4389 Weaver Court North Hilliard, Ohio 43026
Re: K183236
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: February 7, 2019 Received: February 8, 2019
Dear Mr. Bracken:
We have reviewed vour 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
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183236
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)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
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SUBMITTER'S INFORMATION
| Owner: | Nanofiber Solutions, LLC |
|---|---|
| Address: | 4389 Weaver Court North |
| Hilliard, OH 43026 | |
| Official Correspondent: | Ronald L. Bracken |
| 770-597-7656 | |
| ronny.bracken@nanofibersolutions.com | |
| Date Summary Prepared: | February 7, 2019 |
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 |
| Predicate Device(s): | BioWick™ X Implant with Driver, K172186 |
| Reason for Submission: | New Device |
| 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 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: | The Rotium™ Bioresorbable Wick accessory when utilized in |
| conjunction with suture anchors has very similar technological | |
| characteristics compared to the predicate, BioWick™ X Implant | |
| with Driver (K172186). Physical and mechanical properties | |
| such as wick materials, wick construction, wick thickness, wick | |
| density and wick retention are similar between the products. |
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Performance Data: Biocompatability
The Rotium™ Bioresorbable Wick has been tested according to ISO 10993, Biological Evaluation of Medical Devices. The following testing was conducted: Cytotoxicity. Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, 12 Week Systemic Toxicity, 4-Week Muscle Implantation, 8-Week Muscle Implantation, 12-Week Muscle Implantation, Genotoxicity and Pyrogenicity. The Rotium™ Bioresorbable Wick was found to be non-cytotoxic, nonirritating and nonsensitizing. The Rotium™ Bioresorbable Wick exhibited no systemic toxicity. It was non-pyrogenic and non-mutagenic. 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.
Bench Testing
The following test were conducted to demonstrate substantial equivalence to the predicate device's wick: dimensional analysis, density, tensile strength, strain at break, flexibility, suturability, cannula compatibility and wick retention strength.
Animal Testing
Bioresorbable Wick accessory used in The Rotium™ conjunction with suture anchors was evaluated in an ovine rotator cuff model. Biomechanical testing and histological analysis confirmed that the use of the Rotium™ bioresorbable wick did not introduce any new safety or effectiveness issues.
- Substantial Equivalence: The Rotium™ Bioresorbable Wick accessory when utilized in coniunction with suture anchors is substantially equivalent to the BioWick™ X Implant with Driver (K172186). The Rotium™ Bioresorbable Wick accessory raises no new questions of safety or effectiveness as compared to the predicate devices. The Rotium™ Bioresorbable Wick 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 BioWick X predicate device. The minor differences regarding placement of the bioresorbable wick and wick retention between the Rotium™ device and its predicate device raise no new issues of safety or effectiveness.
- 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™ Bioresorbable Wick should perform as intended in the specified use conditions.