BIOCHARGE

K241912 · Nanofiber Solutions, LLC · MAI · Jul 29, 2024 · Orthopedic

Device Facts

• Record ID: K241912
• Device Name: BIOCHARGE
• Applicant: Nanofiber Solutions, LLC
• Product Code: MAI · Orthopedic
• Decision Date: Jul 29, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIOCHARGE™ is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

Device Story

BIOCHARGE is a bioresorbable wick accessory used in rotator cuff repair; placed over tendon to facilitate tendon-bone reattachment. Device is an electrospun, non-woven, microporous, microfiber matrix composed of PLCL and PGA polymers. Used in conjunction with suture anchors; design includes a pre-built pathway for suture passage. Supplied gamma-sterilized for single use. Intended for clinical use by surgeons during orthopedic procedures. Device acts as a scaffold to support healing; output is the physical presence of the matrix at the repair site. No software or algorithmic components.

Clinical Evidence

Bench testing only. Design verification testing confirmed the design change has no negative impact on performance compared to the predicate. Biocompatibility and animal testing results from the predicate devices (K231641, K201414, K183236) remain applicable.

Technological Characteristics

Electrospun, non-woven, microporous, microfiber matrix. Materials: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). Form factor: Wick accessory. Sterilization: Gamma-sterilized. Single-use. Design includes pre-built pathway for suture passage.

Indications for Use

Indicated for use in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

Regulatory Classification

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.

Predicate Devices

• Rotium® Bioresorbable Wick (K231641)

Reference Devices

• Rotium® Bioresorbable Wick (K183236)
• Rotium® Bioresorbable Wick (K201414)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 29, 2024

Nanofiber Solutions, LLC
Jason Chakroff
QA/RA Manager
5164 Blazer Parkway
Dublin, Ohio 43017

Re: K241912
Trade/Device Name: BIOCHARGE
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: July 1, 2024
Received: July 1, 2024

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.

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).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K241912 - Jason Chakroff
Page 2

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 (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-reporting-combination-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.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Christopher Ferreira -S

for

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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K241912 | |
| Device Name BIOCHARGETM | |
| Indications for Use (Describe) BIOCHARGETM 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. | |
| 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 [e-mail] | |
| "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." | |

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K241912 Page 1/2

# Nanofiber SOLUTIONS

## SUBMITTER'S INFORMATION

Owner: Nanofiber Solutions, LLC
Address: 5164 Blazer Parkway
Dublin, OH 43017
Official Correspondent: Jason T. Chakroff
614-565-4161
[e-mail]
Date Summary Prepared: July 23, 2024

## DEVICE INFORMATION

Name of Device: BIOCHARGE™
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, K231641
Reference Device: Rotium® Bioresorbable Wick, K183236
Reason for Submission: Design updates to facilitate suture passage through the device.

Indication for Use: BIOCHARGE™ is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

Device Description: BIOCHARGE™ is a bioresorbable wick accessory to be used in conjunction with suture anchors for rotator cuff repair. BIOCHARGE is placed over the tendon and is designed to facilitate tendon-bone reattachment. BIOCHARGE is an electrospun, non-woven, microporous, microfiber matrix. It is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). BIOCHARGE 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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K241912 Page 2/2

**Technological Characteristics:** The device design has been updated to include a pre-built pathway for suture passage through the device. No other changes have been made to the technological characteristics of the device.

**Performance Data:** The updated device has undergone design verification testing to confirm that the design change has no negative impact on bench testing results compared to the predicate. The design change will have no impact on the Biocompatibility or Animal Testing results of the predicate (K231641, K201414, K183236).

**Substantial Equivalence:** BIOCHARGE™ is substantially equivalent to the predicate, Rotium™ Bioresorbable Wick (K231641, K201414, K183236). The device intended use, indications, environment of use, principles of operation, materials of construction, body contact, packaging, technological characteristics, sterilization, labeling, shelf life, or performance are unchanged. The design change raises no new safety or effectiveness questions.

**Conclusion:** BIOCHARGE™ is substantially equivalent to the primary predicate device.