FlexBand Plus
Device Facts
| Record ID | K192112 |
|---|---|
| Device Name | FlexBand Plus |
| Applicant | International Life Sciences |
| Product Code | FTL · General, Plastic Surgery |
| Decision Date | Sep 27, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Artelon® FlexBand, FlexPatch, and FlexBand Plus Tissue Reinforcement products are intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Artelon® FlexBand, FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
Device Story
FlexBand Plus is a knitted surgical mesh made of polycaprolactone-based polyurethaneurea fibers; designed for soft tissue reinforcement. Device acts as a degradable scaffold incorporated into patient tissue. Subject device adds pre-attached sutures to mesh ends and a backing card for packaging; otherwise identical to predicate. Used in surgical settings by physicians. Mesh is sutured to soft tissue to provide reinforcement; does not replace structural integrity of tendons. Benefits include scaffold support during healing. Supplied sterile in peel pouches.
Clinical Evidence
No clinical data. Bench testing only. Performed suture retention, suture strength, dimensional, transit, and packaging testing on sterilized product to validate modifications.
Technological Characteristics
Knitted mesh; material: polycaprolactone-based polyurethaneurea. Dimensions: 0.03cm, 0.05cm, 0.07cm widths; 8cm, 16cm, 34cm lengths. Supplied sterile via E-Beam. Includes pre-attached sutures and backing card. Non-active, degradable scaffold.
Indications for Use
Indicated for general surgical soft tissue reinforcement and reinforcement of soft tissues repaired by suture/anchors during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps). Not for replacing body structure or providing full mechanical strength for tendon repair.
Regulatory Classification
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.
Predicate Devices
- FlexBand (K071887)
Submission Summary (Full Text)
{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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 27, 2019
International Life Sciences Tiffini Wittwer Regulatory Affairs 2252 Northwest Parkway SE Marietta, Georgia 30067
Re: K192112
Trade/Device Name: FlexBand Plus Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: August 27, 2019 Received: August 30, 2019
Dear Tiffini Wittwer:
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
{1}------------------------------------------------
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K192112
Device Name FlexBand, FlexPatch, and FlexBand Plus
Artelon® FlexBand, FlexBand Plus Tissue Reinforcement products are intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
Artelon® FlexBand, FlexPatch, and FlexBand Plus are also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
Artelon® FlexBand, FlexBand Plus are not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the bone, provide mechanical strength for the tendon repair. Artelon® Tissue Reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> |
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
## 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."
{3}------------------------------------------------
| Submitter: | International Life Sciences DBA Artelon®<br>2252 Northwest Pkwy SE, Suite G<br>Marietta, GA 30067 | | FlexBand™ Plus | Artelon Tissue | Analysis of Difference |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Date Prepared | July 31, 2019 | | (Subject Device) | Reinforcement | |
| Contact Person: | Tiffini Wittwer, MPH<br>Director Regulatory Affairs<br>Phone: 707.799.6732<br>E-mail: twittwer@mededge.io | | | (Predicate Device) | |
| Trade Name: | FlexBand Plus™ | 510(k) Number | To be determined | K071887 | |
| Common Name: | Mesh, Surgical, Polymeric devices | Decision Date | | | |
| Classification: | Class II | Manufacturer | International Life<br>Sciences | International Life Sciences | |
| Product Code: | FTL, 21 CFR 878.3300 | Classification | Class II | Class II | |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K071887 - FlexBand™ (formerly called Artelon® Tissue<br>Reinforcement) | Product Code | FTL | FTL | |
| Device Description: | FlexBand™ and FlexBand™ Plus products are a knitted mesh<br>made from ARTELON® fibers. Artelon® fiber is made of<br>polycaprolactone-based polyurethaneurea. The construction<br>permits the mesh to be cut into any desired shape or size without<br>unraveling.<br>The Flexband Plus™ devices have a suture attached to each end<br>of the ARTELON® mesh strips. The pre-loaded suture is<br>intended to improve usability in the operating room. The sutured<br>FlexBand™ Plus is packaged with two commercial (off-the-shelf)<br>stainless steel passing needles. The device is supplied sterile, one<br>product per package, in double layer peel pouch packaging.<br>The FlexBand™ and FlexBand Plus™ devices are available in<br>several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of<br>8cm, 16cm, and 34cm for each width. | Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | |
| Indication for Use: | Artelon® FlexBand, FlexPatch, and FlexBand Plus Tissue<br>Reinforcement products are intended for use in general surgical<br>procedures for reinforcement of soft tissue where weakness<br>exists.<br>Artelon® FlexBand, FlexPatch, and FlexBand Plus are also<br>intended for reinforcement of soft tissues that are repaired by<br>suture or suture anchors, during tendon repair surgery including<br>reinforcement of rotator cuff, patellar, Achilles, biceps, or<br>quadriceps tendons.<br>Artelon® FlexBand, FlexPatch, and FlexBand Plus are not<br>intended to replace normal body structure or provide the full<br>mechanical strength to support the rotator cuff, patellar, Achilles,<br>biceps, or quadriceps tendons. Sutures, used to repair the tear,<br>and sutures or bone anchors, used to attach the tissue to the bone. | Indications for Use | Same | Artelon® Tissue Reinforcement is<br>intended for use in general surgical<br>procedures for reinforcement of soft<br>tissue where weakness exists.<br>Artelon® Tissue Reinforcement is<br>also intended for reinforcement of<br>soft tissues that are repaired by<br>suture or suture anchors, during<br>tendon repair surgery including<br>reinforcement of rotator cuff,<br>patellar, Achilles, biceps, or<br>quadriceps tendons.<br>Artelon® Tissue Reinforcement is<br>not intended to replace normal body<br>structure or provide the full<br>mechanical strength to support the<br>rotator cuff, patellar, Achilles,<br>biceps, or quadriceps tendons.<br>Sutures, used to repair the tear, and<br>sutures or bone anchors, used to<br>attach the tissue to the bone, provide | |
| | | | | | |
| | | mechanical strength for the tendon<br>repair. Artelon® Tissue<br>Reinforcement reinforces soft tissue<br>and provides a degradable scaffold<br>that is incorporated into the patient's<br>own tissue. | | | |
| Intended Use | Same | Soft tissue reinforcement | | | |
| Material | Same | polycaprolactone-based<br>polyurethaneurea | | | |
| Available Sizes | Same | 0.3 x 8cm<br>0.3 x 16 cm<br>0.3 x 32 cm<br>0.5 x 8 cm<br>0.5 x 16 cm<br>0.5 x 32 cm<br>0.7 x 8 cm<br>0.7 x 16 cm<br>0.7 x 32 cm | | | |
| Suture Attached | Yes | No | Suture retention testing,<br>suture strength testing,<br>and user validation<br>testing demonstrate that<br>the difference does not<br>create additional risk to<br>safety and effectiveness<br>of the subject device | | |
| Packaging<br>Configuration | Device is placed on<br>backing card and put<br>into pouch | Device is placed directly in pouch | Transit testing and<br>packaging validation<br>demonstrate that the<br>difference does not<br>create additional risk to<br>safety and effectiveness<br>of the subject device | | |
| Sterilization<br>Method | Same | E-Beam | | | |
| Single Use Only | Same | Yes | | | |
| Risk Analysis: | A risk analysis was performed for the modifications done for<br>the subject device, in accordance to ISO 14971:2012 Medical<br>Devices – Applications of Risk Management to Medical<br>Devices and International Life Sciences Risk Management SOP | | | | |
## 510(k) Summary:
{4}------------------------------------------------
provide mechanical strength for the tendon repair. Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
Technological The devices are used in surgical procedures where soft tissue Characteristics: reinforcement is needed. During the surgical procedure the user will suture the device to the desired soft tissues. The material provides a physical scaffold and degrades over time leaving the healed intact tissue in place. The differences between the predicate and the subject device, is the addition of pre-attached sutures to the end of each device and the addition of a backing card to hold the device in the packaging. The predicate and subject devices are available in the exact same sizes.
{5}------------------------------------------------
of suture and packaging. Based on risk identification, verification and validation activities were carried out to ensure the risk acceptability criteria have been met and the risks have been mitigated. All testing was performed on sterilized product. Performance Testing: Based on the risks identified, the following tests were
performed on the FlexBand Plus™:
{6}------------------------------------------------
| Suture retention testing Suture strength testing Dimensional testing Transit testing Packaging testing | |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions: | The changes made to the previously cleared FlexBand™ devices do not raise different questions regarding the safety and effectiveness of the device. FlexBand Plus™ is substantially equivalent to the predicate devices. This conclusion is based upon the devices' identical intended use, indications for use, principles of operation, fundamental scientific technology, and performance specifications. The changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent. The conclusions of testing demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device. |
