FlexBand®, FlexPatch®, and FlexBand® Plus are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Device Description

The FlexBand® / FlexPatch® / FlexBand® Plus products are knitted mesh made from ARTELON® fibers. ARTELON® fiber is made of degradable polycaprolactone-based polyurethane urea. The construction permits the mesh to be cut into any desired shape or size without unraveling. FlexBand® Plus devices have suture attached to each end of the knitted mesh strip. The pre-loaded suture is intended to aid in usability in the operating room. The devices are supplied sterile, one product per package in double layer peel pouch packaging.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

It's important to note that the provided FDA 510(k) summary for FlexBand®, FlexPatch®, and FlexBand® Plus does not detail specific quantitative acceptance criteria with numerical thresholds, nor does it describe a formal "study" in the typical sense of a clinical trial or a statistically powered performance study against such criteria.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance data" section primarily describes types of mechanical testing performed to support this equivalence, rather than a direct measurement against predefined numerical acceptance criteria for a new clinical claim.

Therefore, the following information is extracted and presented based on what is explicitly stated or directly implied in the given text. Many fields, particularly those related to clinical studies, will be marked as "Not Applicable" or "Not Provided" because the submission is for substantial equivalence based on in-vitro performance and literature review, not a new clinical efficacy study with specific PIs.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Material Composition	Similar material to predicate device K192112: "ARTELON® fiber is made of degradable polycaprolactone-based polyurethane urea."	Material is stated to be the same as the predicate device (K192112).
Knit Patterns/Design	Similar knit patterns and design to predicate device K192112. The construction permits the mesh to be cut into any desired shape or size without unraveling.	Knit patterns and design are stated to be the same as the predicate device (K192112).
Product Sizes/Packaging Configuration	Similar product sizes and packaging configuration to predicate device K192112. Supplied sterile, one product per package in double layer peel pouch packaging.	Product sizes and packaging configuration are stated to be the same as the predicate device (K192112).
Suture Retention	Provide "adequate mechanical properties for use in ligament soft tissue reinforcement." (Implied: similar or better performance than predicate or established benchmarks for surgical mesh).	Mechanical testing (Suture Retention Testing) was performed and "The performance data risk / benefit analysis concluded that the differences do not affect the safety and effectiveness... in relation to the predicate." No specific numerical results are provided.
Tensile Strength	Provide "adequate mechanical properties for use in ligament soft tissue reinforcement." (Implied: similar or better performance than predicate or established benchmarks for surgical mesh).	Mechanical testing (Tensile Strength Testing) was performed and "The performance data risk / benefit analysis concluded that the differences do not affect the safety and effectiveness... in relation to the predicate." No specific numerical results are provided.
Sterilization	Radiation sterilization (E-Beam method, minimum 25 kGy)	Device is sterilized via E-Beam method at a minimum of 25 kGy, consistent with predicate K151083.
Biocompatibility	(Implicit for surgical mesh): Biocompatible with the human body.	While not explicitly detailed as a criterion, as an implant, biocompatibility is assessed. No specific data is provided in the summary, but it's a standard requirement for such devices. The "degradable polycaprolactone-based polyurethane urea" material suggests established biocompatibility.
Endotoxin Levels	Maintain endotoxin levels below specified limits for medical devices.	"Routine endotoxin (LAL) testing is performed on each production lot to monitor endotoxin levels." Implies satisfactory performance.
Clinical Effectiveness/Safety	Effective and safe for use in surgical procedures for reinforcement of soft tissue where weakness exists, specifically for tendon and ligament repair. (Based on comparison to predicate and literature review).	"Clinical literature was provided on the subject device involving ligament reinforcement procedures. The reviewed literature shows the device is effective when used in the proposed ligament indication." This refers to previously published literature, not a new clinical study for this 510(k).

Regarding the "Study that Proves the Device Meets the Acceptance Criteria" and other requested details:

As highlighted above, the submission is focused on demonstrating substantial equivalence (SE) to predicate devices by showing that the current device has the same technological characteristics or differences that do not raise different questions of safety and effectiveness. It does not describe a singular, novel study designed to meet specific quantitative performance criteria for a new clinical claim.

2. Sample Size Used for the Test Set and Data Provenance:
- Mechanical Testing (Suture Retention, Tensile Strength): Not explicitly stated. These are in-vitro tests, not human data. The sample size would be for the number of device units tested.
- Clinical Literature: The "Clinical literature" section refers to existing published studies on "the subject device involving ligament reinforcement procedures." This implies retrospective data analysis from already completed studies, not a new prospective test set for this 510(k). The provenance (e.g., country of origin) of these literature studies is not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For the mechanical testing, ground truth is based on physical measurements of device properties. For the clinical literature, the "ground truth" (clinical effectiveness) would have been established by the authors and expert reviewers of those original published studies, but not specifically for this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication of a test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used:
- Mechanical Testing: In-vitro physical measurement results (e.g., force in Newtons, displacement in mm) for suture retention and tensile strength.
- Clinical Literature: Peer-reviewed clinical outcomes and effectiveness data from published studies concerning the device in relevant surgical procedures.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this device and submission, as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set exists for this device.

Summary

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May 26, 2023

Image /page/0/Picture/1 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.

International Life Sciences Tiffini Wittwer Vice President Quality and Regulatory Affairs 2150 Northwest Parkway SE Suite G Marietta, Georgia 30076

Re: K230316

Trade/Device Name: FlexBand®; FlexPatch®; FlexBand® Plus Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: QWJ, FTL, OWW Dated: April 26, 2023 Received: April 27, 2023

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, 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

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Indications for Use

510(k) Number (if known) K230316

Device Name

FlexBand®, FlexPatch®, and FlexBand® Plus

Indications for Use (Describe)

FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

Type of Use (Select one or both, as applicable)
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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: K230316

FlexBand®/ FlexPatch® / FlexBand® Plus

I. Submitter Information

Submitter:	International Life Sciences (dba Artelon)
Address:	2150 Northwest Pkwy SESuite GMarietta GA 30076
Telephone:	+1 (800) 610-3446
Contact:	Tiffini Wittwer, MPH
Date Prepared:	May 23, 2023

Device Information II.

Trade Name(s):	FlexBand® / FlexPatch® / FlexBand® Plus
Common Name:	Surgical Mesh
Classification:	Class II
Regulation:	21 CFR 878.3300
Classification Name:	Mesh, Surgical, Absorbable, Orthopedics, Reinforcement of Ligamen
Classification Panel:	Orthopedic

QWJ, OWW, FTL Product Codes:

Predicate Device Information III.

The FlexBand® / FlexPatch® / FlexBand® Plus devices described in this submission are substantially equivalent to the following predicate devices:

The FlexBand® / FlexPatch® / FlexBand® Plus (K192112)

BioBridge™ Collagen Matrix (K151083)

IV. Device Description

V. Indication for Use

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FlexBand®, FlexPatch®, and FlexBand Plus® are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

FlexBand®, FlexPatch®, and FlexBand Plus® are also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

FlexBand®, FlexPatch®, and FlexBand Plus® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendons, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Comparison of Technological Characteristics With the Predicate Devices VI.

FlexBand®, FlexPatch®, and FlexBand Plus® devices have the same principles of operation as the predicate devices (K192112 and K151083). They are all implants intended for the reinforcement of soft tissues that are repaired by suture or other fixation devices. The devices are used in various surgical procedures where soft tissue reinforcement is needed.

FlexBand®, FlexPatch®, and FlexBand Plus® products are similar to the BioBridge predicate (K151083) in the following ways:

Intended use, to share load placed on the primary repair and provide structural scaffold . for torn or damaged soft tissue;
Indication for Use
Radiation sterilization (E-Beam method, minimum 25 kGy) ●
Biodegradable
May be cut to size to meet surgeons' preference ●

There have been no changes to the FlexBand®, FlexPatch®, and FlexBand Plus® products since the prior 510(k) clearance. Therefore, FlexBand®, FlexPatch®, and FlexBand Plus® products are the same as the FlexBand®, FlexPatch®, and FlexBand Plus® predicate (K192112) in the following ways:

. Material
Knit patterns and design. .
Product sizes and packaging configuration

VII. Performance Data

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Mechanical testing

Suture Retention Testing ●
Tensile Strength Testing ●

The tests listed above provide objective evidence that the FlexBand®, FlexBatch®, and FlexBand Plus® devices provide adequate mechanical properties for use in ligament soft tissue reinforcement. The performance data risk / benefit analysis concluded that the differences do not affect the safety and effectiveness of the FlexBand®, FlexPatch®, and FlexBand Plus® device in relation to the predicate.

Routine endotoxin (LAL) testing is performed on each production lot to monitor endotoxin levels.

Clinical Literature

Clinical literature was provided on the subject device involving ligament reinforcement procedures. The reviewed literature shows the device is effective when used in the proposed ligament indication.

VIII. Conclusion

Based on the above information the FlexBand®, FlexPatch®, and FlexBand Plus® products are substantially equivalent to the soft tissue reinforcement predicate devices:

The FlexBand® / FlexPatch® / FlexBand® Plus (K192112)

BioBridge™ Collagen Matrix ([K151083](https://510k.innolitics.com/search/K151083))

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.