(53 days)
Not Found
No
The 510(k) summary describes a passive, inert surgical mesh product for tissue reinforcement. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for reinforcing soft tissue where weakness exists and during tendon repair surgery, which are therapeutic applications.
No
This device is a tissue reinforcement product used in general surgical procedures to reinforce soft tissue and is not designed to diagnose medical conditions.
No
The device description clearly states it is a knitted mesh made from ARTELON® fibers, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the products are for "reinforcement of soft tissue where weakness exists" and "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery". This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "knitted mesh made from ARTELON® fibers" and its physical characteristics and packaging. This is consistent with a surgical implant.
- 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 treatment. The device itself is implanted into the body.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
FlexBand™ and FlexBand™ Plus products are a knitted mesh made from ARTELON® fibers. Artelon® fiber is made of polycaprolactone-based polyurethaneurea. The construction permits the mesh to be cut into any desired shape or size without unraveling.
The Flexband Plus™ devices have a suture attached to each end of the ARTELON® mesh strips. The pre-loaded suture is intended to improve usability in the operating room. The sutured FlexBand™ Plus is packaged with two commercial (off-the-shelf) stainless steel passing needles. The device is supplied sterile, one product per package, in double layer peel pouch packaging.
The FlexBand™ and FlexBand Plus™ devices are available in several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm for each width.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (general surgical procedures), rotator cuff, patellar, Achilles, biceps, or quadriceps tendons
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 Testing: Based on the risks identified, the following tests were performed on the FlexBand Plus™:
- 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.
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.
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
§ 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.
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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Submitter: | International Life Sciences DBA Artelon®
2252 Northwest Pkwy SE, Suite G
Marietta, GA 30067 | | FlexBand™ Plus | Artelon Tissue | Analysis of Difference |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Date Prepared | July 31, 2019 | | (Subject Device) | Reinforcement | |
| Contact Person: | Tiffini Wittwer, MPH
Director Regulatory Affairs
Phone: 707.799.6732
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
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:
• K071887 - FlexBand™ (formerly called Artelon® Tissue
Reinforcement) | Product Code | FTL | FTL | |
| Device Description: | FlexBand™ and FlexBand™ Plus products are a knitted mesh
made from ARTELON® fibers. Artelon® fiber is made of
polycaprolactone-based polyurethaneurea. The construction
permits the mesh to be cut into any desired shape or size without
unraveling.
The Flexband Plus™ devices have a suture attached to each end
of the ARTELON® mesh strips. The pre-loaded suture is
intended to improve usability in the operating room. The sutured
FlexBand™ Plus is packaged with two commercial (off-the-shelf)
stainless steel passing needles. The device is supplied sterile, one
product per package, in double layer peel pouch packaging.
The FlexBand™ and FlexBand Plus™ devices are available in
several sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of
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
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, FlexPatch, and 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 tissue to the bone. | Indications for Use | Same | Artelon® Tissue Reinforcement is
intended for use in general surgical
procedures for reinforcement of soft
tissue where weakness exists.
Artelon® Tissue Reinforcement is
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® Tissue Reinforcement is
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 tissue to the bone, 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. | | | |
| Intended Use | Same | Soft tissue reinforcement | | | |
| Material | Same | polycaprolactone-based
polyurethaneurea | | | |
| Available Sizes | Same | 0.3 x 8cm
0.3 x 16 cm
0.3 x 32 cm
0.5 x 8 cm
0.5 x 16 cm
0.5 x 32 cm
0.7 x 8 cm
0.7 x 16 cm
0.7 x 32 cm | | | |
| Suture Attached | Yes | No | Suture retention testing,
suture strength testing,
and user validation
testing demonstrate that
the difference does not
create additional risk to
safety and effectiveness
of the subject device | | |
| Packaging
Configuration | Device is placed on
backing card and put
into pouch | Device is placed directly in pouch | Transit testing and
packaging validation
demonstrate that the
difference does not
create additional risk to
safety and effectiveness
of the subject device | | |
| Sterilization
Method | Same | E-Beam | | | |
| Single Use Only | Same | Yes | | | |
| Risk Analysis: | A risk analysis was performed for the modifications done for
the subject device, in accordance to ISO 14971:2012 Medical
Devices – Applications of Risk Management to Medical
Devices and International Life Sciences Risk Management SOP | | | | |
510(k) Summary:
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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. |