(53 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for a surgical mesh device called "FlexBand Plus." This document describes the device, its intended use, and a comparison to a predicate device ("FlexBand") to demonstrate substantial equivalence.
However, the provided text does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it detail typical metrics associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" described in this document refer to the physical and mechanical properties of the surgical mesh and its packaging, and how these perform compared to a previously cleared product.
Specifically, the "performance testing" section lists:
- Suture retention testing
- Suture strength testing
- Dimensional testing
- Transit testing
- Packaging testing
It then states that these tests were performed to ensure "risk acceptability criteria have been met and the risks have been mitigated." The conclusion notes that 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."
Therefore, I cannot answer most of your specific questions as they pertain to AI/ML device evaluation, as the provided document is for a traditional medical device (surgical mesh) and does not involve AI.
For the parts of your request that can be answered based on the provided document:
1. A table of acceptance criteria and the (reported) device performance
Based on the document, the acceptance criteria are not explicitly detailed in numerical form, but are implied to be "the same as the predicate device" and sufficient to "demonstrate that there are no new risks and the device is substantially equivalent" for the specific physical and mechanical tests mentioned. The document states that the testing demonstrated the device is "as safe, as effective, and performs as well as or better than the legally marketed device."
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Suture retention testing | Met current standards / benchmarks for suture retention comparable to predicate device. | "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." |
| Suture strength testing | Met current standards / benchmarks for suture strength comparable to predicate device. | "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." |
| Dimensional testing | Conformed to specified dimensions (0.03cm, 0.05cm, and 0.07cm widths in lengths of 8cm, 16cm, and 34cm). | Not explicitly detailed in the document, but implied to be within acceptable ranges to be considered substantially equivalent to predicate, which has "the exact same sizes." |
| Transit testing | Maintained integrity and sterility after simulated transit conditions. | "Transit testing and packaging validation demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Packaging testing | Maintained critical physical properties and sterility during shipping and storage, ensuring no additional risks due to new packaging configuration (addition of backing card). | "Transit testing and packaging validation demonstrate that the difference does not create additional risk to safety and effectiveness of the subject device." |
| Risk Analysis | Conforms to ISO 14971:2012, demonstrating risks are acceptable and mitigated. | "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." Confirmed risks were mitigated and acceptable. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for any of the performance tests (suture, dimensional, transit, packaging). The provenance of the data is from the manufacturer, International Life Sciences DBA Artelon, and is likely prospective testing specifically conducted for this 510(k) submission. No country of origin for the data is specified, but the submitter is based in Georgia, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical mesh, not an AI/ML device requiring expert interpretation of outputs. The "ground truth" here would be the physical properties and performance of the device under mechanical/physical testing, measured by standard engineering methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation/labeling of data for AI/ML and not a physical device.
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, as this is related to AI/ML device evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is related to AI/ML device evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is based on engineering and physical testing standards, such as tensile strength, dimensional accuracy, packaging integrity, and the outcomes of a risk analysis per ISO 14971:2012.
8. The sample size for the training set
Not applicable, as this is related to AI/ML device evaluation. There is no "training set" for a physical surgical mesh in this context.
9. How the ground truth for the training set was established
Not applicable, as this is related to AI/ML device evaluation.
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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
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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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| Submitter: | International Life Sciences DBA Artelon®2252 Northwest Pkwy SE, Suite GMarietta, GA 30067 | FlexBand™ Plus | Artelon Tissue | Analysis of Difference | |
|---|---|---|---|---|---|
| Date Prepared | July 31, 2019 | (Subject Device) | Reinforcement | ||
| Contact Person: | Tiffini Wittwer, MPHDirector Regulatory AffairsPhone: 707.799.6732E-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 LifeSciences | 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® TissueReinforcement) | Product Code | FTL | FTL | |
| Device Description: | FlexBand™ and FlexBand™ Plus products are a knitted meshmade from ARTELON® fibers. Artelon® fiber is made ofpolycaprolactone-based polyurethaneurea. The constructionpermits the mesh to be cut into any desired shape or size withoutunraveling.The Flexband Plus™ devices have a suture attached to each endof the ARTELON® mesh strips. The pre-loaded suture isintended to improve usability in the operating room. The suturedFlexBand™ Plus is packaged with two commercial (off-the-shelf)stainless steel passing needles. The device is supplied sterile, oneproduct per package, in double layer peel pouch packaging.The FlexBand™ and FlexBand Plus™ devices are available inseveral sizes; 0.03cm, 0.05cm, and 0.07cm widths in lengths of8cm, 16cm, and 34cm for each width. | Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | |
| Indication for Use: | Artelon® FlexBand, FlexPatch, and FlexBand Plus TissueReinforcement products are intended for use in general surgicalprocedures for reinforcement of soft tissue where weaknessexists.Artelon® FlexBand, FlexPatch, and FlexBand Plus are alsointended for reinforcement of soft tissues that are repaired bysuture or suture anchors, during tendon repair surgery includingreinforcement of rotator cuff, patellar, Achilles, biceps, orquadriceps tendons.Artelon® FlexBand, FlexPatch, and FlexBand Plus are notintended to replace normal body structure or provide the fullmechanical 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 isintended for use in general surgicalprocedures for reinforcement of softtissue where weakness exists.Artelon® Tissue Reinforcement isalso intended for reinforcement ofsoft tissues that are repaired bysuture or suture anchors, duringtendon repair surgery includingreinforcement of rotator cuff,patellar, Achilles, biceps, orquadriceps tendons.Artelon® Tissue Reinforcement isnot intended to replace normal bodystructure or provide the fullmechanical strength to support therotator cuff, patellar, Achilles,biceps, or quadriceps tendons.Sutures, used to repair the tear, andsutures or bone anchors, used toattach the tissue to the bone, provide | |
| mechanical strength for the tendonrepair. Artelon® TissueReinforcement reinforces soft tissueand provides a degradable scaffoldthat is incorporated into the patient'sown tissue. | |||||
| Intended Use | Same | Soft tissue reinforcement | |||
| Material | Same | polycaprolactone-basedpolyurethaneurea | |||
| Available Sizes | Same | 0.3 x 8cm0.3 x 16 cm0.3 x 32 cm0.5 x 8 cm0.5 x 16 cm0.5 x 32 cm0.7 x 8 cm0.7 x 16 cm0.7 x 32 cm | |||
| Suture Attached | Yes | No | Suture retention testing,suture strength testing,and user validationtesting demonstrate thatthe difference does notcreate additional risk tosafety and effectivenessof the subject device | ||
| PackagingConfiguration | Device is placed onbacking card and putinto pouch | Device is placed directly in pouch | Transit testing andpackaging validationdemonstrate that thedifference does notcreate additional risk tosafety and effectivenessof the subject device | ||
| SterilizationMethod | Same | E-Beam | |||
| Single Use Only | Same | Yes | |||
| Risk Analysis: | A risk analysis was performed for the modifications done forthe subject device, in accordance to ISO 14971:2012 MedicalDevices – Applications of Risk Management to MedicalDevices 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.
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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™:
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| 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. |
§ 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.