(267 days)
No
The device description and performance studies focus on the material properties and mechanical function of a resorbable mesh for tendon repair. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the management and protection of tendon injuries, and its mechanism of action is to function as a protective layer during healing, which directly addresses a medical condition.
No
This device is described as an implantable, partially resorbable mesh designed to provide an augmentation layer over an injured tendon, functioning as a protective layer during healing. Its use is therapeutic, not diagnostic, as it does not identify, monitor, or detect a disease or condition.
No
The device description clearly states it is a partially resorbable mesh comprised of physical materials (Hyaff and PET fibers) and is provided as a sterile patch for surgical implantation. This is a physical medical device, not software.
Based on the provided information, the Integrity Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and protection of tendon injuries, which is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical implant designed to provide a protective layer over an injured tendon. It does not involve testing samples from the human body to provide diagnostic information.
- Mechanism of Action: The mechanism of action is physical protection and separation of tissues during healing, not the detection or measurement of substances or characteristics in vitro.
- Performance Studies: The performance studies focus on the physical and biological interaction of the implant with the tendon and surrounding tissues in an animal model, not on the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Integrity Implant is a surgically implanted device used for the physical support and protection of injured tendons.
N/A
Intended Use / Indications for Use
The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Product codes (comma separated list FDA assigned to the subject device)
OWX
Device Description
The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.
The Integrity Implant will be made available in 2 sizes:
- 20mm X 25mm
- 25mm X 30mm
The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure.
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)
Biocompatibility testing
The Integrity Implant is characterized according to ISO 10993-1 as an implant medical device having long-term contact duration (≥30d) to tissue/bone. The biocompatibility evaluation for the Integrity Implant was conducted in accordance with the FDA guidance document issued on September 4, 2020: "Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The endpoints of biological evaluation included the following tests:
- Chemical Characterization/Toxicological Risk Assessment
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Material Mediated Pyrogenicity
- Bacterial Endotoxin (LAL)
- Genotoxicity
- Implantation/Biodegradation
Performance Testing - Bench
The following bench tests were performed on the Integrity Implant:
- Sterility
- Shelf Life
- Dimensions
- Thickness
- Mesh Basis Weight/Density
- Mesh Knit Characteristics
- Pore Size
- Patch Stiffness
- Patch Compliance
- Tear Resistance
- Suture Pull-out/Retention Strength
- Bacterial Endotoxin Limits
- Residual Solvents
Performance Testing - Animal
Study Purpose: To characterize bone ingrowth, local tissue responses and biomechanical effectiveness of repair of the rotator cuff with the Integrity Implant against the predicate, Collagen Tendon Sheet (Regeneten), and a control.
Sample Size: Forty-seven (47) skeletally mature sheep were enrolled.
Model: Adult bilateral infraspinatus model with time points at 6, 12 and 26 weeks.
Specific Aims:
- To evaluate the gross macroscopic appearance
- To evaluate the radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography.
- To evaluate the mechanical properties of the repair.
- To evaluate and compare the histological responses.
Key Results: - No study related complications or premature deaths.
- All surgical procedures completed without incident.
- No adverse reactions noted in the in-life phase; all animals ambulated normally.
- Gross dissections and harvest did not reveal any adverse reactions in the subject, predicate, or control groups.
- Blood work and distant organ pathology were normal.
- Radiographic endpoints (radiographs, micro-computed tomography, 3T MRI scanning) demonstrated no adverse reactions.
- Tensile testing of the repaired rotator cuff demonstrated that the subject device and the predicate device performed substantially equivalent; no differences found between groups.
- Histology results demonstrated that the subject and predicate devices resorb with time, providing a substantially equivalent regenerative scaffold for new collagenous tissue formation.
- Both the Subject and Predicate device supported new collagen tissue formation via fibroblasts that infiltrated over and within the devices.
- Conclusion: No questions regarding efficacy; subject and predicate devices are substantially equivalent based on animal study outcomes.
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.
K160364, K201572, K073251, K211563
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
August 17, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Anika Therapeutics, Inc. Wei Zhao Executive Director, Regulatory Affairs 32 Wiggins Ave. Bedford, Massachusetts 01730
Re: K223538
Trade/Device Name: IntegrityTM Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWX Dated: July 18, 2023 Received: July 18, 2023
Dear Wei Zhao:
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,
Jesse Muir -S
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
2
Indications for Use
510(k) Number (if known) K223538
Device Name Integrity Implant
Indications for Use (Describe)
The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon 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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K223538 Page 1 of 5
510(k) Summary
l. SUBMITTER
Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730
Phone: 781-457-9000
Contact Person: Wei Zhao, Executive Director, Regulatory Affairs Date Prepared: August 15, 2023
II. DEVICE
Name of Device: Integrity™ Implant Common or Usual Name: Tendon Protector Classification Name: Mesh, Surgical (878.3300) Regulatory Class: II Product Code: OWX
III. PREDICATE DEVICE
Collagen Tendon Sheet, K112423
IV. REFERENCE DEVICES
Versawrap Tendon Protector, K160364 Tapestry Biointegrative Implant, K201572 HyaloMatrix PA, K073251 Pitch-Patch, K211563
V. DEVICE DESCRIPTION
The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.
The Integrity Implant will be made available in 2 sizes:
- 20mm X 25mm
- 25mm X 30mm
4
K223538 Page 2 of 5
The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.
The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.
VI. INDICTATIONS FOR USE
The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A table comparing the key features of the subject and predicate device is provided below.
| | Integrity Implant
(Subject Device) | Collagen Tendon Sheet
(Predicate Device) | Discussion |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(K) No. | TBD | K112423 | N/A |
| Device Class | Class II | Class II | Same |
| Product Code | OWX | FTM | Same |
| Classification | Mesh, Surgical | Mesh, Surgical | Same |
| Intended Use/
Indication for
Use | Management and
protection of tendon
injuries in which there has
been no substantial loss of
tendon tissue. | Management and
protection of tendon
injuries in which there has
been no substantial loss of
tendon tissue. | Same |
| Material Type | Hyaff and PET | Type I Collagen | See "Discussion of
Differences" below |
| Resorbable | Partial | Yes | See "Discussion of
Differences" below |
| Configuration | Sheet | Sheet | Same |
| Nominal Sizes | 20 X 25 mm
(2.0 X 2.5 cm)
25 X 30 mm
(2.5 X 3.0 cm) | 2 X 2.5 cm
2.5 X 3 cm | Same |
| Reusable | No | No | Same |
| Packaging | Tray within a peel pouch | Double peel package | See "Discussion of
Differences" below |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Same |
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K223538 Page 3 of 5
Discussion of Differences
Material:
The subject device differs from the predicate in its material type. The subject device is composed of Hyaff, (esterified hyaluronic acid [HA]) and PET. The predicate device is composed of Type I Collagen derived from bovine Achilles' tendon. The PET (natural and with D&C Blue No. 6) used in the subject device has been added for structural integrity and increased mechanical strength. The PET with D&C Blue No. 6 was added for visibility during surgical procedures. Despite differences in the material type, the subject device has been proven substantially equivalent per performance testing.
Resorption:
The predicate device is considered fully resorbable, while the subject device is considered partially resorbable. The majority of the subject device (Hyaff portion) will be resorbed with the PET remaining. PET has a long history of demonstrated biocompatibility and is used in numerous FDA approved implantable devices that include high-strength polyester sutures.
Packaging:
The predicate and subject device both have similar packaging systems consist of a double peel package. The predicate device has a secondary sterile barrier that also provides additional protection. Both packaging configurations ensure sterile integrity of the applicable device.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The Integrity Implant is characterized according to ISO 10993-1 as an implant medical device having long-term contact duration (≥30d) to tissue/bone. The biocompatibility evaluation for the Integrity Implant was conducted in accordance with the FDA guidance document issued on September 4, 2020: "Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The endpoints of biological evaluation included the following tests:
- Chemical Characterization/Toxicological Risk Assessment ●
- Cytotoxicity
- Sensitization ●
- Irritation
- Systemic toxicity
- Material Mediated Pyrogenicity
- Bacterial Endotoxin (LAL)
- Genotoxicity
- . Implantation/Biodegradation
Performance Testing - Bench
The following bench tests were performed on the Integrity Implant:
6
- Sterility ●
- Shelf Life
- Dimensions
- Thickness
- Mesh Basis Weight/Density
- Mesh Knit Characteristics
- Pore Size
- Patch Stiffness
- Patch Compliance
- Tear Resistance
- Suture Pull-out/Retention Strength ●
- Bacterial Endotoxin Limits
- . Residual Solvents
Performance Testing - Animal
The purpose of the study was to characterize bone ingrowth, local tissue responses and biomechanical effectiveness of repair of the rotator cuff with the Integrity Implant against the predicate, Collagen Tendon Sheet (Regeneten), and a control. An adult bilateral infraspinatus model with time points at 6, 12 and 26 weeks was used. A total of forty-seven (47) skeletally mature sheep were enrolled. The specific aims of the study at 6, 12 and 26 weeks were:
- To evaluate the gross macroscopic appearance
- To evaluate the radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography.
- To evaluate the mechanical properties of the repair.
- To evaluate and compare the histological responses. ●
There were no study related complications or premature deaths in this study. All surgical procedures were completed without incident. No adverse reactions were noted in the in-life phase of the study and all animals ambulated normally throughout the study periods. Gross dissections and harvest did not reveal any adverse reactions in the subject, predicate, or control groups. Blood work and distant organ pathology were normal for all animals in this study.
Radiographic endpoints using radiographs and micro-computed tomography and 3T MRI scanning demonstrated no adverse reactions.
Tensile testing of the repaired rotator cuff demonstrated that the subject device and the predicate device performed substantially equivalent and, did not reveal any differences between the groups.
Histology results from the current study demonstrated that the subject and predicate devices resorb with time providing a substantially equivalent regenerative scaffold for new collagenous tissue formation. Both the Subject and Predicate device supported new collagen tissue formation via fibroblasts that infiltrated over and within the devices.
No questions regarding the efficacy of the Integrity Implant were raised and the subject and predicate devices can be viewed as substantially equivalent based on the outcomes of the animal study.
7
Clinical Data
No clinical studies were conducted using the Integrity Implant prior to the 510(k) submission.
Conclusions
The Integrity Implant is considered substantially equivalent to the Collagen Tendon Sheet. The two devices have the same indication. Both devices have similar characteristics. Testing data also indicated the performance characteristics of the two devices is substantially equivalent. Any differences in characteristics, such as the material, do not raise additional questions of safety and effectiveness.