(264 days)
No
The device description and performance studies focus on the mechanical and material properties of a tissue tack and delivery system, with no mention of AI or ML capabilities.
Yes.
The device is used for fixation of prosthetic or biologic material to soft tissues to aid in the healing process during and after surgical procedures.
No
The device, Anika Tissue Tack, is described as a fixation system used for surgical procedures to secure prosthetic or biologic material to soft tissues during healing. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (dart shaped tacks, delivery instrument) made of bioabsorbable PLGA, stainless steel, and high-temperature plastics. It also mentions packaging and sterilization, indicating a hardware-based medical device.
Based on the provided information, the Anika Tissue Tack is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures." This describes a surgical implant or fixation device used in vivo (within the body) during a procedure.
- Device Description: The description details a physical device (tacks and a delivery instrument) made of bioabsorbable material and stainless steel, designed for mechanical fixation. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical fixation during surgery.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The Anika Tissue Tack is a surgical tool used to physically attach materials within the body.
N/A
Intended Use / Indications for Use
The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.
Product codes
GDW
Device Description
The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
The following non-clinical tests and/or analysis were performed for the subject device to demonstrate the safety and effectiveness along with substantial equivalence to the predicate device:
- Mechanical retention strength, tensile & shear
- Degradation testing including mass loss, molar mass and mechanical evaluation.
- Insertion and removal evaluation
- Biocompatibility Testing
- Bacterial endotoxin limit test
No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Rotation Medical Soft Tissue Staple- K131637
Reference Device(s)
OptiFix™ AT Absorbable Fixation System with Articulating Technology - K170278, TissueTak device - K203117
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2023
Anika Therapeutics, Inc. Shajunath Nirupama Sr. Regulatory Affairs Specialist 32 Wiggins Avenue Bedford, Massachusetts 01730
Re: K222487
Trade/Device Name: Anika Tissue Tack Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: August 15, 2022 Received: August 17, 2022
Dear Shajunath Nirupama:
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,
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Mark Trumbore" is written in a large font on the left side of the image. On the right side of the image, it says "Digitally signed by Mark Trumbore -S" and "Date: 2023.05.08 11:03:49 -04'00'".
Mark Trumbore Assistant Director DHT4A: Division of General 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) K222487
Device Name Anika Tissue Tack
Indications for Use (Describe)
The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.
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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Image /page/3/Picture/0 description: The image shows the logo for the company "ANIKA". The logo consists of a blue circular graphic on the left, followed by the word "ANIKA" in blue capital letters. The circular graphic appears to be a stylized letter "A" or a similar abstract design. The overall design is clean and modern.
510(K) Summary
[As required by 21 CFR 807.92]
Date Prepared: April 7, 2022 510(k) Number: K222487
Submitter Name
Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730 Establishment No: 3007093114
Contact Person
Shajunath Nirupama Sr. Regulatory Affairs Specialist Office: (781) 457-9230 Email: snirupama@anika.com
General Information
Table 1: General Information
| General Information of Subject Device | |
|---|---|
| Trade Name | Anika Tissue Tack Fixation System |
| Common Name | Tissue Tack |
| 510(k) Submitter | Anika Therapeutics, Inc. |
| Class | II |
| Classification Name | Staple, Implantable |
| Regulation | 21 CFR 878.4750 |
| Product Code | GDW |
| Review Panel | General & Plastic Surgery |
| Primary Predicate & 510(K) | Rotation Medical Soft Tissue Staple- |
| K131637 | |
| Reference Device & 510(K) | OptiFix™ AT Absorbable Fixation System |
| with Articulating Technology - K170278 | |
| TissueTak device - K203117 |
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Image /page/4/Picture/0 description: The image shows the word "ANIKA" in blue, with a stylized blue logo to the left of the word. The logo appears to be a circular design with curved lines and a small dot inside. The font of the word "ANIKA" is a sans-serif typeface, and the letters are evenly spaced.
Device Description
The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.
Indication for Use
The Anika Tissue Tack Fixation System is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.
Substantial Equivalence Summary
Anika Therapeutics has demonstrated that for the purposes of the FDA's regulation of medical devices, the Anika Tissue Tack is substantially equivalent in indications for use, design principles and performance to the predicate device (Rotation Medical Soft Tissue Staple, K131637) and reference devices (OptiFix™ AT Absorbable Fixation System with Articulating Technology - K170278 and TissueTak device, K203117).
| Device Name | Anika Tissue Tack Fixation System
Subject Device | Rotation Medical Soft Tissue
Staple (RMST)
Predicate Device | Comparison |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(k) No: | K222487 | K131637 | N/A |
| Product Code | GDW | GDW | Same |
| Indications for Use | The Anika Tissue Tack Fixation System is
Indicated for the fixation of prosthetic or
biologic material to soft tissues in various
minimally invasive and open surgical
procedures, such as rotator cuff repair. | The RMST Staple is intended for
fixation of prosthetic material to
soft tissues in various minimally
invasive and open surgical
procedures, such as the
management and protection of
tendon injuries in which there has
been no substantial loss of
tendon tissue. | Substantially
Equivalent
(see
Discussion
below) |
| Color | D&C Violet #2 | D&C Violet #2 | Same |
| Physical form | Dart shaped Tack | Staple shaped Tack | Same as
reference
device
(K17027) |
| Size | 6mm, 7mm, 8mm | 6.5mm | Substantially |
Table 2: Substantial Equivalence Comparison
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Image /page/5/Picture/0 description: The image shows the logo for ANIKA. The logo consists of a blue circular graphic on the left, followed by the word "ANIKA" in blue capital letters. The graphic appears to be a stylized letter "A" within the circle.
| | | | Equivalent
(see
Discussion
below) |
|---------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Material | bioabsorbable Purasorb PLG 82/18 (L-
lactide/Glycolide Polymer) dyed with D&C
Violet No. 2 | bioabsorbable Purasorb PLG 82/18 (L-lactide/Glycolide
Polymer) dyed with D&C Violet
No. 2 | Same |
| Body Contact | Implant (>30 days) | Implant (>30 days) | Same |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Same |
| Packaging | Tacks are pre-loaded into a caddy that is
inserted into sealed Tyvek and foil
pouches and inserted into a carton. | Tacks are pre-loaded into a
caddy that is inserted into sealed
Tyvek and foil pouches and
inserted into a carton. | Same |
Discussion
Indications for Use Statement:
The subject device and predicate device are used similarly to aid in the management of the tendon injuries, such as rotator cuff repair, by affixing a prosthetic material to tissue. The subject device can also affix biologic materials to tissues to aid in the management of the tendon injuries. The subject device has been mechanically tested for this additional indication and no concerns related to the safety and effectiveness were raised. Additionally, the reference device, TissueTak by Via Surgical Ltd. cleared under K203117 is also intended for fixation of prosthetic or biologic material to soft tissues.
Technological Characteristics:
The subject device ranges in size from 6-8mm in length to account for the variations in tendon thickness.
However, subject device's 6-8mm range reflects a nomenclature difference in comparison with predicate and reference devices, as Anika is using the overall length of the device in its naming convention. The longest "depth of purchase" of 6.5mm (for 8mm total length) is the same as the 6.5mm "depth of purchase" of the predicate device and reference device (K170278). Mechanical evaluations have demonstrated no significant difference in pull out or shear strength for varying shaft lengths. Therefore, the device length as described does not affect device safety and effectiveness compared to the predicate and reference devices.
In degradation testing results show that both the subject device and predicate device are identical in degradation time and are substantially equivalent. The differences in the shape and size of subject device versus the predicate does not raise any concerns in comparison to the predicate device as demonstrated by mechanical evaluation.
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Image /page/6/Picture/0 description: The image shows the word "ANIKA" in blue, with a blue circular logo to the left of the word. The logo appears to be a stylized letter "A" inside of a circle. The text is in a sans-serif font and is evenly spaced. The background is white.
Performance Testing Summary
The following non-clinical tests and/or analysis were performed for the subject device to demonstrate the safety and effectiveness along with substantial equivalence to the predicate device:
- Mechanical retention strength, tensile & shear
- Degradation testing including mass loss, molar mass and mechanical evaluation.
- . Insertion and removal evaluation
- . Biocompatibility Testing
- . Bacterial endotoxin limit test
Clinical Testing Summary
No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System.
Conclusion
All similarities and differences described above were evaluated. Based on the justifications described in the subsequent sections of this submission, none of the differences raised significant concern regarding the safety or efficacy of the devices. Therefore, Anika Therapeutics has determined that the subject device, Anika Tissue Tack Fixation System is substantially equivalent to the predicate device and is safe and effective for the intended use.