(150 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a physical implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a fixation system for soft tissue grafts or reinforcement meshes to bone, which is a structural or mechanical support function, not a therapeutic treatment of a disease or condition.
No
The device is described as a fixation system for soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs, rather than a tool for diagnosis.
No
The device description explicitly states it consists of bone staples (hardware made of PEEK) and a delivery instrument (also hardware). It is a physical implant and delivery system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Integrity™ Bone Staple Fixation System is a surgical implant used to physically attach soft tissue grafts or reinforcement meshes to bone during surgery. It is a mechanical device used directly on the patient's body.
- Intended Use: The intended use clearly states "fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs." This is a surgical procedure, not a diagnostic test performed on a sample.
The description and intended use clearly indicate this is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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 substantial equivalence to the predicate devices:
- Mechanical retention strength, tensile & shear
- Insertion and removal evaluation
- Biocompatibility Testing; Cytotoxicity, Sensitization, and Irritation
- Bacterial endotoxin limit test
No clinical or animal data were required to support the substantial equivalence.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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May 22, 2023
Anika Therapeutics Inc. Shajunath Nirupama Sr. Regulatory Affairs Specialist 32 Wiggins Avenue Beford, Massachusetts 01730
Re: K223860
Trade/Device Name: IntegrityTM Bone Staple Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 4, 2023 Received: May 5, 2023
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
1
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 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,
Sara S. Thompson -S
For
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223860
Device Name
IntegrityTM Bone Staple Fixation System
Indications for Use (Describe)
The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
[As required by 21 CFR 807.92]
Date Prepared: May 18, 2023,
510(k) Number: K223860
Submitter Name
Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730 Establishment No: 3007093114
Contact Person
Shajunath Nirupama Sr. Regulatory Affairs Specialist Phone: 781-457-9230 Email: snirupama@anika.com
General Information
| General Information of Subject Device | |
|---|---|
| Trade Name | Integrity™ Bone Staple Fixation System |
| Common Name | Non-Degradable Bone Staple |
| 510(k) Submitter | Anika Therapeutics, Inc. |
| Class | II |
| Classification Name | Bone Fixation Fastener |
| Regulation | 21 CFR 888.3040 |
| Product Code | MBI |
| Review Panel | Orthopedic |
| Primary Predicate & 510(K) | Rotation Medical Bone Staple (RMB)- K131635 |
| Rotation Medical (Now Smith & Nephew) |
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Device Description
The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.
Indication for Use
The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.
Substantial Equivalence Summary
Anika Therapeutics has demonstrated that for the purposes of the FDA's regulation of medical devices, the Integrity™ Bone Staple Fixation System is substantially equivalent to the predicate Rotation Medical Bone Staple (K131635) in terms of intended use, material, design principles and performance.
| Device Name | Integrity ™ Bone
Staple Fixation
System | Rotation Medical Bone Staple (RMB
Staple) | Comparison |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------|
| 510(k) No: | K223860 | K131635 | N/A |
| Manufacturer | Anika Therapeutics,
inc. | Rotation Medical
(now Smith & Nephew) | N/A |
| Classification | II | II | Same |
| Product code | MBI | MBI | Same |
| Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| Regulation
Description | Bone Fixation Fastener | Bone Fixation Fastener | Same |
| Panel | Orthopedics | Orthopedics | Same |
| Indications for
Use | The Integrity ™ Bone
Staple Fixation System
is indicated for the
fixation of soft tissue
grafts or reinforcement
meshes to bone during
rotator cuff repairs. | The RMB Staple is indicated for fixation of
soft tissue grafts during rotator cuff repair. | Substantially Equivalent (See
discussion below) |
| General Physical
form | Staple Shaped Tack | Staple Shaped Tack | Same |
Table 5B- Substantial Equivalence Comparison
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| Material | PEEK | PEEK | Same |
|---|---|---|---|
| Color | Natural | Natural | Same |
| Dimensions | 11.5 mm in overall height, | ||
| 6.1 mm width | 11 mm in overall height, | ||
| 6.1mm width | Substantially Equivalent (See | ||
| discussion below) | |||
| Body Contact | Implant (>30 days) | Implant (>30 days) | Same |
| Packaging | Staples are pre-loaded | ||
| into a caddy that is | |||
| packaged in a double | |||
| pouch | Staples are pre-loaded onto an inserter | ||
| device in a dual blister pack | See discussion below |
Discussion
Indications for Use Statement:
Both the subject and predicate devices are indicated for use during rotator cuff repair surgery to aid in the management tendon injuries. The subject device is designed to affix soft tissue graft or reinforcement mesh to bone which has been mechanically tested and did not raise any concerns on safety and effectiveness. There are no additional questions on safety and effectiveness of the subject device as compared to the predicate.
Dimensions:
The difference in dimension is not expected to impact the safety and effectiveness of the device as higher tensile and shear retention strength have been demonstrated in the subject device mechanical performance testing.
Packaging:
The package for both subject and predicate devices are industry standard packages. The Integrity Bone Staples has double sterile barrier packaging. They are pre-loaded into a caddy that is packaged in a double pouch to ensure adequate protection and sterility of the subject device during the shelf life. The predicate device is packaged in a sealed dual blister pack that provides protection and maintains sterility during the shelf life. The difference in package configuration from the predicate does not raise any new concerns of safety and efficacy of the subject device.
Performance Testing Summary
The following non-clinical tests and/or analysis were performed for the Subject Device to demonstrate the substantial equivalence to the predicate devices:
- Mechanical retention strength, tensile & shear ●
- Insertion and removal evaluation
- Biocompatibility Testing; Cytotoxicity, Sensitization, and Irritation
- Bacterial endotoxin limit test
No clinical or animal data were required to support the substantial equivalence.
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Conclusion
The Integrity ™ Bone Staple Fixation System subject to this submission has similar indications for use statement, same intended use, same material, and general physical form. The testing data has demonstrated the performance of the Integrity ™ Bone Staple Fixation System and the predicate device, Rotation Medical Bone Staple is substantially equivalent. Any differences in characteristics do not raise additional questions of safety and effectiveness.