Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 5, 2017 Nanova Biomaterials, Inc. Mr. Andrew Ritts Director of Regulatory Affairs 3806 Mojave Court Columbia, Missouri 65202 Re: K163672 Trade/Device Name: Nanova Screw-in Suture Anchor, Nanova Push-in Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: March 17, 2017 Received: March 27, 2017 Dear Mr. Ritts: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163672 Device Name Nanova Push-In Suture Anchor #### Indications for Use (Describe) Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> </span> </span> | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☐</span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163672 Device Name Nanova Screw-In Suture Anchor #### Indications for Use (Describe) Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span> </div> | |----------------------------------------------|----------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "NANOVA" in blue, with a slightly stylized font. The letters are bold and have a slight gradient effect, with the top of the letters being a lighter shade of blue than the bottom. The background is white. ### 510(k) Summary - Submitted By: 1) Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682 | Contact Person: | Andrew Ritts | Phone: (573) 823-3114 | |--------------------|----------------|-----------------------| | Secondary Contact: | Richard Lebens | Phone: (573) 875-6682 | - Establishment Registration No.: 2) - 3) Date Prepared: - 4) Device Trade Name: - 5) Device Common Name: - Device Classification Name/ 6) Product code/ Regulation number: 7) Classification Panel: - 8) Device Class: 9) Predicated Devices: Nanova™ Screw-In Suture Anchor is believed to be substantially equivalent to BioComposite Corkscrew (K082810). Class II Tissue/ 3011430871 Suture Anchor MAI/888.3030 Orthopedic December 19, 2016 Nanova™ Screw-In Suture Anchor Fastener, Fixation, Biodegradable, Soft Nanova™ Push-In Suture Anchor is believed to be substantially equivalent to BioComposite PushLock (K082810) and Osteoraptor (K151105). 10) Indication for Use: Nanova"M Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures - Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy - Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis - Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. - Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair {5}------------------------------------------------ NanovaTM Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures - Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair #### 11) Device Description: The NanovaTM Suture Anchor is comprised of two types: Screw-In and Push-In. Nanova™ Screw-In Suture Anchor is a cannulated, threaded, tapered anchor with integral eyelet for suturing soft tissue to bone. Nanova™ Push-In Suture Anchor is a cannulated anchor with integral evelet for suture soft tissue to bone. In addition the Push-In anchor can use a knotless technique by capturing suture. Suture anchors are preloaded with suture on a handled inserter with a hex driver. The device is made from a copolymer of absorbable 70-30 Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanoval Screw-In Suture Anchors are single use, prescription, long term implant, no drug. #### 12) Substantial Equivalence: The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence: a) The applicant device has the same intended use as the 510(k) cleared predicate listed above. b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design. Nanova-10 Suture Anchor is packaged in a similar manner to its predicate and many 510k cleared products already on the market. Benchtop testing shows similar strengths between Nanova™ Suture Anchor and the {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "NANOVA" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is white, which makes the blue letters stand out. predicates. Table 1 and 2 compares NanovaTM Suture Anchors to their predicates. | Table 1 Technological comparison of Nanova™ Screw-In Suture Anchor and | |------------------------------------------------------------------------| | BioComposite Corkscrew (K082810). | | Name | Nanova™ Screw-In Suture Anchor | BioComposite Corkscrew (K082810). | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Intended use (same) | Fixation of suture (soft tissue) to bone | Fixation of suture (soft tissue) to bone | | Sterility (same) | EtO at 10-6 SAL | EtO at 10-6 SAL | | Configuration/ Dimensions (D=diameter, L=length, S= # of sutures) | 4.5 mm D, 15 mm L, 2 S<br>5.5 mm D, 15 mm L, 3 S<br>6.5 mm D, 15 mm L, 3 S | 4.5 mm D, 15 mm L, 2 S<br>5.5 mm D, 15 mm L, 2 or 3 S<br>6.5 mm D, 15 mm L, 2 or 3 S | | Packaging (same) | Anchor loaded with suture on driver sealed in Tyvek pouch, which is then sealed in a foil pouch | Anchor loaded with suture on driver sealed in Tyvek pouch, which is then sealed in a foil pouch | | | | Table 2. Technical Comparison of Nanova "M Push-In Suture Anchor, Osteoraptor | | |--|--------------------------------------------------|-------------------------------------------------------------------------------|--| | | (K151105), and Bio-Composite PushLock (K082810). | | | | Name | Nanova™ Push-In<br>Suture Anchor | Osteoraptor (K151105). | Bio-Composite<br>PushLock™ (K082810) | |-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Fixation of suture (soft<br>tissue) to bone | Fixation of suture (soft<br>tissue) to bone | Fixation of suture (soft<br>tissue) to bone | | Sterility<br>(same) | EtO at 10-6 SAL | EtO at 10-6 SAL | EtO at 10-6 SAL | | Configuration/<br>Dimensions<br>(D=diameter,<br>L=length, S=<br># of sutures) | 2.5 mm D, 12.6 mm L, 1S<br>3.5 mm D, 12.6 mm L, 1S<br>4.5 mm D, 12.6 mm L, 1S | 2.3 mm* D, 15 mm L, 1S<br>2.9 mm* D, 15 mm L, 1S | 2.4 mm D, 11.3 mm L, 1S<br>2.9 mm D, 15.5 mm L, 1S<br>3.5 mm D, 19.5 mm L, 1S<br>4.5 mm D, 28 mm L, 1S | | Packaging<br>(same) | Anchor loaded with suture<br>on driver sealed in Tyvek<br>pouch, which is then<br>sealed in a foil pouch | Anchor loaded with suture<br>on driver sealed in foil<br>pouch | Anchor loaded with suture<br>on driver sealed in plastic<br>tray with Tyvek pouch,<br>which is then sealed in a<br>foil pouch | * Osteoraptor size based off hole size, not anchor size {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "NANOVA" in blue, block letters. The letters are bold and sans-serif. The background is white. In addition Nanova™ Suture Anchor and predicates are made from similar materials, polylactic acid and calcium phosphate composites. Performance strength of NanovaTM Suture Anchor is similar to their predicates. Nanova™ Suture Anchor has the same Intended Use as the predicate devices to which it was compared, and there are no differences in technological characteristics which raise new questions of safety and / or effectiveness. Therefore, Nanova"M Suture Anchor is substantially equivalent. - 13) Non-Clinical Performance Testing: Non-clinical testing was completed to assess its performance. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility risk assessment conducted and a benchtop assessment. ISO 10993 was utilized for testing biocompatibility (all testing passed). Mechanical and performance testing was compared with the predicate, which resulted in similar mechanical and performance to the predicate (all testing passed). Nanova™ Screw-In Suture Anchor was tested by: axial pullout strength, axial fatigue strength, max torque, insertion torque, and immersion pullout strength. Nanova™ Push-In Suture Anchor was tested by: axial pullout strength, axial fatigue strength, and immersion pullout strength. - 14) Clinical Performance Testing: Clinical performance data was not included. #### Conclusion: Nanova Biomaterials Inc. believes that Nanova™ Suture Anchor is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.