Avitus(r) Bone Harvester

{0}------------------------------------------------ March 31, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". Avitus Orthopaedics, Inc. % William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street Leola, Pennsylvania 17540 Re: K210631 Trade/Device Name: Avitus® Bone Harvester Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: March 1, 2021 Received: March 3, 2021 Dear William G. McLain: 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, Laura C. Rose, 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}------------------------------------------------ ## SECTION 4. INDICATIONS FOR USE STATEMENT | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | |-------------------------------------------------------------------------|--| | Form Approved: OMB No. 0910-012<br>Expiration Date: 06/30/2020 | | | Indications for Use | | | See PRA Statement below. | | | 510(k) Number (if known) | | | K210631 | | | Device Name | | | Avitus® Bone Harvester | | | Indications for Use (Describe) | | The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors). | Type of Use (Select one or both, as applicable) | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <table style="border:none"><tr><td><span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | 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](mailto: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."* FORM FDA 3881 (7/17) {3}------------------------------------------------ Submission Number: K210631 Date Received: 03/03/2021 ## Section 5 ## 510(k) Summary #### 5.1 Submission Owner and Correspondent ### Submission Owner Avitus Orthopaedics, Inc. Mr. Maxim Budyansky and Mr. Neil Shah Co-Presidents, Co-Founders 6 Armstrong Rd. 2nd Floor Shelton, CT 06484 ### Submission Correspondent Additionally, the following individual is identified as a submission correspondent. Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bill.mclain@keystoneregulatory.com #### 5.2 Date Summary Prepared March 1, 2021 #### Device Trade Name 5.3 Avitus® Bone Harvester #### 5.4 Device Common Name Bone Harvester {4}------------------------------------------------ #### 5.5 Device Classification Name Instrument, Biopsy Classified as Class 2, product code KNW at 21 CFR 876.1075 #### 5.6 Legally Marketed Device To Which The Device Is Substantially Equivalent The Avitus® Bone Harvester is substantially equivalent to the Avitus® Bone Harvester cleared under K170539. #### 5.7 Description of the Device The proposed device is a minimally invasive manual non-powered cancellous bone and marrow graft harvester that can also be used for the removal of infected, necrotic, and diseased cancellous bone. The proposed changes described in this submission add to the types of materials to be collected to include infected, necrotic, or diseased cancellous bone. The Avitus® Bone Harvester consists of a metal cutting tip and shaft with transparent plastic handle, filter, collection chamber, and a threaded plastic cap. The principles of action for the proposed device with revised indications for use are identical to the predicate device. The Avitus® Bone Harvester is a manual surgical instrument that harvests cancellous bone and marrow, and debrides infected, necrotic, or diseased cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing to connect to a vacuum source. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes, cuts, and collects the material into the reservoir filter insert inside the Handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. #### Indications for Use 5.8 The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors). #### 5.9 Technological Characteristics The proposed modifications described in this submission have not resulted in any changes to technological characteristics. The overall design, materials of construction and sterilization methods remain the Same The only change is to modify the indications for use from: The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow. to The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors). {5}------------------------------------------------ ## SECTION 5. 510(K) SUMMARY To account for differences in the indication for use, the Instructions for Use have been modified by: - · stating the revised indications for use, - adjusting the contraindications, and - · providing procedural steps for removal of infected, necrotic, or diseased bone. Table 5.1 provides additional detail regarding similarities and differences related to Technological Characteristics. {6}------------------------------------------------ # K210631 Page 4 of 8 | Feature | Proposed Device - Avitus®<br>Bone Harvester | Predicate Device - Avitus®<br>Bone Harvester (K170539) | Comments on Similarities and Differences | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Regulation, Product Code, and<br>Review Panel | Class II, Product Code KNW,<br>Classified at 21 CFR 876.1075,<br>Gastroenterology-urology biopsy<br>instrument review panel | Class II, Product Code KNW,<br>Classified at 21 CFR 876.1075,<br>Gastroenterology-urology biopsy<br>instrument review panel | The classification regulation,<br>product code and review panel<br>for the proposed and predicate<br>devices are identical. There are<br>no differences. | | Indications for Use | The Avitus® Bone Harvester is<br>intended to harvest cancellous<br>bone and marrow; to debride and<br>capture infected, necrotic or dis-<br>eased cancellous bone (e.g.<br>OS-<br>teomyelitis, cancellous bone tu-<br>mors). | The Avitus® Bone Harvester is<br>intended to harvest cancellous<br>bone and marrow. | The indications for use are identi-<br>cal in relation to harvesting can-<br>cellous bone and marrow. They<br>differ in that the proposed indi-<br>cation for use adds debridement<br>and capture of infected, necrotic<br>or diseased cancellous bone (e.g.<br>osteomyelitis, cancellous bone tu-<br>mors). | | Diameters | 5,6,8mm | 5,6,8mm | The diameters are<br>identical.<br>There are no differences. | | Collection Reservoir | Located inside handle proximal<br>to the suction canister | Located inside handle proximal<br>to the suction canister | The location of the collection<br>reservoir is identical. There are<br>no differences. | | Cutting Tip | Metal round cutting tip located<br>at the distal most end of the de-<br>vice with a cannulation for bone<br>material to enter | Metal round cutting tip located<br>at the distal most end of the de-<br>vice with a cannulation for bone<br>material to enter | The cutting tips are identical.<br>There are no differences. | | Cutting Mechanism | Manual hand driven actuation of<br>cutting tip to cut, scrape and<br>carve cancellous bone | Manual hand driven actuation of<br>cutting tip to cut, scrape and<br>carve cancellous bone | The cutting mechanisms are iden-<br>tical. There are no differences. | | Table 5.1: continued | | | | | Feature | Proposed Device - Avitus® Bone Harvester | Predicate Device - Avitus® Bone Harvester (K170539) | Comments on Similarities and Differences | | Hollow Connection Between Handle and Cutting Tip | Yes - Rigid | Yes - Rigid | The connections between the handle and cutting tip are identical. There are no differences. | | Power Source | None | None | The power sources are identical in that there are none. There are no differences. | | Collection Mechanism | Active suction aspirates and pulls the bone graft into the bone graft reservoir | Active suction aspirates and pulls the bone graft into the bone graft reservoir | The collection mechanisms are identical. There are no differences. | | Filter | Filter in lid prevents collected material from going into the suction system. | Filter in lid prevents collected material from going into the suction system | The locations and purposes of the filter are identical. There are no differences. | | Filter Insert | Filter Insert is included | Filter Insert is included | The filter inserts are identical. There are no differences. | | Material Retrieval | Material can be removed from reservoir by unscrewing the cap and tapping out the material or scooping out with an osteotome or other tool | Material can be removed from reservoir by unscrewing the cap and tapping out the material or scooping out with an osteotome or other tool | The material retrieval methods are identical. There are no differences. | | Material Retrieval Using the Filter Insert | The removable Filter Insert can be used to pull out the collected material from inside the bone graft reservoir. | The removable Filter Insert can be used to pull out the collected material from inside the bone graft reservoir. | The methods of retrieving material using the filter insert are identical. There are no differences. | | Anatomical Site | Boney region that contains a cancellous reservoir or infected, necrotic or diseased cancellous bone | Boney region that contains a cancellous reservoir | The anatomical sites are identical. The differences are related to the proposed indication for use. | | Table 5.1: continued | | | | | Feature | Proposed Device - Avitus®<br>Bone Harvester | Predicate Device - Avitus®<br>Bone Harvester (K170539) | Comments on Similarities<br>and Differences | | Sterilization | EtO with SAL of 10-6 | EtO with SAL of 10-6 | The sterilization methods and<br>SALs are identical. There are no<br>differences. | | Packaging | Tyvek covered tray with insert | Tyvek covered tray with insert | The packaging design and config-<br>urations are identical. There are<br>no differences. | | Radiopaque | Yes | Yes | Because the materials of con-<br>struction are identical, the ra-<br>diopaque characteristics are iden-<br>tical. There are no differences. | | Material - Cutting Tip | Stainless Steel | Stainless Steel | The cutting tip materials of con-<br>struction are identical. There are<br>no differences. | | Material - Hollow Shaft | Stainless Steel | Stainless Steel | The hollow shaft materials of con-<br>struction are identical. There are<br>no differences. | | Material - Plastic Com-<br>ponents | Rigid, translucent thermoplastic<br>polymer | Rigid, translucent thermoplastic<br>polymer | The plastic components materi-<br>als of construction are identical.<br>There are no differences. | | Reusable/Disposable | Disposable | Disposable | The devices are disposable.<br>There are no differences. | | Depth Markings | Yes | Yes | The depth markings are identical.<br>There are no differences. | ## Table 5.1: Technological Characteristics Table {7}------------------------------------------------ # K210631 Page 5 of 8 {8}------------------------------------------------ # K210631 Page 6 of 8 E {9}------------------------------------------------ # K210631 Page 7 of 8 | Table 5.1: continued | | |----------------------|--| |----------------------|--| | Feature | Proposed Device - Avitus®<br>Bone Harvester | Predicate Device - Avitus®<br>Bone Harvester (K170539) | Comments on Similarities and Differences | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | The device is manufactured from<br>materials that have been evalu-<br>ated for biocompatibility for their<br>intended patient contact profile<br>according to ISO 10993-1 | The device is manufactured from<br>materials that have been evalu-<br>ated for biocompatibility for their<br>intended patient contact profile<br>according to ISO 10993-1 | The materials of construction are<br>identical. There are no differ-<br>ences, therefore, that will impact<br>biocompatibility. | | Operating<br>Range | Suction 150mmHg - 300mmHg | 150mmHg - 300mmHg | The operating suction ranges are<br>identical. There are no differ-<br>ences. | {10}------------------------------------------------ #### 5.10 Non-Clinical Testing Non-clinical testing was not conducted in association with this submission. #### 5.11 Biocompatibility The proposed Avitus® Bone Harvester (Avitus Orthopaedics, Inc.) was not subject to new biocompatibility testing because there are no new materials associated with this submission. Biocompatibility was conducted in association with prior submissions. #### 5.12 Clinical Testing No clinical studies were conducted in association with this submission. #### 5.13 Conclusions The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate device.