OTS 25 (100-1)

{0}------------------------------------------------ December 7, 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 and 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. OTS Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103 Re: K233429 Trade/Device Name: OTS 25 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 11, 2023 Received: October 11, 2023 Dear Ms. Hogan: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Digitally signed by Jesse Muir -S Jesse Muir -S Date: 2023.12.07 12:24:30 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ ### INDICATIONS FOR USE ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below 510(k) Number (if known) K233249 Device Name OTS 25 Indications for Use (Describe) The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25 may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both mav be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue. Type of Use (Select one or both, as applicable) & Prescription Use (Part 21 CFR 801 Subpart D) Subpart C) □ Over-The-Counter Use (21 CFR 801 ### 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." FORM FDA 3881 (6/20) {4}------------------------------------------------ # 510(k) Summary Prepared on: 2023-10-10 ## Contact Details 21 CFR 807.92(a)(1) | Applicant Name | OTS Medical Ltd. | |---------------------------------|------------------------------------------------------------------| | Applicant Address | 4 Maskit st. Herzliya 4673304 Israel | | Applicant Contact Telephone | +972-54-6171726 | | Applicant Contact | Dr. Assaf Dekel | | Applicant Contact Email | dekel.assaf@gmail.com | | Correspondent Name | Hogan Lovells US LLP | | Correspondent Address | 1735 Market Street, Floor 23 Philadelphia PA 19103 United States | | Correspondent Contact Telephone | 1 267 675 4611 | | Correspondent Contact | Ms. Janice Hogan | | Correspondent Contact Email | janice.hogan@hoganlovells.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | OTS25 | |---------------------|----------------------------------------------------| | Common Name | Smooth or threaded metallic bone fixation fastener | | Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | | Regulation Number | 888.3040 | | Product Code | MBI | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|----------------------------------------------------------|--------------| | K133224 | Y-Knot All-Suture Anchor | MBI | | K110145 | JuggerKnot Soft Anchors | MBI | Device Description Summary 21 CFR 807.92(a)(4) OTS 25 is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene.The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use. {5}------------------------------------------------ ## Intended Use/Indications for Use ### 21 CFR 807.92(a)(5) The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25 may be used in either arthroscopic or open surgical procedures are anchored to the bone, both may be used to reattach soft tissue, such as ligant capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue. ## Indications for Use Comparison ### 21 CFR 807.92(a)(5) The OTS 25 has the exact same intended use of its predicate device the ConMed's Y-Knot® RC All-Suture Anchor with two or three #2 Hi-Fir Sutures (K133224). Namely, both devices are intended to reattach soft tissue to bone in orthopedic surgical procedures. The indications for use of the two devices are identical aside from differences in device name. Both all-suture anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, both suture anchor systems stabilize the damaged soft tissue. In other words, the OTS 25 has the same exact indication for use as its predicate device. Thus, the OTS 25 satisfies the first criterion for a finding of substantial equivalence. ## Technological Comparison ## 21 CFR 807.92(a)(6) The OTS 25 and predicate device have bone anchoring and soft tissue attachments. Both devices are made from a flat suture/ flat sleeve structure that bunches during deployment, providing the same bone fixation method between the anchors. Specifically, the subject device and its predicate use a suture-only anchor where fixation to the bone is achieved by changes to the shape of the suture within the soft cancellous bone when the sutures are tightened, preventing it from being pulled through the in the hard bone. The OTS 25 and the predicates' anchors also share soft tissue attachment method, i.e., suture attachment. Both use #2 sized UHMWPE sutures, with two sutures being supplied with OTS device while two or three sutures are provided with the predicate. As use of two sutures is a subset of the predicate, it does not raise any questions. Both suture anchors are inserted through a predilled hole and the same insertion mechanism as its predicate i knot RC by Conmed (K133224). The fork-shaped inserter, drill bit guide used to insert the device are similar to the predicate's instruments as well, resulting in an equivalent, 8-step insertion method as its predicate. The main difference between the OTS 25 and its predicate is the anchor. While the Y-knot is made of flat braid of Ultra High Molecular Weight Polyethylene (UHMWPE), the OTS 25 anchor is made of a flat sleeve Braided polyester (PET). PET has been in use in other all-suture anchors, such as the JuggerKnot (K110145, reference device), and is a biocompatible, well-established material. #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The following performance testing has been completed for the POTS 25 Device: · Pullout Testing (Static and Dynamic ) - · SterilizationValidation, Pyrogenicity Testing, and Endotoxin Monitoring - · Packaging Testing, Shelf-life Testing - Biocompatibility Testing The series of tests, listed above, has been conducted and successfully completed. The results demonstrate that the OTS 25 provides adequate mechanical properties for its use. Following nonclinical tests, it was concluded that OTS 25 is as safe, as effective, and performs at least as well as the legally marketed predicate device.