IDEAL Ziploop

{0}------------------------------------------------ November 30, 2023 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. Riverpoint Medical Becca DeFrancia Regulatory Affairs Manager 825 NE 25th Avenue Portland, Oregon 97232 Re: K233552 Trade/Device Name: IDEAL Ziploop Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 3, 2023 Received: November 3, 2023 Dear Becca DeFrancia: 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" (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). {1}------------------------------------------------ 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 QS 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, # Sara S. Thompson -S For 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 Submission Number (if known) K233552 Device Name IDEAL Ziploop Indications for Use (Describe) The Riverpoint Medical IDEAL Ziploop is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and modern, and the green color suggests growth and stability. ### 510(k) SUMMARY Riverpoint Medical IDEAL Ziploop Adjustable Button Loop #### Submitter Information | Submitter's Name: | Riverpoint Medical | |------------------------|-------------------------------------------------| | Address: | 825 NE 25th Ave.<br>Portland, OR 97232 | | Phone Number: | (503) 517-8001 or (971) 288-1083 | | Fax Number: | (503) 517-8002 | | Registration Number: | 3006981798 | | Contact Person: | Becca DeFrancia<br>(503) 517-8001 | | Date of Preparation: | November 3, 2023 | | Device Name | | | Trade Name: | IDEAL Ziploop | | Common or Usual Names: | Suture Retention Device, Button Loop | | Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue | # Device Classification | FDA Class: | II | |-------------------------|-----------------------------------------------------------------| | Product Classification: | 888.3040: Smooth or threaded metallic bone<br>fixation fastener | | Classification Code: | MBI | # Predicate Device - K171060 Riverpoint Medical OrthoButton AL K230212 – Riverpoint Medical OrthoButton AL {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters RP in white on a green rounded square. To the right of the square is the word RIVERPOINT in green. #### Device Description The Riverpoint Medical IDEAL Ziploop adjustable button loop is comprised of an ultrahigh molecular weight polyethylene (UHMWPE) loop combined with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white), dyed blue, or dyed black. A titanium (Ti-6Al-4V ELI per ASTM F136) plate or button is affixed to the loop during the procedure for configurations where the button is not pre-attached to the loop. For models that come with a pre-attached titanium plate, the procedure is the same except the titanium plate is passed through the void. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the bone tunnel and secure into place. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting. The classification for the IDEAL Ziploop is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI. ### Intended Use / Indications for Use The Riverpoint Medical IDEAL Ziploop is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction. # Performance Data The sutures used to construct the IDEAL Ziploop meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for tensile strength. Non-clinical performance testing for the IDEAL Ziploop included a sterilization adoption validation, biocompatibility testing per ISO10993- 1:2018 - Biological Evaluation of Medical Devices, product packaging validation per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices. LAL and rabbit pyrogencity testing has demonstrated that the IDEAL Ziploop does not raise any additional concerns regarding pyrogenicity. Non-clinical mechanical testing was performed to verify the fixation strength of the IDEAL Ziploop using cyclic testing as compared to the predicate device. Results of performance testing for the IDEAL Ziploop device concluded that the device performed comparably to the predicate device and the validations performed demonstrated that the IDEAL Ziploop met all requirements for its intended use. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in a green square, followed by the word "RIVERPOINT" in green, sans-serif font. The logo is simple and modern, and the green color suggests growth and stability. #### Substantial Equivalence and Comparison of Technical Characteristics The IDEAL Ziploop product line has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the IDEAL Ziploop and the predicate device are sterilized using the same processes, are composed of the same materials, and are tested per the same performance requirements. The minor difference in technical characteristics is limited to 1) a new button design, 2) affixing a clip-on button component for configurations without a pre-attached button, 3) new implantable suture loop configurations and 4) new packaging insert. These minor differences do not raise new questions of safety or effectiveness; therefore, the IDEAL Ziploop product line is substantially equivalent to the currently marketed OrthoButton AL predicate device. #### Conclusion The information provided in this Special 510(k) demonstrates that the Riverpoint Medical IDEAL Ziploop is substantially equivalent to the predicate device.