Saffron Fixation System

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June 10, 2022 Coloplast A/S Gayatri Ghadge Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411 Re: K220420 > Trade/Device Name: Saffron™ Fixation System Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: PBQ Dated: May 9, 2022 Received: May 10, 2022 Dear Gayatri Ghadge: 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. {1}------------------------------------------------ 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-regulatoryinformation/postmarketing-safety-reporting-combination-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, Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220420 Device Name Saffron™ Fixation System ### Indications for Use (Describe) The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | <div> <span style="font-family: sans-serif; font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span style="font-family: sans-serif; font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </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." {3}------------------------------------------------ # 510(k) SUMMARY | I.<br>SUBMITTER<br>510(K) Owner's Name: | Coloplast A/S | |----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Holtedam 1<br>3050 Humlebaek, Denmark | | Phone/Fax/Email: | Office: 612-422-3206<br>Email: usggh@coloplast.com | | Name of Contact Person: | Gayatri Ghadge<br>Principal Regulatory Affairs Specialist | | Address/Contact: | 1601 West River Road North<br>Minneapolis, MN 55411 | | Date Prepared: | June 7, 2022 | | II.<br>DEVICE<br>Trade or Proprietary Name: | Saffron™ Fixation System | | Common or Usual Name:<br>Regulation Number:<br>Regulation Name:<br>Product Code: | Pelvic ligament fixation system<br>21 CFR 884.4530<br>Obstetric-gynecologic specialized manual instrument<br>PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic<br>Use) | | Regulatory Class: | II | #### III. PREDICATE DEVICE Anchorsure, 510(k)-cleared on October 12, 2012 under K120831. The predicate device has not been subject to a design-related recall. #### DEVICE DESCRIPTION IV. The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.. {4}------------------------------------------------ The physician transvaginally inserts the distal end of the delivery tool with a loaded anchor through the dissected tissue to the desired location. The physician manually positions the tip of the distal end at the location where the anchor is to be placed and manually presses the plunger advancing the cannula in the fixation tool and releasing the anchor into the tissue. The anchor penetrates the chosen landmark to provide a permanent fixation point for the loaded suture. The Saffron Fixation device is a single use device which is supplied sterile. The Saffron Anchor is an implantable device which is supplied sterile. The Saffron Fixation System has a shelf life of 6 months. #### V. INDICATIONS FOR USE The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor. | VI. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE | |-----|------------------------------------------------------| | | PREDICATE DEVICE | | | Subject Device | Predicate Device | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | | Saffron Fixation System | Anchorsure | | | K220420 | K120831 | | Regulation<br>Number | 21 CFR 884.4530 | 21 CFR 884.4530 | | Product Code | PBQ | PBQ | | Indications for<br>Use | The Saffron™ Fixation System is<br>indicated for attaching suture to<br>ligaments of the pelvic floor. | Anchorsure is indicated for<br>attaching suture to ligaments of the<br>pelvic floor. | | Target Structures | Pelvic floor ligaments | Pelvic floor ligaments | | Anchor<br>Placement<br>Duration | Permanent Implant | Permanent Implant | | Anchor Materials | Polysulfone, titanium oxide<br>colorant | Polyether ether ketone (PEEK) | | Anchor<br>Dimensions | Length: 9.29 mm<br>Height: 3.44 mm<br>Width: 1.65 mm | Diameter: 3 mm<br>Length: 7 mm | | Delivery System<br>Materials | Polypropylene (plunger),<br>polycarbonate (handle), stainless<br>steel 304 (shaft), polycarbonate /<br>acrylonitrile butadiene styrene<br>(ABS) (distal tip) | Stainless steel 303,<br>polyoxymethylene | | Delivery System<br>Dimensions | Fixation Tool shaft diameter: 4 mm<br>Fixation Tool shaft length: 200 mm | Anchoring Handle tube diameter: 6<br>mm<br>Anchoring Handle tube length: 204<br>mm | | Accessories<br>Provided | No, compatible with any suture<br>size 0 or smaller | Yes, USP size 0 polypropylene<br>suture and curved stainless steel | {5}------------------------------------------------ | | | surgical needle | |---------|---------------------|---------------------| | Sterile | Yes, ethylene oxide | Yes, ethylene oxide | Saffron Fixation System and the Anchorsure are both permanent anchoring devices that can be used to secure the suture to pelvic floor ligaments. Saffron has the same intended use, target population, sterilization technique, and duration of use as the predicate device. The differences between the two devices are the dimensions, provided accessories, anchor and delivery system design, and component materials. These differences do not raise different questions of safety or effectiveness. These differences were evaluated with performance testing to demonstrate substantial equivalence to the predicate device. #### PERFORMANCE DATA VII. The following performance data was provided in support of the substantial equivalence determination. ## Biocompatibility Testing Biocompatibility testing was conducted based upon ISO 10993-1 (2020): Biological evaluation of medical devices – Part 1: "Evaluation and testing within a risk management process" and FDA Guidance for Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - September 4, 2020. The delivery tool was evaluated for the following biocompatibility endpoints, in accordance with an external communicating device contacting tissue/bone/dentin for a limited duration (≤ 24 hours): - Cytotoxicity per ISO 10993-5:2009 ● - Guinea Pig Maximization Sensitization per ISO 10993-10:2010 ● - Intracutaneous Reactivity Irritation per ISO 10993-10:2010 ● - Acute Systemic Toxicity per ISO 10993-11:2017 ● - . Material-Mediated Pyrogenicity per USP<151> The anchor was evaluated for the following biocompatibility endpoints, in accordance with an implant device contacting tissue/bone for a permanent duration: - Cytotoxicity per ISO 10993-5:2009 - Guinea Pig Maximization Sensitization per ISO 10993-10:2010 - Intracutaneous Reactivity Irritation per ISO 10993-10:2010 . - Acute Systemic Toxicity per ISO 10993-11:2017 ● - Material-Mediated Pyrogenicity per USP<151> ● - . Subacute/subchronic toxicity with intramuscular implantation per ISO 10993-11:2017 - Genotoxicity per ISO 10993-3:2014 - Implantation per ISO 10993-6:2016 ● {6}------------------------------------------------ Chemical characterization and toxicological risk assessment in accordance with ISO 10993-18:2020 was completed on the anchor to address the biocompatibility endpoints of: - Chronic toxicity - . Carcinogenicity ### Mechanical/ Performance Testing The below testing was performed: - Anchor penetration force ● - Anchor detachment force ● - Cannula compressive strength - Anchor eyelet strength ● - Anchor holding force - Anchor insertion force - Anchor tab torque strength - Anchor tab shear strength - Anchor tab fracture strength - Anchor tab removal force - Anchor eyelet/suture compatibility ● - Anchor eyelet capacity - Anchor MR compatibility assessment per 2014 FDA guidance document Establishing ● Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Shaft rotation - Delivery device maximum actuation force ● - Delivery device feedback force - Delivery device minimum actuation force ● - Delivery device shaft stiffness - Delivery device torque strength - Delivery device tensile strength - Delivery device plunger strength - Visual and dimensional testing of the anchor and delivery device ● - Label and barcode evaluation - Sterile barrier seal strength - Sterile barrier integrity after aging - Full package integrity after transportation simulation per ASTM D4169-16 - Shelf Life/Expiration date - Usability testing per the 2016 FDA guidance document Applying Human Factors and ● Usability Engineering to Medical Devices - Non-clinical Cadaver testing {7}------------------------------------------------ ## Sterilization The Saffron Fixation System is sterilized using ethylene oxide in a validated cycle, demonstrating a sterility assurance level (SAL) of 106. Sterilization was completed per ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices and summarized in accordance with the 2016 FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. ### Packaging and Distribution The Saffron Fixation System was subjected to packaging performance and stability testing to establish compliance with ISO 11607-1:2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems". Results of testing demonstrate that the sterile barrier packaging systems can withstand the hazards of climatic stressing, transportation, and storage while adequately maintaining the functional integrity of the product and sterile barrier integrity throughout the product's shelf life of 6 months. ### Animal/Clinical Testing No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices. ## VIII. CONCLUSIONS The Saffron™ Tissue Fixation System has been demonstrated to be substantially equivalent to the predicate, Anchorsure, cleared under premarket notification number K120831, based on the non-clinical performance data provided. The Saffron™ Fixation System is as safe and effective as the predicate device to support a substantial equivalence determination.