Cypris eXact Suture Placement Device

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May 3, 2024 Cypris Medical % Erin Gontang Senior Consultant Ram+ 2251 San Diego Avenue, B-257 San Diego, California 92110 Re: K240185 Trade/Device Name: Cypris eXact Suture Placement Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: GEJ Dated: January 23, 2024 Received: January 23, 2024 Dear Erin Gontang: 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. {1}------------------------------------------------ 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). 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, Julie A. Morabito -S Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices {2}------------------------------------------------ OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240185 Device Name Cypris eXact Suture Placement Device Indications for Use (Describe) The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | 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 "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}------------------------------------------------ # 510(k) SUMMARY K240185 DATE PREPARED May 1, 2024 ## MANUFACTURER AND 510(k) OWNER Cypris Medical, Inc. 4541 N. Ravenswood Ave. #202 Chicago, IL 60640, USA Phone: +1 888-433-5002 OFFICIAL CONTACT Dan Holton, President & CEO #### REPRESENTATIVE/CONSULTANT Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC ROM+ 2251 San Diego Ave, Suite B-257 San Diego, CA 92110, USA Phone: +1 412-816-8290 Email: egontang@rqmplus.com akomiyama@rqmplus.com #### DEVICE INFORMATION | Trade/Proprietary Name | Cypris eXact Suture Placement Device | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | Suture Placement Device | | Regulatory Class: | I | | Regulation Number/Name: | 21 CFR 878.4800/Manual Surgical Instrument for General Use | | Product Code: | GEJ | | Classification Panel | General & Plastic Surgery | | Premarket Review | Office of Health Technology 4<br>(Surgical and Infection Control Devices)<br>Division of Health Technology 4B<br>(Infection Control and Plastic and Reconstructive Surgery) | {5}------------------------------------------------ ## PREDICATE DEVICE IDENTIFICATION The Cypris eXact Suture Placement Device is substantially equivalent to the following: | 510(k) Number | Predicate Device Name<br>/ Manufacturer | Predicate/Reference | |------------------------|--------------------------------------------------------------------|---------------------| | Class I, 510(k) Exempt | Cypris eXact 5.1 Suture Placement Device<br>/ Cypris Medical, Inc. | Primary Predicate | | K233355 | Cypris eXact Suturing System<br>/ Cypris Medical, Inc. | Reference Device | | K994290 | Bard Endoscopic Suturing System<br>/ C.R. Bard, Inc. | Reference Device | The predicate and reference devices have not been subject to a design related recall. #### DEVICE DESCRIPTION The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver. # INDICATIONS FOR USE The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Cypris Medical believes the Cypris eXact Suture Placement Device is substantially equivalent to the primary predicate device based on the information summarized here: The Cypris eXact Suture Placement Device has the same intended use as the primary predicate device, and they are identical with respect to formulation, processing, and sterilization. The difference between the subject and predicate devices is that the Cypris eXact Suture Placement Device is packaged with a vacuum connector, which gives the option of connecting the suture placement device to a vacuum source. {6}------------------------------------------------ ### SUBSTANTIAL EQUIVALENCE The Cypris eXact Suture Placement Device is substantially equivalent to the primary predicate device in its intended use, as well as formulation, processing, and sterilization. The substantial equivalence table for the comparison of the subject and predicate devices is provided below. | | Subject Device | Predicate Device | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Cypris Medical, Inc. | Cypris Medical, Inc. | | | Cypris eXact Suture Placement Device | Cypris eXact 5.1 Suture Placement Device | | | K240185 | Class I (510(k) Exempt) | | Indications for Use | The Cypris eXact Suture Placement Device<br>is indicated for use in general soft tissue<br>approximation when used with sutures. | The Cypris eXact 5.1 Suture Placement<br>Device is indicated for use in general soft<br>tissue approximation. | | Regulation Number | 21 CFR 878.4800 | 21 CFR 878.4800 | | Regulation Description | Manual Surgical Instrument for General Use | Manual Surgical Instrument for General Use | | Product Code/Name | GEJ / Carrier, Ligature | GEJ / Carrier, Ligature | | Classification | Class I | Class I | | 510(k) Exempt | No | Yes | | Device Description | The Cypris eXact Suture Placement Device<br>is for use in general soft tissue approximation<br>by surgeons, is single-use, and is provided<br>sterile. It is a hand-held device used for the<br>placement of a surgical suture, and the device<br>consists of a handle, needle driver, and tissue<br>capture port. | The Cypris eXact Suture Placement Device<br>is for use in general soft tissue approximation<br>by surgeons, is single-use, and is provided<br>sterile. It is a hand-held device used for the<br>placement of a surgical suture, and the device<br>consists of a handle, needle driver, and tissue<br>capture port. | | Intended Use | General Soft Tissue Approximation | General Soft Tissue Approximation | | Device Materials | Polycarbonate<br>Stainless Steel | Polycarbonate<br>Stainless Steel | | Single Use Device | Yes | Yes | | Tissue Capture | Manual Palpation | Manual Palpation | | Method | Vacuum-Assisted Palpation | | | Suture Deployment | The suture is threaded into needle proximal<br>of tissue capture port. When deployed, the<br>needle passes through tissue, pushing the<br>suture through the tissue. The suture is<br>captured in the distal end of the device, and<br>then the needle is retracted | The suture is threaded into needle proximal<br>of tissue capture port. When deployed, the<br>needle passes through tissue, pushing the<br>suture through the tissue. The suture is<br>captured in the distal end of the device, and<br>then the needle is retracted | | Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | | Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity | Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity | | | Reference Device | Reference Device | | | Cypris Medical, Inc. | C.R. Bard, Inc. | | | Cypris eXact Suturing System | Bard Endoscopic Suturing System | | | K233355 | K994290 | | Indications for Use | Cypris eXact Suture PP (Polypropylene)<br>The Cypris eXact Suture (PP) is indicated for<br>use in general soft tissue approximation<br>and/or ligation, including use in<br>cardiovascular, ophthalmic and neurological<br>procedures.<br>Cypris eXact Suture PTFE | For endoscopic placement of suture(s) in the<br>soft tissue of the esophagus and stomach and<br>for approximation of tissue for the treatment<br>of symptomatic Gastroesophageal Reflux<br>Disease. | | | (Polytetraflouroethylene)<br>The Cypris eXact Suture (PTFE) is indicated<br>for use in all types of soft tissue<br>approximation and/or ligation, including<br>dental and general surgeries. | | | | Cypris eXact Suture PDO (Polydioxanone)<br>The Cypris eXact Suture (PDO) is indicated<br>for use in general soft tissue approximation<br>and/or ligation, but not for use in<br>cardiovascular or neurological tissues,<br>microsurgery or ophthalmic surgery. | | | | The Cypris eXact 5.1 Suture Placement<br>Device can be used in conjunction with<br>eXact Sutures, which are indicated for use in<br>general soft tissue approximation and/or<br>ligation. | | | Regulation Number | 21 CFR 878.4840<br>21 CFR 878.5010<br>21 CFR 878.5035<br>21 CFR 878.4800 | 21 CFR 876.1500 | | Regulation<br>Description | Absorbable polydioxanone surgical suture<br>Nonabsorbable polypropylene surgical suture<br>Nonabsorbable expanded<br>polytetrafluoroethylene surgical suture<br>Manual Surgical Instrument for General Use | Endoscope and Accessories | | Product Code/Name | NEW / Suture, Surgical, Absorbable,<br>Polydioxanone<br>GAW / Suture, Nonabsorbable, Synthetic,<br>Polypropylene<br>NBY / Suture, Surgical, Nonabsorbable,<br>Expanded, PTFE<br>GEJ / Carrier, Ligature | ODE / Endoscopic Suture/Plication System,<br>Gastroesophageal Reflux Disease (GERD) | | Classification | Class II | Class II | | 510(k) Exempt | No | No | | Device Description | The Cypris eXact Suturing System is<br>comprised of the Cypris eXact Suture and the<br>Cypris eXact 5.1 Suture Placement Device.<br>The Cypris eXact Suture and the Cypris | The Bard Endoscopic Suturing System<br>consists of a capsule assembly with suction<br>tubing and a fixed head knot pusher that<br>attaches to the distal end of a flexible | | | eXact 5.1 Suture Placement Device are for | endoscope or a through-the-scope knot | | Intended Use | use in general soft tissue approximation by surgeons, are single-use, and are provided sterile. | pusher, plus a needle assembly, pusher wire, guidewire and suture cutter that all pass through an endoscope's biopsy channel. | | | General Soft Tissue Approximation | Place Stitches and Tie Suture Material to Approximate Soft Tissue Under Endoscopic Visualization | | Device Materials | Polycarbonate<br>Stainless Steel | Plastic<br>Stainless Steel | | Single Use Device | Yes | Yes | | Tissue Capture Method | Manual Palpation | Vacuum-Assisted Palpation | | Suture Deployment | The suture is threaded into needle proximal of tissue capture port. When deployed, the needle passes through tissue, pushing the suture through the tissue. The suture is captured in the distal end of the device, and then the needle is retracted | The handle assembly is manually activated, advancing the needle through the tissue, at which time the suture tag is pushed through the needle assembly by the pusher wire until the suture tag exits the needle and is captured within the end cap of the capsule assembly. The handle and needle are then retracted. | | Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | | Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity | Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity | {7}------------------------------------------------ The named reference devices provided additional information to help substantiate the safety and effectiveness of the subject device and the use of vacuum-assisted palpation. Information about both reference devices is provided below. {8}------------------------------------------------ # SUMMARY OF NON-CLINICAL TESTING The Cypris eXact Suture Placement Device underwent biocompatibility testing as an external communicating device with limited contact (≤24 hours) with tissue. The following biocompatibility endpoints were evaluated: cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. The Cypris eXact Suture Placement Device was tested to evaluate the integrity of the sterile barrier and the functionality of the device following 3 years of real-time aging. The shelf-life of the Cypris eXact Suture Placement Device is 3 years. Performance testing of the Cypris eXact Suture Placement Device and a comprehensive vacuum safety evaluation were completed. Testing demonstrated that the subject device performs as expected and that the use of vacuum-assisted palpation is equivalent to the use of manual palpation by the predicate device. Peak suction force was measured at a vacuum level of 25.0 inHg, a likely vacuum level used in clinical settings. At this vacuum level, the minimum, maximum, and average measured peak suction force achieved by the Cypris eXact Suture Placement Device was 0.753 1bf, 1.052 1bf, and 0.904 1bf, respectively. # CONCLUSION Based on the totality of evidence, including performance testing and a comprehensive vacuum safety evaluation. Cypris Medical concluded that use of vacuum-assisted palpation with the subject device does not raise different questions of safety and effectiveness relative to the predicate device. The Cypris eXact Suture Placement Device is determined to be substantially equivalent to the predicate device.