Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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. 10/19/2022 Sirius Medical Systems B.V. Bram Schermers CEO/cto High Tech Campus 41 Eindhoven, North Brabant 5656AE Netherlands Re: K222643 Trade/Device Name: Sirius Pintuition Seed. Sirius Pintuition Probe. Sirius Pintuition Base Unit Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PBY Dated: September 1, 2022 Received: September 1, 2022 # Dear Bram Schermers: 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. 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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 {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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, Deborah Fellhauer RN. BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222643 Device Name Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit Indications for Use (Describe) The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (<30 days) a lumpectomy site inteded for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed can be located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical removal. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ | | SPECIAL 510(K) | | | | |---------------------------------------------------------------|----------------|----------------|--|---------| | | Meta | Identification | | Version | | sirius medical | | 002575 | | 2.0 | | | Classification | Page | | | | | PUBLIC | | | 1 of 4 | | Title | | | | | | K200734 Sirius Pintuition Probe Modification: Resterilization | | | | | ### 6 510(k) Summary 6.1 ### Submitter Information Submitter's name: Sirius Medical Systems B.V. Address: High Tech Campus 41 5656 AE Eindhoven The Netherlands Contact Person: Bram Schermers CEO 0031 6 2011 6299 Telephone: E-mail: bram.schermers@sirius-medical.com Date summary prepared: Monday, July 25, 2022 ### 6.2 Device Information | Trade name: | Sirius Pintuition Seed and Sirius Pintuition Detector | |-------------------------|-------------------------------------------------------| | Common name / device: | Temporary Tissue Marker | | Regulation description: | Implantable Clip | | Regulation number: | 21 CFR 878.4300 | | Regulatory Class: | Class II | | Review Panel: | General & Plastic Surgery | | Product Code: | PBY | ### 6.3 Predicate Device Sirius Pintuition Seed and Sirius Pintuition Detector (K200734) ### 6.4 Device Description The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System. The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (<30 days) marking of a lumpectomy site intended for surgical removal. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length). The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during breast surgery to plan the surgical approach and guide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm). {4}------------------------------------------------ | SPECIAL 510(K) | | | | | | | | | | | | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--|----------------|--------|---------|-----|----------------|--------|------|--------| | <img alt="sirius medical logo" src=""/> | <table><tr><td>Meta</td><td></td></tr><tr><td>Identification</td><td>002575</td></tr><tr><td>Version</td><td>2.0</td></tr><tr><td>Classification</td><td>PUBLIC</td></tr><tr><td>Page</td><td>2 of 4</td></tr></table> | Meta | | Identification | 002575 | Version | 2.0 | Classification | PUBLIC | Page | 2 of 4 | | Meta | | | | | | | | | | | | | Identification | 002575 | | | | | | | | | | | | Version | 2.0 | | | | | | | | | | | | Classification | PUBLIC | | | | | | | | | | | | Page | 2 of 4 | | | | | | | | | | | | Title | | | | | | | | | | | | ## K200734 Sirius Pintuition Probe Modification: Resterilization The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed. ### 6.5 Intended Use The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical removal. ### 6.6 Summary of Technological Characteristics | Elements of<br>Comparison | Sirius Pintuition System (Predicate) | Sirius Pintuition System (Changed) | Comparison | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) ID | K200734 | [TBD] | N/A | | Regulation<br>Number | §878.4300 | §878.4300 | Same | | Regulation<br>Description | Implantable Clip | Implantable Clip | Same | | Regulatory<br>Class | Class II | Class II | Same | | Product Code | PBY | PBY | Same | | Intended use | Temporary marking of a breast lumpectomy<br>site for surgical removal | Temporary marking of a breast lumpectomy<br>site for surgical removal | Same | | Indications for<br>use | The Sirius Pintuition Seed is intended to be<br>placed percutaneously in the breast to mark<br>temporarily (< 30 days) a lumpectomy site<br>intended for surgical removal. Using imaging<br>guidance (such as ultrasound or<br>radiography) or aided by non-imaging<br>guidance (Sirius Pintuition Detector) the<br>Sirius Pintuition Seed is located and<br>surgically removed with the target tissue.<br>The Sirius Pintuition Detector is intended for<br>the non-imaging detection and localization<br>of the Sirius Pintuition Seed that has been<br>implanted in a lumpectomy site intended for<br>surgical removal. | The Sirius Pintuition Seed is intended to be<br>placed percutaneously in the breast to mark<br>temporarily (< 30 days) a lumpectomy site<br>intended for surgical removal. Using imaging<br>guidance (such as ultrasound or<br>radiography) or aided by non-imaging<br>guidance (Sirius Pintuition Detector) the<br>Sirius Pintuition Seed is located and<br>surgically removed with the target tissue.<br>The Sirius Pintuition Detector is intended for<br>the non-imaging detection and localization<br>of the Sirius Pintuition Seed that has been<br>implanted in a lumpectomy site intended for<br>surgical removal. | Same | | Type of Use | Prescription Use | Prescription Use | Same | | Anatomical<br>Locations | Breast | Breast | Same | | Elements of<br>Comparison | Sirius Pintuition System (Predicate) | Sirius Pintuition System (Changed) | Comparison | | Technological<br>Characteristics | The Sirius Pintuition System utilizes non-<br>imaging technologies that are comprised of<br>a console that incorporates electronics and<br>a simple user interface, plus a probe<br>handpiece.<br>A location marker (Pintuition Seed) is placed<br>percutaneously in situ at the clinical target<br>site by a delivery system and then the<br>detector handpiece is used for the<br>intraoperative detection and localization of<br>the implanted marker.<br>The handpiece is connected by a flexible<br>cable to a console unit that provides the<br>user with a visual indication of the presence<br>and proximity of the marker. | The Sirius Pintuition System utilizes non-<br>imaging technologies that are comprised of<br>a console that incorporates electronics and<br>a simple user interface, plus a probe<br>handpiece.<br>A location marker (Pintuition Seed) is placed<br>percutaneously in situ at the clinical target<br>site by a delivery system and then the<br>detector handpiece is used for the<br>intraoperative detection and localization of<br>the implanted marker.<br>The handpiece is connected by a flexible<br>cable to a console unit that provides the<br>user with a visual indication of the presence<br>and proximity of the marker. | Same | | Probe type | Handheld, flexible, cord-connected, reusable | Handheld, flexible, cord-connected, reusable | Same | | Probe tissue<br>contacting<br>material | Poly Ether Ether Ketone (PEEK) | Poly Ether Ether Ketone (PEEK) | Same | | Probe sterility | Use of sterile sheath mandatory for use in<br>sterile area | Use of sterile sheath no longer mandatory if<br>sterilization is performed. | CHANGED | | Reprocessing<br>Instructions | Manual, wipe-based cleaning and<br>disinfection | Manual, wipe-based cleaning and<br>disinfection | Same | | | Manual, immersion based high-level<br>disinfection | Manual, immersion based high-level<br>disinfection | Same | | | No sterilization option provided. | Sterilization in STERRAD NX and NX100<br>systems | CHANGED | | User Feedback | Real-time visual and audible | Real-time visual and audible | Same | | Sensing Depth | 0-50 mm | 0-50 mm | Same | | Seed/Marker<br>Materials | Commercially Pure Titanium Grade II<br>(Tissue-contacting)<br>Neodymium magnet (Internal) | Commercially Pure Titanium Grade II<br>(Tissue-contacting)<br>Neodymium magnet (Internal) | Same | | Seed/Marker<br>diameter | 1.65mm | 1.65mm | Same | | Seed/Marker<br>length | 5.20mm | 5.20mm | Same | | Sterility | Ethylene Oxide | Ethylene Oxide | Same | | Visibility | X-ray, Ultrasound | X-ray, Ultrasound | Same | | Type | Preloaded, single-use, needle implanter | Preloaded, single-use, needle implanter | Same | | Material | 304 Stainless Steel | 304 Stainless Steel | Same | | Delivery device<br>gauge | 14G | 14G | Same | {5}------------------------------------------------ | Meta | SPECIAL 510(K) | |----------------|----------------| | Identification | 002575 | | Version | 2.0 | | Classification | PUBLIC | |----------------|--------| | Page | 3 of 4 | | Title | sirius medical | |-------|----------------| |-------|----------------| # K200734 Sirius Pintuition Probe Modification: Resterilization {6}------------------------------------------------ | sirius medical | Meta | SPECIAL 510(K) | | |----------------|----------------|----------------|--| | | Identification | Version | | | | 002575 | 2.0 | | | | Classification | Page | | | | PUBLIC | 4 of 4 | | ## K200734 Sirius Pintuition Probe Modification: Resterilization ### 6.7 Summary of Non-Clinical Performance Data Testing was conducted to evaluate and characterize the safety and performance of the Sirius Pintuition Localization System. Pre-clinical testing included: - ADDED: Sterilization validation and functional compatibility testing. ● - . Design verification - System accuracy and range verification ● - Biocompatibility evaluation ● - MR safety testing ● - . Sterilization validation - Packaging validation . - . Shelf life validation - Electrical safety testing ● ### 6.8 Summary of Clinical Performance Data An analysis of available data was conducted to evaluate and characterize the clinical safety and performance of the Sirius Pintuition Localization System. The clinical data support the safety and effectiveness of the device: - Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices. ### 6.9 Conclusion The Sirius Pintuition Localization System has the same Intended Use as the predicate device (K200734). The device is identical, apart from the changes proposed related to (re)sterilization of the Probe in STERRAD NX and NX100 systems. These changes do not impact substantial equivalence, the devices can be considered to be substantially equivalent. 4