(48 days)
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.
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).
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.
This document is a marketing approval letter from the FDA for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, with a focus on a modification related to the resterilization of the Sirius Pintuition Probe. As such, the information provided primarily relates to demonstrating the substantial equivalence of the modified device to its predicate, rather than a full, de novo study proving the initial efficacy of the entire system.
Therefore, many of the requested data points (like sample size for test set, number of experts for ground truth, MRMC study, training set size, etc.) are not explicitly present in the provided text as this is a 510(k) "Special" submission, indicating a modification to an already cleared device. The focus is on verifying the impact of the modification (resterilization) on safety and performance, rather than re-proving the original device's effectiveness.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's overall performance (e.g., specific accuracy metrics). Instead, it focuses on demonstrating that the modification (resterilization) does not negatively impact the established safety and performance of the device.
The reported device performance is largely a qualitative statement of comparability to the predicate device due to the nature of a Special 510(k).
| Acceptance Criteria (Implied for Modification) | Reported Device Performance |
|---|---|
| Probe Sterility (after resterilization) | Sterilization in STERRAD NX and NX100 systems is validated and implemented. The modification allows for sterilization, removing the mandatory sterile sheath requirement if sterilized. |
| Functional Compatibility (after resterilization) | Testing was conducted to evaluate "functional compatibility" of the modified device after resterilization. (Specific results are not detailed, but the conclusion of substantial equivalence implies satisfactory performance). |
| Overall Safety and Performance of the Sirius Pintuition Localization System (post-modification) | "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..." |
| Biocompatibility (after resterilization, if applicable to new probe material/interaction) | Biocompatibility evaluation was conducted. (Assumed satisfactory, as no adverse findings are mentioned). |
| MR Safety Testing (after resterilization, if applicable to any new material or component interaction) | MR safety testing was conducted. (Assumed satisfactory). |
| Electrical Safety Testing (after resterilization, if applicable to any changes in electrical components/housing) | Electrical safety testing was conducted. (Assumed satisfactory). |
| Packaging Validation (for new or affected components) | Packaging validation was conducted. (Assumed satisfactory). |
| Shelf Life Validation (for new or affected components) | Shelf life validation was conducted. (Assumed satisfactory). |
| Design Verification | Design verification was conducted. (Assumed satisfactory). |
| System Accuracy and Range Verification | System accuracy and range verification was conducted. (Assumed satisfactory and unchanged from predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The testing involved "ADDITIONAL: Sterilization validation and functional compatibility testing" along with other elements like design verification, system accuracy/range verification, biocompatibility, MR safety, packaging, shelf life, and electrical safety. These tests would involve various samples of the device and its components, but specific numbers are not given.
- Data Provenance: Not explicitly stated, though Sirius Medical Systems B.V. is based in the Netherlands. The tests are described as "pre-clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/specified. This document describes pre-clinical validation studies relating to a device modification (resterilization), not a study evaluating human performance or diagnostic accuracy that would typically involve expert-established ground truth on a test set of clinical cases.
4. Adjudication Method for the Test Set
Not applicable/specified. This type of information is generally relevant for studies involving human interpretation or diagnostic decision-making using images or clinical data, where conflicting expert opinions might need to be resolved. This document pertains to validation of a physical device modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this particular submission. The submission is a "Special 510(k)" for a modification (resterilization of the probe) to an already cleared device. MRMC studies are typically used to evaluate the diagnostic accuracy of the entire system (algorithm + human reader) in clinical use, which would have been part of the original device's clearance or a new, significant indication. This document references a "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," but this is not the same as an MRMC study on the effectiveness of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Sirius Pintuition System is a localization system that relies on a physical probe and magnetic seed for non-imaging detection and localization, guided by a human user. There isn't an "algorithm-only" component in the sense of an AI-driven image analysis tool. The device provides "audible and visual cues (distance in mm)" to the user.
7. The Type of Ground Truth Used for the Test Set
The concept of "ground truth" in the context of this submission (a device modification for resterilization) is related to objective physical and biological parameters:
- Sterility Validation: Absence of viable microorganisms after sterilization.
- Functional Compatibility: The device operating within specified performance parameters (e.g., accuracy, range) after resterilization.
- Biocompatibility: Absence of adverse biological reactions to the device materials.
- Safety Standards: Compliance with electrical safety and MR safety standards.
These are established through laboratory testing and engineering verification, not typically through expert consensus, pathology, or outcomes data in the typical sense for diagnostic algorithms.
8. The Sample Size for the Training Set
Not applicable/specified. The Sirius Pintuition System is a magnetic localization device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of image or clinical data for model development. The system operates based on established physical principles of magnetism.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there isn't a "training set" for this type of device. The system's functionality is based on physics and engineered specifications.
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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. 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. 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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 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).
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| SPECIAL 510(K) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| MetaIdentification002575Version2.0ClassificationPUBLICPage2 of 4 | 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 ofComparison | Sirius Pintuition System (Predicate) | Sirius Pintuition System (Changed) | Comparison |
|---|---|---|---|
| 510(k) ID | K200734 | [TBD] | N/A |
| RegulationNumber | §878.4300 | §878.4300 | Same |
| RegulationDescription | Implantable Clip | Implantable Clip | Same |
| RegulatoryClass | Class II | Class II | Same |
| Product Code | PBY | PBY | Same |
| Intended use | Temporary marking of a breast lumpectomysite for surgical removal | Temporary marking of a breast lumpectomysite for surgical removal | Same |
| Indications foruse | The Sirius Pintuition Seed is intended to beplaced percutaneously in the breast to marktemporarily (< 30 days) a lumpectomy siteintended for surgical removal. Using imagingguidance (such as ultrasound orradiography) or aided by non-imagingguidance (Sirius Pintuition Detector) theSirius Pintuition Seed is located andsurgically removed with the target tissue.The Sirius Pintuition Detector is intended forthe non-imaging detection and localizationof the Sirius Pintuition Seed that has beenimplanted in a lumpectomy site intended forsurgical removal. | The Sirius Pintuition Seed is intended to beplaced percutaneously in the breast to marktemporarily (< 30 days) a lumpectomy siteintended for surgical removal. Using imagingguidance (such as ultrasound orradiography) or aided by non-imagingguidance (Sirius Pintuition Detector) theSirius Pintuition Seed is located andsurgically removed with the target tissue.The Sirius Pintuition Detector is intended forthe non-imaging detection and localizationof the Sirius Pintuition Seed that has beenimplanted in a lumpectomy site intended forsurgical removal. | Same |
| Type of Use | Prescription Use | Prescription Use | Same |
| AnatomicalLocations | Breast | Breast | Same |
| Elements ofComparison | Sirius Pintuition System (Predicate) | Sirius Pintuition System (Changed) | Comparison |
| TechnologicalCharacteristics | The Sirius Pintuition System utilizes non-imaging technologies that are comprised ofa console that incorporates electronics anda simple user interface, plus a probehandpiece.A location marker (Pintuition Seed) is placedpercutaneously in situ at the clinical targetsite by a delivery system and then thedetector handpiece is used for theintraoperative detection and localization ofthe implanted marker.The handpiece is connected by a flexiblecable to a console unit that provides theuser with a visual indication of the presenceand proximity of the marker. | The Sirius Pintuition System utilizes non-imaging technologies that are comprised ofa console that incorporates electronics anda simple user interface, plus a probehandpiece.A location marker (Pintuition Seed) is placedpercutaneously in situ at the clinical targetsite by a delivery system and then thedetector handpiece is used for theintraoperative detection and localization ofthe implanted marker.The handpiece is connected by a flexiblecable to a console unit that provides theuser with a visual indication of the presenceand proximity of the marker. | Same |
| Probe type | Handheld, flexible, cord-connected, reusable | Handheld, flexible, cord-connected, reusable | Same |
| Probe tissuecontactingmaterial | Poly Ether Ether Ketone (PEEK) | Poly Ether Ether Ketone (PEEK) | Same |
| Probe sterility | Use of sterile sheath mandatory for use insterile area | Use of sterile sheath no longer mandatory ifsterilization is performed. | CHANGED |
| ReprocessingInstructions | Manual, wipe-based cleaning anddisinfection | Manual, wipe-based cleaning anddisinfection | Same |
| Manual, immersion based high-leveldisinfection | Manual, immersion based high-leveldisinfection | Same | |
| No sterilization option provided. | Sterilization in STERRAD NX and NX100systems | CHANGED | |
| User Feedback | Real-time visual and audible | Real-time visual and audible | Same |
| Sensing Depth | 0-50 mm | 0-50 mm | Same |
| Seed/MarkerMaterials | Commercially Pure Titanium Grade II(Tissue-contacting)Neodymium magnet (Internal) | Commercially Pure Titanium Grade II(Tissue-contacting)Neodymium magnet (Internal) | Same |
| Seed/Markerdiameter | 1.65mm | 1.65mm | Same |
| Seed/Markerlength | 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 devicegauge | 14G | 14G | Same |
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| Meta | SPECIAL 510(K) |
|---|---|
| Identification | 002575 |
| Version | 2.0 |
| Classification | PUBLIC |
|---|---|
| Page | 3 of 4 |
| Title | sirius medical |
|---|---|
| ------- | ---------------- |
K200734 Sirius Pintuition Probe Modification: Resterilization
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| 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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.