(336 days)
The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue.
The Sirius Pintuition Detector is intended only for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
The Sirius Pintuition Seed and Sirius Pintuition Detector (consisting of Base Unit and Probe) are part of the Sirius Pintuition Localization System.
The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length variants).
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 surgery to plan the surgical approach and quide 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.
Here's a summary of the acceptance criteria and study information for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for performance (e.g., a specific accuracy threshold or a certain rate of successful localization). Instead, it lists various pre-clinical tests and a clinical evaluation to demonstrate safety and performance.
However, based on the Summary of Technological Characteristics and the Summary of Non-Clinical Performance Data, we can infer the aspects that were evaluated to ensure the device performs as intended:
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| System accuracy and range | Verified through pre-clinical testing |
| Biocompatibility | Evaluated through pre-clinical testing |
| MR Safety | Tested through pre-clinical testing |
| Sterilization validation | Validated through pre-clinical testing |
| Packaging validation | Validated through pre-clinical testing |
| Shelf-life validation | Validated through pre-clinical testing |
| Electrical safety | Tested through pre-clinical testing |
| Compatibility with implanted AIMDs | Analyzed through pre-clinical testing |
| Clinical Safety and Performance | Supported by clinical evaluation and literature data |
| Functional operation as intended | Verified and validated through non-clinical testing |
| Meeting design specifications | Verified and validated through non-clinical testing |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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 performance 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 in various soft tissue types."
- Sample Size: The document does not specify a numerical sample size for the test set of the clinical evaluation. It refers to "available data," "clinical safety and performance data," and "extensive evaluation of available literature data."
- Data Provenance: The data provenance is described as a combination of:
- Data from the "actual device" (implying prospective or recent retrospective studies specific to this version).
- Data from a "previous version of the device."
- "Extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices." This indicates that the provenance is varied and includes retrospective literature reviews.
- Country of Origin: The country of origin for the clinical data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). The clinical evaluation is broad and references existing clinical data and literature.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore does not provide an effect size for human readers with vs. without AI assistance. The device in question (Sirius Pintuition) is a localization system, not an AI software intended to assist human readers in image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Sirius Pintuition system is designed to be used by a human operator ("Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and guidesurgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm)").
Therefore, a standalone performance study without human-in-the-loop would not be applicable or relevant to its intended use, and the document does not describe such a study. The "System accuracy and range verification" under non-clinical data would assess the device's inherent capability, but always within the context of a user interacting with it.
7. Type of Ground Truth Used
Based on the description of the device's function (locating and surgically removing the target tissue along with the implanted seed), the ground truth for clinical evaluation would likely involve:
- Pathology: To confirm whether the resected tissue contained the target lesion and the implanted seed.
- Surgical Confirmation: Direct visual or palpation confirmation during surgery of successful seed and lesion removal.
- Imaging Confirmation: Post-operative imaging (e.g., X-ray, ultrasound) to confirm removal of the seed and, if applicable, the target lesion.
The document does not explicitly state "pathology" or "outcome data" as ground truth, but given the indication for surgical removal, these are the most logical forms of truth. The clinical evaluation supported "safety and performance," which inherently relies on such confirmation.
8. Sample Size for the Training Set
The Sirius Pintuition system is a hardware device for localization based on magnetic principles, not a machine learning or AI algorithm in the context of image analysis that typically requires a "training set." Therefore, the concept of a "training set" in the context of an algorithm or AI is not applicable to this device as described.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" doesn't apply to this type of device, this question is not relevant to the information provided.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 9, 2023
Sirius Medical Systems B.V. Bram Schermers CEO High Tech Campus 41 Eindhoven, North-Brabant 5656AE Netherlands
Re: K223682
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: NEU Dated: October 10, 2023 Received: October 10, 2023
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 (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"
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(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 OS 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).
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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Alexander Nguyen -S 2023.11.09 16:45:00 -05'00'
for Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K223682
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 soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue.
The Sirius Pintuition Detector is intended only for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue 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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| 510(K) | K223682 | |||
|---|---|---|---|---|
| sirius medical | Meta | Identification | Version | |
| Classification | 003075 | 3.0 | ||
| PUBLIC | Page | 1 of 4 | ||
| Title | ||||
| Sirius Pintuition Modification - Indication Extension |
1 510(k) Summary
1.1 Submitter Information
| Submitter's name: | Sirius Medical Systems B.V. |
|---|---|
| Address: | High Tech Campus 415656 AEEindhovenThe Netherlands |
| Contact Person: | Bram SchermersCEO |
| Telephone: | 0031 6 2011 6299 |
| E-mail: | bram.schermers@sirius-medical.com |
| Date summary prepared: | Thursday, November 9, 2023 |
1.2 Device Information
| Trade name: | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius PintuitionBase Unit |
|---|---|
| Common name / device: | Tissue Marker |
| Regulation description: | Implantable Clip |
| Regulation number: | 21 CFR 878.4300 |
| Regulatory Class: | Class II |
| Review Panel: | General & Plastic Surgery |
| Product Code: | NEU |
1.3 Predicate and Reference Devices
| 510(k)Number | Trade Name | Submitter | ProductCode | PrimaryPredicate(A) | ReferenceDevice (B) |
|---|---|---|---|---|---|
| K222643 | Sirius Pintuition Seed, SiriusPintuition Probe, SiriusPintuition Base Unit | SiriusMedicalSystems | PBY | X | |
| K200734 | Sirius Pintuition Seed, SiriusPintuition Probe, SiriusPintuition Base Unit | SiriusMedicalSystems | PBY | X | |
| K181007 | Cianna Medical SAVI ScoutReflector and SAVI ScoutSystem | CiannaMedical, Inc. | NEU | X |
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| 510(K) | K223682 | ||||
|---|---|---|---|---|---|
| sirius medical | Meta | Identification | Version | ||
| 003075 | 3.0 | ||||
| Classification | Page | ||||
| PUBLIC | 2 of 4 |
Title
Sirius Pintuition Modification - Indication Extension
| 510(k)Number | Trade Name | Submitter | ProductCode | PrimaryPredicate(A) | ReferenceDevice (B) |
|---|---|---|---|---|---|
| K183400 | EnVisio Navigation Sytem | ElucentMedical, Inc | NEU | X | |
| K181692 | 5cm Tag Applicator, 7cm TagApplicator, 10 Cm TagApplicator, 5 Cm TagApplicator (10 Pack), 7 | HealthBeacons,Inc. | NEU | X |
1.4 Device Description
The Sirius Pintuition Seed and Sirius Pintuition Detector (consisting of Base Unit and Probe) are part of the Sirius Pintuition Localization System.
The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length variants).
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 surgery to plan the surgical approach and quide 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.
1.5 Intended Use
The Sirius Pintuition Seed is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue 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 only for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
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| sirius medical | 510(K) | K223682 | |||
|---|---|---|---|---|---|
| Meta | Identification | 003075 | Version | 3.0 | |
| Classification | PUBLIC | Page | |||
| 3 of 4 |
Title
Sirius Pintuition Modification – Indication Extension
Summary of Technological Characteristics 1.6
| Elements ofComparison | Sirius Pintuition System (Predicate,K222643) | Sirius Pintuition System (Modified) | Comparison |
|---|---|---|---|
| SYSTEM | |||
| 510(k) ID | K222643 | K223682 | N/A |
| RegulationNumber | §878.4300 | §878.4300 | Same |
| Product CodeDescription | Implantable Clip | Marker, Radiographic, Implantable | MODIFIED¹ |
| Regulatory Class | Class II | Class II | Same |
| Product Code | PBY | NEU | MODIFIED¹ |
| Intended use | Temporary (<30 days) marking of a breastlumpectomy site intended for surgicalremoval | Long-term (>30 days) marking of a biopsysite or a soft tissue site intended for surgicalremoval | MODIFIED |
| Indications foruse | The Sirius Pintuition Seed is intended to beplaced percutaneously in the breast to marktemporarily (< 30 days) a lumpectomy siteintended for surgical removal. Usingimaging guidance (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 soft tissue to mark(>30 days) a biopsy site or a soft tissue siteintended for surgical removal. Usingimaging guidance (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 intendedonly for the non-imaging detection andlocalization of the Sirius Pintuition Seed thathas been implanted in a soft tissue biopsysite or a soft tissue site intended for surgicalremoval. | MODIFIED |
| Type of Use | Prescription Use | Prescription Use | Same |
| AnatomicalLocations | Breast | Soft tissue | MODIFIED |
| 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 (NO CHANGE) | |||
| 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 |
| User Feedback | Real-time visual and audible | Real-time visual and audible | Same |
| Sensing Depth | 0-50 mm | 0-50 mm | Same |
1 PBY is the product code for 'Temporary Tissue Marker'. The current 510(k) is intended to extend the implantation duration for the Seed beyond what could be considered temporary, it is therefore more suited to be classified as
"Marker, Radiographic, Implantable", which is code NEU, and m
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| 510(K) | K223682 | ||||
|---|---|---|---|---|---|
| Meta | Identification | 003075 | Version | 3.0 | |
| Classification | PUBLIC | Page | |||
| 4 of 4 |
Title
Sirius Pintuition Modification - Indication Extension
| Elements ofComparison | Sirius Pintuition System (Predicate,K222643) | Sirius Pintuition System (Modified) | Comparison |
|---|---|---|---|
| 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 |
| DELIVERY DEVICE (NO CHANGE) | |||
| 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 |
1.7 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:
- Design verification ●
- System accuracy and range verification .
- Biocompatibility evaluation .
- MR safety testing
- . Sterilization validation
- . Packaging validation
- Shelf-life validation .
- Electrical safety testing .
- . Compatibility analysis Pintuition Seed and implanted AIMDs
1.8 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 performance 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 in various soft tissue types.
1.9 Conclusion
The Sirius Pintuition Localization System has been compared to the legally marketed device (K222643) with respect to technological characteristics, performance, safety characteristics, labeling, and is similar in Intended Use. Non-clinical testing was conducted to verify and validate the performance of the device and ensure the Sirius Pintuition Localization System functions as intended and meets design specifications to perform the intended use. The device is identical to the predicate device, apart from the modifications for use. These changes do not impact substantial equivalence, and the devices can be considered to be substantially equivalent.
§ 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.