Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Device Facts
| Record ID | K223682 |
|---|---|
| Device Name | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
| Applicant | Sirius Medical Systems B.V. |
| Product Code | PBY · General, Plastic Surgery |
| Decision Date | Nov 9, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
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.
Device Story
System consists of implantable Titanium seed, handheld probe, and base unit; used for soft tissue localization. Seed implanted percutaneously into biopsy/surgical site; acts as magnetic marker. During surgery, surgeon uses probe to detect seed; magnetic field sensing determines seed location. Base unit provides real-time audible and visual distance cues to surgeon. Enables precise surgical approach and removal of target tissue. Used in clinical settings; operated by physicians. Benefits include accurate localization of non-palpable lesions, facilitating surgical excision.
Clinical Evidence
Clinical evaluation included data from the subject device, previous versions, and literature review of the predicate and benchmark devices across various soft tissue types. Data supports safety and performance for the intended use.
Technological Characteristics
Implant: Commercially Pure Titanium Grade II, Neodymium magnet; 1.65mm x 5.20mm. Delivery: 14G 304 Stainless Steel needle. Detector: Handheld PEEK probe, cord-connected to mains-powered base unit. Sensing: Magnetic field detection (0-50mm range). Sterilization: Ethylene Oxide. Connectivity: Wired probe-to-console.
Indications for Use
Indicated for patients requiring percutaneous marking of soft tissue biopsy sites or sites intended for surgical removal for periods exceeding 30 days. Used for localization and surgical removal of target tissue.
Regulatory Classification
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Predicate Devices
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K222643)
Reference Devices
- Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K200734)
- Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007)
- EnVisio Navigation Sytem (K183400)
- 5cm Tag Applicator, 7cm Tag Applicator, 10 Cm Tag Applicator, 5 Cm Tag Applicator (10 Pack), 7 (K181692)
Related Devices
- K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit · Sirius Medical Systems B.V. · Feb 24, 2021
- K252892 — SCOUT MD Surgical Guidance System · Merit Medical Systems, Inc. · Dec 19, 2025
- K232865 — Magseed Pro Magnetic Marker System · Endomagnetics Ltd., · Jun 28, 2024
- K163541 — Magseed Magnetic Marker System · Endomagnetics Ltd., · Jan 13, 2017
- K193189 — RFID Localization System · Health Beacons, Inc. · May 6, 2020
Submission Summary (Full Text)
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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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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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 41<br>5656 AE<br>Eindhoven<br>The Netherlands |
| Contact Person: | Bram Schermers<br>CEO |
| 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 Pintuition<br>Base 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)<br>Number | Trade Name | Submitter | Product<br>Code | Primary<br>Predicate<br>(A) | Reference<br>Device (B) |
|------------------|------------------------------------------------------------------------------------|------------------------------|-----------------|-----------------------------|-------------------------|
| K222643 | Sirius Pintuition Seed, Sirius<br>Pintuition Probe, Sirius<br>Pintuition Base Unit | Sirius<br>Medical<br>Systems | PBY | X | |
| K200734 | Sirius Pintuition Seed, Sirius<br>Pintuition Probe, Sirius<br>Pintuition Base Unit | Sirius<br>Medical<br>Systems | PBY | | X |
| K181007 | Cianna Medical SAVI Scout<br>Reflector and SAVI Scout<br>System | Cianna<br>Medical, 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)<br>Number | Trade Name | Submitter | Product<br>Code | Primary<br>Predicate<br>(A) | Reference<br>Device (B) |
|------------------|---------------------------------------------------------------------------------------------------------|----------------------------|-----------------|-----------------------------|-------------------------|
| K183400 | EnVisio Navigation Sytem | Elucent<br>Medical, Inc | NEU | | X |
| K181692 | 5cm Tag Applicator, 7cm Tag<br>Applicator, 10 Cm Tag<br>Applicator, 5 Cm Tag<br>Applicator (10 Pack), 7 | Health<br>Beacons,<br>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 of<br>Comparison | Sirius Pintuition System (Predicate,<br>K222643) | Sirius Pintuition System (Modified) | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| SYSTEM | | | |
| 510(k) ID | K222643 | K223682 | N/A |
| Regulation<br>Number | §878.4300 | §878.4300 | Same |
| Product Code<br>Description | 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 breast<br>lumpectomy site intended for surgical<br>removal | Long-term (>30 days) marking of a biopsy<br>site or a soft tissue site intended for surgical<br>removal | MODIFIED |
| 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<br>imaging 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 soft tissue to mark<br>(>30 days) a biopsy site or a soft tissue site<br>intended for surgical removal. Using<br>imaging 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<br>only for the non-imaging detection and<br>localization of the Sirius Pintuition Seed that<br>has been implanted in a soft tissue biopsy<br>site or a soft tissue site intended for surgical<br>removal. | MODIFIED |
| Type of Use | Prescription Use | Prescription Use | Same |
| Anatomical<br>Locations | Breast | Soft tissue | MODIFIED |
| 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 (NO CHANGE) | | | |
| 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 |
| User Feedback | Real-time visual and audible | Real-time visual and audible | Same |
| Sensing Depth | 0-50 mm | 0-50 mm | Same |
<sup>1</sup> 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 of<br>Comparison | Sirius Pintuition System (Predicate,<br>K222643) | Sirius Pintuition System (Modified) | Comparison |
|-----------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------|
| 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 |
| 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 device<br>gauge | 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.
