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

K200734 · Sirius Medical Systems B.V. · PBY · Feb 24, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K200734
• 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: Feb 24, 2021
• 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 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.

Device Story

System consists of implantable Pintuition Seed, handheld Pintuition Probe, and mains-powered Pintuition Base Unit. Seed (1.65 x 5mm, Titanium-encased Neodymium magnet) placed percutaneously in breast tissue via 14G needle. Probe detects magnetic field generated by seed; base unit processes signal to provide real-time audible and visual distance feedback (0-50mm range) to surgeon. Used in clinical/surgical settings to guide lumpectomy procedures. Enables precise localization of target tissue for excision; benefits patient by facilitating accurate removal of breast lesions.

Clinical Evidence

Clinical evaluation included performance data from the subject device, a previous version, and literature review of the predicate and benchmark devices. No specific clinical trial metrics (e.g., sensitivity/specificity) provided in summary; safety and effectiveness supported by design verification, system accuracy/range testing, biocompatibility, MR safety, and sterilization validation.

Technological Characteristics

System uses magnetic sensing. Seed: Grade II Titanium exterior, Neodymium magnet core. Probe: PEEK tissue-contacting material. Delivery: 14G 304 stainless steel needle. Connectivity: Cable-connected probe to console. Sterilization: Ethylene Oxide. Sensing depth: 0-50mm. Visual/audible feedback.

Indications for Use

Indicated for patients requiring temporary (<30 days) marking of a breast lumpectomy site for surgical removal. Used for percutaneous placement of a tissue marker and subsequent intraoperative detection/localization of the marker to guide surgical excision.

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

• Endomag Magseed and Sentimag (K163541)

Submission Summary (Full Text)

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February 24, 2021

Sirius Medical Systems B.V. Bram Schermers Clinical Application Specialist High Tech Campus 41 Eindhoven, North Brabant 5656AE Netherlands

Re: K200734

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: January 18, 2021 Received: January 25, 2021

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

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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 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. 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)

## K200734

Device Name

Sirius Pintuition Localization System (Sirius Pintuition Seed and Sirius Pintuition Detector)

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 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 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) | |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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| | PREMARKET NOTIFICATION 510(k) | | |
|--------------------------------------------|-------------------------------|--|--|
| <img alt="sirius medical logo" src="..."/> | | | |

| Meta | |
|----------------|-----------|
| Identification | 001015 |
| Version | 2.0 |
| Classification | PUBLIC |
| Page | 15 of 121 |

Sirius Pintuition Localization System (Sirius Pintuition Seed and Sirius Pintuition Detector)

### 5 510(k) Summary

#### 5.1 Submitter Information

| Submitter's name: | Sirius Medical Systems B.V. |
|------------------------|-----------------------------------|
| Address: | High Tech Campus 41 |
| | 5656 AE |
| | Eindhoven |
| | The Netherlands |
| Contact Person: | Bram Schermers |
| | Product Owner |
| Telephone: | 0031 6 2011 6299 |
| E-mail: | [e-mail] |
| Date summary prepared: | March 9th, 2020 |

#### 5.2 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 |

#### 5.3 Predicate Device

Endomag Magseed and Sentimag (K163541)

#### 5.4 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 (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.

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| | PREMARKET NOTIFICATION 510(k) | | |
|----------------|-------------------------------|----------------|-----------|
| | Meta | Identification | Version |
| sirius medical | | 001015 | 2.0 |
| | Classification | | Page |
| | PUBLIC | | 16 of 121 |

# Sirius Pintuition Localization System (Sirius Pintuition Seed and Sirius Pintuition Detector)

#### 5.5 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.

#### Summary of Technological Characteristics 5.6

| Elements of<br>Comparison | Sirius Pintuition System | Predicate: Magseed Magnetic Marker<br>System | Comparison | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|
| | SYSTEM | | | | |
| 510(k) ID | [TBD] | K163541 | 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<br>lumpectomy site for surgical removal | Temporary marking of a breast<br>lumpectomy site for surgical removal | Same | | |
| Indications<br>for use | The Sirius Pintuition Seed is intended to<br>be placed percutaneously in the breast<br>to mark temporarily (< 30 days) a<br>lumpectomy site intended for surgical<br>removal. Using imaging guidance (such<br>as ultrasound or radiography) or aided<br>by non-imaging guidance (Sirius<br>Pintuition Detector) the Sirius Pintuition<br>Seed is located and surgically removed<br>with the target tissue.<br>The Sirius Pintuition Detector is<br>intended for the non-imaging detection<br>and localization of the Sirius Pintuition | The Endomag Magseed Magnetic Marker<br>is intended to be placed percutaneously in<br>the breast to mark temporarily (< 30 days)<br>a lumpectomy site intended for surgical<br>removal. Using imaging guidance (such as<br>ultrasound or radiography) or aided by non-<br>imaging guidance (Endomag Sentimag®<br>System) the Endomag Magseed Magnetic<br>Marker is located and surgically removed<br>with the target tissue.<br>The Endomag Sentimag® System is<br>intended for the non-imaging detection and<br>localization of the "Endomag Magseed | Same | | |
| | Seed that has been implanted in a<br>lumpectomy site intended for surgical<br>removal. | Magnetic Marker" that has been implanted<br>in a lumpectomy site intended for surgical<br>removal | | | |
| Type of Use | Prescription Use | Prescription Use | Same | | |
| Anatomical<br>Locations | Breast | Breast | Same | | |

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| | PREMARKET NOTIFICATION 510(k) | | |
|----------------|-------------------------------|----------------|-----------|
| | Meta | Identification | Version |
| sirius medical | | 001015 | 2.0 |
| | Classification | | Page |
| | PUBLIC | | 17 of 121 |

Title

# Sirius Pintuition Localization System (Sirius Pintuition Seed and Sirius Pintuition Detector)

| Elements of<br>Comparison | Sirius Pintuition System | Predicate: Magseed Magnetic Marker<br>System | Comparison |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Techno-<br>logical<br>Charac-<br>teristics | The Sirius Pintuition System utilizes<br>non-imaging technologies that are<br>comprised of a console that<br>incorporates electronics and a simple<br>user interface, plus a probe handpiece.<br><br>A location marker (Pintuition Seed) is<br>placed percutaneously in situ at the<br>clinical target site by a delivery system<br>and then the detector handpiece is used<br>for the intraoperative detection and<br>localization of the implanted marker.<br><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<br>presence and proximity of the marker. | The Magseed Magnetic Marker System<br>utilizes non-imaging technologies that are<br>comprised of a console that incorporates<br>electronics and a simple user interface,<br>plus a probe handpiece.<br><br>A location marker (Magseed) 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><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<br>presence and proximity of the marker. | Same |
| DETECTOR | | | |
| Probe type | Handheld, flexible, cord-connected,<br>reusable | Handheld, flexible, cord-connected,<br>reusable | Same |
| Probe tissue<br>contacting<br>material | Poly Ether Ether Ketone (PEEK) | Poly Ether Ether Ketone (PEEK) | Same |
| User<br>Feedback | Real-time visual and audible | Real-time visual and audible | Same |
| Sensing<br>Depth | 0-50 mm | 0-30 mm | Similar. Sirius<br>Pintuition System<br>has improved<br>sensing depth. |
| SEED/MARKER | | | |
| Seed/Marker<br>Materials | Commercially Pure Titanium Grade II<br>(Tissue-contacting)<br>Neodymium magnet (Internal) | Surgical Grade Stainless Steel | Similar. Both<br>biocompatible<br>exterior. Internal<br>material different<br>due to different use<br>of magnetism. |
| Seed/Marker<br>diameter | 1.65mm | 1.0mm | Similar. Pintuition<br>Seed is slightly<br>larger to enable<br>greater sensing<br>depth. |
| Seed/Marker<br>length | 5.20mm | 5.0mm | Similar |
| Sterility | Ethylene Oxide | Ethylene Oxide | Same |
| Visibility | X-ray, Ultrasound | X-ray, Ultrasound | Same |
| DELIVERY DEVICE | | | |
| Type | Preloaded, single-use, needle implanter | Preloaded, single-use, needle implanter | Same |
| Material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Elements of<br>Comparison | Sirius Pintuition System | Predicate: Magseed Magnetic Marker<br>System | Comparison |
| Delivery<br>device gauge | 14G | 18G | Similar. Pintuition<br>gauge is slightly<br>larger to enable<br>implantation of<br>larger Seed. |

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| | PREMARKET NOTIFICATION 510(k) | | |
|----------------|-------------------------------|----------------|-----------|
| | Meta | Identification | Version |
| sirius medical | | 001015 | 2.0 |
| | Classification | Page | |
| | PUBLIC | | 18 of 121 |

Sirius Pintuition Localization System (Sirius Pintuition Seed and Sirius Pintuition Detector)

#### 5.7 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

#### 5.8 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.
#### 5.9 Conclusion

The Sirius Pintuition Localization System has the same Intended Use as the predicate device. The different technological characteristics have not led to additional questions of safety or effectiveness. The data presented in the remainder of this submission show substantial equivalence of the Sirius Pintuition Localization System with the predicate device.