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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Sirius Pintuition Localization System. While it discusses the device's intended use, technological characteristics, and a summary of non-clinical and clinical performance data, it does not explicitly detail a study proving the device meets acceptance criteria in the format or with the specific quantitative data requested in your prompt.

Specifically, the document states:

"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..." (page 18, section 5.7). This indicates that such tests were performed, but the document does not provide the acceptance criteria table or the reported device performance results from these tests.
"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." (page 18, section 5.8). This describes a clinical evaluation based on various data sources, but it does not outline a specific comparative clinical study (like an MRMC study) or provide details on how "safety and effectiveness" were quantified for this specific device against defined criteria.

Therefore, I cannot extract the information required to populate the fields in your request comprehensively from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing quantitative performance against specific acceptance criteria in a comprehensive study report.

In summary, the document lacks the specific details required for:

A table of acceptance criteria and reported device performance: No such table or detailed performance data is present.
Sample size and data provenance for the test set: Not specified for any quantitative clinical or performance test.
Number of experts and qualifications for ground truth: Not applicable as no explicit 'ground truth' establishment for a diagnostic test is described.
Adjudication method: Not applicable.
MRMC comparative effectiveness study details (effect size, human readers improvement): No such study is mentioned or detailed. The clinical evaluation refers to literature reviews and data from previous versions/predicate, not a direct human reader study with this device.
Standalone (algorithm only) performance: Not applicable, as this is a physical device, not an AI algorithm.
Type of ground truth used: Not applicable for device performance (rather than diagnostic accuracy).
Sample size for training set: Not applicable, as it's not an AI model.
How ground truth for training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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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	PREMARKET NOTIFICATION 510(k)

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:	bram.schermers@sirius-medical.com
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 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 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 ofComparison	Sirius Pintuition System	Predicate: Magseed Magnetic MarkerSystem	Comparison
	SYSTEM
510(k) ID	[TBD]	K163541	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 breastlumpectomy site for surgical removal	Temporary marking of a breastlumpectomy site for surgical removal	Same
Indicationsfor use	The Sirius Pintuition Seed is intended tobe placed percutaneously in the breastto mark temporarily (< 30 days) alumpectomy site intended for surgicalremoval. Using imaging guidance (suchas ultrasound or radiography) or aidedby non-imaging guidance (SiriusPintuition Detector) the Sirius PintuitionSeed is located and surgically removedwith the target tissue.The Sirius Pintuition Detector isintended for the non-imaging detectionand localization of the Sirius Pintuition	The Endomag Magseed Magnetic Markeris intended to be placed percutaneously inthe breast to mark temporarily (< 30 days)a lumpectomy site intended for surgicalremoval. Using imaging guidance (such asultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimag®System) the Endomag Magseed MagneticMarker is located and surgically removedwith the target tissue.The Endomag Sentimag® System isintended for the non-imaging detection andlocalization of the "Endomag Magseed	Same
	Seed that has been implanted in alumpectomy site intended for surgicalremoval.	Magnetic Marker" that has been implantedin a lumpectomy site intended for surgicalremoval
Type of Use	Prescription Use	Prescription Use	Same
AnatomicalLocations	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 ofComparison	Sirius Pintuition System	Predicate: Magseed Magnetic MarkerSystem	Comparison
Techno-logicalCharac-teristics	The Sirius Pintuition System utilizesnon-imaging technologies that arecomprised of a console thatincorporates electronics and a simpleuser interface, plus a probe handpiece.A location marker (Pintuition Seed) isplaced percutaneously in situ at theclinical target site by a delivery systemand then the detector handpiece is usedfor the intraoperative detection andlocalization of the implanted marker.The handpiece is connected by a flexiblecable to a console unit that provides theuser with a visual indication of thepresence and proximity of the marker.	The Magseed Magnetic Marker Systemutilizes non-imaging technologies that arecomprised of a console that incorporateselectronics and a simple user interface,plus a probe handpiece.A location marker (Magseed) 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 thepresence and proximity of the marker.	Same
DETECTOR
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
UserFeedback	Real-time visual and audible	Real-time visual and audible	Same
SensingDepth	0-50 mm	0-30 mm	Similar. SiriusPintuition Systemhas improvedsensing depth.
SEED/MARKER
Seed/MarkerMaterials	Commercially Pure Titanium Grade II(Tissue-contacting)Neodymium magnet (Internal)	Surgical Grade Stainless Steel	Similar. Bothbiocompatibleexterior. Internalmaterial differentdue to different useof magnetism.
Seed/Markerdiameter	1.65mm	1.0mm	Similar. PintuitionSeed is slightlylarger to enablegreater sensingdepth.
Seed/Markerlength	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 ofComparison	Sirius Pintuition System	Predicate: Magseed Magnetic MarkerSystem	Comparison
Deliverydevice gauge	14G	18G	Similar. Pintuitiongauge is slightlylarger to enableimplantation oflarger 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.

Regulation Number and Section

§ 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.