(341 days)
Not Found
No
The device description and principle of operation are based on magnetism for detection and localization, with no mention of AI or ML algorithms for data processing, interpretation, or decision-making.
No.
The device is used for localizing a lumpectomy site for surgical removal and guiding surgery, not for treating a disease or condition.
No
The device is a localization system used to mark and find a surgical site, not to diagnose a condition. It aids in guiding surgical removal rather than identifying or characterizing a disease.
No
The device description clearly outlines both hardware components (Sirius Pintuition Seed, Sirius Pintuition Detector which includes a Base Unit and Probe) and their physical interaction based on magnetism. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sirius Pintuition Localization System is a medical device used for localization of a surgical target (lumpectomy site) within the breast. It involves implanting a marker and using a detector to find it. This is a surgical guidance tool, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use clearly states the device is for "marking temporarily... a lumpectomy site intended for surgical removal" and for "non-imaging detection of the Sirius Pintuition Seed... implanted in a lumpectomy site intended for surgical removal." This describes a surgical localization and guidance procedure, not an in vitro diagnostic test.
Therefore, the Sirius Pintuition Localization System falls under the category of a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (
§ 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.
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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
1
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
2
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 ( ☑ 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 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 (