(226 days)
The Smart Finder is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
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This document, K203509, is a 510(k) clearance letter for a mammographic x-ray system called "SMART FINDER." It primarily covers the administrative aspects of the device's clearance for marketing. It does not contain information regarding detailed acceptance criteria, study methodologies, performance metrics (such as sensitivity, specificity, AUC), sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/CAD device.
The "SMART FINDER" device, as described, is intended for "mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement." This suggests it's a hardware device used for image-guided procedures, not an AI or CAD software that analyzes images for diagnostic aid.
Therefore,Based on the provided text, I cannot provide the requested information about device acceptance criteria and the study proving it meets them. The document is a 510(k) clearance letter for a medical device called "SMART FINDER," which is described as a "mammographic x-ray system" used for stereotactic guidance in procedures like fine needle aspiration and biopsy.
This document does NOT contain the following information:
- A table of acceptance criteria and reported device performance: This letter is an administrative clearance, not a technical report on performance.
- Sample sizes used for the test set and data provenance: No study details are provided.
- Number of experts used to establish ground truth and their qualifications: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: No study details are provided.
- If a standalone (algorithm only) performance study was done: No study details are provided.
- The type of ground truth used: No study details are provided.
- The sample size for the training set: No study details are provided.
- How the ground truth for the training set was established: No study details are provided.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. However, the details of the studies and data used to demonstrate this substantial equivalence are not included in this administrative letter.
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July 14, 2021
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IMS Giotto S.p.A. % Ms. Marisa Testa CEO- QA/RA Consultant THEMA S.r.l. Via Saragat, 5 Imola, BO 40026 ITALY
Re: K203509
Trade/Device Name: SMART FINDER Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: Class II Product Code: IZH Dated: June 11, 2021 Received: June 14, 2021
Dear Ms. Testa:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K203509
Device Name SMART FINDER
Indications for Use (Describe)
The Smart Finder is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.