(139 days)
Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.
The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.
Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .
The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.
This document describes the Planmed Nuance DigiGuide, a stereotactic biopsy system for Full Field Digital Mammography (FFDM). The submission is a 510(k) premarket notification (K121963) to the FDA.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for the Planmed Nuance DigiGuide does not explicitly define quantitative acceptance criteria for its performance. Instead, it relies on a comparison to a predicate device and qualitative assessments.
| Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device | Device functions similarly, has similar design and composition. | Considered similar in design, composition, and function to K021945 Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) = Planmed DigiGuide. The biopsy procedure, needle guidance unit, and control are the same. |
| Image Quality (Clinical Test) | At least equal to the old system (predicate device). | The image quality scored was at least equal to the old system. |
| Accuracy and Reliability (Clinical Test) | Accurate and reliable in clinical use. | The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use. |
| Compliance with Set Specifications (Nonclinical) | Compliance with set specifications. | Nonclinical verification tests at the factory and accuracy tests by a 3rd party show compliance with set specifications. |
| Workflow Improvement (Implicit) | Faster and more accurate procedure due to technical differences. | Removes the need to move the detector between stereo exposures and mark the reference in images, "making the procedure faster and more accurate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 20 stereotactic biopsies.
- Data Provenance: Conducted at a mammography screening facility. The information does not explicitly state the country of origin, but the manufacturer is based in Finland. It is a prospective clinical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the 20 stereotactic biopsies. It mentions "a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system," implying experienced healthcare professionals were involved in the clinical evaluation.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the clinical test set. It describes the "end result" of the comparison study, suggesting a consensus or evaluation process by the clinical site's staff.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI versus without AI assistance?
No MRMC comparative effectiveness study was mentioned. This device is a hardware system for biopsy guidance, not an AI-assisted diagnostic tool for human readers. The clinical test was a comparison of the new hardware system to its predicate, focusing on image quality, accuracy, and reliability during the biopsy procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
This is not applicable as the Planmed Nuance DigiGuide is a hardware system for biopsy guidance, requiring human operation. It is not an algorithm with standalone performance.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was likely defined by the success and accuracy of the biopsy procedure itself, including successful tissue acquisition and the clinical assessment of the system's performance (image quality, accuracy, reliability) by experienced users at the mammography screening facility. It is implied to be expert clinical assessment rather than pathology or outcomes data specifically. The statement "The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use" suggests a clinical consensus on performance.
8. The Sample Size for the Training Set
No training set is mentioned as this device is a hardware system, not a machine learning algorithm requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Planm K121963
510K) SUMMARY
DATE October 12, 2012 NOV 2 1 2012
PRODUCT, CLASSIFICATION NAME
Trade name: Planmed Nuance DigiGuide Common name: Stereotactic biopsy for Full Field Digital Mammography (FFDM) System Classification: MUE, Class II Regulation number: 21 CFR 892.1715
MANUFACTURER
Planmed Oy Asentajankatu 6 / Sorvaajankatu 7 FI-00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planmed Nuance DigiGuide is an optional system for stereotactic biopsy. It consists of a needle guidance unit attached to Planmed Nuance or Planmed Nuance Excel digital mammographic Xrav units.
The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.
PRODUCT DESCRIPTION
Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .
The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.
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SUBSTANTIAL EQUIVALENCE
We consider this product modification to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
K021945 Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) = Planmed DigiGuide
The biopsy procedure is the same in both systems. Also the needle guidance unit and its control are the same. The main technical difference between the two systems is the detector used. The new system removes 1) the need to move the detector between the stereo exposures, and 2) also the need to mark the reference in the images, making the procedure faster and more accurate.
The nonclinical verification tests made at the factory and accuracy tests conducted by a 3ª party show compliance with set specifications.
The clinical tests were conducted at a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system. The comparison study included 20 stereotactic biopsies. The end result was that the image quality scored was at least equal with the old system. The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use.
The comparison of characteristics supports substantial equivalence. Planmed Nuance DigiGuide is as safe and effective as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services, featuring three curved lines emanating from a central point.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2012
Planmed OY % Mr. Bob Pienkowski Managing Director 100 North Gary Avenue, Suite A ROSELLE IL 60172
Re: K121963
Trade/Device Name: Planmed Nuance DigiGuide Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: MUE Dated: October 12, 2012 Received: October 17, 2012
Dear Mr. Pienkowski:
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. 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.
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
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Robert A. Ochs
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121963
Device Name: Planmed Nuance DigiGuide
Indications for Use:
Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.
The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Robert A. Ochs 2012.11.21 10:46:32 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
. 510(k)
Page 1 of
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.