(165 days)
No
The summary describes a software option that uses stereotactic pairs of 2D X-ray images to determine the 3D location of lesions for biopsy guidance. There is no mention of AI, ML, or any related terms, nor is there any description of training or test sets typically associated with AI/ML development. The focus is on image acquisition and geometrical accuracy for localization.
No.
This device is for guidance of minimally invasive or interventional procedures, such as biopsy, and not for treating a disease or condition.
No
The device is described as a "Biopsy System" that provides guidance for "minimally invasive or interventional procedures in the breast," such as biopsy and pre-surgical localization, using information from medical images. While it uses imaging data to locate lesions, its primary function is to guide interventional procedures rather than to diagnose conditions. The term "diagnostic device" usually refers to devices that identify or detect disease, which is distinct from guiding procedures to address confirmed or suspected disease.
Yes
The device is described as an "additional software option" that builds upon an existing hardware platform (Senographe Pristina) and does not require any hardware modification. The description explicitly states the add-on includes "Software: A new software version".
Based on the provided information, the Pristina Serena Bright device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The definition of an IVD involves examining specimens such as blood, urine, or tissue outside of the body to provide information about a person's health.
- Pristina Serena Bright is an imaging and guidance system. The description clearly states that it uses X-ray images (specifically CESM) to locate lesions and provide guidance for interventional procedures on the patient. It does not analyze biological samples.
- The intended use is for image-guided procedures. The primary function is to help guide biopsies and other procedures based on the location of lesions identified through imaging.
Therefore, Pristina Serena Bright falls under the category of a medical device used for imaging and procedural guidance, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).
CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
Pristina Serena Bright is a Biopsy System for Senographe Pristina. It is an additional software option that builds upon the Pristina Serena device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina platform). Pristina Serena was cleared on May 14, 2018 (K173576).
Pristina Serena Bright enables biopsy medical application to be done using Contrast Enhanced Spectral Mammography images.
The Pristina Serena Bright add-on includes the following items:
Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application.
Pristina Serena Bright option is compatible with previously installed Senographe Pristina systems. Pristina Serena Bright does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena (K173576) was also not modified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM)
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Non-Clinical Data – Image Quality and Dose test that demonstrates that images acquired with Pristina Serena Bright are of same quality as images acquired with Senographe Pristina with SenoBright HD at similar dose levels.
- Non-Clinical Data – Biopsy accuracy testing: verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch).
- Non-clinical Data – Study that demonstrates the compatibility of the biopsy application on the Pristina Serena platform with the timeframe of the contrast agent visibility in the breast.
These tests were performed to provide the requisite data to substantiate performance and substantial equivalence. The testing demonstrated that Pristina Serena Bright performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pristina Serena (K173576)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SenoBright HD (K172404)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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May 15, 2020
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GE Healthcare % Barthelemy Arman Regulatory Affairs Leader 283 rue de la Miniere 78530 Buc FRANCE
Re: K193334
Trade/Device Name: Pristina Serena Bright Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: April 10, 2020 Received: April 17, 2020
Dear Barthelemy Arman:
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 801 and Part 809); 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-reporting
1
combination-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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K193334
Device Name Pristina Serena Bright
Indications for Use (Describe)
The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).
CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.
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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3
510(k) Premarket Notification Submission
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Section 5: 510(k) Summary
PRISTINA SERENA BRIGHT
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GE Healthcare
510(k) Premarket Notification Submission
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: | May 13th, 2020 |
---|---|
Submitter: | GE Healthcare |
GE Medical Systems SCS | |
283 RUE DE LA MINIERE | |
78530 BUC - FRANCE | |
Primary Contact Person: | Barthélémy Arman |
Regulatory Affairs Leader | |
283 rue de la Minière | |
78530 Buc - FRANCE | |
Phone : +33 1 30 70 40 40 | |
Email : Barthelemy.ARMAN1@ge.com | |
Secondary Contact Person: | Gregory Pessato, |
Regulatory Affairs Program Manager, | |
GE Medical Systems SCS | |
283 RUE DE LA MINIERE | |
78530 BUC - FRANCE | |
Phone : + 33 1 30 70 93 16 | |
Email : gregorypessato@ge.com | |
Device Trade Name: | Pristina Serena Bright |
Common/Usual Name: | Stereotaxy biopsy guidance application using contrast imaging |
Classification Names: | |
Product Code: | 21 CFR 892.1715, Class II |
MUE | |
Predicate / Reference | |
Device(s): | Pristina Serena (K173576) - predicate / SenoBright HD (K172404) - |
reference | |
Device Description: | Pristina Serena Bright is a Biopsy System for Senographe Pristina. It is |
an additional software option that builds upon the Pristina Serena | |
device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina | |
platform). Pristina Serena was cleared on May 14, 2018 (K173576). | |
Pristina Serena Bright enables biopsy medical application to be done | |
using Contrast Enhanced Spectral Mammography images. | |
The Pristina Serena Bright add-on includes the following items: | |
Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application. | |
Pristina Serena Bright option is compatible with previously installed | |
Senographe Pristina systems. Pristina Serena Bright does not require | |
any hardware modification on the Senographe Pristina platform. The | |
hardware that was cleared on Pristina Serena (K173576) was also not | |
modified. | |
Intended Use: | Pristina Serena Bright is an optional accessory of Senographe Pristina |
intended to provide accurate location of lesions in the breast in three | |
dimensions. | |
Indications for Use | The Pristina Serena Bright option provides the three-dimensional |
location of target lesions, using information obtained from stereotactic | |
pairs of two-dimensional X-ray images acquired with Contrast Enhanced | |
Spectral Mammography (CESM) under the same breast compression. | |
This information provides guidance for a variety of minimally invasive or | |
interventional procedures in the breast such as: vacuum assisted | |
biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine | |
needle aspirations (FNA). | |
CESM-Biopsy application is indicated for patients with suspicious lesions | |
only seen with certainty when imaged with a contrast agent or that do | |
not have a definite correlate on mammography or ultrasound. | |
Technology: | Pristina Serena Bright reuses the Stereotaxy principle of the cleared |
device Pristina Serena with Contrast Enhanced Spectral Mammography | |
(CESM) images instead of 2D images to determine the three- | |
dimensional (3D) location (X, Y and Z coordinates) of an object of | |
interest in the breast (such as a suspicious lesion). |
With Pristina Serena Bright, the stereotaxy biopsy process uses a stereo
|
| | |
| | breast at the exact target position (biopsy of sample tissue or
placement of a hook wire for guidance of surgical interventions). With
Pristina Serena Bright reuses the positioning of the biopsy device
holder from Pristina Serena which is motorized and takes into account
the geometry of the biopsy needles, so when the biopsy device holder is
in place, the user introduces the needle in the breast until reaching the
mechanical stop of the biopsy device holder. As the biopsy needle is
fixed on and guided by the biopsy device holder (not handed), the
needle tip (or notch) will then be at the target lesion 3D coordinates. |
| | As it was for Pristina Serena option, the Pristina Serena Bright allows
two different needle approaches for Biopsy: vertical and horizontal (left
or right). |
| | In vertical approach, the needle is introduced from the "top" of the compressed breast. In horizontal approach, the needle is introduced from the side of the compressed breast. Depending on patient morphology and location of the lesion to be
biopsied in the breast, a radiologist might choose an approach or the
other. Usually an effort is made to use an approach that would limit the
distance crossed by the needle in the breast to reach the target
location. |
| | Pristina Serena Bright option uses the Image chain of the Senographe
Pristina platform with SenoBright HD (CESM application) thus the image
quality of images during the biopsy procedure is equivalent to that of
SenoBright HD . |
| Substantial Equivalence /
Predicate and Reference
Devices | The Pristina Serena Bright has identical intended use and substantially
equivalent indications for use to its legally marketed predicate device,
the Pristina Serena .
The functionalities, specifications and technological characteristics of
Pristina Serena Bright option are identical or equivalent to Pristina
Serena .
The principles of operation, image quality and dose characteristics and
performances of the Pristina Serena Bright are equivalent to those of
the reference device SenoBright HD .
The Pristina Serena Bright was designed to provide an image quality
performance equivalent to SenoBright HD and the same accuracy as
Pristina Serena as demonstrated in Image Quality and Accuracy
Performance Testing. |
| Benefit-Risk Analysis: | The proposed Pristina Serena Bright device offers the same benefits
and risk as the predicate device Pristina Serena except for the following:
Improved benefit by allowing to perform breast biopsy for
patients with suspicious findings only clearly seen when imaged
with a contrast agent or that do not have a definite correlate on
mammography or ultrasound, meaning potential earlier
detection of breast cancer and earlier initiation of treatment. Increased risk due to the use of contrast agent injection. The
same contrast injection protocols are used in CESM and CESM-
guided Biopsy, so this risk is identical to the Reference device
SenoBright HD for CESM diagnostic imaging. As compared to the alternative standard of care MRI-guided Biopsy,
Pristina Serena Bright might offer the following benefits:
From a workflow and access perspective: potential benefit with
regards to reduced cost and faster access. From a patient perspective: potentially improved patient
comfort for patients with claustrophobia and allows to handle
patients that cannot be imaged with MRI due to the presence
of metallic objects in their body and is a shorter procedure. Regarding the other alternative to CESM-guided Biopsy, i.e. surgical
biopsy, it presents a higher risk profile as it is a more invasive
procedure, it has a longer recovery time and it has a higher risk of
infection and bruising. Besides it might remain difficult for the surgeon
to localize the appropriate area to be biopsied as no biopsy hook/wire
would have been able to be placed in the breast prior to surgery. |
| | Overall GE Healthcare believes that as the increased risk is accompanied
by an increase in benefit, the proposed device has a comparable
benefit-risk profile to the predicate device. |
| Determination of Substantial
Equivalence: | Pristina Serena Bright has successfully completed required design
control testing per GE Healthcare's quality management system. No
unexpected test results were obtained. This new device was designed
and will be manufactured under the Quality System Regulations of
21CFR 820 and ISO 13485. The following quality assurance measures
were applied to the development of the system:
Risk Analysis Design Reviews Software Development Lifecycle Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) |
| | - Safety testing (Verification)
- Simulated use testing (Validation) |
| | The safety and performance of the Pristina Serena Bright option was
demonstrated through full verification testing and additional
engineering bench performance testing such as: - Non-Clinical Data – Image Quality and Dose test that
demonstrates that images acquired with Pristina Serena
Bright are of same quality as images acquired with
Senographe Pristina with SenoBright HD at similar dose
levels. - Non-Clinical Data – Biopsy accuracy testing: verification of
the geometrical accuracy between the target lesion
identified on the X-ray Stereo pair images and the actual
position of the biopsy needle tip (or needle notch). - Non-clinical Data – Study that demonstrates the
compatibility of the biopsy application on the Pristina
Serena platform with the timeframe of the contrast agent
visibility in the breast.
These tests were performed to provide the requisite data to
substantiate performance and substantial equivalence. The testing
demonstrated that Pristina Serena Bright performs according to
specifications and functions as intended. |
| Conclusion: | Based on: conformance to standards; development under GE
Healthcare's quality management system and design controls; benefit-
risk analysis, successful verification/validation testing and additional
bench performance testing and clinical testing, GE Healthcare believes
that the Pristina Serena Bright option is substantially equivalent to its
predicate device Pristina Serena (K173576) and reference device
SenoBright HD (K162268). Therefore, GE concludes that Pristina Serena
Bright is as safe and effective for its intended use as its predicate
device. |
5
GE Healthcare
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8
GE Healthcare
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