(603 days)
No
The device description details a microarray-based gene expression analysis and a calculation of a molecular profile index based on correlation to a template. There is no mention of AI, ML, or any learning algorithms. The process is described as a direct comparison and calculation based on a predefined template.
No.
This device is an in vitro diagnostic test that provides prognostic information by assessing the risk of distant metastasis using gene expression profiling. It is not used for directly treating a disease or condition.
Yes
The text describes MammaPrint as a "qualitative in vitro diagnostic test service" that uses "gene expression profile... to assess a patients' risk for distant metastasis." It is also indicated for use by physicians "as a prognostic marker." These phrases clearly indicate that the device is used to diagnose or predict a medical condition.
No
The device description clearly outlines a process involving physical components like microarrays, RNA isolation, hybridization, scanning, and data acquisition from a physical sample (tumor tissue). While software is used for data analysis and index calculation, it is an integral part of a larger hardware-based in vitro diagnostic test service, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "MammaPrint® is a qualitative in vitro diagnostic test service..."
- Performed on biological samples: The test uses "fresh breast cancer tissue samples," which are biological specimens taken from the human body.
- Provides diagnostic information: The test assesses a patient's "risk for distant metastasis," which is a diagnostic assessment of their disease prognosis.
- Performed in a laboratory: The description mentions it is "performed in a single laboratory" and involves laboratory processes like RNA isolation, hybridization, and scanning.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MammaPrint is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patient's risk for distant metastasis.
The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size = 61 years`).
Intended User / Care Setting
Physicians / a single laboratory
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)
Analytical performance.
MammaPrint analytical (i.e., non-clinical) performance characteristics investigated comprise Precision, Reproducibility, Cutoff, Sensitivity, Specificity, Accuracy, Robustness and Ruggedness.
The technical validity of MammaPrint is determined on multiple individual validation experiments; a comprehensive three-way inter-laboratory comparison study between three independent laboratories in three different countries (Dutch, French and U.S.); data of about 200 analyses of two reference samples over a period of 12 months, used to monitor experiment-to-experiment quality; and quality controls for which the cut-off for all QCs is based on over 5000 hybridizations (2500 samples) performed at Agendia.
Based on 12 month repeated experiments of a Low Risk and High Risk control sample (i.e., more than 190 independent analyses), the Analytical Accuracy of the measurement is 98,5%.
Classification performance
Based on the analytical performance of MammaPrint, the accuracy of classifying a sample as High Risk or Low Risk, is at least 98.9% (i.e., 1.1% false negative classification).
Borderline Sample
As a result of the technical inaccuracy, analytical measurements (i.e., MammaPrint Index) can fall within a pre-defined area around the classification cut-off between the High Risk and Low Risk profile (i.e., "Borderline Sample").
Based on the results of independent MammaPrint analyses over a time period of over 2 years, it has been shown that less than 5% of the analyzed samples are considered to be "Borderline Samples".
"Borderline Samples" have approximately a 90% classification accuracy (i.e. 10% chance of false classification).
Clinical Data
Clinical performance testing is based on the following studies:
| Study | Purpose | Time Frame | Comments |
|---|---|---|---|
| Nature Paper (1) | Development of breast cancer prognosis 70-gene profile (LNO, |
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
(a)
Identification. A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
0
KOH092
510k Summary
1. Assigned 510(k) number
The assigned 510(k) number is 081092
- Company
DEC 11 2009
Agendia BV
Sciencepark 406 1098XH Amsterdam
The Netherlands
Telephone : 31 20 462 1523
Facsimile : 31 20 462 1505
3. Contact
Guido Brink, Senior Director Regulatory Affairs and Quality Assurance
- Date Prepared
April 10th, 2008
5. Proprietary Name
MammaPrint®
6. Classification Name
Gene expression profiling test system, for breast cancer prognosis.
7. Common Name
Multivariate device for cancer prognosis
8. Classification
Class II, regulated under 21 CFR 866.6040, product code NYI
9. Predicate Device
Agendia BV's MammaPrint (K080252)
1
10. Device Description
The MammaPrint service is a microarray based gene expression analysis of a tumor. The analysis is based on several processes: isolation of RNA from frozen tumor tissue sections, DNA'se treatment of isolated RNA, linear amplification and labeling of DNA'se treated RNA, cRNA purification, hybridization of the cRNA to the MammaPrint microarray, scanning the MammaPrint microarray and data acquisition (feature extraction), index calculation and determination of the risk of distant recurrence in breast cancer patients.
The MammaPrint analysis is designed to determine the gene activity of specific genes in a tissue sample compared to a reference standard. The result is an expression profile, or fingerprint, of the sample.
The correlation of the sample expression profile to a template (the mean expression profile of 44 tumors with a known good clinical outcome) is calculated and the molecular profile index of the sample is determined (Low Risk, High Risk).
11. Intended Use
MammaPrint is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patient's risk for distant metastasis.
The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size