(102 days)
Not Found
No
The description focuses on gene expression analysis and correlation to a template, which is a statistical method, not explicitly AI/ML. There is no mention of AI, DNN, or ML in the text.
No
The device is an in vitro diagnostic test service used as a prognostic marker to assess a patient's risk for distant metastasis, not to treat or prevent a condition.
No
The Intended Use / Indications for Use section explicitly states that MammaPrint® is indicated for use by physicians "as a prognostic marker only." While it is an "in vitro diagnostic test service," its stated purpose is to assess a patient's risk for distant metastasis, not to diagnose a condition.
No
The device description clearly outlines a process involving physical steps like tissue handling, RNA isolation, hybridization to a microarray, scanning, and data acquisition, which are hardware-dependent laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "MammaPrint® is a qualitative in vitro diagnostic test service..." This directly identifies it as an IVD.
- Device Description: The description details a process performed in vitro (outside the body) on a biological sample (fresh breast cancer tissue). It involves laboratory procedures like RNA isolation, amplification, hybridization, and data analysis to determine a gene expression profile.
- Purpose: The test is used to assess a patient's risk for distant metastasis, providing information to physicians for use as a prognostic marker. This is a diagnostic purpose, even though it's for prognosis.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
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 patients' risk for distant metastasis.
The test is performed for breast cancer patients who are less than 61 years old, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The MammaPrint® result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.
Product codes
NYI
Device Description
The MammaPrint service is a microarray based gene expression analysis of a tumor. The analysis is based on several processes: using fresh tissue stored in RNAlater, 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), calculation and determination of the risk of 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 of the sample is determined (Low Risk, High Risk).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast (tumor tissue samples)
Indicated Patient Age Range
Less than 61 years old
Intended User / Care Setting
Physicians / single laboratory
Description of the training set, sample size, data source, and annotation protocol
Nature Paper (1)
Type: Training
Purpose: 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
Section 5: 510(k) Summary
- Assigned 510(k) number The assigned 510(k) number is
is K070675
JUN 2 2 2007
-
Company Agendia BV Slotervaart Medical Center 9D Louwesweg 6, 1066EC Amsterdam The Netherlands : 31 20 512 9161 Telephone : 31 20 51291 62 Facsimile
-
Contact Guido Brink, Director Quality Management and Regulatory Affairs
-
Date Prepared March 1st 2007
-
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
- Predicate Device
Agendia BV's MammaPrint (K062694)
1
10. Device Description
The MammaPrint service is a microarray based gene expression analysis of a tumor. The analysis is based on several processes: using fresh tissue stored in RNAlater, 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), calculation and determination of the risk of 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 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 who are less than 61 years old, with Stage I or Stage II disease, with tumor size 10% chance of false classification).
Looking at all generated data it is concluded that the MammaPrint analysis is considered to be Precise, Reproducible, Sensitive, Specific, Accurate and Robust and valid for the Intended Use.
3
13. Clinical Data
Clinical performance testing is based on the following studies:
| Study | Purpose | Time Frame | Comments |
|---|---|---|---|
| Nature Paper (1) | |||
| Type: Training | Development of | ||
| breast cancer | |||
| prognosis 70-gene | |||
| profile (LNO, |