(86 days)
Not Found
No
The device description focuses on a physical acrylic plate with puncture holes and accompanying software for calculating puncture location and depth based on user input of coordinates. There is no mention of AI or ML algorithms being used for image analysis, lesion detection, or any other function. The software appears to be a calculation tool based on provided data.
No.
The device is described as an "Intervention Aid" used to localize lesions and perform needle biopsies, indicating its function as a tool to facilitate a medical procedure rather than directly treating or mitigating a disease.
No
Explanation: The device is used to assist with needle biopsies and localize lesions, which are interventional and procedural tasks, not diagnostic ones. It helps in the performance of a biopsy, which is a diagnostic tool, but the device itself is not performing the diagnosis.
No
The device description explicitly details physical components like an acrylic plate, frame, sliding locator plate, fiduciary marker plate, and needle guide, in addition to the software package.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device function: The "MICS INTERVENTION AID" is a physical device used in conjunction with an MR scanner and breast coil to localize lesions and guide needle biopsies within the female breast. It is a tool for performing a medical procedure directly on the patient's body.
- No sample analysis: The device does not analyze any biological samples taken from the patient. Its purpose is to aid in the physical process of accessing a lesion for biopsy.
Therefore, the device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.
Product codes
LNH
Device Description
The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
female breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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APR 2 4 2002
EXHIBIT 2 MACHNET BV PO BOX 85444 NL-3508 AK UTRECHT THE NETHERLANDS
AMERSFOORTSEWEG 24 A NL-3951 LB MAARN PHONE +31(0)343 444 355 FAX +31(0)343 444 934 Contact: Abe van der Werf, President January 25, 2002 510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)." Classification Name: Accessory to Magnetic Resonance Diagnostic Device Product Code LNH, Stereotactic Localization Device Common/Usual Name: Accessory to MRI Device
-
- Indications for Use (intended use) .. For use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.
-
- Description of the device: The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option
1
Photo of Machnet Product
Image /page/1/Picture/1 description: The image shows a close-up of a piece of equipment, possibly a machine or electronic device. The equipment has a dark, perforated panel with a grid of circular holes. The panel is positioned beneath a flat surface with a circular opening, suggesting a functional or ventilation purpose. The overall image is somewhat grainy and lacks fine detail.
-
- Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | Philips Medical Systems
Stereotactic Localization
Device (SLD) K000832 and
MRI Devices Corp Model
MR-Biopsy 160, K010570,
and Siemens Medical
Systems MR Breast Biopsy
Device K010773 | MICS INTERVENTION
AID (MICS-MIA and
MICS-MIAS |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for use | For use in conjunction with
a Magnetic Resonance
Scanner to localize lesions
in female breasts and
perform needle biopsies
accurately | SAME |
| Use with MRI Model | Philips, GE, Siemens
GE Signa® :(3X-LX) 1.5T,
1.0T. 0.5T MR scanners | GE Signa :(3X-LX) 1.5T,
1.0T, 0.5T MR scanners |
- Testing information and Conclusion 6.
In all material respects, the "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS) is substantially equivalent to Philips Medical Systems Stereotactic Localization Device (SLD) K000832 and MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device K010773. Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct segments, representing the department's focus on health, human services, and the well-being of the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
od and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2002
Machnet BV % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K020289
Trade/Device Name: MICS Intervention Aid, Catalog # MICS-MIA and MICS-MIAS Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: March 18, 2002 Received: March 19, 2002
Dear Mr. Kamm:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication. The I Dr I in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or Comphares an (rotification" (21 CFR Part 807.97). Other general information on of felection to promative the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number K020289
The "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)" is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V OR Over the Counter Use (Per 21 CFR 801.109)
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020289
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