(29 days)
Not Found
No
The summary describes a standard MRI system and its components, focusing on hardware and image acquisition. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is used for targeting prostatic lesions under MR guidance, which is an imaging and guidance function, not a therapeutic treatment itself. It produces images and provides guidance; it does not treat the disease.
No
The 'Intended Use / Indications for Use' explicitly states, "Promaxo MR images are not intended to be used for diagnostic purposes".
No
The device description explicitly details hardware components such as permanent magnets, gradient coils, RF coils, spectrometer, and signal amplifiers, indicating it is a physical MRI system, not software only.
Based on the provided information, the Promaxo Magnetic Resonance Imaging (MRI) System II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Promaxo MRI System II is used to produce images of the prostate and adjoining tissues within the patient's body.
- The intended use is for imaging and guidance during procedures. The system is used to produce images for targeting prostatic lesions under MR guidance. This is an in-vivo imaging and procedural guidance application, not an in-vitro diagnostic test.
- The device description details an imaging system. The description focuses on the components and function of an MRI system, which is a medical imaging modality.
Therefore, the Promaxo MRI System II falls under the category of a medical imaging device used for in-vivo imaging and procedural guidance, not an IVD device.
N/A
Intended Use / Indications for Use
The Promaxo Magnetic Resonance Imaging (MRI) System II is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR quidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.
Product codes
LNH, MOS
Device Description
The Promaxo MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
1.5T or 3T MR image acquired without an endorectal coil
Anatomical Site
prostate and adjoining tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained urologist or interventional/urologic radiologist; office-based
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 Testing: No design modifications have been made to the cleared Promaxo MRI System. The only change is to the Indications for Use. An assessment of the change was performed and it was determined that the modified Indications for Use any new risks. Thus, testing previously performed for the Promaxo MRI System is appropriate and sufficient for Use. Therefore, no additional performance data is required.
Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
Conclusions: Based on the technological characteristics, intended use and modified Indications for Use, the Promaxo MRI System II can be found substantially equivalent to the identified predicate device.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 5, 2023
Promaxo, Inc. % Veronica Sanz QA/RA Manager 70 Washington St. Suite 407 Oakland, CA 94607
Re: K232361
Trade/Device Name: Promaxo MRI System II Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: August 3. 2023 Received: August 7, 2023
Dear Veronica Sanz:
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.
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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); 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-reportingcombination-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.
D.G.K.
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Promaxo MRI System II
Indications for Use (Describe)
The Promaxo Magnetic Resonance Imaging (MRI) System II is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR quidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K232361
510(k) Summary
Prepared on: 2023-08-04
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Promaxo, Inc. | |
|---|---|---|
| Applicant Address | 70 Washington St Suite 407 Oakland CA 94607 United States | |
| Applicant Contact Telephone | (510) 462-5456 | |
| Applicant Contact | Ms. Veronica Sanz | |
| Applicant Contact Email | vsanz@promaxo.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Promaxo MRI System II | |
| Common Name | Magnetic resonance diagnostic device | |
| Classification Name | System, Nuclear Magnetic Resonance Imaging | |
| Regulation Number | 892.1000 | |
| Product Code | LNH / MOS | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K202518 | Promaxo MRI System | LNH/MOS |
| Davice Decerintion Summary | 21 CED 207 00/2/1\ |
The MRI System that is subject of this 510(k) is identical to the device cleared in K202518, with the exception of a modification to the Indications for Use statement.
The Promaxo MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view.
Intended Use/Indications for Use
The Promaxo Magnetic Resonance Imaging (MR) System II is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.
Indications for Use Comparison
The modified Indications for Use include co-registration with a diagnostic 1.5T MR image acquired without an endorectal coil. This modification to the Indications for Use does not afficacy of the device because the device design and intended use are identical to the predicate.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
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Technological Comparison
21 CFR 807.92(a)(6)
The technological characteristics of Promaxo MRI System II are identical to the predicate device:
- Comprised of a magnet, magnet enclosure, electromagnetic gradient coils, RF transmission coil, and RF receiver coil
- Have the main magnet comprised of an array of permanent magnets
- Measure spatial distribution of protons exhibiting magnetic resonance
- Capable of imaging T1, T2, and Diffusion-Weighted Imaging
- Cryogen free
- Provide an interactive user interface to operate the device
- The z-gradient is built into the main magnetic field and, as a result, the system does notrequire an electromagnetic z-gradient coil
- The device includes a template holder to be used for procedures under MR guidance
- The device includes an MR guidance user interface workfow such as template calibration with imported MR images
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Testing
No design modifications have been made to the cleared Promaxo MRI System. The only change is to the Indications for Use. An assessment of the change was performed and it was determined that the modified Indications for Use any new risks. Thus, testing previously performed for the Promaxo MRI System is appropriate and sufficient for Use. Therefore, no additional performance data is required.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
Conclusions
Based on the technological characteristics, intended use and modified Indications for Use, the Promaxo MRI System II can be found substantially equivalent to the identified predicate device.