(52 days)
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No
The document describes a standard MRI system and its components. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The software is described as an "interactive program with user friendly interface," which is not indicative of AI/ML capabilities.
No
The device is described as a diagnostic tool that produces images to assist in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that PICA is "indicated for use as magnetic resonance diagnostic devices (MRDD)" and that the images produced "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states it is a "Whole Body MRI System" composed of hardware components like a Magnet, Patient Table, Coils, and a Client PC, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PICA is a magnetic resonance diagnostic device (MRDD) that produces images of the internal structure and/or function of the head, body, or extremities. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process, where the device interacts directly with the patient's body to obtain information.
- Device Description: The description details a whole body MRI system, which is a type of medical imaging equipment used on living patients.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body. IVDs are specifically designed for testing these types of samples.
Therefore, PICA falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
PICA is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
Pica Whole Body MRI System is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is aninteractive program with user friendly interface.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
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Intended User / Care Setting
Trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, Pica Whole Body MRL System met all design specifications and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
mStar MPF4500 (K073457)
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.
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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).
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§ 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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Time Medical System
Abbreviated 510(k) Report for Pica MRI system
Ref No.: A2008-025-060 Section XI 510(k) Summary
Section XI 510(k) Summary
JUL 2 4 2009
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:_
Date of Submission: March 9, 2009
| Sponsor: | |
|---|---|
| ---------- | -- |
Time Medical Limited
G/F Bio-Informatics Centre, No. 2 Science Park West Avenue, Hong Kong Science Park, Shatin, New Territories, Hong Kong, China Contact Person: Johnson Chong, VP Product Development T: +852 2156 1711 F: +852 2156 0908
Correspondent:
Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: +86-21-64264468 Email: Diana.hong@mid-link.net
Proposed Device Trade Name Pica Whole Body MRI System Model: TMS-MRI-3000WB-01 Classification Name: System, Nuclear Magnetic Resonance Imaging Product Code: LNH Regulation Number: 892.1000 Device Class: II
Predicate Device:
mStar MPF4500 (K073457)
XI-1
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Time Medical System Abbreviated 510(k) Report for Pica MRI system
Ref No .: A2008-025-060 Section XI 510(k) Summary
PICA is indicated for use as magnetic resonance diagnostic devices (MRDD) Intended Use: that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles. Device Description: Pica Whole Body MRI System is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is aninteractive program with user friendly interface. Performance testing including clinical and laboratory testing was conducted Testing Conclusion: to validate and verify that the proposed device, Pica Whole Body MRL System met all design specifications and was substantially equivalent to the predicate device. SE Conclusion: Pica Whole Body MRI System, is claimed to be Substantially Equivalent (SE) to the predicate device, mStar MPF4500 (K073457)
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Time Medical Limited % Mr. Morten Simon Christensen Asst. Manager, Program Reviewer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
JUL 2 4 2009
Re: K091580
Trade/Device Name: Pica Whole Body MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 17, 2009 Received: July 22, 2009
Dear Mr. Christensen:
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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Time Medical System Abbreviated 510(k) Report for Pica MKI system
Rel No.: A2008-025-060 Exhibit #B Indication for Use
Exhibit #B Indication for Use Form
510(k) Number: K091580 Device Name: Pica Whole Body MRI System
Indications for Use:
PICA is indicated (ive use as magnetic resonance diagnostic devices (MRUD) that produce transverse. sagitud, coronal and oblique cross sectional immes, and that display the interast structure of the head. body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis,
Pica may also be used for imaging daring interventional procedures when performed with MR compatible devices such as, in mort display und MIK safe biopsy needles.
Preseription Use _ ・ (Parl 21 CFR 801 Subpart Di
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLF-ASSE DO NOT WRITE BELOW THIS LIME-CONTINUE ON ANQUILIAR PAGE OF METORED)
Concurrence of CDRH, Office of Device I:valuation {ODI }
Page 1 of 1
Louie B. Nunn
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number