(90 days)
Pica Whole Body MRI System, TMS-MRI-3500WB-01, 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.
It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Pica Whole Body MRI System is a 0.35T 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 an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body MRI System (K091580), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.
The provided text is a 510(k) Summary for a Pica Whole Body MRI System. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, ground truth establishment, or clinical study results in the manner requested.
Specifically, the document states: "Performance testing was conducted to validate and verify that the proposed device, Pica Whole Body MRI System met all design specifications and was substantially equivalent to the predicate device." It also mentions "modifications" to the existing and cleared Pica Whole Body MRI System (K091580) in Magnet (Static Field Strength), Appearance, Receive Coil, and some specifications.
Without further documentation, it's impossible to answer the specific questions about acceptance criteria and study details. This 510(k) summary is a high-level overview and does not delve into the detailed performance data or study methodology.
Therefore, for each point requested:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The text only states that performance testing was conducted to meet "all design specifications" and demonstrate "substantial equivalence," but no specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document does not mention any sample sizes, data provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided text. The document does not describe the establishment of ground truth or the involvement of experts for any test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. No information about adjudication methods is provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not available in the provided text. This device is an MRI system, not an AI-powered diagnostic tool for image interpretation. Therefore, a MRMC comparative effectiveness study comparing human readers with AI assistance would not be relevant for this type of submission. The document focuses on the hardware and basic functionality of the MRI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not available in the provided text. As this is an MRI system, standalone algorithm performance in the context of AI is not relevant. The device's performance relates to image acquisition quality, field strength, and other physical/technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided text. Ground truth information is not provided. For an MRI system, ground truth might relate to image quality metrics, object visibility, or signal-to-noise ratios, often established through phantom studies or comparison with accepted reference standards, but these details are not in the document.
8. The sample size for the training set
- Not applicable / Not available in the provided text. This is an MRI hardware system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable / Not available in the provided text. See point 8.
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Time Medical System Special 510(k) Report for Pica MRI system
Ref No.: SHA01220090522FDA Section VII 510(k) Summary
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Section VIII 510(k) Summary
MAR 2 4 2010
| This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | |
|---|---|
| Date of Submission: | December 23, 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 | |
| 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 | |
| Proposed Device. | Pica Whole Body MRI System TMS-MRI-3500WB-01 |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification | Class II / LNH / 892.1000 |
| Predicate Device: | Pica Whole Body MRI System TMS-MRI-3000WB-01 (K091580) |
| Intended 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. | |
| Device Description: | Pica Whole Body MRI System is a 0.35T 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. It is a modified system to the | |
| existed and cleared Pica Whole Body MRI System (K091580), in Magnet (Static Field Strength), | |
| Appearance, Receive Coil and some specifications. | |
| Testing Conclusion: | Performance testing was conducted to validate and verify that the proposed device, Pica Whole |
| Body MRI 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, Pica Whole Body MRI System (K091580). | |
: . ·
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Image /page/1/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Time Medical Limited % Ms. Diana Hong Submission Correspondent Shanghi Mid-Link Business Consulting Co., Ltd Suite SD. No. 19. Lane 999. Zhongshan Road (S-2) Shanghai, 200030 CHINA
MAR 2 4 2010
Re: K093984
Trade/Device Name: Pica Whole Body MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 1, 2010 Received: March 2, 2010
Dear Ms. Hong:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093984
Device Name: __ Pica Whole Body MR System
Indications for Use:
"Pica Whole Body MRI System, TMS-MRI-3500WB-01, 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.
It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles."
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K093984
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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.