(113 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and basic software functionality.
No.
The device is described as a diagnostic device that produces images to assist in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as magnetic resonance diagnostic devices (MRDD)".
No
The device description explicitly lists multiple hardware components (Magnet, Patient Table, Gradient Coil, etc.) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pica Whole-Body MRI System is an imaging device that produces images of the internal structure and function of the body. It works by using magnetic fields and radio waves, not by analyzing biological specimens.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images to assist in diagnosis when interpreted by a physician. This is consistent with an in vivo imaging device, not an in vitro diagnostic.
The device description and intended use clearly indicate that this is an imaging system used to visualize the inside of the body directly, not to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
Pica Whole-Body MRI System 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.
Hybrid Pica may also be used for imaging during interventional procedures when performed with NMR compatible devices such as, in room display and MR safe biopsy needles.
Product codes
LNH
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, RE Transmission Coil, RE Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP(R) Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body NMR System (K093984), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, body, or extremities
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)
Safety and performance testing were conducted to validate and verify that the filing device, Hybrid Pica Whole-Body MRI. System met all design specifications and was substantially equivalent to the 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.
0
JUL 26 2011
KII0942 TIME MEDICAL
ﺗﻮﻧ
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | 31-March-2011 |
|---|---|
| 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: John Baby, Director - Regulatory Affairs | |
| Correspondent: | 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: John Baby, Director - Regulatory Affairs | |
| Filing Device: | Pica Whole-Body MRI System TMS-MRI-3500WB-02 |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Classification Class | Class II / LNH / 892. 1000 |
| Predicate Device: | Pica Whole Body MRI System TMS-MRI-3500WB-01 (K093984) |
| Intended Use: | Pica Whole-Body MRI System 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. | |
| Hybrid Pica may also be used for imaging during interventional | |
| procedures when performed with NMR 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, RE Transmission Coil, RE 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 NMR | |
| System (K093984), in Magnet (Static Field Strength), Appearance, | |
| Receive Coil and some specifications. | |
| Testing Conclusion: | Safety and performance testing were conducted to validate and verify that |
| the filing device, Hybrid 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 (K093984) |
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Image /page/1/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right. To the right of the symbol, the letters "DE" are visible, suggesting that the image is part of a larger document or logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 6 2017
Mr. John Baby Time Medical Limited G/F Bio-informatics Centre No. 2 Science Park West Avenue, Hong Kong Science Park Shatin, New Territories HONG KONG CHINA
Re: K110942
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 15, 2011 Received: July 18, 2011
Dear Mr. Baby:
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
2
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/ReportaProblem/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,
Mary Pastel
Mary S. Pastel, Sc.D. 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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K110942
Indications for Use
510(k) Number (if known): K110942
Device Name: PICA Whole-body MRI System
Indications for Use:
PICA Whole-Body MRI System 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 Whole-Body MRI System 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.
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)
Mury Stott
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
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