← Product Code [LNH](/productcode/LNH) · K992412 # IPASS BOLUS TRACKING (K992412) _Philips Medical Systems (Cleveland), Inc. · LNH · Aug 17, 1999 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992412 ## Device Facts - **Applicant:** Philips Medical Systems (Cleveland), Inc. - **Product Code:** [LNH](/productcode/LNH.md) - **Decision Date:** Aug 17, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Picker International Eclipse/Polaris systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. ## Device Story iPass Bolus Tracking is an MRI software option for Picker Eclipse/Polaris systems; improves image quality in contrast-enhanced angiography by coordinating contrast agent arrival with k-space data collection. Input: real-time MRI signal intensity within a user-defined Region of Interest (ROI). Operation: software automatically calculates average pixel intensity; detects 30% increase to determine bolus arrival time; triggers scan sequence. Includes AutoVoice feature for technician-to-patient communication. Output: automated timing for scan initiation; improved angiographic image quality. Used in clinical MRI suites; operated by technicians. Benefits: optimizes contrast timing for enhanced diagnostic image quality; reduces manual timing errors. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological comparison and performance characteristics of the software-based bolus tracking feature relative to the predicate system. ## Technological Characteristics Software-based MRI enhancement; operates on existing Eclipse/Polaris MRI hardware. Features automated ROI pixel intensity calculation and bolus arrival time detection. Includes AutoVoice intercom integration. Connectivity: integrated into MRI system console. No specific materials or energy sources beyond the host MRI system. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Eclipse / Polaris system ([K964626](/device/K964626.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) #### 1. General Information | Classification: | Class II
Magnetic Resonance Imaging (MRI) System | | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option | | | Proprietary Name: | iPass Bolus Tracking | | | Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
Contact: Elaine K. Keeler, Ph.D
Phone: (440) 473-3000 | | | | FDA Owner Number: #1580240
FDA Registration Number: #1525965 | | | Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. | | #### 2. Intended Uses The iPass Bolus Tracking option does not change the existing intended use and indications for the Eclipse/Polaris systems as defined below. The Picker International Eclipse/Polaris systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. #### 3. Device Description The Picker iPass Bolus Tracking option improves image quality by coordinating the arrival of the contrast agent with the collection of the data for the center of k-space. The option also includes an auto-voice feature to assist the technician in communicating with the patient. {1}------------------------------------------------ ### Safety and Effectiveness 4. The Picker iPass Bolus Tracking option is similar in technological characteristics and intended use to the Picker Eclipse/Polaris system. The following table has been created to demonstrate their substantial equivalence. | Parameter | iPass Bolus Tracking | Predicate Device - Eclipse / Polaris
system (K964626) | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sequence Capabilities /
Requirements | Same. | 2D RF-FAST sequence, Volume
contrast enhanced angio sequence. | | Simulate Scan Feature | Same simulate-scan feature is now
also used to improve image
quality of contrast enhanced
angiography scans. | Software uses a simulate-scan feature
to improve image quality of single-
shot EPI sequences. | | ROI Analysis | Software automatically calculates
average pixel intensity of the ROI
and reports when a 30% increase
in this value occurs. | User can draw a ROI and calculate
the average pixel intensity. This
manual analysis can be repeated on a
series of scans to determine when an
increase occurs. | | Bolus Arrival Time
Calculation | Software automatically calculates
arrival time based on ROI
analysis. Manual override is
possible. | User manually determines arrival time
based on ROI analysis. | | Intercom Capabilities | AutoVoice feature instructs the
patient and/or technician during
scan. | Technician can communicate with the
patient via intercom during scan. | | Intended Use and
Indications for Use | Same. | The Picker International
Eclipse/Polaris systems are indicated
for use as a NMR device that
produces images that: (1) correspond
to the distribution of protons
exhibiting NMR, (2) depend upon the
NMR parameters (proton density,
flow velocity, spin-lattice relaxation
time (T1), and spin-spin relaxation
time (T2)) and (3) display the soft
tissue structure of the head and whole
body. When interpreted by a trained
physician, these images yield
information that can be useful in the
determination of a diagnosis. | # Substantial Equivalence Chart PICKER INTERNATIONAL, INC. (IPASS) I - 2 {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or flames. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 7 1999 Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 Re: K992412 iPass Bolus Tracking MRI System Dated: July 15, 1999 Received: July 20, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH Dear Dr. Keeler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): iPass Bolus Tracking Device Name: Indications for Use: (Per 21 CFR 801.109) The iPass Bolus Tracking option does not change the existing intended use and indications for the Eclipse/Polaris systems as defined below. The Picker International Eclipse/Polaris systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dey 510(k) Number Prescription Use OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K992412](https://fda-staging.innolitics.com/device/K992412) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com