K013810 · W. L. Gore & Associates, Inc. · MOS · Nov 27, 2001 · Radiology
Device Facts
Record ID
K013810
Device Name
CARDIOVASCULAR ARRAY
Applicant
W. L. Gore & Associates, Inc.
Product Code
MOS · Radiology
Decision Date
Nov 27, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
The Cardiovascular Array is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems. Its large field of view will allow for integrated images of the complete thorax, including vasculature, the abdomen, pelvis, spine and extremities. A specialized sub-array will provide high resolution images of the thoracic region.
Device Story
Cardiovascular Array is a receive-only phased array MRI surface coil; consists of 10 elements in flexible anterior and posterior 'paddle' configuration. Designed for use with GE Signa 1.5T MRI systems. Device conforms to various body sizes; large field of view enables imaging of thorax, vasculature, abdomen, pelvis, spine, and extremities without patient repositioning. Specialized sub-array provides high-resolution thoracic imaging. Operates via active and passive decoupling; includes MR-safe cable. Used by radiology technicians/physicians in clinical MRI settings to acquire diagnostic images; output is processed by the MRI system to assist clinicians in diagnostic decision-making.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Receive-only phased array MRI coil; 10-element flexible design. Materials: biocompatible closed cell polyethylene foam. Decoupling: active and passive. Connectivity: compatible with GE Signa 1.5T MRI systems. Includes MR-safe cable.
Indications for Use
Indicated for patients requiring MRI imaging of the thorax, vasculature, abdomen, pelvis, spine, and extremities using GE Signa 1.5T MRI systems.
Regulatory Classification
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.
{0}------------------------------------------------
## NOV 2 7 2001
## 7. Premarket Notification 510(k) Summary
a. Submitter:
W. L. Gore and Associates, Inc. 1901 Barksdale Rd. Newark, DE 19711
800-441-7404 Phone:
Tracy Wolf Contact:
Date Prepared: October 17, 2001
- b. Name of Device:
Cardiovascular Array Trade Name:
Common Name: MRI Surface Coil
Coil, Magnetic Resonance, Speciality Device Name:
- c. Identification of Predicate Devices:
on of Predicate Devices.
The GE Cardiac Array is the predicate device which was found The OL Cardial Afray is any processions the premarket notification to be substainmally oquit receive only, phased array surface process. These for use with GE Signa® 1.5T MRI Systems.
- d. Description of the Applicant Device:
I of the Applicant Dorios:
The Cardiovascular Array is a receive only phased array coll, The Cardiovasourar + 2009 and a posterior "paddle." The phased array design includes 10 elements in a flexible coil, which array design mendatibody sizes. The coil produces high conforms to different GE Signa® 1.5T MRI Systems.
- e. Intended Use:
The Cardiovascular Array is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems. Its large field applications with OD organise of the complete thorax, including of view will allow for integrated vasculature, the abdomen, pelvis, spine and extremities. A specialized sub-array will provide high resolution images of the thoracic region. The predicate ingh icsolution miages of as a me areas of anatomy, but must be repositioned on the patient, between images. The Cardiovascular array with its large field of view can image these areas without repositioning.
{1}------------------------------------------------
The Cardiovascular Array is substantially equivalent to the predicate device with regard to intended use, by imaging a variety of anatomical locations using phased array, receive only surface coils. The descriptive information and performance data contained within this Premarket Notification submission are sufficient to demonstrate substantial equivalence of the applicant device (Cardiovascular Array) to the predicate device (GE Cardiac Array).
- f. Technical Characteristics
The Cardiovascular Array uses the same mode of operation, a receive only coil, as the predicate device. It utilizes active decoupling as does the predicate device. The Cardiovascular Array further enhances patient safety by including passive decoupling, and the MR safe cable.
The materials are similar, the patient contact areas for both the applicant and predicate devices, are composed of a biocompatible closed cell polyethylene foam.
In summary, the Cardiovascular Array (applicant) and the GE Cardiac Array (predicate) utilize similar technology and materials. There are no patient safety concerns raised as a result of the clearance of the Cardiovascular Array.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
W.L. Gore & Associates, Inc. c/o Mr. Mark Job TUV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K013810
Trade/Device Name: Cardiovascular Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 13, 2001 Received: November 15, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosale) to regally the enactment date of the Medical Device American by and Drug commerce prior to May 20, 1976, the exactions of the Federal Food, Drug, 1994, Drug, devices that have been icclassince in accera approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market also as the Act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (500 a0010) in Existing major regulations affecting your device can be it may be subject to additional controlial Linking may on 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 I lease be advised that I Dri 3 issualited on our device complies with other requirements of the Act that I DA has made a decidinations administered by other Federal agencies. You must of any I ederal statutes and roginnents, including, but not limited to: registration and listing compry with an the Act 3 requirements, modeling, a
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic fordint in the quality systems (20) -18)
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) pręmarket I notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Drice 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), please It you dosite tpositive at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 regulation entitled, "Misbranding Other of Somphares to premarket notification" (21 CFR Part 807.97). Other general information on by releveloo to promation the Act may be obtained from the Division of Small Manufacturers, Jour responseering of the many of 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,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
KC013810
Page 1_of_1
510(k) Number (if known): __________________________________________________________
Coil, Magnetic Resonance, Speciality Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Cardiovascular Array is intended for multiple imaging applications with GE Sigua(R) 1.5T MRI Systems. Its large field of view will allow with GE Sigual(R) 1.51 MK. Systems. Including the heart, and its associated for images of the complete chords, and spine. A specialized sub-array vasculature, the abdomen, pervis and open and of the thoracic region, :
Nov 15 3 21 PM '01
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rate Phillips he nccs
(Optional Format 3-10-98)
RA
II
SK4J
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
