The MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: . Pulmonary thromboembolism when anticoagulants are contraindicated. . Failure of anticoagulant therapy for thromboembolic disease. . Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
Device Story
Intravascular filter system for permanent placement in inferior vena cava (IVC) to prevent pulmonary embolism. Device consists of 12 electropolished shape-memory nitinol wires (6 legs, 6 arms) with central hook; legs feature hooks and arms feature laser-welded titanium anchors to resist migration. Delivered via 10 French introducer sheath and dilator set using Seldinger technique; dilator supports 0.038" guidewire and contrast power injection. Used in clinical settings by physicians. Provides bi-level filtration; anchors and hooks secure filter in vessel wall. Benefits patient by capturing emboli in IVC, preventing migration to lungs. Filter is retrievable per specific procedural instructions.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by extensive in vitro and in vivo bench testing. In vitro testing included fatigue resistance, anchor weld tensile strength, migration resistance (cephalad/caudal), removal force, MRI compatibility, trackability, pushability, deployment accuracy, centering/tilt, entanglement, biocompatibility, and corrosion resistance. In vivo testing included retrievability, fatigue, migration resistance, penetration/perforation, caval patency/damage/narrowing, deployment ease/accuracy, and fluoroscopic visibility.
Indicated for patients requiring prevention of recurrent pulmonary embolism via permanent vena cava placement. Applicable for: pulmonary thromboembolism with anticoagulant contraindication; failure of anticoagulant therapy; emergency treatment for massive pulmonary embolism; chronic, recurrent pulmonary embolism where anticoagulants failed or are contraindicated.
Regulatory Classification
Identification
A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.
Special Controls
*Classification.* Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
Predicate Devices
ECLIPSE™ Filter System – Jugular/Subclavian Delivery Kit (K101431)
Submission Summary (Full Text)
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K102511
P. 1 of 4
Page 19
#### MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kit 510(k) Summary 21 CFR 807.92
AUG 2 4 2011
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
# Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-638-2906 |
| Fax: | 480-449-2546 |
| Contact: | Joni Creal, Regulatory Affairs Associate |
| Date: | August 31, 2010 |
#### Subject Device Name:
| Device Trade Name: | MERIDIAN™ Filter System –<br>Jugular/Subclavian Delivery Kit (MD800J) |
|-----------------------|------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Filter, Intravascular, Cardiovascular |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Product Code: | DTK |
| Predicate Devices: | ECLIPSE™ Filter System – Jugular/Subclavian Delivery<br>Kit (K101431: Clearance June 25, 2010) |
# Summary of Change:
. .
The primary modification to the predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431), compared to the subject device, the MERIDIAN™ Jugular/Subclavian Delivery System, is the addition of one downward pointing titanium anchor which is laser welded to each filter wire arm (6 total). In
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addition, the Jugular delivery system has been modified to accommodate the filter design changes and minor changes have been made to the IFU.
# Device Description:
The MERIDIAN™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the six legs provide the lower level of filtration and the six arms provide the upper level of filtration. The legs contain hooks and the arms contain anchors to resist filter movement. The MERIDIAN™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The subject MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the MERIDIAN™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire, enables a contrast medium power injection up to 800 psi maximum pressure, and is fitted with two radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip for identification of the distal end of the sheath and a hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and delivery mechanism to deploy the MERIDIAN™ Filter.
#### Indications for Use of Device:
The subject device, the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit, is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulants are contraindicated.
- . Failure of anticoagulant therapy for thromboembolic disease.
- . Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
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MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
#### Technological Comparison to Predicate Devices:
The technological characteristics of the subject device, the MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kit, are substantially equivalent to those of the predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431), in terms of intended use, indications for use, application, user population, operating principle, delivery system design, filter bi-level design, fundamental scientific technology, packaging configuration, and sterilization method.
## Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated using in vitro and in vivo testing performed as outlined below:
## In Vitro
- Fatigue Resistance .
- Anchor Weld Tensile Strength .
- Cephalad Migration Resistance .
- Caudal Migration Resistance ●
- Removal Force .
- . MRI Compatibility
- Delivery System Trackability .
- . Delivery System Pushability
- . Deployment Accuracy
- Filter Centering (Tilt) .
- Arm/Leg Entanglement (Configuration) .
- Biocompatibility .
- Corrosion Resistance .
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K102571
p. 4 of 4
Page 22
# In Vivo
- Retreivability .
- Fatigue Resistance .
- Cephalad Migration Resistance .
- Caudal Migration Resistance .
- Penetration Resistance ◆
- Perforation .
- Caval Patency .
- Caval Damage .
- Caval Narrowing .
- Delivery System Trackability .
- Delivery System Pushability .
- Ease of Deployment (Deployment Force) t
- Deployment Accuracy .
- Filter Centering (Tilt) ●
- Arm/Leg Entanglement (Configuration) ◆
- Filter Visibility Under Fluoroscopy .
- Delivery System Visibility Under Fluoroscopy .
The results from these tests demonstrate that the technological characteristics and performance criteria of the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is comparable to the predicate device and that the subject device can perform in a manner substantially equivalent to devices currently on the market for the same intended use.
#### Conclusions:
The MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is substantially equivalent to the legally marketed predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431).
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bard Peripheral Vascular, Inc. c/o Ms. Joni Creal Regulatory Affairs Associate 1625 West Third Street Tempe, AZ 85281
AUG 2 4 2011
Re: K102511
Trade Name: MERIDIAN Filter System - Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: June 27, 2011 Received: June 28, 2011
Dear Ms. Creal:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{5}------------------------------------------------
Page 2 - Ms. Joni Creal
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Si-
Sincerely yours,
Bram Zuckerman, M.D.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kits
Indications for Use:
The MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulants are contraindicated.
- . Failure of anticoagulant therapy for thromboembolic disease.
- . Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
Prescription Use_X (Part21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|
| | and the comments of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the fir | |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | ------------------------------------- | |
| (Divis | | |
| | | |
| | | |
| | Division of Cardiovascular Devices | |
| | | |
| | | |
510(k) Number_K 10254
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Part 1 — Search, results, and everyday workflows 16 min
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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.
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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.
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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.
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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.
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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.
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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.
