The Sapphire Detachable Fibered Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Device Story
Sapphire Detachable Fibered Coil System consists of platinum alloy wire wound into primary coils and secondary helical shapes; nylon fibers secured to primary coil. Device includes positioning wire with stainless steel core, stainless steel coil at distal end, and Teflon jacket. Detachment achieved via battery-operated Sapphire Detachment System (SDS) which dissolves detachment element. Used in neurovascular procedures by neurosurgeons/interventionalists to embolize intracranial aneurysms, AVMs, and fistulae. Coil placement via endovascular approach; detachment triggered by clinician using SDS. Provides mechanical occlusion of vascular abnormalities; benefits include treatment of otherwise inoperable or high-risk intracranial lesions.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by in-vivo and in-vitro studies and technological comparison to predicate devices.
Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for traditional surgery or inoperable, and for embolization of neurovascular abnormalities including arteriovenous malformations and arteriovenous fistulae.
Regulatory Classification
Identification
A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
Predicate Devices
MTI Sapphire Detachable Fibered Coil System (K031852)
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K03372
JAN - 9 2004
## Micro Therapeutics, Inc. Micro Therapeutics, Inc.
Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System
| 510(k) Summary | |
|-----------------|--------------------------------------------------------------------|
| Trade Name: | Sapphire Detachable Fiber Coils |
| Generic Name: | Artificial Embolization Coil |
| Classification: | Class III, 21 CFR 882.5950 |
| Submitted By: | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, California 92618 |
| Contact: | Florin Truuvert |
#### Predicate Device:
| Number | Description | Clearance Date |
|---------|---------------------------------------------|-------------------|
| K031852 | MTI Sapphire Detachable Fibered Coil System | August 20, 2003 |
| K030392 | MTI Sapphire Detachable Coil System | July 21, 2003 |
| K901337 | Cook, Inc. Hilal Embolization Microcoil | November 13, 1990 |
#### Device Description
The Sapphire Detachable Fibered Coil System is manufactured from a platinum alloy wire, which is first wound into primary coil and then formed into a secondary helical shape. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (Sapphire Detachment System, SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.
#### Indication For Use
The Sapphire Detachable Fibered Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable.
The Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
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## Micro Therapeutics, Inc. Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System
## Purpose Of the Submission
This Premarket Notification is submitted to obtain marketing clearance for a change in the indication for use of the Sapphire Detachable Fibered Coil System. The Sapphire fibered coils have originally received 510(k) clearance (K031852) on August 20, 2003 for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae as well as arterial and venous cmbolization in the peripheral vasculature.
The proposed change in indication is to expand the use of the fibered coils in ancurysm. This is supported by in-vivo, in-vitro studies as well as technological comparison to the predicate device, Cook, Inc. Hilal embolization Microcoil.
| Characteristics | Cook, Hilal Embolization Microcoil | Sapphire Fibered Coils |
|------------------------------|------------------------------------|------------------------|
| Microcoil system supplied as | Sterile, single use | Same |
| Coils shapes | Straight and Curled | Helix and Cyclone |
| Coil length and diameter | Various | Same |
| Catheter compatibility | 18" | 10" and 18" |
| Radiopacity | Radiopaque from Pt alloy wire. | Same |
| MRI Compatibility | Yes | Same |
| Material | | |
| Main Coil | Platinum alloy | Same |
| Fiber Material | Synthetic fiber | Nylon 6-6 |
| Detachment Element | Stainless Steel | Same |
#### Comparison To the Predicate Device
#### Summary of Substantial Equivalence
The above comparison table demonstrates the technological similarity and equivalincy of the Sapphire fibered coils compared with the predicate device, Cook, Inc. Hilal embolization Microcoil. The two devices have the same intended use and incorporate the same basic technological design.
In summary, the Sapphire fibered coils described in this submission are, in our opinion, substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2004
Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K033372
Trade/Device Name: Sapphire Detachable Fibered Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: October 20, 2003 Received: October 29, 2003
Dear Ms. Truuvert:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications forchenced above and no sure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard ment date of the Medical Device Amendments, or to commerce phor to May 20, 1978, as econdance with the provisions of the Federal Food, Drug, devices that have been rochanied in equire approval of a premarket approval application (PMA). alle Cosmette Act (11ct) that ao not required to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provided on the practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a 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 I reast of advised that I Dris a lossantes complies with other requirements of the Act that I Driving and regulations administered by other Federal agencies. You must or any i edelia all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot STequirements,01); good manufacturing practice requirements as set CI K ratt 607); laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35001 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Florin Truuvert
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you've substantial equivalence of your device of your device to a legally promation of neations "The 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 If you desire specific advice 107 Jour a01) 594-4659. Also, please note the regulation entitled, Connact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational and Consumer 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
Sincercly yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): KOIJIJZZ
Device Name: Sapphire Detachable Fiber Coil System
Indications For Use:
The Sapphire Detachable Fibered Coils are intended for the endovascular embolization of The Sapphire Detactiable Hibered Couls are interestion, or the pation, or the pation. of the pation.'S intractal aneurysms that — because of the the provention to be a) very general medical condition – are tonsidered by the arranges, or b) be inoperable.
The Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro The Sapphire Detactiable Fibered Oulis are ulos interious and arteriovenous fistulae.
vascular abnormalities, such as, atteriovenous malformations and arteriovenous fistulae.
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 Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K033372
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.
