K032840 · Atrion Medical Products, Inc. · KOE · Mar 3, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K032840
Device Name
ATRION MEDICAL QL INFLATION DEVICE
Applicant
Atrion Medical Products, Inc.
Product Code
KOE · Gastroenterology, Urology
Decision Date
Mar 3, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5520
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
Device Story
Atrion Medical QL Inflation Device is a manual balloon inflation/deflation system. Components include a locking palm grip for plunger control, a manometer for pressure monitoring, and a connecting tube. Operated by clinicians in a medical setting, the device connects to balloon dilatation catheters. The user manually manipulates the plunger to generate pressure, which is displayed on the manometer, allowing for controlled inflation and deflation of the balloon during interventional procedures. The device facilitates precise pressure management to assist in catheter-based therapies.
Clinical Evidence
Bench testing only. Materials contacting the solution were tested for safety and biocompatibility, confirming the product is safe for its intended use.
Technological Characteristics
Manual inflation/deflation device featuring a locking palm grip, plunger, manometer, and connecting tube. Operating pressure range varies by model. Materials contacting the solution have been verified for safety.
Indications for Use
Indicated for use with balloon dilatation catheters to create, monitor, and deflate balloon pressure during clinical procedures.
Regulatory Classification
Identification
A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.
Special Controls
*Classification.* (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Predicate Devices
Atrion Medical Products Balloon Catheter Inflation Device (K972964)
Ryder International (USCI Ideal) Balloon Catheter Inflation Device (K953522)
Scimed Encore 26 and Encore 30 Inflation Devices (K955869)
Submission Summary (Full Text)
{0}------------------------------------------------
K032-840
# 12. SUMMARY OF SAFETY AND EFFECTIVENESS
| Date of Preparation: | September 9, 2003 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atrion Medical QL® Inflation Device |
| Classification Name: | Balloon Inflation/Deflation Device |
| Manufacturer: | Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016 |
| Contact: | Mr. Dan Clark,<br>Atrion Medical Products, Inc.<br>1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: (256) 586-1580, ext. 220<br>Fax: (256) 586-8529<br>Email: dclark@atrionmedical.com |
#### Predicates:
Atrion Medical Products Balloon Catheter Inflation Device, K972964. Athon Mediour Productional (Bard Eagle) Urological Balloon Catheter Inflation Device, K962611 Ryder International (USCI Ideal) Balloon Catheter Inflation Device, K953522 Scimed Encore 26 and Encore 30 Inflation Devices, K955869
### Device Description:
Device Description: The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.
## Intended Use:
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
# Technological Characteristics:
The Atrion Medical QL® Inflation Device has an operating pressure range of vacuum to The Athor Medical QL® Innation Dother Hached, while the predicate devices have a 40 alln, depending on the manomote ending on the predicate. There are no other range of valuant to it characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.
## Testing:
The materials of the device which contact the solution in use have been tested using The materials of the do not these studies indicate that the product is safe for its intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Mr. Dan Clark Vice President Regulatory and Quality Atrion Medical Products, Inc. P.O. Box 564 1426 Curt Francis Road ARAB AL 35016
Re: K032840
Trade/Device Name: Atrion Medical QL® Inflation Device Regulation Number: 21 CFR §876.5520 Regulation Name: Urethral dilator Product Code: 78 KOE Regulation Number: 21 CFR §870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II-Product Code: 78 MAV Dated: January 14, 2004 Received: January 16, 2004
Dear Mr. Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to the enactment date of the Medical Device Amendments, or to conninered pror to they 20, 2017 11:57 accordance with the provisions of the Federal Food, Drug, de noos that have been that do not require approval of a premarket approval application (PMA). and Cosmette Act (110.) that Concerner subject to the general controls provisions of the Act. The r on may, therefore, maines of the Act include requirements for annual registration, listing of general controll provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial 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 i that FDA has made a determination that your device complies with other requirements of the Act that I Dry has made a astd regulations administered by other Federal agencies. You must or any I ederal statutes and requirements, including, but not limited to: registration and listing Comply with an the Hot in (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 087), acomisg (2S) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant of a provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k)
1972) 1 This letter will allow you to begin marketing your intist equivalence of your device to a legally premarket notification. The FDA inding of succements of the succe 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 of If you desire specific advice for your device on on the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotive and as a sected to regulation entitled, "Masbranding, of ther agencral Office of Compliance at (301) 594-4057. This, post 807.97) you may obtain. Other general by reference to premarket nonication (21CH F are over (1) jocd from the Division of Small
information on your responsibilities under the Act may be obtained from the (800) 6 information on your responsionalizes under the Assistance at its toll-free mumber (80) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free manag Manufacturers, International and Collisation Assistences in the Marian and Smamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# 13. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ko32\$46
Device Name: Atrion Medical QL® Inflation Device
Indications For Use:
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor
and money of the first and the the ballean The immation Device is foot and to deflate the balloon.
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NET - CONTINE BELOW - NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use<br>(Per 21 CFR 801.109) | <div>✓</div> |
|------------------------------------------|--------------|
|------------------------------------------|--------------|
OR Over-The- Counter Use
(Optional Format 1-2-96)
| (Division Sig | <div>Nancy Brogdon</div> |
|--------------------------------------------------------------|--------------------------|
| Division of Re ctive, Abdominal,<br>and Radiological Devices | |
| 510(k) Number | K032840 |
000059
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.
