K972964 · Atrion Medical Products, Inc. · KOE · Oct 10, 1997 · Gastroenterology, Urology
Device Facts
Record ID
K972964
Device Name
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
Applicant
Atrion Medical Products, Inc.
Product Code
KOE · Gastroenterology, Urology
Decision Date
Oct 10, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5520
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
Device Story
Device is a manual, single-use balloon catheter inflation system. Components include a 20 cc plastic syringe, screw-type plunger, locking lever, rotating palm grip, manometer for pressure monitoring, and connecting tube. Operated by clinicians during balloon dilation procedures. User manually rotates palm grip to advance plunger, inflating balloon; manometer provides real-time pressure feedback (range: vacuum to 10-20 atm). Device facilitates controlled dilation of anatomical structures. No automated or electronic components.
Clinical Evidence
Bench testing only. Materials contacting contrast solution tested per USP guidelines; results indicate safety for intended use.
Technological Characteristics
Manual plastic syringe with screw-type plunger, locking lever, and rotating palm grip. Includes manometer and connecting tube. Fluid capacity: 20 cc. Operating pressure: vacuum to 10-20 atm. Single-use. No electronic or software components.
Indications for Use
Indicated for patients undergoing gastrointestinal (GI), gastrouterine (GU), or lacrimal duct balloon catheter dilation procedures requiring balloon inflation, pressure monitoring, and deflation.
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
Ryder International Urological Balloon Catheter (Bard® Eagle™) Inflation Device (K962611)
Submission Summary (Full Text)
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Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 205 586 1580 Fax 205 586 8529
K972964
OCT 10 1997
**Atrion**
#### SUMMARY OF SAFETY AND EFFECTIVENESS 12.
| Date of Preparation: | August 7, 1997 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atrion Medical Balloon Catheter 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, Atrion Medical Products, Inc.<br>PO Box 564, 1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: (205) 586-1580, Fax: (205) 586-5553 |
| Predicate: | Ryder International Urological Balloon Catheter (Bard®<br>Eagle™) Inflation Device cleared under K962611 |
# Device Description/Intended Use:
The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube.
The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.
The inflation device is intended for single use while performing balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
# Technological Characteristics:
The Atrion Medical Balloon Catheter Inflation Device has an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached, while the predicate device has a range of vacuum to 20 atm. The Atrion Medical Balloon Catheter Inflation Device has no stopcock, while the predicate device does. There are no other significant technological characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.
# Summary of Safety Testing:
The materials of the device which contact the contrast solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.
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Image /page/1/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a series of flowing lines, possibly representing people or services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# OCT 1 0 1997
Mr. Dan Clark Vice President, Regulatory and Ouality Atrion Medical Products, Inc. 1426 Curt Francis Road P.O. Box 564 Arab, Alabama 35016
Re: K972964
Atrion Medical Balloon Catheter Inflation Device Dated: August 7. 1997 Received: August 11, 1997 Regulatory class: II and I 21 CFR 8876.5520/Product code: 78 KOE 21 CFR §886.4350/Product code: 86 HNW
Dear Mr. Clark:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 (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 requirement, as set forth in the Quality System Regulation (OS) 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 Radiation Control provisions, or other Federal laws or regulations.
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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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/dsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K972964_____________________________________________________________________________________________________________________________________________
Device Name: Atrion Medical Balloon Catheter Inflation Device
Indications For Use:
The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K972964 | (Optional Format-1-2-96) |
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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.
