K123258 · Catheter Research, Inc. · LKF · Jan 31, 2013 · Obstetrics/Gynecology
Device Facts
Record ID
K123258
Device Name
THE ADVANCE CATHETER FOR HSG AND SIS
Applicant
Catheter Research, Inc.
Product Code
LKF · Obstetrics/Gynecology
Decision Date
Jan 31, 2013
Decision
SESE
Submission Type
Special
Regulation
21 CFR 884.4530
Device Class
Class 2
Indications for Use
The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.
Device Story
Advance Catheter for HSG and SIS; plastic tube with distal inflatable balloon; proximal stopcock for balloon inflation via syringe; center lumen for fluid injection; luer connector; introducing sheath for stiffening/guidance. Used in clinical setting by physicians for hysterosalpingography and saline infusion sonohysterography. Sheath design allows placement inside cervical canal without dilation, improving patient comfort. Device delivers contrast media or saline to visualize uterine cavity and fallopian tubes. Benefits include enhanced ease of insertion and diagnostic visualization of reproductive tract pathologies.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility per ISO 10993, balloon integrity, tensile strength, and flow testing.
Technological Characteristics
Plastic catheter with inflatable balloon; 5F and 7F sizes; luer connector; stopcock; introducing sheath. Biocompatible materials per ISO 10993. Mechanical device; no energy source or software.
Indications for Use
Indicated for female patients undergoing HSG or SIS for evaluation of suspected polyps, fibroids, adhesions, endometrial thickening, or fallopian tube patency. Available in 5F (nulliparous cervix) and 7F (multiparous cervix) sizes.
Regulatory Classification
Identification
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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 § 884.9.
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K123258
PAGE 1 OF 2
#### SECTION 5 510(k) Summary
JAN 3 1 2013
Applicant/Sponsor:
Catheter Research, Inc. 5610 W. 82nd St. Indianapolis, IN 46278
Contact Person:
Babacar Diouf 317-872-0074 x3512
10/03/2012
Date:
Proprietary Name:
Classification Name:
Product Code:
LKF
Classification Regulation:
Unclassified, Pre-Amendment 510(k) Submission
The Advance Catheter for HSG and SIS
Cannula, Manipulator/Injector, Uterine;
## Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
| HS and SHG Catheters | K032835 |
|-------------------------|---------|
| FemVue™ Catheter System | K083690 |
Device Description: The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.
An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.
Intended Use: Delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes
The predicate device is intended for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes.
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Summary of Technologies: The subject Advance Catheter has the identical technologies as the predicate device. Both devices are assembled in the same work environment using the same manufacturing lines.
The Advance Catheter is identical in materials and function to CRI's presently marketed product with the exception of the sheath.
The Advance catheter also shares substantially equivalent key features with the FemVue™ Catheter System (K083690), including similar principles of operation for device placement and an equivalent transcervical sheath.
Non-clinical/Clinical Testing: Biocompatibility testing per ISO10993 and performance testing (balloon integrity, tensile testing, flow testing, etc.).
| Equivalence Summary | | | |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate | Proposed | Comments/Discussions |
| Catheter<br>Components | HSG Catheter | The Advance<br>Catheter for HSG<br>and SIS | Substantially Equivalent: No<br>significant differences in<br>design, manufacturing,<br>material, sterilization, or<br>packaging. |
| Sheath | Tube flaired at the<br>distal end | Tube with two steps<br>and smaller OD | Allows for placement inside<br>cervical canal and increase<br>patient comfort. |
| Indication for<br>Use | Delivery of diagnostic<br>contrast media agents<br>or saline into the<br>female reproductive<br>tract for examination<br>of the uterus and<br>fallopian tubes | Delivery of<br>diagnostic contrast<br>media agents or<br>saline into the female<br>reproductive tract for<br>examination of the<br>uterus and fallopian<br>tubes | Identical |
| Procedure | Sheath is placed at<br>the face of the cervix. | Sheath is placed<br>inside the cervical<br>canal. | Enhances ease of insertion<br>(see attached letter from Dr.<br>Charles E. Miller) |
| Biocompatibility<br>testing and<br>performance<br>testing | Flow rate and joints<br>tensile strength meet<br>set requirements.<br>The product is<br>biocompatible per<br>ISO10993 | Flow rate and joints<br>tensile strength<br>meet set<br>requirements. The<br>product is<br>biocompatible per<br>ISO10993 | See test reports in sections<br>15 and 18. |
In conclusion, since both catheters are similar, we feel that testing performed on the Advance catheter and the information from the predicates devices are sufficient to support the safety and effectiveness of the Advance catheter.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, black and white design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Catheter Research, Inc. % Mr. Babacar Diouf Vice President of Regulatory Affairs and Quality Systems 5610 West 82nd Street INDIANAPOLIS IN 46278
Re: K123258
Trade/Device Name: The Advance Catheter for HSG and SIS Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: January 9, 2013 Received: January 23, 2013
Dear Mr. Diouf:
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.
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Page 2 - Mr. Babacar Diouf
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 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.
Sincerely yours,
Herbert P.Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# SECTION 4 - Indications for Use Statement
510(k) Number (if known): K123258
Device Name: The Advance Catheter for HSG and SIS
## Indications for Use:
The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.
The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.
The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.
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)
Prescription Use (Per 21 CFR 801.109) or
Over-The-Counter Use
# Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123258 510(k) Number
Exhibit 4R - Page 4 -1 of 1
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.
