The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Device Story
Dual lumen polyurethane catheter; 5.0 or 7.0 Fr diameter; 30 cm length; open or closed-end tip options. Silicone balloon (1.0 mL or 1.5 mL volume) used to anchor catheter in uterine cavity. Physician-operated during hysterosalpingography or saline infusion sonohysterography. Device delivers contrast medium or saline to evaluate tubal patency or access uterine cavity. Supplied sterile (ethylene oxide) for single-use. Clinical benefit: facilitates diagnostic imaging of uterine cavity and fallopian tubes.
Clinical Evidence
Bench testing only. Testing included sterilization validation (ISO 11135-1:2007), biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010), transportation simulation (ASTM D4169-16), package integrity (ASTM F2096-11, ASTM F88-09, ASTM F1866-09), and bench performance (simulated use, balloon integrity, balloon diameter/volume, lumen patency, tensile testing). All predetermined acceptance criteria met.
Indicated for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for evaluation of tubal patency via hysterosalpingography or access for saline infusion sonohysterography.
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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October 26, 2018
Cook Incorporated Yan Li Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K180291
> Trade/Device Name: Cook® Silicone Balloon HSG Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 24, 2018 Received: September 25, 2018
Dear Yan Li:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -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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# Indications for Use
510(k) Number (if known) K180291
Device Name Cook® Silicone Balloon HSG Catheter
Indications for Use (Describe)
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Type of Use (Select one or both, as applicable)
| <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 201 Subpart D) |
|------------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background. The red background is shaped like a trapezoid.
COOK INCORPORA 750 DANIELS WAY, P.O. BC BLOOMINGTON, IN 47402-048 12.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.CO
## K180291 Page 1 of 4
## 510(k) Summary Cook® Silicone Balloon HSG Catheter Date Prepared: October 26, 2018
| Submitted By: | |
|------------------------|-----------------------------------------------------|
| Applicant: | Cook Incorporated |
| Contact: | Yan Li |
| | Rohini Patel |
| Applicant Address: | Cook Incorporated |
| | 750 Daniels Way |
| | Bloomington, IN 47404 |
| Contact Phone: | (812) 339-2235 x104987 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Cook® Silicone Balloon HSG Catheter |
| Device Common Name: | HSG Catheter |
| Regulation Number: | 21 CFR §884.4530 |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |
| Device Classification: | Class II |
# Predicate Device:
u Vue® HSG/SHG Catheter, Cook Incorporated, K160217
The predicate device has not been subject to any design-related recalls.
## Device Description:
The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter.
The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has a two-year shelf-life.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, uppercase letters on a red background. To the right of the word "COOK" is a registered trademark symbol. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 48 BLOOMINGTON, IN 47402-0489 U.S 812.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.COM
# Indications for Use:
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
# Comparison to Predicate Device:
The following table compares the Cook® Silicone Balloon HSG Catheter to the predicate device:
| Device<br>Characteristics | K180291<br>Cook® Silicone<br>Balloon HSG Catheter | K160217<br>uVue® HSG/SHG<br>Catheter | Comparison |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Cook® Silicone<br>Balloon HSG Catheter<br>is used for delivery of<br>contrast medium or<br>saline into the uterine<br>cavity and fallopian<br>tubes for the evaluation<br>of tubal patency using<br>hysterosalpingography,<br>or to access the uterine<br>cavity for saline<br>infusion<br>sonohysterography. | The uVue™ HSG/SHG<br>Catheter is intended to<br>access the uterine<br>cavity for<br>sonohysterography<br>(SHG) and<br>hysterosalpingography<br>(HSG). | Same intended use: Both<br>devices are intended for use<br>in delivery of contrast<br>medium or saline to the<br>uterine cavity for HSG and<br>sonohysterography<br>procedures |
| Balloon<br>Material | Silicone | Silicone | Same |
| Balloon Volume<br>(mL) | 5.0 Fr: 1 mL<br>7.0 Fr: 1.5 mL | 1.5 mL | Different: The subject device<br>includes a smaller diameter<br>device version. This<br>difference does not raise<br>different questions of safety<br>and effectiveness (S&E). |
| Catheter<br>Tubing Material | Polyurethane | Polyurethane | Same |
| Catheter<br>Tubing Outer<br>Diameter (Fr) | 5.0 and 7.0 | 6.2 | Different: The subject device<br>catheter diameters are smaller<br>and larger than the predicate<br>device. This difference does<br>not raise different questions<br>of S&E. |
| Length (cm) | 30 | 26 | Different: The subject device<br>is longer than the predicate<br>device. This difference does<br>not raise different questions<br>of S&E. |
| Lumen Number | 2 | 3 | Different: Both devices have<br>two functional lumens for<br>balloon inflation and contrast<br>medium/saline infusion. The<br>third lumen of the predicate<br>device contains the internal |
| Device<br>Characteristics | K180291<br>Cook® Silicone<br>Balloon HSG Catheter | K160217<br>uVue® HSG/SHG<br>Catheter | Comparison |
| Radiopaque<br>Positioner | None | Yes | stylet. This difference does<br>not raise different questions<br>of S&E. |
| Internal Stylet | None | Yes | Different: The subject device<br>does not include a positioner<br>along the catheter shaft. This<br>difference does not raise<br>different questions of S&E. |
| | | | Different: The subject device<br>does not include an internal<br>stylet in the catheter shaft.<br>This difference does not raise<br>different questions of S&E. |
| | | | Different: The 5 Fr device is<br>supplied with a 1.0 mL |
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S. 312.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
syringe. The inclusion of a
smaller syringe does not raise different questions of S&E.
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font in the upper portion of the image. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font.
IR P
In
Accessory
3 mL syringe
As shown above, the subject and predicate device have intended use. In regards to technological characteristics, the subject and predicate device are similar in that they utilize comparable materials and are both supplied with syringes for inflation of the silicone balloons. However, differences do exist as described in the table above (e.g., dimensions, balloon volume, lumen number, lack of a stylet and positioner in the subject device, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
# Performance Data:
The following testing was performed to demonstrate that the Cook® Silicone Balloon HSG Catheter met applicable design and performance requirements. All predetermined acceptance criteria were met in the following tests.
- . Sterilization Validation testing per ISO 11135-1:2007
- . Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009 o
1 or 3 mL syringe
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 o
- Intracutaneous Irritation testing per ISO 10993-10:2010 o
- Transportation Simulation study per ASTM D4169-16
- 트 Package Integrity testing after aging to two (7.0 Fr) or three (5.0 Fr) years:
- Bubble Leak test per ASTM F2096-11 O
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- o Seal Strength testing per ASTM F88-09
MEDICA
- Visual Inspection per ASTM F1866-09 O
- 트 Bench Performance studies before and after aging to two (7.0 Fr) or three (5.0 Fr) years demonstrated that all predetermined acceptance specifications were met in the following tests:
- o Simulated Use: Testing demonstrated that the catheter was able to be inserted through the cervical canal of a model of a nulliparous cervix, the syringe was able to mate with catheter check valve, inflate balloon to labeled volume, and deflate balloon fully.
- Balloon Integrity Test: Testing demonstrated that the catheter and balloon did not o show any abnormalities such as breakage, leakage, or cracking at the balloon joint or balloon material when filled to the labeled volume. It also demonstrated that the catheter and balloon did not leak after being filled to the labeled volume and submerging in a 37°C water bath for a minimum of 10 minutes.
- Balloon Diameter and Maximum Balloon Volume Testing: Testing assessed the o balloon diameter when filled with the maximum fill volume (i.e., 1.0 or 1.5 mL), and the maximum balloon pressure and volume at catastrophic failure of the test articles. Test results met the pre-defined acceptance specifications for these devices.
- Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure.
- Tensile Testing (hub to shaft, shaft, shaft to manifold, extension tubing to o manifold): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
# Conclusion:
The results of the performance testing described above demonstrates that the Cook® Silicone Balloon HSG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.
