Single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The Tao embryo transfer catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.
Device Story
Tao Embryo Transfer Catheter System; sterile, single-use device for introducing embryos into uterine cavity. System comprises pellethane outer sleeve and polyethylene inner catheter. Outer sleeve features distal portion with easy-to-shape design and sphere-shaped soft cap at tip. Cap minimizes cervical trauma and reduces potential mucus, blood, or bacterial contamination of inner catheter and embryos. Inner catheter available in end-port or side-port configurations. Used in IVF clinics by trained clinicians. ETO sterilized. Benefits include reduced trauma and contamination during embryo transfer.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, materials, and intended use comparisons.
Technological Characteristics
Materials: pellethane (outer sleeve), polyethylene (inner catheter). Design: two-part system with sphere-shaped soft cap. Sterilization: ETO. Single-use. No electronic or software components.
Indications for Use
Indicated for patients undergoing IVF embryo transfer procedures. Intended for introduction of embryos into the uterine cavity by experienced clinicians in appropriate facilities.
Regulatory Classification
Identification
Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Submission Summary (Full Text)
{0}------------------------------------------------
510(K) Tao Embryo Transfer Catheter System
AUG 2 7 2001
## Chapter 5 TRADITIONAL 510(K) SUMMARY Tao Embryo Transfer Catheter System
| APPLICATION DATE: | May 22, 2001 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | TTJ Biomedical, LLC<br>2885 Aurora Avenue, Suite 15<br>Boulder, CO 80303<br>303-444-5026 303-444-9713 (fax) |
| CONTACT: | Richard Jortberg, MS, MAI<br>Manager, TTJ Biomedical, LLC<br>2885 Aurora Avenue, Suite 15<br>Boulder, CO 80303<br>303-444-5026; 303-444-9713 (fax)<br>REJ@RJAssociatesInc.Com |
| TRADE NAME: | Tao Embryo Transfer Catheter System |
| COMMON NAME: | Embryo Transfer Catheter |
| CLASSIFICATION NAME: | Assisted Reproduction Catheter |
| DEVICE CLASS: | Class II |
| REGISTRATION NUMBER: | To be registered upon completion of 510(K)<br>review process |
| REGULATION NUMBER: | 21 CFR 884.6110 |
| PRODUCT CODE (PROCODE): | 85 MOF |
| 510(K) TYPE: | Traditional |
K012220
page 1 of 2
{1}------------------------------------------------
## TRADITIONAL 510(K) SUMMARY (Continued) Tao Embryo Transfer Catheter System
### SUBSTANTIAL EQUIVALENCE / PREDICATE DEVICES:
The Tao Embryo Transfer Catheter system is substantially equivalent to applicable published requirements due to conformance with descriptions from CFR 884.6110 Assisted Reproduction Catheters as described in the Final Rule in the Federal Register, Vol. 63, No. 175, September 10, 1998, page 48436. In addition, the Tao catheter is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. Finally, due to similarity with respect to indications for use, materials and physical construction to predicate devices, the Tao catheter meets the requirement for section 510(K) substantial equivalence.
#### INDICATIONS FOR USE:
Devices are intended for single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The sterile Tao Embryo Transfer Catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.
#### DEVICE DESCRIPTION/ TECHNICAL CHARACTERISTICS:
The Tao Embryo Transfer Catheter system consists of two devices which are used for introducing embryos into the uterine cavity. This sterile, single use embryo transfer system consists of a pellethane outer sleeve and a polyethelene inner catheter. The outer sleeve has a distal portion which has an easy-to-shape design. At the tip, the outer sleeve is protected by a sphere-shaped soft cap. The revolutionary design of the cap not only significantly minimizes trauma when passing the cervix, but it also minimizes possible mucus, blood and bacterial contamination of the inner catheter and embryos. The inner catheter has two different designs, with one having an end-port and the other a side-port. Predicate devices do not use the proprietary design of the sphere-shaped cap of the outer sleeve.
{2}------------------------------------------------
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/3 description: The image shows a partial view of the Department of Health logo. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH" is partially visible, running vertically along the left side of the image.
AUG 2 7 2001
Mr. Richard Jortberg, MS, MAI Manager, TTJ Biomedical, LLC TTJ Biomedical, LLC 2885 Aurora Avenue, Suite 15 BOULDER CO 80303
Re: K012220
Tao Embryo Transfer Catheter System (IVF Reproduction Transfer Catheter) Dated: May 22, 2001 Received: July 16, 2001-Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF
Dear Mr. Jortberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section 516(x) hourselves or use stated in the enclosure) to legally marketed predicate devices device is substantially equivacile for the morelies to the Medical Device Amendments, or to devices of the Medical of the May 2014 at 11:44 am marketed in meets as commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act .
therefore, market the device, subject to the general therefore, market the device, subject on the general or no noversion, and increasing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematice Approval), it may be subject of Erderel Results of to such additional controls. Existing major reaulttions affecting your device can be found in the Code of Federal Regulations, to such additional comitrois. Existure high regulations areomes compliance with the Current Good Manufacturing I I tic Z , Patis 800 to 693. A Subsantany quartation (QS) for Medical Devices: General regulation (21 CFR Part Practice requirements, as set tour in the Quality Dystem Aconnistration (FDA) will verify such assumptions. Failure ozon and the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to conting your device in the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in alle I oderal not sections 531 the Act for devices under the Electronic Product 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 I his letter will allow 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 If you desire specific at 10 years contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, advolume of your convertion promation" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International 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/dsmaldsmamain.html".
Sincerely yours.
Nancij broydon
U.S.A.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
# Chapter 4 STATEMENT OF INDICATIONS FOR USE:
Ver/ 3 - 4/24/96 Applicant: TTJ Biomedical, LLC KOL2220 510(k) Number (if known): Device Name: Tao Embryo Transfer Catheter System Indications For Use:
Intended Use: Single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The Tao embryo transfer catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.
**Prescription Use**
Haneyc. Bordon
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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.
