WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
Applicant
CooperSurgical, Inc.
Product Code
MQF · Obstetrics/Gynecology
Decision Date
Jul 26, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.6110
Device Class
Class 2
Indications for Use
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Device Story
Wallace Malleable Stylet is a sterile, single-use accessory for Wallace Catheters used during in vitro fertilization (IVF). Device consists of soft stainless steel wire encapsulated in Fluoroethylenepropylene (FEP) sheath with rounded tip and plastic luer hub. Available in 18 cm and 23 cm lengths. Operated by physicians in clinical settings to provide structural support to catheters, facilitating navigation through impeded cervical passages. Device does not perform automated analysis or processing; it serves as a mechanical aid to improve catheter placement success, thereby assisting in oocyte collection or embryo transfer procedures.
Clinical Evidence
Bench testing only. Testing included visual and dimensional inspection, functional testing, one-cell Mouse Embryo Assay for toxicity, and Limulus Amoebocyte Lysate (LAL) test for bacterial endotoxins. Biological safety assessment performed per ISO 10993-1:1994.
Technological Characteristics
Materials: Stainless steel wire, Fluoroethylenepropylene (FEP) sheath, plastic luer hub. Dimensions: 18 cm and 23 cm working lengths. Principle: Mechanical support/stiffening for catheters. Sterilization: Sterile, single-use. No software or electronic components.
Indications for Use
Indicated for patients undergoing in vitro fertilization procedures where cervical passage is impeded. Contraindicated in patients with recent pelvic inflammatory disease, chronic cervical infection, or for intrafallopian tube procedures.
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).
Predicate Devices
Assisted reproduction catheters (21 CFR 884.6110)
Submission Summary (Full Text)
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90349
JUL 26 1999
## 510(k) SUMMARY
The Summary of Safety and Effectiveness on Malleable Stylets Catheters reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
| Applicant | Debra Pekar, Manager Regulatory Affairs<br>CooperSurgical<br>15 Forest Parkway<br>Shelton, CT 06484 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 203/929-6321 |
| Facsimile | 203/925-0135 |
| Date | February 01, 1999 |
| Name | Wallace Malleable Stylets |
| Classification | Assisted Reproduction Catheters, 21 CFR 884.6110 |
| Predicate: | 884.6110 Assisted reproduction catheters<br>21 CFR Part 884<br>[Docket No. 97N – 0335]<br>Obstetric and Gynecologic Devices; Reclassification of Medical Devices Used for<br>In Vitro Fertilization and Related Assisted Reproduction Procedures.<br>Effective Date: October 13, 1998 |
| Description | The Wallace Malleable Stylet comprises a soft stainless steel wire, which is totally<br>encapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing is<br>formed and closed at one end into a smooth rounded tip, and is encapsulated at the<br>other end within an insert plastic molded luer hub. The stylet is supplied with a<br>FEP outer sheath, which is insert molded into a plastic luer hub. The models are<br>available in two sizes, 18 cm and 23 cm of working length and are for single use<br>only. |
| Intended Use | The Family of Wallace Malleable Stylets are a sterile single-use device intended to<br>be used in conjunction with a Wallace Catheter for <i>in vitro</i> fertilization procedures<br>where passage through the cervix is impeded. |
| Contraindications | Not intended for use in the presence of or after recent pelvic inflammatory disease<br>or chronic cervical infection.<br><br>Not intended for intrafallopian tube procedures. |
| Caution | Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. |
| Technological<br>Characteristics | There are no published standards for these particular types of products, and as such<br>tests have been developed which are considered sufficient to ensure the efficacy<br>and safety of the device(s) for its intended use. Such tests include - Visual;<br>Dimensional; Functional; one-cell Mouse Embryo Assay; and Bacterial Endotoxin<br>(Limulus Amoebocyte) Assay. |
| Data Submitted | The biological safety assessment of the Wallace Catheters has been performed in<br>accordance with the International Standard ISO 10993, Part 1:1994, "Biological<br>Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993<br>the selection of tests, taking into consideration the particular application of the<br>product e.g. collection of human oocytes, transfer of embryos and washed<br>spermatozoa, embryo toxicity and bacterial endotoxin test were performed. |
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, arranged in a cascading or flowing manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Thomas G. Williams Director of Quality Assurance And Regulatory Affairs CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484
Dear Mr. Williams:
Re: K990349 Wallace Malleable Stylets Dated: June 25, 1999 Received: June 28, 1999 Requiatory Class: II 21 CFR §884.6110/Procode: 85 MQF
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 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). 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 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 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 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, "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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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): | K990349 |
|---------------------------|---------|
|---------------------------|---------|
Wallace Malleable Stylets Device Name: ____
Indications For Use:
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.
## Contraindication:
Not intended for use in the presence of or after recent pelvic inflammatory disease or chronic cervical infection.
Not intended for intrafallopian tube procedures.
## Caution:
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
(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 01.109)
OR
Over-The-Counter-Use _
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
(Optional Format 1-2-96)
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.
