K011840 · Cervilenz, Inc. · HHM · Aug 10, 2001 · Obstetrics/Gynecology
Device Facts
Record ID
K011840
Device Name
CERVILENZ UTERINE MEASURING SOUND
Applicant
Cervilenz, Inc.
Product Code
HHM · Obstetrics/Gynecology
Decision Date
Aug 10, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 1
Indications for Use
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
Device Story
Cervilenz Measuring Sound is a single-use, disposable device designed for measuring the depth and/or length of the uterus, cervix, and vagina. The device functions via manual insertion into the cervical canal, mirroring the operating principle of traditional uterine sounds. Fabricated from medical-grade plastics, it provides a physical measurement of anatomical dimensions. It is intended for use by healthcare professionals in clinical settings. The device output is a direct physical measurement used to assist clinicians in gynecological procedures or assessments. It offers the benefit of a disposable, single-use tool to reduce cross-contamination risks compared to reusable instruments.
Clinical Evidence
Bench testing only. The device was evaluated for accuracy and reproducibility of measurements and found to perform equivalently to commercially available uterine sounds.
Technological Characteristics
Single-use, disposable uterine sound. Fabricated from medical-grade plastics with established biocompatibility. Manual insertion operating principle. Dimensions and form factor are comparable to traditional uterine sounds.
Indications for Use
Indicated for measuring the depth and/or length of the uterus, cervix, and vagina in patients requiring such gynecological assessment.
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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AUG 1 0 2001
Confidential Premarket Notification
K011 840
Page 1 of 2
## SECTION 11
# SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in Fills STO(t) buth the requirements of SMDA 1990 and 21 CFR 807.92.
### Submitter's name, address, telephone number, contact person, and date 1. summary prepared;
- Cervilenz, Inc. Applicant a. 17752 Sky Park Circle, Suite 285 Irvine, CA 92614 (949) 975-1515
- Judy F. Gordon, D.V.M. b. Contact Person: ClinReg Consulting Services, Inc. (949) 854-6314
- June 7, 2001 Date Summary Prepared: c.
#### Name of device, including trade name and classification name: 2.
| a. | Trade/Proprietary Name: | Measuring Sound |
|----|-------------------------|-----------------|
| b. | Classification Name: | Uterine Sound |
### Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:
| Company: | Cook OB/GYN |
|---------------|---------------------------------|
| Device: | Teflon Uterine Sound |
| 510(k) : | K870550 |
| Date Cleared: | 1987 |
| Company: | Searle Laboratories |
| Device: | Mark-7 Disposable Uterine Sound |
| 510(k) : | K760170 |
| Date Cleared: | 1976 |
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K011840
Page 2 of 2
### A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.
#### ડ. Statement of intended use:
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
#### Statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device.
The technological characteristics of the Cervilenz Measuring Sound are comparable to those of the predicate and legally marketed uterine sounds, with regard to dimensions, materials of fabrication, and operating principle.
#### 7. Brief summary of nonclinical tests and results:
The Cervilenz Measuring Sound was found to perform equivalently to commerciallyavailable uterine sounds when evaluated for accuracy and reproducibility of measurements. Thus, the technological changes in the Cervilenz Uterine Sound do not raise any new issues of safety, effectiveness or performance of the product.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2001
Cervilenz, Inc. c/o Judy F. Gordon, D.V.M. Regulatory Consultant ClinReg Consulting Services, Inc. 18732 Saginaw IRVINE CA 92612
Re: K011840 Cervilenz™ Measuring Sound Dated: June 11, 2001 Received: June 12, 2001 Regulatory Class: I 21 CFR§884.4530/Procode: 85 HHM
Dear Dr. Gordon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have and associetes we have reviewed your Scholl 310x) nombations of muse stated in the enclosure) to legally marketed predicate devices device is stossimally equivalent (tot the materient and the Medical Device Amendments, or to devices of to devices of to devices of to devices of to devices of to devices of marketed in mierslate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recalasmed in accordance will als provisions of the Act. The general controls provisions of the Act therefore, market the device, subject of the Editoris pro nectice, labeling practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premater Approval), it may be subject of Enders Results of President President President President If your device is classined (Secadore) into clubs it (Openal Ocentrely or the form in the Code of Feceral Regulations, to such additional controls. Existilly equivalent detecting yourses compliance with the Current Good Manufacturing (11 (CE) Pre 11th 21, Parts 800 0 693. A substantialion (QS) for Medical Devices: Cencral regulation (21 CFR Partice requirements, Foiling Practice requirencens, as set than in the Quality Dyson regulation (FDA) will verify such assumptions. Failure 620) and may with the GMP regulations, the regulatory action. In addition, FDA may publish further announcements to comply will the GMP Tegulation nay result in regulation on this response to your premarket notification submission the dust concerning your device in the Four Regiser. Trease nown responses 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 I fills letter will allow you to obgally 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 dovice tor your device of Compliance at (301) 594-4639. Additionally, for questions on the promision ulaghosite 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 entined, "Misolanding of Petericanoli" (area in " (ar of Sreal) Manufacturers Assistance at its toll-free number (800) 138-2011 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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Page 1 of 1
510(k) Number (if known): KO II840
Device Name: Cerileuz Measuring Sound
Indications for Use:
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use
OR
Nancy C. Bergdon
(Division Sign-Off)
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011840
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.
