K972630 · CooperSurgical, Inc. · HEX · Feb 2, 1998 · Obstetrics/Gynecology
Device Facts
Record ID
K972630
Device Name
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
Applicant
CooperSurgical, Inc.
Product Code
HEX · Obstetrics/Gynecology
Decision Date
Feb 2, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1630
Device Class
Class 2
Indications for Use
The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.
Device Story
System integrates standard colposcope (stereo microscope, halogen light, green filter) with digital documentation unit (CCD camera, embedded computer, LCD monitor). Operated by physicians in clinical settings for magnified tissue visualization. Digital system captures, stores, and displays images; allows textual entry of patient history and clinical observations; generates integrated reports with images and text. Features include software-based green filter and glare-reduction procedure for wet tissue imaging. Output viewed on monitor or printed for clinical review. Facilitates longitudinal tracking of tissue abnormalities and biopsy site selection.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
System comprises a stereo microscope with halogen light source and optional green filter on a mobile base. Digital components include CCD camera, embedded computer, and LCD monitor. Software features include digital image storage, report generation, software-based green filter, and glare-reduction algorithm for wet tissue.
Indications for Use
Indicated for patients requiring colposcopic examination of the vagina, cervix, and external genitalia for the diagnosis of abnormalities and selection of biopsy sites.
Regulatory Classification
Identification
A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
Special Controls
*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Welch Allyn Model 88000 Video Colposcope (K955635)
Welch Allyn Model 89000 Video Colposcope (K955635)
Submission Summary (Full Text)
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K 972636
P192
# 510(k) Summary CooperSurgical Digital Colposcopy System
1. Sponsor
FEB - 2 1998
CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484 (203) 929-6321 Telephone: Facsimile: (203) 925-0135
John Grasso Contact Person: Vice President, Operations
July 11, 1997 Date Prepared:
#### Device Name 2.
Classification Name: Colposcope, 21 CFR 884.1630, Class II CooperSurgical Digital Colposcopy System Proprietary Name:
#### Intended Use 3.
The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.
### Device Description 4.
The colposcope portion of the CooperSurgical Digital Colposcopy System consists of a stereo microscope with a halogen light source and optional green filter, and is mounted on a mobile base. The Digital Documentation System consists of a CCD camera, an embedded computer, an LCD monitor, a "palm-mouse" pointing
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K972630
PLOL
device, an optional keyboard, and an optional printer. The functional requirements of the Digital Documentation System include:
- Storing digital images for viewing during the colposcopy exam, and for . printing and/or later review
- Storing textual information about a patient's medical history related to . colposcopy
- Storing textual information about observations seen during a colposcopy . examination
- Printing a colposcopy report that integrates images and textual information. .
- Implementation of the software green filter. . .
- A patent-pending procedure to reduce the amount of distracting glare which . is often present in pictures of the cervix and other wet tissue.
## Basis For Substantial Equivalence 5.
The CooperSurgical Digital Colposcopy System is substantially equivalent to the Leisegang Model 1D Colposcope, manufactured by Leisegang Medical, Inc., and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. The Leisegang device received 510(k) premarket notification clearance under K940094 while the Welch Allyn devices were cleared under K955635.
The CooperSurgical, Leisegang and Welch Allyn colposcopes are all intended to permit direct viewing and imaging of the tissues of the vagina and cervix to diagnose abnormalities and select areas for biopsy. While the Leisegang device is video adaptable, the CooperSurgical and Welch Allyn devices contain integrated imaging systems. These imaging systems provide the physician with a means to record pictures of the tissues for review over time.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 1998
CooperSurgical, Inc. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants. Inc. 49 Plain Street North Attleboro, MA 02760
Re: K972630
CooperSurgical Digital Colposcopy System Dated: December 24, 1997 Received: December 29, 1997 Regulatory Class: II 21 CFR 884.1630/Procode: 85 HEX
Dear Ms McNamara-Cullinane:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Resultations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 marked 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/dsmamain.html".
Sincerely yours,
W. Liao Yu
Lillian Yin, Ph.D. 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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K912630 510(k) Number (if known):
CooperSurgical Digital Colposcopy System Device Name:
Indications For Use:
The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.
The image contains a black line.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doler R. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1972630 510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
CooperSurgical Digital Colposcopy System 510(k)
7/11/97
Page vi
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.
