K972662 · Cryogen, Inc. · GEH · Oct 1, 1997 · General, Plastic Surgery
Device Facts
Record ID
K972662
Device Name
CRYOGEN CRYOSURGICAL SYSTEM
Applicant
Cryogen, Inc.
Product Code
GEH · General, Plastic Surgery
Decision Date
Oct 1, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The CryoGen Cryosurgical System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.
Device Story
Cryosurgical system for tissue destruction via extreme cold; consists of disposable control unit, cryoprobe, and console with compressor, microprocessor, and user interface. Operates on Joule-Thomson principle: pressurized coolants expand through orifice to generate tip temperatures of -100 to -120 °C. Closed system prevents coolant contact with patient/physician and atmospheric exhaust. Used by clinicians in various surgical specialties; provides localized tissue ablation. Benefits include precise, controlled tissue destruction without shaft/handle cooling.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on design, materials, and functional comparison to predicate devices.
Technological Characteristics
Closed-loop cryosurgical system; Joule-Thomson cooling principle; microprocessor-controlled; disposable control unit and cryoprobe; console-based compressor. Materials and design specifications are equivalent to predicate devices.
Indications for Use
Indicated for surgical tissue ablation via extreme cold in dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology, and urology. Excludes endometrial ablation.
Regulatory Classification
Identification
(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.
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1007
K972662
CryoGen, Inc. San Diego, CA Premarket Notification July 2, 1997
## X. 510(k) Summary
## Name of Device
Trade name:
Common name: Classification name:
CrvoGen Crvosurgery System Cryosurgical Unit and Accessories Cryosurgical Unit and Accessories (21 CFR 878.4350)
#### Predicate devices
| Device | Premarket Notification |
|-------------------------------|------------------------|
| Frigitronics CE-4 & CE-4G | Pre-<br>Amendment |
| Frigitronics CCS 100 | K811390 |
| CMS AccuProbe | K904421 |
| CMS AccuProbe 550/530 | K953637 |
| CryoGen Cryosurgical System 1 | K964971 |
#### Device description & Principle of Operation
The CryoGen Cryosurgery System consists of three components: the disposable Control Unit, the Cryoprobe and the Console, which contains the compressor system, microprocessor and user interface. The CryoGen Cryosurgery System is a cryosurgical device incorporating a gas cooled cryoprobe. Operation of the System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended to destroy tissue by the application of extreme cold. Temperatures of -100 to -120 ℃ are developed at the tip of the cryoprobe. These temperatures are within the range of the predicate devices and is sufficient to achieve the desired tissue effect. None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no coeling along the shaft of the probe nor at the handle that is held by the user during treatment.
# 000019
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CryoGen, Inc. San Diego, CA Premarket Notification July 2, 1997
#### Intended use
The CryoGen Cryosurgical System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology. This intended use is identical to the intended use for the predicate crvosurgical devices.
### Technological characteristics
The technological characteristics of the CryoGen Cryosurgical System 2 are the same as those of the CryoGen Cryosurgical System 1, and the other predicates listed elsewhere in this premarket notification. These devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization.
### Summarv
By virtue of design, materials, function and intended use, the CryoGen Cryosurgical System 2 is substantially equivalent to the CryoGen Cryosurgical System 1 which is cleared under K964971. It is also equivalent to the predicate devices, both pre-amendment and cleared via the Premarket Notification process, which have been included in this submission.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's seal, which includes an emblem of a stylized human figure with three faces in profile, representing health, hope, and service. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Cheryl L. Shea. . Vice President Regulatory Affairs/Quality Assurance CryoGen, Inc. 6199 Cornerstone Court East Suite 106 San Diego, California 92121
OCT - 1 1997
Re: K972662
> Trade Name: CryoGen Cryosurgery System Regulatory Class: II Product Code: GEH Dated: July 2, 1997 Received: July 3, 1997
Dear Ms. Shea:
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 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.
´ Please be advised that this substantial equivalence determination does not include an indication for cryoablation of the endometrium. The use of cryosurgery for endometrial ablation raises new types of safety and effectiveness questions when compared to currently identified predicate devices used for this purpose and therefore will require approval of a premarket approval application (PMA) for this indication.
Since, no data has been developed to establish the safety and effectiveness of this cryosurgical device for endometrial ablation, you may not market or promote such use until you have submitted such data and received clearance or approval for this claim.
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#### Page 2 - Ms. Shea
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 Regulations, 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 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 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) 594-4639. 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, "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,
folly
Celia M. Witten, M.D., Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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CryoGen, Inc. San Diego, California Premarket Notification July 2, 1997
# Indications Statement
Device Name: CryoGen Cryosurgical System 510(k) Number:
## Indications for use:
છે.
The CryoGen Cryosurgical System is indicated for the ablation of tissue by the application of extreme cold in the areas of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.
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#### Concurrence of CDRH, Office of Device Evaluation (ODE)
t.co/e
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
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.
