K970995 · Cryomedical Sciences, Inc. · GEH · Jul 7, 1997 · General, Plastic Surgery
Device Facts
Record ID
K970995
Device Name
CMS CRYOLITE
Applicant
Cryomedical Sciences, Inc.
Product Code
GEH · General, Plastic Surgery
Decision Date
Jul 7, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700. The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, etc. and veterinary medicine.
Device Story
CMS Cryo-lite System is a disposable, hand-held cryosurgical device. It utilizes physician-selected cryogens (liquid nitrogen, nitrous oxide, carbon dioxide, or argon) forced under pressure through interchangeable cryoprobes. The device is used by physicians to destroy unwanted tissue by applying extreme cold to a target site. The cryoprobe is positioned using ultrasound, other imaging, or visual observation. The system is non-electric and portable, featuring a hand-held body and either a self-contained cryogen packet or a transfer line to an external cryogen source. It provides an alternative to surgical resection when resection is not indicated.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Non-electric, hand-held cryosurgical unit. Materials: various materials for interchangeable cryoprobes. Energy source: pressurized cryogens (liquid nitrogen, nitrous oxide, carbon dioxide, argon). Flow control: manual dial with markings. Form factor: portable, hand-held body with cryogen packet or transfer line. Sterilization: not specified.
Indications for Use
Indicated for destruction of unwanted tissue in dermatology, gynecology, general surgery, and veterinary medicine.
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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K970995
510(k) SUMMARY
JUL 7 1997
March 19, 1997
Submitted by:
Cryomedical Sciences, Inc.
1300 Piccard Drive
Rockville, Maryland 20850
(301) 417-7070
Fax (310) 417-7077
Contact:
Richard J. Reinhart, Ph.D.
President and CEO
or
Susan Hayes
Administrative Manager
Operations
Proprietary name: CMS Cryolite
Common name: Cryosurgical Unit, Cryogenic Surgical Device or Cryoprobe
Classification: Cryosurgical unit with Liquid Nitrogen, Nitrous Oxide, Carbon Dioxide, Class II [21 CFR § 878.4350(a)].
The CMS Cryo-lite® System is a completely disposable hand-held cryosurgical device. Both Cryo-lite® System Models 2001 and 2002 consist of hand-held body, a physician-selected cryogen packet and single cryoprobe of varying materials, sizes and shapes. Cryogens available with this system are liquid nitrogen, nitrous oxide, carbon dioxide and argon.
The Cryo-lite® System is used to destroy unwanted tissue by application of extreme cold to the selected site. The cryogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound, another imaging device or visual observation then becomes cold and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
The CMS Cryo-lite® System is similar in form and function to the Frigitronics' Cryocare I System and its Cryo Surg Model 5900 (K840536) and Cabot Medical's Cryomedics MT700. Intended use for the CMS Cryo-lite® System is the same as those listed for the CMS Cryolite® System predicate devices.
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COMPARISON OF FEATURES BETWEEN THE FRIGITRONICS MODEL 5900 SYSTEM AND THE CMS CRYO-LITE SYSTEM
| FEATURES | Frigitronics 5900 | Cryolite System |
| --- | --- | --- |
| Cryoprobes | Spray and closed-tip | Spray and closed-tip |
| Cryoprobes | Various, interchangeable | Various, interchangeable |
| Power source | Non-electric | Non-electric |
| Cryogen | Liquid nitrogen | Choice of liquid nitrogen, carbon dioxide, nitrous oxide and argon |
| Flow control | Adjustable flow rates, trigger type | Dial with flow rate markings |
| Size | Portable, hand-held | Portable, hand-held |
| Capacity | 500 ml cryogen container | 9 oz. cryogen packet and different capacities depending on commercial cryogen containers used with transfer line |
COMPARISON OF FEATURES BETWEEN THE CRYOMEDICS MT700 SYSTEM AND THE CMS CRYO-LITE SYSTEM
| FEATURES | Cryomedics MT700 | Cryolite System |
| --- | --- | --- |
| Cryogen | Choice of nitrous oxide and carbon dioxide | Choice of liquid nitrogen, carbon dioxide, nitrous oxide and argon |
| Flow control | Dial with flow rate control | Dial with flow rate markings |
| Size | Portable, hand-held | Portable, hand-held |
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# COMPARISON OF FEATURES BETWEEN THE FRIGITRONICS MODEL CS-76/CRYOCARE I SYSTEM AND THE CMS CRYO-LITE SYSTEM
K940526
| FEATURES | Frigitronics CS-76/Cryocare I | Cryolite System |
| --- | --- | --- |
| Cryoprobes | Spray and closed-tip | Spray and closed-tip |
| Cryoprobes | Various sizes and materials, interchangeable | Various sizes and materials, interchangeable |
| Power source | Non-electric | Non-electric |
| Cryogen | Liquid nitrogen | Liquid nitrogen, carbon dioxide, nitrous oxide and argon |
| Flow control | Adjustable flow rates, trigger type | Dial with control markings |
| Size | Portable, hand-held trigger with LN_{2} transfer line attached to LN_{2} vacuum insulated containers | Portable, hand-held, with cryogen packet or cryogen transfer line to an external cryogen source |
| Capacity | 1 liter | 9 oz. cryogen packet and different sizes of commercial cryogen containers used with transfer line |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Richard J. Reinhart, Ph.D.
President and CEO
Cryomedical Sciences, Inc.
1300 Piccard Drive
Rockville, Maryland 20850-4303
JUL - 7 1997
Re: K970995
Trade Name: CMS Cryolite
Regulatory Class: II
Product Code: GEH
Dated: June 19, 1997
Received: June 20, 1997
Dear Dr. Reinhart:
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.
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 (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.
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Page 2 - Richard J. Reinhart, Ph.D.
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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K970995
# Indications For Use
The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700. The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, etc. and veterinary medicine.
Prescription: ☑ (Per 21 CFR 801.109)
Over-the-Counter Use
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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.
