K023757 · Endocare, Inc. · GEH · Dec 5, 2002 · General, Plastic Surgery
Device Facts
Record ID
K023757
Device Name
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
Applicant
Endocare, Inc.
Product Code
GEH · General, Plastic Surgery
Decision Date
Dec 5, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 878.4350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition the system is intended: for use in the following indications: General Surgery - Destruction of warts or lesions - Palliation of tumors of the oral cavity, rectum and skin - Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia. Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia. Oncology - Ablation of cancerous or malignant tissue - Ablation of benign tumors - Palliative intervention. Neurology - Freezing of nerve tissue in pain management/cryoanalgesia. Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Proctology - Ablation of benign or malignant growths of the anus or rectum - Ablation of hemorrhoids. Thoracic Surgery - Ablation of arrhythmic cardiac tissue - Ablation of cancerous lesions.
Device Story
Cryocare Surgical System is a console-based cryosurgical unit for tissue ablation. System uses inert Argon gas to deliver extreme cold to targeted tissue via disposable CryoProbes operating on the Joule-Thompson principle; Helium gas is used for warming. Console monitors up to eight CryoProbes and eight independent T-type needle thermocouples (TempProbes) for real-time temperature feedback. Operated by physicians in clinical settings; system features manual control or an 'AutoFreeze' mode for pre-programmed treatment parameters. IBM-compatible microprocessor manages system control via remote keypad. Output allows clinicians to visualize and monitor tissue freezing/thawing cycles, enabling precise ablation of tumors, prostate tissue, and other lesions. Benefits include minimally invasive tissue destruction and controlled cryoanalgesia.
Clinical Evidence
Bench testing only. Included in-vitro time and temperature performance testing under simulated use conditions. Software validation performed per IEC 60601-1-4 and FDA guidance.
Technological Characteristics
Console-based cryosurgical unit; utilizes inert Argon (freezing) and Helium (warming) gases. Joule-Thompson principle for cooling at distal probe tips. T-type needle thermocouples for temperature monitoring. IBM-compatible microprocessor control. System supports up to eight disposable CryoProbes and eight TempProbes. Software validation per IEC 60601-1-4.
Indications for Use
Indicated for patients requiring tissue ablation or freezing in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, tumors, skin lesions, warts, hemorrhoids, and arrhythmic cardiac tissue.
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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DEC 0 5 2002
| 04 7
endocare.
# Attachment 5
| 510(k) Summary<br>Prepared November 7, 2002 | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------|
| TRADE NAME | Cryocare Surgical System | | |
| CLASSIFICATION | Class II (21 CFR 878.4350) | | |
| SUBMITTED BY | Endocare, Inc.<br>201 Technology<br>Irvine, CA 92618 | CONTACT | Eben Gordon<br>Regulatory Affairs<br>949.450.5424<br>949.450.5300 |
| PREDICATE DEVICE | K011074 Cryocare Surgical System<br>Decision date: January 25, 2002 | | |
| DEVICE DESCRIPTION | The Cryocare Surgical System consists of a compact, easy-to-operate<br>console and associated accessories that include CryoProbes to deliver cold<br>temperatures to the targeted tissue and TempProbes to monitor<br>temperatures in the surrounding tissue.<br>The control console operates off standard 120/230 VAC (60/50 Hz) wall<br>power and utilizes inert Argon gas. The console can control up to eight,<br>single-use, disposable CryoProbes.<br>The CryoProbes operate on the Joule-Thompson Principle and the<br>refrigerative capacity is limited to the distal tip of the probes. Each<br>CryoProbe incorporates a thermocouple to monitor probe temperature.<br>Helium gas is used after the freezing process. As the gas passes through<br>the J-T port, there is a significant pressure drop which conversely results in<br>an increase in the gas temperature.<br>The console can also monitor up to eight independent TempProbes. The<br>TempProbes are standard T-type needle thermocouples.<br>An IBM-compatible microprocessor serves as the host computer. System<br>control is accomplished through a remote control keypad.<br>The system can be operated manually or using the AutoFreeze option,<br>which allows users to pre-program specific treatment parameters. | | |
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| INDICATIONS FOR<br>USE | The Cryocare Surgical System has the same intended use as previously<br>cleared for the Cryocare Surgical System - K011074. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cryocare Surgical System is intended for use in open, minimally<br>invasive or endoscopic surgical procedures in the areas in general surgery,<br>urology, gynecology, oncology, neurology, dermatology, ENT, proctology,<br>pulmonary surgery and thoracic surgery. The system is designed to<br>freeze/ablate tissue by the application of extreme cold temperatures<br>including prostate and kidney tissue, liver metastases, tumors, skin lesions,<br>and warts. |
| TESTING | In-vitro testing of the Cryocare Surgical System included time and temperature<br>performance under simulated use conditions. Software validation was<br>performed in accordance with IEC 60601-1-4 and the General Principles of<br>Software Validation; Final Guidance for Industry and FDA Staff (January 11,<br>2002).<br>All testing of the product yielded acceptable results. |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The modified Cryocare Surgical System is substantially equivalent to the<br>predicate device in intended use and principles of operation. |
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocare, Inc. c/o Mr. Eben Gordon Senior Director of Regulatory Affairs 201 Technology Drive Irvine, CA 92618
Re: K023757
Trade/Device Name: Cryocare Surgical System, Model Cryo 20 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Code: OCL, GEH Dated: November 7, 2002 Received: November 8, 2002
Dear Mr. Gordon:
This letter corrects our substantially equivalent letter of December 05, 2002.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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#### Page 2 - Mr. Eben Gordon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Edgmee
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Endocare, Inc. Special 510(k): Crvocare Surgical System
# Attachment 2
# Indications for Use Statement
510(k) Number:
# K 023757
Device Name: Cryocare Surgical System
Indications for Use:
The Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition the system is intended: for use in the following indications:
General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
## Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Millican
Prescription Use ________(Per 21 CFR 801.109)
Division of neral, Restorative and Neurol . ical Devices
510(k) Number
Page 74 of 80
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#### Endocare, Inc. Special 510(k): Cryocare Surgical System
Indications for Use Statement (Continued)
### Urology
- · Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
#### Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia
#### Oncology
- Ablation of cancerous or malignant tissue
- · Ablation of benign tumors
- · Palliative intervention
#### Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
#### Dermatology
- · Ablation or freezing of skin cancers and other cutaneous disorders
#### Proctology
- · Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
#### Thoracic Surgery
- · Ablation of arrhythmic cardiac tissue
- Ablation of cancerous lesions
# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
# Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Melburn
(Divisio (gn-Off)
Divisio General Restorati
Prescription Use _______ (Per 21 CFR 801.109)
510(k) Number K023751
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.
