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 Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CryoGen Cryosurgery System, which focuses on establishing substantial equivalence to predicate devices rather than proving a new device's meeting of acceptance criteria through a dedicated study with performance metrics.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, and expert adjudication are not available in the provided document, as they are not typically required for a 510(k) submission where substantial equivalence to existing devices is claimed.

However, I can extract and infer some information based on the content related to substantial equivalence.

Here's a breakdown of what can be gleaned and what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices. It doesn't typically include a table of specific acceptance criteria (e.g., minimum temperature achieved, speed of freezing, lesion size) and a corresponding performance report from a novel study designed to meet those criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document discusses the technical characteristics and intended use in comparison to predicate devices, but it does not describe a "test set" in the context of a performance study with specific metrics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. There is no mention of a test set requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a test set requiring adjudication, this method is not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

This information is not provided. The device is a physical cryosurgical unit, not an AI or imaging diagnostic tool. An MRMC study is irrelevant in this context.

6. If a Standalone (Algorithm only without human-in-the-loop) Performance Study was done

This information is not provided. This is not an AI or algorithmic device; therefore, a standalone performance study in that context is not applicable. The device's operation is based on the Joule-Thomson principle, a physical process.

7. The Type of Ground Truth Used

This information is not provided. As there's no mention of a performance study requiring ground truth, its type is not discussed.

8. The Sample Size for the Training Set

This information is not provided. The device is not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not provided. Not applicable to this type of device.

What is available/inferable from the document regarding "acceptance criteria" and "proof":

While not framed as "acceptance criteria" in the traditional sense of a performance study, the entire 510(k) submission acts as a demonstration that the device acceptably performs similarly to predicate devices.

Implicit Acceptance Criteria (Substantial Equivalence): The primary "acceptance criteria" for a 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices. This means that the device must be as safe and effective as a legally marketed device in the same class and for the same indications for use.
"Study" (Comparison to Predicates): The "study" that proves the device meets these implicit criteria is the comparison of its technological characteristics and intended use to predicate devices.
- Device Performance (as reported in the document):
  - Principle of Operation: "Operation of the System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling."
  - Temperature Achieved: "Temperatures of -100 to -120 ℃ are developed at the tip of the cryoprobe."
  - Sufficiency of Temperature: "These temperatures are within the range of the predicate devices and is sufficient to achieve the desired tissue effect."
  - Safety Features: "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 cooling along the shaft of the probe nor at the handle that is held by the user during treatment."
  - Technological Characteristics Comparison: "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... These devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
  - Intended Use Comparison: "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 cryosurgical devices."
Ground Truth (for Substantial Equivalence): The "ground truth" for determining substantial equivalence is the established safety and effectiveness of the identified predicate devices. The new device is evaluated against these known safe and effective precedents.

In summary, the provided document does not describe a study in the sense of a performance trial with specific calculated metrics against predefined acceptance criteria for a novel device. Instead, it details a 510(k) submission which relies on demonstrating the new device's equivalence to existing, already-cleared devices based on shared design, materials, principle of operation, product specifications, sterilization, and intended use. The "proof" is this detailed comparison allowing the FDA to conclude "substantial equivalence."

Summary

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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-Amendment
Frigitronics CCS 100	K811390
CMS AccuProbe	K904421
CMS AccuProbe 550/530	K953637
CryoGen Cryosurgical System 1	K964971

Device description & Principle of Operation

000019

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CryoGen, Inc. San Diego, CA Premarket Notification July 2, 1997

Intended use

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:

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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)

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(Division Sign-Off) (Division of General Restorative Devices 510(k) Number

X Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
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.(b)
Classification. Class II.