Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice

Device Description

The CryoPen system provides a safe means of freezing tissue without the use of cryogenic liquids or greenhouse gases. The system consists of multiple pen cores, a Stirling cooler which rejects heat, and a variety of reusable tips for dermatologic and gynecology applications. When used properly, the system will deliver effective temperature for tissue ablation. The model number of this Cryosurgical system is CT-2000.

The Stirling cooler is used to lower the temperature of the CryoPen units to temperatures of -105 degrees Celsius. It operates on a 24 V DC external power supply powered by 115 (or 220) V AC obtained from conventional convenience outlets. The housing of the cooler provides necessary electrical safety features and electromagnetic compatibility. A temperature indicator indicates the readiness of the CryoPen units during cool down,

AI/ML Overview

The provided text appears to be a 510(k) summary for a medical device called the "CryoPen Cryosurgical System." It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies.

The document states: "based on the nonclinical bench testing performed on ballistic gelatin. Data generated from bench testing shows the CryoPen is able to freeze the same volume and mass as the Wallach LL100." This indicates that the equivalence was demonstrated through bench testing, not a clinical study with human patients or expert evaluations.

Therefore, I cannot provide the requested information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

Based on the provided text, the most relevant information regarding performance and its comparison to a predicate device is:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria (Implied)	Reported Device Performance (CryoPen)
Ability to freeze tissue	Able to freeze tissue without cryogenic liquids or greenhouse gases
Delivered Temperature	-105 degrees Celsius
Effectiveness for tissue ablation	Will deliver effective temperature for tissue ablation
Freezing Volume and Mass	Able to freeze the same volume and mass as the Wallach LL100

2. Sample size used for the test set and the data provenance
The document mentions "nonclinical bench testing performed on ballistic gelatin." This indicates that the testing was not performed on human subjects. No specific sample size (e.g., number of tests, volume of gelatin) is provided, nor is the country of origin of the data specified. The data is from retrospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" was established through physical measurements of freezing volume and mass in ballistic gelatin during bench testing, not through expert human evaluation.

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process for this bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The CryoPen is a surgical instrument and not an AI device, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The CryoPen is a physical cryosurgical system, not an algorithm. Its performance is inherent to its mechanical and thermal properties.

7. The type of ground truth used
The ground truth used was physical measurements of freezing volume and mass in ballistic gelatin, compared to the performance of the predicate device.

8. The sample size for the training set
Not applicable. Bench testing for substantial equivalence does not typically involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. There was no training set in the context of this 510(k) submission.

Summary

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<116756 510(k) Summary of Safety and Effectiveness

CryoPen, Inc. CryoPen Cryosurgical System Traditional 510(k)

A. General Information

Applicant:	CryoPen, Inc.
Address:	2010 E. Continental Blvd.Suite DSouthlake, TX 76092
Contact Person:	Dr. Michael Haas
Telephone:	888-246-3928
Facsimile:	817-549-0012
Date Prepared:	April 25, 2011
Device Trade Name:	CryoPen Cryosurgical System
Common Name:	Cryosurgical Unit and Accessories
Classification Name:	Unit, Cryosurgical, Accessories

B. Description of the Device

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There are currently four different size tips for use in general surgery and dermatological applications as well as four different size tips for use in gynecology applications. They are:

Application	Tip Sizes
General/Dermatology	3mm, 5mm, 7mm, 10mm
Gynecology	3mm, 10mm, 19mm, 25mm

C. Intended Use Statement

Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

Cryosurgical instrument used to necrose unwanted tissue, generally in the gynecological and dermatological practice

D. Components

CONTENTS:	ITEM NUMBER:
Base Unit
CryoPen® Cooling System Assembly (1ea.)	CT-2000
Reservoir Solution 500ml (1ea.)	CT2-RS-1001
Reservoir Tube- Plastic (23ml)	CT2-RS-1002
Reservoir Tube Cap (1ea.)	CT2-RS-1003
Cleaning Swabs -Single end 14"(6)	CT2-SW-1000
Transfer Pipette- ½ dozen	CT2-PP-1000
CryoPen® Operators Packet	CT2-OP1000

General/Dermatological Configuration
Non-Sterile re-usable CryoPen® tip (1ea.) 3mm	CT2-T-5003
Non-Sterile re-usable CryoPen® tip (1ea.) 5mm	CT2-T-5005
Non-Sterile re-usable CryoPen® tip (1ea.) 7mm	CT2-T-5007
Non-Sterile re-usable CryoPen® tip (1ea.) 10mm	CT2-T-5010
Pen Core - Blue (4)	CT2-C-1000
Temperature Indicator (Grey) (1ea.)	CT2-T1-1000

Gynecological Configuration
Non-Sterile GYN Handle (1 ea.)	GY2-1100
GYN Pen Cores - Green (2 ea.)	GY2-2201
Non-Sterile Re-usable CryoPen® tip (1ea.) 3mm	GY2-2303
Non-Sterile re-usable CryoPen® tip (1ea.) 10mm	GY2-2310
Non-Sterile re-usable CryoPen® tip (1ea.) 19mm	GY2-2319
Non-Sterile re-usable CryoPen® tip (1ea.) 25mm	GY2-2324
Blank Core (1ea.)	GY2-3001
Temperature Indicator (Green) (1ea.)	GY2-4100

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E. Substantial Equivalence

The CryoPen cryosurgical system is substantially equivalent to the Wallach LL100 Predicate Device, approved on February 4, 1981, (reference K803311) based on the nonclinical bench testing performed on ballistic gelatin. Data generated from bench testing shows the CryoPen is able to freeze the same volume and mass as the Wallach LL100.

The CryoPen and the Wallach LL100 destroy tissue using cryogenic temperatures. However, the CryoPen does not rely on a cryogenic gas such as nitrous oxide or carbon dioxide for cryoablation. Instead, the CryoPen uses a chilled copper mass fashioned into a treatment medium. The contacting metal incorporated in the cryotips used with the CryoPen are made of aluminum, which differs from the predicate contact material of stainless steel. Appropriate biocompatibility and sterility testing was performed on the aluminum cryotips used in the CryoPen and accessories.

The modified CryoPen and accessories have the following similarities to those which previously received 510(k) concurrence:

· have the same indicated use,
· destroy unwanted tissue by cryoablation, and
· method of sterilization

The Wallach LL100 510(k) K803311 has indications of "a cryosurgical instrument used to necrose unwanted tissue, generally in the gynecological and dermatological practice". The CryoPen and Accessories has clearance as a Cryosurgical unit used "for ablative type surgical technique" with use on "multiple organ systems, wide range of disease, viral, premalignant and malignant tissue." Additionally, the CryoPen system is adding the same intended use as the LL100 for use in the gynecological and dermatological practices.

Additionally, the CryoPen and Accessories uses the same sterilization methods as the Wallach LL100, cold soak and autoclave.

In summary, the CryoPen and Accessories described in this submission are substantially equivalent to the predicate device as the safety, efficacy, and intended use are equivalent,

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is in black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cyrol'en, Inc. % Michael Haas, M.D. 2010 East Continental Boulevard Suite D Southlake, Texas 76092

9 2011

Re: K110754

Trade/Device Name: CyroPen and Accessories (Model: CT-2000) Regulation Number: 21 CFR 878.4350 Regulation Name: Cyrosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: August 31. 2011 Received: September 01, 2011

Dear Dr. Haas:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Michael Haas, M.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Roblino mpit

DEP CLint Dir

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number

K110754

Device Name

CryoPen and Accessories (Model: CT-2000)

Indications for Use

Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Kiri RP Duke Sherman

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110754

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.