The Cryocare CS™ Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, 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 Description

The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe® devices to monitor temperatures in the surrounding tissue.

AI/ML Overview

This document is a 510(k) summary for the HealthTronics Cryocare CS Surgical System, indicating FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets a specific set of acceptance criteria for a new clinical application.

Therefore, the requested information about acceptance criteria, detailed study design, reader performance, and ground truth establishment cannot be fully provided from this document as it is not a clinical study report.

Here's what can be inferred or stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs."

The document lists "Verification /Validation Activities" which are related to engineering and safety performance rather than clinical outcome acceptance criteria:

Acceptance Criteria Category	Reported Device Performance (as inferred)
Conformance to Product Specifications & Equivalence to Predicate	"Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs." "Verification and validation for the proposed modifications were conducted in accordance with internal protocols conforming to international standards and FDA guidance documents." "Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use."
Performance Testing	- Isotherm Testing: Performed, implying satisfactory results, but no specific metrics given.- Functional Testing (ice-ball necking, shaft leak, noise): Performed, implying satisfactory results, but no specific metrics given.
Shelf-Life Testing	Performed, implying acceptable shelf-life.
Electrical Safety Testing	Performed, implying compliance with electrical safety standards.
Electromagnetic Compatibility Testing	Performed, implying compliance with EMC standards.
Software Verification and Validation	Performed, implying software functions as intended and safely.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This document does not describe a clinical test set with a sample size for evaluating a specific clinical outcome. The testing performed ("non-clinical testing," "verification/validation activities") is related to device engineering specifications, performance, and safety, not a clinical trial.
Therefore, there is no information on data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as this document describes non-clinical engineering and safety testing, not a study requiring expert-established ground truth for a clinical diagnosis or outcome.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable for the same reason as point 3.

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:

No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This device is a cryosurgical system, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This document refers to a cryosurgical system, which is a physical medical device. It does not describe an algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the engineering and safety testing described, the "ground truth" would be established by technical specifications and international standards, rather than clinical ground truth types like pathology or outcomes data. For example, for "Isotherm Testing," the ground truth would be the expected temperature profile under specific conditions, and for "Electrical Safety Testing," it would be the safety standards.

8. The sample size for the training set:

This document does not describe a machine learning model or AI, and therefore, no training set or its sample size.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for a machine learning model described.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (Cryocare CS Surgical System). It outlines the device's indications for use, its technological characteristics, and that non-clinical engineering and safety testing was performed to demonstrate substantial equivalence to a predicate device. It does not contain information about clinical studies with specific acceptance criteria, clinical test sets, expert ground truth establishment, or AI/algorithm performance.

Summary

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

June 25, 2015

HealthTronics Incorporated Ms. Maritza Ward Manager, Regulatory Affairs 9825 Spectrum Drive, Building 2 Austin, Texas 78717

Re: K141110

Trade/Device Name: Cryocare CS® Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 20, 2015 Received: May 21, 2015

Dear Ms. Ward:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Maritza Ward

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K141110

Device Name Cryocare CS Surgical System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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HealthTronics™

Cryocare CS® Surgical System 510(k) Summary K141110

DATE:	May 20, 2015
COMPANY:	Endocare, a wholly owned subsidiary of HealthTronics, Inc. 9825 Spectrum Drive, Building 2 Austin, TX 78717
CONTACT:	Maritza Ward Manager, Regulatory Affairs Telephone: (512) 439-8361 Fax: (512) 439-8311
PROPRIETARY TRADE NAME	CryoCare CS® Surgical System
CLASSIFICATION NAME:	Cryosurgical Unit and Accessories
CLASS:	II
PRODUCT CODE:	GEH
REGULATION NUMBER:	21 CFR 878.4350

Cryocare CS®-3 Surgical System	K101333	Cleared 06/14/2010
Endocare® 2.4mm V-Probe™ Cryoprobe	K101333	Cleared 06/14/2010
Endocare® 2.4 mm Cryoprobe	K011074	Cleared 02/28/2006

PRODUCT DESCRIPTION:

INDICATIONS FOR USE

The Cryocare CS 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

HealthTronics, Inc. 1 9825 Spectrum Drive, Building 3 | Austin, TX 787 17 | 512.328.2892

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Image /page/5/Picture/0 description: The image shows the logo for HealthTronics. The logo consists of a stylized "HT" inside of a circle on the left, followed by the word "HealthTronics" in a sans-serif font. The letters are outlined in black, and the word "HealthTronics" is slightly slanted to the right. There is a trademark symbol to the right of the word.

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 hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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

TECHNOLOGICAL CHARACTERISTICS:

The proposed Cryocare CS Surgical System console and cryoprobe designs are identical to their predicates with the exception of

. minor hardware and software updates, relative to the console
. a modification to the material used to fabricate the vacuum sleeve for vacuum insulated cryoprobes

HealthTronics, Inc. 19825 Spectrum Drive, Building 3 | Austin, TX 78717 | 512.328.2892

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Image /page/6/Picture/0 description: The image shows the word "HealthTronics" in a stylized font. To the left of the word is a logo consisting of the letters "HT" inside of a circle. The letters in the word "HealthTronics" are outlined in black. The logo and the word are slightly tilted to the right.

. a new right-angle handle design option for the cryoprobes offered in 1.7 mm and 2.4 mm diameters.
The subject designs have the same fundamental technological features and intended use and are compatible with the same Cryocare CS Surgical System consoles and accessories as their predicate designs.

NON-CLINICAL TESTING

Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed modifications were conducted in accordance with internal protocols conforming to international standards and FDA guidance documents.

Verification /Validation Activities

Performance Testing ●
- o Isotherm Testing
- o Functional Testing (ice-ball necking, shaft leak, noise)
Shelf-Life Testing
Electrical Safety Testing .
Electromagnetic Compatibility Testing
Software Verification and Validation .

CONCLUSION:

Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended 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.