The CryoThin™ Surgical System is intended for cryosurgery in the fields of general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastase, tumors, skin lesions, and warts. The system has the following specific indications:

General Surgery

· Destruction of warts or lesions
· Palliation of tumors of the oral cavity, rectum and skin
· Ablation of breast fibroadenomas
· 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, 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 cancerous lesions

Device Description

Cryosurgery is the use of ultra-low temperatures for selectively freezing and destroying diseased tissues in situ. The CryoThin™ Surgical System is designed to ablate benign and malignant tissues using cryosurgery.

The system utilizes the Joule-Thomson effect for freezing. It uses high-pressure argon gas that undergoes throttling expansion to induce freezing inside the closed tip of the Cryo probe to freeze the target tissue around the probe tip. Low-pressure argon is electrically heated and blown into the probe tip to thaw the tissue around it.

The CryoThin Surgical System consists of a console, a cart, and accessories. The system must be used in conjunction with the Cryo probes for freeze and thaw functions, and the Temp probes for monitoring the temperature in target or adjacent tissues.

AI/ML Overview

The provided FDA 510(k) summary for the CryoThin™ Surgical System and Accessories primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not include an acceptance criteria table with reported device performance for clinical endpoints, nor does it detail a clinical study with human patients, statistical metrics like sensitivity/specificity, or expert adjudication for ground truth.

Here's an analysis based on the information provided, highlighting what is present and what is notably absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not contain a table of acceptance criteria with reported device performance for clinical outcomes. Instead, it lists comprehensive non-clinical tests that the device passed to demonstrate safety and performance.

Acceptance Criteria Category	Specific Criteria (Expected but not provided in quantitative/clinical terms)	Reported Device Performance (from document)
Electrical Safety	Compliance with IEC 60601-1	"Passed Electrical Safety Testing in accordance with IEC 60601-1."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	"Passed Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2."
Human Factors and Usability	Compliance with IEC 60601-1-6 and IEC 62366	"Passed Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366."
Software Development	Compliance with IEC 62304 and FDA guidance	"Passed Software development in accordance with IEC 62304 and the FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.""
Biocompatibility	Compliance with ISO 10993 series	"Passed Biocompatibility Testing in accordance with ISO 10993 series of standards."
Sterilization Validation	Compliance with ISO 11137 series, ISO 11737 series	"Passed Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2."
Shelf-life Testing	Compliance with ASTM F 1980-16	"Passed Shelf-life testing in accordance with ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices."
Service (Accelerated) Life Testing	Compliance with IEC 62506:2013	"Passed Service life testing in accordance with IEC 62506:2013 Methods for Product Accelerated Testing."
Package Verification Testing	Compliance with ASTM F 1980-16	"Passed Package Verification Testing in accordance with ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices."
Packaging Testing	Compliance with ASTM D 4169-16	"Passed Packaging Testing in accordance with ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems DC13 Level II."
Cleaning and Disinfection of Reusable Probes	Demonstrated support for stated use life	"Passed Cleaning and Disinfection of Reusable Probes testing to support the stated use life."
Iceball and Isotherm Testing	Ability to cool target tissue to desirable therapeutic temperature	"Passed Iceball and isotherm testing to demonstrate the subject device ability to cool target tissue to desirable therapeutic temperature." (No specific temperature range or iceball size is provided in the summary.)
Compatibility with Imaging Modalities	Demonstrated compatibility with commonly used modalities	"Passed Compatibility testing to demonstrate subject device compatibility with the most commonly used imaging modalities." (No specific modalities listed.)

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

This information is not provided in the document. The testing described is non-clinical and lab-based (e.g., electrical safety, biocompatibility, sterilization validation, iceball formation). There is no mention of a human patient test set.

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

This information is not applicable as no human-in-the-loop clinical test set or ground truth established by experts is described in this 510(k) summary. The "ground truth" for non-clinical tests would be defined by the technical standards themselves (e.g., a device either meets the specified resistance or it doesn't).

4. Adjudication Method for the Test Set

This information is not applicable as no human-in-the-loop clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "The information and data provided in this Traditional 510(k) application demonstrated that the subject device met the safety and performance specifications and did not raise any new safety or effectiveness issues. Thus, the subject device is considered to be substantially equivalent to the legally marketed predicate devices." This indicates a substantial equivalence pathway, which typically relies on demonstrating similar technological characteristics and performance to already cleared devices, rather than conducting new clinical effectiveness studies, especially MRMC studies comparing human readers with and without AI assistance. This device is a surgical system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a cryosurgical system, a physical medical device, not an algorithm or AI product requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to the device's ability to perform its intended function (e.g., forming an iceball of a certain size and temperature), which is covered by the "Iceball and isotherm testing." The summary states it demonstrated the ability to cool target tissue to desirable therapeutic temperature, implying successful standalone function for its primary mechanism.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by the technical specifications and standards (e.g., IEC, ISO, ASTM standards) against which the device performance is measured. For the iceball and isotherm testing, the ground truth would be the measured temperature and iceball size achieved compared to predefined therapeutic targets/specifications.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical cryosurgical device, not a machine learning or AI model that requires a training set of data.

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

This information is not applicable as there is no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

November 27, 2023

Medinux (Tianjin) Technologies Co., Ltd. Ms. Diana Zhang, B.A. Manager, Regulatory Affairs Room 401, Unit 3, Building K1 6 Haitai Fazhan 6th Road, Huayuan Industrial Park Tianjin 300384 China

Re: K231661

Trade/Device Name: CryoThin™ Surgical System and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: November 3, 2023 Received: November 3, 2023

Dear Ms. Zhang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.27 10:22:03 -05'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231661

Device Name CryoThin™ Surgical System and Accessories

Indications for Use (Describe)

The CryoThin Surgical System is intended for cryosurgery in the fields of general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastase, tumors, skin lesions, and warts. The system has the following specific indications:

General Surgery

· Destruction of warts or lesions
· Palliation of tumors of the oral cavity, rectum and skin
· Ablation of breast fibroadenomas

· 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, 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 cancerous lesions

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K231661 510(k) SUMMARY

CryoThin™ Surgical System and Accessories

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:	Medinux (Tianjin) Technologies Co., Ltd.Room 401, Unit 3, Building K16 Haitai Fazhan 6th RoadHuayuan Industrial ParkTianjin 300384China
Company ContactPerson:	Ms. Diana Zhang, B.A.Manager, Regulatory AffairsPhone: (86) 22 86 392 536Fax: (86) 22 87 930 633dianazhang@medinux.com
Trade/Device Name:Manufacturer:Regulation Number:Regulation Name:Regulation Class:Product Code:	CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.21 CFR 878.4350Cryosurgical unit and accessoriesClass IIGEH
Predicate Devices /Reference 510(k):	CRYOCARE TOUCH System and Accessories (K201588)Visual-ICE® Cryoablation System (K143564)
Date of Preparation:	November 23, 2023

Device Description:

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Indications for Use:

The CryoThin Surgical System is intended for cryosurgery in the fields of 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. The system has the following specific indications:

General Surgery

Destruction of warts or lesions
Palliation of tumors of the oral cavity, rectum and skin
Ablation of breast fibroadenomas ●
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 beniqn 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

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Ablation of benign or malignant growths of the anus or rectum .
Ablation of hemorrhoids .

Thoracic Surgery

Ablation of cancerous lesions

Technological Comparison:

Table 1 below provides a comparison of the technological characteristics of the subject device with the predicate devices.

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Table 1 Subject and Predicate Device Comparison

	Subject Device	Predicate Device 1	Predicate Device 2
Feature	CryoThin Surgical System andAccessories	CRYOCARE TOUCH System andAccessories	Visual-ICE Cryoablation System	Comparison
510(k) Number	-	K201588	K143564	-
Trade/DeviceName	CryoThin Surgical System andAccessories	CRYOCARE TOUCH System andAccessories	Visual-ICE Cryoablation System	-
Manufacturer	Medinux (Tianjin) TechnologiesCo., Ltd.	Varian Medical Systems, Inc.	Galil Medical Inc.	Same
RegulationNumber	21 CFR 878.4350	21 CFR 878.4350	21 CFR 878.4350	Same
RegulationName	Cryosurgical unit andaccessories	Cryosurgical unit andaccessories	Cryosurgical unit and accessories	Same
RegulationClass	Class II	Class II	Class II	Same
Product Code	GEH	GEH	GEH	Same
Indications forUse	The CryoThin Surgical System isintended for cryosurgery in thefields of general surgery,urology, gynecology, oncology,neurology, dermatology, ENT,proctology, pulmonary surgeryand thoracic surgery. Thesystem is designed tofreeze/ablate tissue by theapplication of extreme coldtemperatures including	The CRYOCARE TOUCH Systemis intended for use in open,minimally invasive, orendoscopic surgical proceduresin the areas in general surgery,urology, gynecology, oncology,neurology, dermatology, ENT,proctology, pulmonary surgeryand thoracic surgery. Thesystem is designed tofreeze/ablate tissue by the	The Visual-ICE CryoablationSystem is intended forcryoablative destruction of tissueduring surgical procedures. TheVisual-ICE System is indicated foruse as a cryosurgical tool in thefields of general surgery,dermatology, neurology(including cryoanalgesia),thoracic surgery, ENT,gynecology, oncology,	Same
Feature	Subject DeviceCryoThin Surgical System andAccessories	Predicate Device 1CRYOCARE TOUCH System andAccessories	Predicate Device 2Visual-ICE Cryoablation System	Comparison
	prostate and kidney tissue, livermetastases, tumors, skinlesions, and warts.	application of extreme coldtemperatures including prostateand kidney tissue, livermetastases, tumors, skinlesions, and warts.	proctology, and urology. Thissystem is designed to destroytissue by the application ofextreme cold temperaturesincluding prostate and kidneytissue, liver metastases, tumors,skin lesions, and warts.
	The system has the followingspecific indications:	In addition, the system isintended for use in thefollowing indications:	The Visual-ICE CryoablationSystem has the following specificindications:
	General Surgery• Destruction of warts orlesions• Palliation of tumors of theoral cavity, rectum and skin• Ablation of breastfibroadenomas• Ablation of leukoplakia of themouth, angiomas, sebaceoushyperplasia, basal cell tumors ofthe eyelid or canthus area,ulcerated basal cell tumors,dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,hemorrhoids, anal fissures,perianal condylomata, pilonidal	General Surgery• Destruction of warts or lesions• Palliation of tumors of the oralcavity, rectum and skin• Ablation of breastfibroadenomas• Ablation of leukoplakia of themouth, angiomas, sebaceoushyperplasia, basal cell tumors ofthe eyelid or canthus area,ulcerated basal cell tumors,dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,hemorrhoids, anal fissures,perianal condylomata, pilonidal	• Urology : Ablation of prostatetissue in cases of prostate cancerand Benign Prostate Hyperplasia(BPH)• Oncology : Ablation ofcancerous or malignant tissueand benign tumors, andpalliative intervention• Dermatology : Ablation orfreezing of skin cancers andother cutaneous disordersDestruction of warts or lesions,angiomas, sebaceous
Feature	Subject DeviceCryoThin Surgical System andAccessories	Predicate Device 1CRYOCARE TOUCH System andAccessories	Predicate Device 2Visual-ICE Cryoablation System	Comparison
	cysts, actinic and seborrheickeratoses, cavernoushemangiomas, recurrentcancerous lesions	cysts, actinic and seborrheickeratoses, cavernoushemangiomas, recurrentcancerous lesions	hyperplasia, basal cell tumors ofthe eyelid or canthus area,ulcerated basal cell tumors,dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,actinic and seborrheic keratosis,cavernous hemangiomas, peri-anal condylomata, and palliationof tumors of the skin.
	Urology• Ablation of prostate tissue incases of prostate cancer andbenign prostatic hyperplasia	Urology• Ablation of prostate tissue incases of prostate cancer andbenign prostatic hyperplasia
	Gynecology• Ablation of malignantneoplasia or benign dysplasia ofthe female genitalia	Gynecology• Ablation of malignantneoplasia or benign dysplasia ofthe female genitalia	• Gynecology: Ablation ofmalignant neoplasia or benigndysplasia of the female genitalia
	Oncology• Ablation of cancerous ormalignant tissue• Ablation of benign tumors• Palliative intervention	Oncology• Ablation of cancerous ormalignant tissue• Ablation of benign tumors• Palliative intervention	• General surgery: Palliation oftumors of the rectum,hemorrhoids, anal fissures,pilonidal cysts, and recurrentcancerous lesions, ablation ofbreast fibroadenomas
	Neurology• Freezing of nerve tissue inpainmanagement/cryoanalgesia	Neurology• Freezing of nerve tissue inpainmanagement/cryoanalgesia	• ENT: Palliation of tumors of theoral cavity and ablation ofleukoplakia of the mouth
	Dermatology• Ablation or freezing of skincancers and other cutaneous	Dermatology• Ablation or freezing of skincancers and other cutaneous	• Thoracic surgery: Ablation ofarrhythmic cardiac tissue
	Subject Device	Predicate Device 1	Predicate Device 2
Feature	CryoThin Surgical System andAccessories	CRYOCARE TOUCH System andAccessories	Visual-ICE Cryoablation System	Comparison
	disordersProctology• Ablation of benign ormalignant growths of the anusor rectum• Ablation of hemorrhoidsThoracic Surgery• Ablation of cancerous lesions	disordersProctology• Ablation of benign ormalignantgrowths of the anus or rectum• Ablation of hemorrhoidsThoracic Surgery• Ablation of cancerous lesions	cancerous lesions• Proctology: Ablation of benignor malignant growths of the anusor rectum, and hemorrhoids
Mechanism ofaction	Joule-Thomson effect	Joule-Thomson effect	Joule-Thomson effect	Same
Freeze gas	Argon gas	Argon gas	Argon gas	Same
Thaw gas	Argon gas	Helium gas	Helium gasArgon gas	Same as PredicateDevice 2
Electrical Thaw	Yes (electrical heated argongas)	N/A	Yes (electrical heated argon gas)	Same as PredicateDevice 2
Humaninterfacedevice /connections	• 1×touch screen monitor	• 1×touch screen monitor• 1×Remote Keypad	• 1×touch screen monitor	Same as PredicateDevice 2

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K231661

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K231661

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K231661

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Summary of Performance Data (Non-clinical testing):

The CryoThin Surgical System and Accessories have the same principle of operation, intended use, and very similar technological characteristics as the predicate devices.

Comprehensive tests and analysis have been performed on the subject device which demonstrated the safety and performance characteristics of the device. The non-clinical testing done on the subject device include the following:

Electrical Safety Testing in accordance with IEC 60601-1. a.
b. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2.
Human Factors and Usability Testing in accordance with IEC 60601-1-6 and C. IEC 62366.
Software development in accordance with IEC 62304 and the FDA's Guidance, d. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Biocompatibility Testing in accordance with ISO 10993 series of standards. e.
Sterilization Validation in accordance with ISO 11137-1. ISO 11137-2. 11137-3. f. ISO 11737-1, and ISO 11737-2.
Shelf-life testing in accordance with ASTM F 1980-16 Standard Guide for ರು. Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Service life testing in accordance with IEC 62506:2013 Methods for Product h. Accelerated Testing.
Package Verification Testing in accordance with ASTM F 1980-16 Standard i. Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
i. Packaging Testing in accordance with ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems DC13 Level II.
Cleaning and Disinfection of Reusable Probes testing to support the stated use k. life.
Iceball and isotherm testing to demonstrate the subject device ability to cool 1. target tissue to desirable therapeutic temperature.
m. Compatibility testing to demonstrate subject device compatibility with the most commonly used imaging modalities.

Conclusion:

The subject device has passed all the above testing. The testing results showed its conformance to applicable requirements specifications and assured that the safety measures taken are adequate and effective. The information and data provided in this Traditional 510(k) application demonstrated that the subject device met the safety and performance specifications and did not raise any new safety or effectiveness issues. Thus, the subject device is considered to be substantially equivalent to the legally marketed predicate devices.

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.