(173 days)
Not Found
No
The document describes a cryosurgery system based on the Joule-Thomson effect and does not mention any AI or ML components in its description, intended use, or performance testing.
Yes
The CryoThin Surgical System is intended for cryosurgery to freeze/ablate tissue for therapeutic purposes, such as the destruction of warts or lesions, ablation of tumors, and treatment of various medical conditions including cancer and benign prostatic hyperplasia.
No.
The CryoThin™ Surgical System is intended for cryosurgery to ablate or freeze diseased tissues in situ, which is a therapeutic function, not a diagnostic one. While it monitors temperature, this monitoring is part of its therapeutic function to ensure proper tissue ablation, not to diagnose a condition.
No
The device description explicitly states that the system consists of a console, a cart, and accessories, and must be used with Cryo probes and Temp probes. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the CryoThin™ Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "cryosurgery" and is designed to "freeze/ablate tissue" in various surgical fields. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description explains how the system works by applying extreme cold temperatures to destroy diseased tissues in situ (in place within the body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CryoThin™ system does not perform any such analysis of specimens.
The CryoThin™ Surgical System is a surgical device used for therapeutic intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and kidney tissue, liver metastase, tumors, skin lesions, warts, oral cavity, rectum, skin, breast, eyelid or canthus area, anus, female genitalia, nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CRYOCARE TOUCH System and Accessories (K201588), Visual-ICE® Cryoablation System (K143564)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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.
4
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5
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 K1
6 Haitai Fazhan 6th Road
Huayuan Industrial Park
Tianjin 300384
China |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact
Person: | Ms. Diana Zhang, B.A.
Manager, Regulatory Affairs
Phone: (86) 22 86 392 536
Fax: (86) 22 87 930 633
dianazhang@medinux.com |
| Trade/Device Name:
Manufacturer:
Regulation Number:
Regulation Name:
Regulation Class:
Product Code: | CryoThin™ Surgical System and Accessories
Medinux (Tianjin) Technologies Co., Ltd.
21 CFR 878.4350
Cryosurgical unit and accessories
Class II
GEH |
| Predicate Devices /
Reference 510(k): | CRYOCARE TOUCH System and Accessories (K201588)
Visual-ICE® Cryoablation System (K143564) |
| Date of Preparation: | November 23, 2023 |
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.
6
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.
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
7
- 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.
8
Table 1 Subject and Predicate Device Comparison
| Subject Device | Predicate Device 1 | Predicate Device 2 | ||
|---|---|---|---|---|
| Feature | CryoThin Surgical System and | |||
| Accessories | CRYOCARE TOUCH System and | |||
| Accessories | Visual-ICE Cryoablation System | Comparison | ||
| 510(k) Number | - | K201588 | K143564 | - |
| Trade/Device | ||||
| Name | CryoThin Surgical System and | |||
| Accessories | CRYOCARE TOUCH System and | |||
| Accessories | Visual-ICE Cryoablation System | - | ||
| Manufacturer | Medinux (Tianjin) Technologies | |||
| Co., Ltd. | Varian Medical Systems, Inc. | Galil Medical Inc. | Same | |
| Regulation | ||||
| Number | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | Same |
| Regulation | ||||
| Name | Cryosurgical unit and | |||
| accessories | Cryosurgical unit and | |||
| accessories | Cryosurgical unit and accessories | Same | ||
| Regulation | ||||
| Class | Class II | Class II | Class II | Same |
| Product Code | GEH | GEH | GEH | Same |
| 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 | The CRYOCARE TOUCH 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 | The Visual-ICE Cryoablation | |||
| System is intended for | ||||
| cryoablative destruction of tissue | ||||
| during surgical procedures. The | ||||
| Visual-ICE System is indicated for | ||||
| use as a cryosurgical tool in the | ||||
| fields of general surgery, | ||||
| dermatology, neurology | ||||
| (including cryoanalgesia), | ||||
| thoracic surgery, ENT, | ||||
| gynecology, oncology, | Same | |||
| Feature | Subject Device | |||
| CryoThin Surgical System and | ||||
| Accessories | Predicate Device 1 | |||
| CRYOCARE TOUCH System and | ||||
| Accessories | Predicate Device 2 | |||
| Visual-ICE Cryoablation System | Comparison | |||
| prostate and kidney tissue, liver | ||||
| metastases, tumors, skin | ||||
| lesions, and warts. | application of extreme cold | |||
| temperatures including prostate | ||||
| and kidney tissue, liver | ||||
| metastases, tumors, skin | ||||
| lesions, and warts. | proctology, and urology. This | |||
| system is designed to destroy | ||||
| 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: | In addition, the system is | |||
| intended for use in the | ||||
| following indications: | The Visual-ICE Cryoablation | |||
| 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 | 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 | • Urology : Ablation of prostate | |||
| tissue in cases of prostate cancer | ||||
| and Benign Prostate Hyperplasia | ||||
| (BPH) | ||||
| • Oncology : Ablation of | ||||
| cancerous or malignant tissue | ||||
| and benign tumors, and | ||||
| palliative intervention | ||||
| • Dermatology : Ablation or | ||||
| freezing of skin cancers and | ||||
| other cutaneous disorders | ||||
| Destruction of warts or lesions, | ||||
| angiomas, sebaceous | ||||
| Feature | Subject Device | |||
| CryoThin Surgical System and | ||||
| Accessories | Predicate Device 1 | |||
| CRYOCARE TOUCH System and | ||||
| Accessories | Predicate Device 2 | |||
| Visual-ICE Cryoablation System | Comparison | |||
| cysts, actinic and seborrheic | ||||
| keratoses, cavernous | ||||
| hemangiomas, recurrent | ||||
| cancerous lesions | cysts, actinic and seborrheic | |||
| keratoses, cavernous | ||||
| hemangiomas, recurrent | ||||
| cancerous lesions | hyperplasia, basal cell tumors of | |||
| the eyelid or canthus area, | ||||
| ulcerated basal cell tumors, | ||||
| dermatofibromas, small | ||||
| hemangiomas, mucocele cysts, | ||||
| multiple warts, plantar warts, | ||||
| actinic and seborrheic keratosis, | ||||
| cavernous hemangiomas, peri- | ||||
| anal condylomata, and palliation | ||||
| of tumors of the skin. | ||||
| Urology | ||||
| • Ablation of prostate tissue in | ||||
| cases of prostate cancer and | ||||
| benign prostatic hyperplasia | 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 | Gynecology | |||
| • Ablation of malignant | ||||
| neoplasia or benign dysplasia of | ||||
| the female genitalia | • 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 | Oncology | |||
| • Ablation of cancerous or | ||||
| malignant tissue | ||||
| • Ablation of benign tumors | ||||
| • Palliative intervention | • General surgery: Palliation of | |||
| tumors of the rectum, | ||||
| hemorrhoids, anal fissures, | ||||
| pilonidal cysts, and recurrent | ||||
| cancerous lesions, ablation of | ||||
| breast fibroadenomas | ||||
| Neurology | ||||
| • Freezing of nerve tissue in | ||||
| pain | ||||
| management/cryoanalgesia | Neurology | |||
| • Freezing of nerve tissue in | ||||
| pain | ||||
| management/cryoanalgesia | • ENT: Palliation of tumors of the | |||
| oral cavity and ablation of | ||||
| leukoplakia of the mouth | ||||
| Dermatology | ||||
| • Ablation or freezing of skin | ||||
| cancers and other cutaneous | Dermatology | |||
| • Ablation or freezing of skin | ||||
| cancers and other cutaneous | • Thoracic surgery: Ablation of | |||
| arrhythmic cardiac tissue | ||||
| Subject Device | Predicate Device 1 | Predicate Device 2 | ||
| Feature | CryoThin Surgical System and | |||
| Accessories | CRYOCARE TOUCH System and | |||
| Accessories | Visual-ICE Cryoablation System | Comparison | ||
| disorders | ||||
| Proctology | ||||
| • Ablation of benign or | ||||
| malignant growths of the anus | ||||
| or rectum | ||||
| • Ablation of hemorrhoids | ||||
| Thoracic Surgery | ||||
| • Ablation of cancerous lesions | disorders | |||
| Proctology | ||||
| • Ablation of benign or | ||||
| malignant | ||||
| growths of the anus or rectum | ||||
| • Ablation of hemorrhoids | ||||
| Thoracic Surgery | ||||
| • Ablation of cancerous lesions | cancerous lesions | |||
| • Proctology: Ablation of benign | ||||
| or malignant growths of the anus | ||||
| or rectum, and hemorrhoids | ||||
| Mechanism of | ||||
| action | 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 gas | |
| Argon gas | Same as Predicate | |||
| Device 2 | ||||
| Electrical Thaw | Yes (electrical heated argon | |||
| gas) | N/A | Yes (electrical heated argon gas) | Same as Predicate | |
| Device 2 | ||||
| Human | ||||
| interface | ||||
| device / | ||||
| connections | • 1×touch screen monitor | • 1×touch screen monitor | ||
| • 1×Remote Keypad | • 1×touch screen monitor | Same as Predicate | ||
| Device 2 |
9
K231661
10
K231661
11
K231661
12
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.