(26 days)
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, 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 turnors, 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
The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).
The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.
The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.
Associated accessories include the following:
I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.
Helium gas is used after the freezing process to thaw tissue. As the gas passes through the J-T port, there is a significant pressure drop, which conversely results in an increase in the gas temperature.
The patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System.
- 2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
- 3.) A warming system for use in urological applications.
The provided text describes the Cryocare CS Surgical System, a cryosurgical unit designed to ablate tissue using extreme cold temperatures. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria and performance metrics.
Here's a breakdown based on the provided information, noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) is a submission for substantial equivalence, which means it compares the new device to a legally marketed predicate device rather than establishing new performance criteria or conducting a clinical trial that measures device performance against predefined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As no new clinical study (with a "test set" of patients or cases) was conducted for this 510(k) submission to demonstrate performance, there is no sample size or data provenance to report. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. Since no new clinical study requiring ground truth establishment was conducted, there are no experts or qualifications to specify.
4. Adjudication Method for the Test Set
This information is not provided. As no new clinical study was conducted, there was no test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with or without AI assistance, or assessing human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/not provided. The Cryocare CS Surgical System is a physical medical device (cryosurgical unit), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used
This information is not applicable. Since no new clinical performance study was conducted to generate specific performance data requiring ground truth, there is no type of ground truth to report for this 510(k) submission. The basis for safety and effectiveness is through comparison to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. As the Cryocare CS Surgical System is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. For the same reasons as above, there is no training set or ground truth establishment method to describe for this device.
Summary of the Study (Basis for Substantial Equivalence):
The "study" in this context is the submission of information to the FDA to demonstrate substantial equivalence to a previously cleared predicate device, the Cryocare CST Surgical System (K050347) marketed by Endocare, Inc.
The rationale for substantial equivalence is based on the following claims:
- Similarity of Design: The Cryocare CS Surgical System patient interface accessory CryoProbe and Cryo-Hose design are "very similar" to the predicate device.
- Identical Intended Uses and Operating Principles: The new device shares the exact same intended uses and operating principles (effectiveness) as the predicate device.
- Identical Operational and Safety Features: The new device's operational features and safety features are the same as those offered by the predicate device.
- Compliance with Standards: The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)].
Conclusion of the Submission:
The submission concludes that the data demonstrates the CryoProbe and Cryo-Hose accessory items are substantially equivalent with respect to indications for use, operating principles, operational features, and safety features. No new issues of safety, effectiveness, or performance were identified compared to the predicate device. This led to the FDA's "Substantial Equivalence" decision.
§ 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.