(28 days)
The Cryocare CN2 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 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
The Cryocare CN2 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). Near Critical Nitrogen (NCN) is utilized as the cryogenic medium. Circulating NCN avoids the 'vapor lock' potential of liquid N2 devices since it is a transition fluid (nitrogen that is neither a liquid, nor a gas).
The Cryocare CN2 System has a fold-down 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 CN2 System can control up to four, single-use, disposable Cryoprobes and monitor up to four independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert liquid nitrogen. An IBM compatible microprocessor serves as the host computer which performs all essential controls and monitoring tasks. Cryoprobe control is achieved via the keypad.
Associated accessories include the following:
- 1.) Cryoprobes that deliver cold temperatures to targeted tissue. Each Cryoprobe incorporates a thermocouple to measure internal Cryoprobe temperatures. Warm room temperature nitrogen gas is used after the freezing process to thaw tissue. The patient contact Cryoprobe (an accessory item to the Cryocare CN2 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 CN2 System.
- TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are 2.) standard T-type thermocouples.
- 3.) A warming system for use in urological applications.
The provided text describes a 510(k) premarket notification for the Cryocare CN2 System, a cryosurgical unit. However, a detailed study proving performance against specific quantitative acceptance criteria is not included in this document. The submission focuses on demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the information provided and what is missing:
The core of this 510(k) submission is based on substantial equivalence to previously cleared predicate devices, not on a new study directly demonstrating performance against quantitative acceptance criteria. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in this document.
Detailed Breakdown based on the provided text:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices as defined by the FDA. This typically means the device has the same intended use, operating principles, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device.
- Reported Device Performance: No specific quantitative performance data (e.g., specific temperatures achieved, freezing rates, iceball sizes) is reported in this document. The performance is deemed equivalent to the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is presented to demonstrate performance against new acceptance criteria. The claim is based on equivalence to predicate devices, which would have had their own validation data.
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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)
- Not applicable as no independent test set with ground truth established by experts is described for this specific submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no independent test set is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a cryosurgical device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is a cryosurgical device, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The ground for approval here is demonstrating equivalence in design, intended use, and operational/safety features to predicate devices that already established their safety and effectiveness through their own approval processes and market use.
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The sample size for the training set
- Not applicable as no AI/machine learning model is described.
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How the ground truth for the training set was established
- Not applicable.
What the document does state about safety and effectiveness:
- "The Cryocare CN2 System complies with the ASTM 'Standard Performance and Safety Specification for Cryosurgical Medical Instruments' [Designation: F 882-84 and Davy 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use."
- Implication: Compliance with this ASTM standard serves as a key element of the safety and effectiveness rationale, effectively acting as an "acceptance criterion" that the device meets. The "study" demonstrating this would be engineering and performance testing against the requirements of ASTM F 882-84. The document does not provide the results of this testing but states that the system complies.
- "The Cryocare CN2 System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device."
- This is the core argument for substantial equivalence.
In summary, for this 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices and compliance with an existing ASTM standard, rather than presenting a new study with specific quantitative performance metrics. The document asserts compliance and equivalence but does not provide the detailed data from the underlying testing or studies.
§ 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.