(27 days)
The Cryocare 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 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 Surgical System consists of a compact, easy-to-operate console and associated accessories that include CryoProbes to deliver cold temperatures to the targeted tissue and TempProbes to monitor temperatures in the surrounding tissue.
The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert Argon gas. The console can control up to eight, single-use, disposable CryoProbes.
The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal tip of the probes. Each CryoProbe incorporates a thermocouple to monitor probe temperature. Helium gas is used after the freezing process. 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 console can also monitor up to eight independent TempProbes. The TempProbes are standard T-type needle thermocouples.
An IBM-compatible microprocessor serves as the host computer. System control is accomplished through a remote control keypad.
The system can be operated manually or using the AutoFreeze option, which allows users to pre-program specific treatment parameters.
The provided text describes a 510(k) summary for the Cryocare Surgical System. It details the device, its intended use, and indicates that "in-vitro testing" and "software validation" were performed. However, it does not provide specific acceptance criteria or the results of a study that directly proves the device meets those criteria, especially in a clinical context.
The document states:
- "In-vitro testing of the Cryocare Surgical System included time and temperature performance under simulated use conditions."
- "Software validation was performed in accordance with IEC 60601-1-4 and the General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)."
- "All testing of the product yielded acceptable results."
This is a general statement of compliance, not a detailed report of findings against specific performance metrics. The submission is a 510(k) for a modified device, declaring substantial equivalence to a predicate device (K011074 Cryocare Surgical System), rather than a de novo submission requiring extensive new clinical performance data to establish safety and effectiveness from scratch.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or explicitly stated based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from "Testing") | Reported Device Performance |
|---|---|
| Time and Temperature Performance (simulated use) | Acceptable results |
| Software Validation (IEC 60601-1-4 & FDA Guidance) | Acceptable results |
Note: The document only states that "All testing of the product yielded acceptable results." It does not provide specific numerical targets for temperature, time, or specific metrics for software validation.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The testing mentioned is "in-vitro testing," so it refers to bench testing rather than patient data.
- Data Provenance: Not applicable in the context of human data. It refers to "simulated use conditions" in a laboratory setting. No country of origin for clinical data is mentioned as no clinical data is presented.
- Retrospective/Prospective: Not applicable as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for in-vitro testing would be based on validated measurement instruments and physical principles, not expert human assessment.
4. Adjudication method for the test set
- Not applicable. This is typically for discrepancies in expert assessments in clinical studies.
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. This is a medical device (cryosurgical system), not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of AI. The device has software for control ("IBM-compatible microprocessor serves as the host computer," "remote control keypad," "AutoFreeze option"), and software validation was performed, but this is for controlling the medical device's physical functions, not for diagnostic or predictive algorithms.
7. The type of ground truth used
- For "time and temperature performance": Likely physical measurements and calibration against known standards.
- For "software validation": Compliance with software lifecycle processes, functional requirements, and safety standards (IEC 60601-1-4) through testing.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.