(145 days)
The ENDOcare Urethral Warming System is an accessory to the cryosurgical system and is indicated to transfer heat to the urethral tissue during urological cryosurgery procedures using the ENDOcare CRYOcare™ Cryosurgical System.
The ENDOcare Urethral Warming System consists of a balloon catheter, PVC tubing set, heater/heater stand and roller pump. The urethral catheter consists of a polyurethane shaft with a polyester balloon. The system provides a steady flow of warm water or saline from an I.V. bag to the catheter in order to transfer heat to the urethral tissue during urological cryosurgery procedures. The catheter has an inlet port which allows the warm water or saline to flow into the balloon, warming the surrounding urethral tissue. An outlet port allows the water or saline to exit the catheter and return to the I.V. bag. The water or saline in the I.V. bag is maintained at a set temperature of 37.5℃ by the heater. A shutoff feature prevents the temperature from exceeding 42°C. The water or saline is circulated by a roller pump from the catheter to the I.V. bag in a closed circuit.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a clinical or performance study with specific metrics, sample sizes, and ground truth establishment.
Instead, the document describes the Endocare Urethral Warming System and focuses on demonstrating its substantial equivalence to a predicate device (Cryomedical Sciences Urethral Warmer) and compliance with general medical device requirements (biocompatibility, sterilization).
Here's a breakdown of the available information, addressing your points where possible, and noting where information is absent:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence at 37.5°C set point (compared to predicate) | The performance of the ENDOcare Urethral Warming System was "determined to be equivalent" to the Cryomedical Sciences Urethral Warmer at a set point temperature of 37.5°C. |
| Biocompatibility | Met by having same material, manufacturing process, chemical composition, body contact, and sterilization method as a previously cleared catheter, per ISO-10993 and FDA matrix. No additional testing performed. |
| Sterility Assurance Level (SAL) for EtO sterilized components (catheter and tubing) | Minimum SAL of 10⁻⁶ will be achieved. |
| Sterility Assurance Level (SAL) for gamma sterilized components (heat exchanger cassette) | Minimum SAL of 10⁻⁶ will be achieved. |
| EtO Residuals (maximum levels) | Ethylene oxide: 25 ppm |
| Ethylene chlorohydrin: 25 ppm | |
| Ethylene glycol: 250 ppm | |
| Material Equivalence (catheter) | Same materials as the marketed predicate device. |
| Component Equivalence (balloon catheter, tubing, heater, roller pump) | Substantially equivalent to the marketed predicate device. |
Missing Information/Not Applicable: The document describes engineering benchmarks and regulatory compliance rather than performance criteria that would typically be associated with a "study" involving human subjects or algorithmic performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of the described testing. The "bench testing" for functional performance likely involved a small number of physical units, but no specific sample size is reported.
- Data Provenance: Not applicable. The testing was in vitro (bench testing) and involved physical devices, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "ground truth" establishment by experts in the context of a clinical study. The functional performance was a direct measurement comparison between two physical systems. Biocompatibility and sterility are based on established standards and laboratory validations, not expert consensus on performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication process for a test set is described.
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:
- Not applicable. This device is a Urethral Warming System, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Functional Performance: The "ground truth" for the functional performance comparison was the direct measurement of temperature maintenance and flow characteristics of the predicate device, which the new device aimed to match. This is an engineering benchmark, not a clinical ground truth.
- Biocompatibility/Sterilization: Ground truth is established by adherence to recognized international standards (ISO-10993, AAMI guidelines) and validation testing against those standards.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning/AI device.
§ 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.