(145 days)
No
The device description details a simple closed-loop system for circulating heated fluid, with no mention of AI, ML, or any complex algorithms for decision-making or adaptation. The control mechanism appears to be a basic thermostat and pump.
No
The device is described as an "accessory" to a cryosurgical system and its function is to "transfer heat to the urethral tissue during urological cryosurgery procedures," which is a supportive rather than a primary therapeutic action itself.
No
This device is described as an "accessory to the cryosurgical system" that transfers heat to urethral tissue during cryosurgery procedures. Its function is to warm tissue, not to diagnose a condition or disease.
No
The device description explicitly lists multiple hardware components: a balloon catheter, PVC tubing set, heater/heater stand, and roller pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ENDOcare Urethral Warming System is a device used during a surgical procedure (urological cryosurgery) to physically warm tissue. It does not analyze samples from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it is an accessory to a cryosurgical system to transfer heat to tissue during a procedure. This is a therapeutic/procedural function, not a diagnostic one.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral 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
Bench testing was conducted to compare the functional performance of the ENDOcare Urethral Warming System to the Cryomedical Sciences Urethral Warmer. At a set point temperature of 37.5℃, the performance of the two systems was determined to be equivalent.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
963970
FEB 25 1997
Section 2.0 - SMDA 1990 Requirements
2.1 510(k) Summary
Device Description
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.
Biocompatibility
The biocompatibility requirements were determined through use of the International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The urethral warming catheter is the only component of the system which has patient contact. The catheter has the same material, manufacturing process, chemical composition, body contact and sterilization method as the marketed catheter. Therefore, per the FDA matrix the biocompatibility requirements were met and no additional testing was performed.
Substantial Equivalence Support
The ENDOcare CRYOcare™ Cryosurgical System is designed for use in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, protocology and urology for the ablation and destruction of tissue by the application of extreme cold. 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 Urethral Warming System is substantially equivalent to the Cryomedical Sciences, Inc. Urethral Warmer which was determined to be substantially equivalent on October 24, 1995 (reference K952895). The ENDOcare Urethral Warming system consists of a balloon catheter, tubing, heater and roller pump which are substantially equivalent to the marketed device. The catheter is the only component with direct patient contact and it is manufactured with the same materials as the marketed device.
1
In Vitro Testing
Bench testing was conducted to compare the functional performance of the ENDOcare Urethral Warming System to the Cryomedical Sciences Urethral Warmer. At a set point temperature of 37.5℃, the performance of the two systems was determined to be equivalent.
Sterilization Methodology
Ethylene oxide will be utilized to sterilize the catheter and tubing set. Sterilization validation will be based on the recommendations in the current AAMI (American Association for the Advancement of Medical Instrumentation) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. A minimum Sterility Assurance Level (SAL) of 10 will be achieved. Sterile barrier packaging will consist of standard disposable medical device packaging containing a plastic film and a coated paper side. This is the same type of sterile barrier packaging that is used with the marketed device. Maximum levels of EtO residuals will not exceed:
25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol
The heat exchanger cassette will be received sterile from the supplier. This component is gamma sterilized. Sterilization validation was based on the recommendations of the current AAMI Guideline for Gamma Radiation to achieve a minimum Sterility Assurance Level (SAL) of 10to.