(126 days)
The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
The UCW System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate. The UCW System includes a Urethral Catheter & Tubing Set and a Warming Kt
The Urethral Catheter is introduced into the bladder to outline the urethral course, and to protect the urethra during therapeutic transperineal, prostatic cryotherapy procedures. The Urethral catheter further transfers heat to the urethral tissue during cryotherapy of the prostate in order to protect the urethra from, excessive cold temperatures. The closed loop Tubing Set is connected to the catheter's inlet and outlet ports and circulates warm sterile water or saline via the Warming Kit that includes a fluid warmer and peristaltic pump.
This 510(k) summary describes a medical device, the UC-CARE Warming System, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the way a clinical trial or performance study for an AI/ML device would. Instead, it focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices.
Therefore, many of the requested fields related to AI/ML performance, ground truth, expert adjudication, and sample sizes for testing/training sets cannot be filled from the provided document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safe and effective as predicate devices. | "The UC Care Warming System is as safe and effective as the Endocase Urethral Warming System and the Galil Medical Seednet device." |
| Same intended uses as predicate devices. | "The UC Care Warming System has the same intended uses..." |
| Similar indications as predicate devices. | "...and similar indications..." |
| Similar technological characteristics as predicate devices. | "...technological characteristics..." |
| Similar principles of operation as predicate devices. | "...and principles of operation as its predicate devices." |
| No new issues of safety or effectiveness compared to predicate devices. | "Any technological differences between the device and its predicate devices raise no new issues of safety or effectiveness." |
| Performance data demonstrates substantial equivalence to predicate devices. | "Performance data demonstrate that the UC Care Warming Device is as safe and effective as the predicate devices. Thus, the UC Care Warming Device is substantially equivalent." |
| Compliance with relevant standards (e.g., ASTM F623-99). | "The UC-Care Warming System has been tested according to various standards and ・・ guidance documents, like the ASTM F623-99 (2006) - Standard Performance Specification for Foley Catheter." |
Study Proving Device Meets Acceptance Criteria:
The document describes a "substantial equivalence" claim based on a comparison to predicate devices and adherence to relevant standards. This is not a clinical study in the typical sense of measuring specific performance metrics against predefined thresholds. Instead, it's a demonstration that the new device shares fundamental characteristics with devices already cleared by the FDA.
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a medical device (warming system), not an AI/ML algorithm that predicts or classifies based on data. The "test set" in this context would refer to the physical device itself being tested for safety and functionality, not a dataset for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of expert consensus, is typically for evaluating the accuracy of an AI/ML algorithm against human expert judgment. This is a physical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to a method for resolving discrepancies among experts when establishing ground truth for an AI/ML algorithm's performance evaluation.
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 relates specifically to the performance of AI/ML systems in conjunction with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a physical medical device, not an AI/ML algorithm that operates in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. This refers to the reference standard against which an AI/ML algorithm's performance is measured. For this physical device, "ground truth" would be the verified safety and functional performance of the device under various conditions, likely verified through engineering tests, biocompatibility tests, and comparison to predicate device specifications.
8. The sample size for the training set:
- Not applicable. This pertains to the data used to train an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This pertains to the labeling or truth assignment of data used to train an AI/ML algorithm.
Summary of Device-Specific Information from the Provided Text:
- Device Name: UC-CARE Warming System (UCW System)
- Intended Use: To transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
- Predicate Devices:
- Performance Standards: Tested according to various standards and guidance documents, specifically mentioning ASTM F623-99 (2006) - Standard Performance Specification for Foley Catheter.
- Conclusion: The manufacturer believes the device is substantially equivalent to its predicate devices without raising new safety or effectiveness concerns based on the provided information.
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510(K) SUMMARY
UC-CARE Warming System
510(k) Number K_090978
| Applicant's Name: | UC-CARE, Ltd.New Ind. Zone, Apollo Bldg.P.O.Box 67Yokneam 20692Tel: (972)4-909-7427Fax: (972)4-993-7323 |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
AUG 1 0 2009
...
: . . .
| Contact Person: | Roni Zvuloni, Ph.D. |
|---|---|
| CTO | |
| UC-CARE, Ltd. | |
| New Ind. Zone, Apollo Bldg. | |
| P.O.Box 67 | |
| Yokneam 20692 | |
| Tel: (972)4-909-7427 | |
| Fax: (972)4-993-7323 |
Trade Name: UC-CARE Warming System (UCW System)
Classification:
Name: Unit, Cryosurgical, Accessories Product Code: GEH Regulation No: CFR 21 878.4350 Class: II Panel: General & Plastic Surgery
Device Description:
The UCW System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate. The UCW System includes a Urethral Catheter & Tubing Set and a Warming Kt
The Urethral Catheter is introduced into the bladder to outline the urethral course, and to protect the urethra during therapeutic transperineal, prostatic cryotherapy procedures. The Urethral catheter further transfers heat to the urethral tissue during cryotherapy of the prostate in order to protect the urethra from, excessive cold temperatures. The closed loop Tubing Set is connected to the catheter's inlet and outlet ports and circulates warm sterile water or saline via the Warming Kit that includes a fluid warmer and peristaltic pump.
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Intended Use Statement:
The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
Predicate Devices: Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Date of approval |
|---|---|---|
| Endocare Urethral Warming System (EndocareInc.) | K963970 | 997125 Feb, |
| SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA , (PresIce™) | K060390 | 27 Apr, 2006 |
Performance Standards:
The UC-Care Warming System has been tested according to various standards and ・・ guidance documents, like the ASTM F623-99 (2006) - Standard Performance Specification for Foley Catheter.
Substantial Equivalence:
The UC Care Warming System is as safe and effective as the Endocase Urethral Warming System and the Galil Medical Seednet device. The UC Care Warming System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Any technological differences between the device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the UC Care Warming Device is as safe and effective as the predicate devices. Thus, the UC Care Warming Device is substantially equivalent.
Conclusion:
. . . . .
UC-CARE Ltd. believes that, based on the information provided in this submission, the UC-Care Warming System is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
UC CARE, Ltd. % Mr. Jonathan S. Kahan Partner Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street. N.W. WASHINGTON DC 20004
AUG 1 0 2009
Re: K090978
Trade/Device Name: UC CARE Warming System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH and EZL Dated: August 3, 2009 Received: August 5, 2009
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html:
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
UC CARE Warming System
510(k) Number (if known):
Device Name:
Indications for Use:
The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)-
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General & Plastic Surgery Devices 510(k) Number
Vleum
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
UC-Care Ltd. Proprietary information
§ 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.