(190 days)
Not Found
No
The summary describes a device that uses radio frequency energy for tissue ablation and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction, which aligns with the definition of a therapeutic device.
No
Explanation: The device is indicated for the "treatment of symptoms" and "uses precisely focused radio frequency (RF) energy to ablate prostate tissue," which describes a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "System" that uses "radio frequency (RF) energy to ablate prostate tissue," and the performance studies mention testing of a "Prostiva Hand Piece," indicating the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of symptoms due to BPH by ablating prostate tissue. This is a therapeutic intervention performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device description clearly states it uses radio frequency energy to ablate prostate tissue. This is a treatment mechanism, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to treat a condition.
N/A
Intended Use / Indications for Use
The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm³.
Product codes
GEI, KNS
Device Description
Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The Prostiva RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
men over the age of 50
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
Performance bench testing and biocompatibility testing were conducted on the proposed Prostiva Hand Piece to ensure that the Prostiva Hand Piece maintains mechanical and electrical integrity with application of additional lubricant and demonstrating that the required design specifications were met. The following performance bench tests were performed: Cycle testing Deployment/retraction testing Simulated lesion testing. The following biocompatibility testing were performed: Cytotoxicity Irritation Sensitization. All of the testing yielded passing results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around an emblem. The emblem consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Urologix, Inc. Georgiann Keyport Regulatory Affairs Consultant 14405 21st Avenue North Minneapolis, MN 55447
Re: K142248
Trade/Device Name: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulaton device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: January 9, 2015 Received: January 12, 2015
Dear Georgiann Keyport,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
Prostiva RF Therapy System
Indications for Use (Describe)
The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm³.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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UROLOGIX®
510(k) Summary
| Date Prepared | January 9, 2015 |
|---|---|
| Applicant | Urologix, Inc. |
| 14405 21st Avenue N. | |
| Minneapolis, MN 55447 | |
| Establishment Registration Number: 2133936 | |
| Contact | Margaret Batchelder |
| Device Name | Prostiva RF Therapy System |
| Classification | |
| Regulation | 878.4400 |
| 876.4300 | |
| Classification | |
| Name | Endoscopic Electrosurgical Unit and Accessories |
| Common Name | Trans-urethral needle ablation |
| Product Code | GEI, KNS |
| Classification | Class II |
| Panel | Gastroenterology/Urology |
| Predicate Device | |
| Name | Prostiva RF Therapy System (K113380) |
| Device | |
| Description | Prostiva RF Therapy is a minimally invasive treatment for |
| patients with lower urinary tract symptoms due to benign | |
| prostatic hyperplasia (BPH). The Prostiva RF Therapy | |
| System uses precisely focused radio frequency (RF) | |
| energy to ablate prostate tissue. | |
| Indications for | |
| Use | The Prostiva RF Therapy System is indicated for the |
| treatment of symptoms due to urinary outflow obstruction | |
| secondary to benign prostatic hyperplasia (BPH) in men | |
| over the age of 50 with prostate sizes between 20 and 50 | |
| cm³. |
4
| Summary of
Technological
Characteristics
Compared to the
Predicate | The modified Prostiva RF Therapy System incorporates
lubricant in additional locations within the Hand Piece. This
same lubricant is also used in the predicate device. The
modified Prostiva RF Therapy System has the same
fundamental design, operating principal and intended use
as the predicate Prostiva RF Therapy System (K113380).
No new issues regarding safety and effectiveness have
been raised. |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The modified The modified Prostiva RF Therapy System is
substantially equivalent to the predicate device, Prostiva
RF Therapy System (K113380). |
| Summary of
Testing | Performance bench testing and biocompatibility testing
were conducted on the proposed Prostiva Hand Piece to
ensure that the Prostiva Hand Piece maintains mechanical
and electrical integrity with application of additional
lubricant and demonstrating that the required design
specifications were met. The following performance bench
tests were performed.
Cycle testing Deployment/retraction testing Simulated lesion testing The following biocompatibility testing were performed. Cytotoxicity Irritation Sensitization. All of the testing yielded passing results. |
| Conclusion | Based on the similarities in the indications for use and
fundamental scientific technology, the modified Prostiva
RF Therapy System is substantially equivalent to the
predicate device, Prostiva RF Therapy System (K113380). |