(29 days)
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.
Medtronic Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Prostiva® RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue. The Prostiva RF Therapy Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.
The provided text describes a 510(k) premarket notification for a medical device, the Prostiva RF Therapy Model 8929 Hand Piece. This notification is for a material change in an already marketed device and therefore the study performed focuses on biocompatibility and functionality after the material change, rather than proving the overall effectiveness of the therapy.
Here's an analysis of the provided text in relation to your questions:
Acceptance Criteria and Device Performance Study for Prostiva RF Therapy Model 8929 Hand Piece
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance acceptance criteria are mentioned in the document. The focus is on demonstrating that a material change does not affect functionality or biocompatibility compared to the predicate device. | - A material change assessment was conducted. |
| - Biocompatibility testing was performed. | |
| - The conclusion was that the change to the insulation of the thermocouple wires does not affect the functionality or biocompatibility of the device. | |
| - The modified device is substantially equivalent to the currently marketed PROSTIVA RF Therapy Model 8929 Hand Piece based on the material change assessment and biocompatibility test results. |
Note: The document explicitly states: "No applicable mandatory performance standards or special controls exist for this device." The purpose of this 510(k) is to demonstrate substantial equivalence following a material change, not to establish initial clinical performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the testing. It mentions a "material change assessment" and "biocompatibility testing." The nature of these tests (e.g., in-vitro, in-vivo) and their specific sample sizes are not detailed.
The data provenance (country of origin, retrospective/prospective) is not mentioned as the testing performed appears to be laboratory-based (biocompatibility) and an assessment of a material change, rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The study is not an AI/diagnostic imaging study that would require expert consensus for ground truth. It focuses on engineering and biological testing related to a material change.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is mentioned or required for this type of testing (material change assessment and biocompatibility).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is not an AI algorithm for diagnostic interpretation that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (hand piece for RF therapy), not a software algorithm.
7. The Type of Ground Truth Used
For the biocompatibility testing, the ground truth would be established by standardized biological assays and tests designed to assess material safety and compatibility with biological systems (e.g., cytotoxicity, sensitization, irritation). These tests have predefined endpoints and acceptance criteria from regulatory standards.
For the material change assessment, the ground truth involves engineering analysis and comparison to the original device's specifications and performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device and study.
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K101139
Page 1 of 2
MAY 2 ] 2010
510(k) Summary
Date Summary Prepared: Applicant:
April 21, 2010
Medtronic Neuromodulation 7000 Central Ave., N.E. Minneapolis, MN 55432
Thomas Reichel Regulatory Affairs Specialist 763-526-9693 763-526-6246 (fax)
Contact:
Trade Name: Prostiva RF Therapy Model 8929 Hand Piece
Classification Name: 21 CFR 876.4300 (Endoscopic electrosurgical unit and accessories)
Name of Predicate Device: Prostiva RF Therapy Model 8929 Hand Piece
Device Description
Medtronic Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Prostiva® RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue. The Prostiva RF Therapy Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.
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.
Performance Standards
No applicable mandatory performance standards or special controls exist for this device.
Substantial Equivalence
The conclusions from assessing the material change and results from biocompatibility testing confirm that the change to the insulation of the thermocouple wires contained in the urethra tube does not affect the functionality or biocompatibility of the device and that the device is therefore substantially equivalent to the currently marketed device. There are no changes in device specifications or indications for use.
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K101139
page 2 of 2
Summary of Testing
A material change assessment was conducted and biocompatibility testing was performed to support the material change in the Prostiva RF Therapy Model 8929 Hand Piece device.
Conclusion
The modified device is substantially equivalent to the currently marketed PROSTIVA RF Therapy Model 8929 Hand Piece based upon the conclusion of the material change assessment and biocompatibility test results.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings, facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Thomas J. Reichel Regulatory Affairs Specialist Medtronic Neuromodulation 7000 Central Avenue, N.E., MS RCW235 MINNEAPOLIS MN 55432
MAY 2 1 2010
Re: K101139
Trade/Device Name: Prostiva® RF Therapy Model 8929 Hand Piece Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS and GEI Dated: April 21, 2010 Received: April 22, 2010
Dear Mr. Reichel:
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 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 of medical device-related
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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/CDRHOffices/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.goy/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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 Statement Form
510(k) Number (if known): 40 mille
Image /page/4/Picture/2 description: The image contains the alphanumeric string "X101139". The text is written in a handwritten style, with the characters slightly slanted. The text is black against a white background.
Device Name: Prostiva® RF Therapy Model 8929 Hand Piece
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. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Per 21 CFR 801.109
Over-The-Counter Use
Samya Kousf
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).