(365 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.
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 provided 510(k) summary for the Medtronic Prostiva RF Therapy System does not include acceptance criteria or a study that proves the device meets specific performance criteria through clinical or comparative effectiveness studies involving human-in-the-loop AI assistance or standalone algorithm performance.
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through design verification/validation and technical assessments of manufacturing process changes. It explicitly states:
- "No applicable mandatory performance standards or special controls exist for this device."
- "The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indications, or sterilization process. None required clinical evidence to evaluate impact to safety and effectiveness."
- "The changes were considered to be routine changes...and the information generated as part of design verification and validation activities or technical assessments confirmed these change did not adversely affect the device's safety or effectiveness."
Therefore, the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.
However, based on the information provided, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Rationale: The submission explicitly states that "No applicable mandatory performance standards or special controls exist for this device," and thus no specific acceptance criteria for performance are outlined. The submission relies on demonstrating that modifications did not adversely affect safety or effectiveness compared to predicate devices, rather than meeting new, quantifiable performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical or comparative effectiveness test set was used for performance evaluation of a new AI/algorithm.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No ground truth establishment by experts for a test set was performed as part of this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No test set requiring expert adjudication was used.
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:
- MRMC Study: No. This submission does not describe an AI-assisted device, nor any MRMC comparative effectiveness study.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This submission does not describe an algorithm-based device that would undergo standalone performance evaluation.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable. The submission does not describe a performance study requiring a specific type of ground truth (e.g., pathology, outcomes data). The evaluation was based on design verification/validation of device changes.
8. The sample size for the training set:
- Sample Size: Not applicable. This submission does not describe a machine learning or AI-based device requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. This submission does not describe a machine learning or AI-based device requiring a training set with established ground truth.
Summary of the Study (as presented in the 510(k) Summary):
The submission describes a "Summary of Testing" that includes:
- "The device design and labeling changes discussed in this document have been verified and/or validated through proper Design Verification/Validation and/or Design Assurance Testing where deemed necessary and applicable."
- "For the proposed change to the manufacturing process of a potentially patient contacting material, an evaluation of supplier testing information confirms that the proposed change does not impact the safety or effectiveness of the device."
This indicates that the "study" conducted was primarily focused on design verification and validation testing, along with technical assessments of manufacturing process changes, to confirm that the modifications did not negatively impact the safety or effectiveness of the device compared to its legally marketed predicate devices. It was not a clinical performance study involving patient data or expert interpretation for new performance claims.
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NOV 1 5 2012
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510(k) Summary
Date Prepared: Applicant:
Contact:
Alternate Contact:
Trade Name:
Patrick Johnson Senior Director Regulatory Affairs Phone: 763-526-6735 Fax: 763-367-1694 (fax) Email: patrick.1.johnson@medtronic.com Prostiva RF Therapy Model 8929 Hand Piece Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope
Establishment Registration Number: 2182207
21 CFR 876.4300 & 21 CFR 878.4400 Classification Name: Endoscopic electrosurgical unit and accessories Regulatory Name:
November 15, 2011
Thomas Reichel
Phone: 763-526-9693 Fax: 763-367-1694 (fax)
Medtronic Neuromodulation
Regulatory Affairs Specialist
Email: tom.j.reichel(@medtronic.com
7000 Central Ave., N.E.
Minneapolis, MN 55432
Regulatory Classification: Class II
Product Code: KNS and GEI
Name of Predicate Device: Prostiva RF Therapy Model 8929 Hand Piece (K101139) TUNA Therapy Model 8930 RF Generator (K052413) TUNA Therapy Model 8934 Return Electrode (K052413) TUNA Therapy Model 6101 Tubing System (K002583) TUNA Therapy Model 8099 Telescope (K002583)
Device Description
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.
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.
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Performance Standards
No applicable mandatory performance standards or special controls exist for this device.
Substantial Equivalence
The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indications, or sterilization process. None required clinical evidence to evaluate impact to safety and effectiveness. The changes were considered to be routine changes to maintain or improve device performance based on internal or external feedback and the information generated as part of design verification and validation activities or technical assessments confirmed these change did not adversely affect the device's safety or effectiveness.
For the proposed change to the manufacturing process of a potentially patient contacting material, an evaluation of supplier testing information confirms that the proposed change does not impact the safety or effectiveness of the device.
The currently marketed products are substantially equivalent to the previously submitted and cleared predicate products.
Summary of Testing
The device design and labeling changes discussed in this document have been verified and/or validated through proper Design Verification/Validation and/or Design Assurance Testing where deemed necessary and applicable.
Conclusion
The modifications to the Prostiva RF Therapy System described in this submission have not altered the fundamental scientific principle or indication of the devices. The current devices are substantially equivalent to the previously submitted and cleared predicate Prostiva RF Therapy and TUNA Therapy devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
November 15, 2012
Medtronic, Inc. Neuromodulation % Mr. Thomas Reichel Senior Regulatory Affairs Specialist 7000 Central Ave., N.E. MINNEAPOLIS MN 55432
Re: K113380
Trade/Device Name: Prostiva RF Therapy Model 8929 Hand Piece Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GEI Dated: November 8, 2012
Received: November 13, 2012
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.
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Page 2 - Mr. Thomas Reichel
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised hat I DA 3 ibsualles syour device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. or ally Federal statutes and regulations administs, but not limited to: registration and 1 ou must compy with an the rece requentions)
Iisting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of ilsung (21 CFR 807), laboring (21 CFR 803); good manufacturing practice requirements Inconcal device-related ad relies of the ) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of clons (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 11 you desire specific advice for your do necessor correces/CDRH/CDRHOffices/ucm115809.htm for go to mup.//www.lua.gov.rtRadiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 the regulations 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 I va may oount 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement Form
510(k) Number (if known): K113380
Prostiva RF Therapy Model 8929 Hand Piece Device Name: Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope
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)
OR Prescription Use X Per 21 CFR 801.109
Over-The-Counter Use _
Benjamin R. Fisher -S 2012.11.15 18:04:44 -05'00'
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
| 510(k) Number | K113380 |
|---|---|
| --------------- | --------- |
§ 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.