(61 days)
The TUNA 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.
The Medtronic TUNA (Transurethral Needle Ablation) Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Medtronic is commercializing the branded product as the PROSTIVA® RF Therapy System which 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 special change being effected in Medtronic's Prostiva RF Therapy Model 8929 Hand Piece. It seeks to demonstrate substantial equivalence to a legally marketed predicate device.
However, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive technical report for a novel medical device.
The document explicitly states: "No applicable mandatory performance standards or special controls exist for this device." and "The results of the design verification testing indicate that the modified PROSTIVA RF Therapy Model 8929 Hand Piece with handle modifications is substantially equivalent to the currently marketed device. There are no changes in specifications or indications for use." It further mentions "Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device and the device met all design and performance requirements."
This indicates that the submission focuses on demonstrating that the modified device is still equivalent to the original predicate device, rather than proving the efficacy or performance of a new device against specific clinical acceptance criteria in a comprehensive study. The "design verification testing" likely refers to engineering tests to ensure the new handle design doesn't negatively impact the device's functionality or safety, not clinical performance metrics.
Therefore, many of your requested items cannot be extracted from this specific 510(k) summary.
Here's what can be gathered or inferred based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated within this document. The document refers to "design and performance requirements" that the device met during design verification testing, but it does not detail these requirements or provide specific quantitative acceptance thresholds for clinical performance or accuracy. Since this is a 510(k) for a modification and not a new device, the primary acceptance criterion is "substantial equivalence" to the predicate device.
- Reported Device Performance: Not explicitly stated in terms of clinical outcomes or performance metrics. The document concludes that "the modified device...met all design and performance requirements" and is "substantially equivalent" to the predicate. This implies that its performance is presumed to be the same as the predicate, but no new quantitative performance data is presented.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable/Not provided. This document describes "design verification testing" for a device modification, which typically involves engineering bench testing rather than clinical testing with a human test set. No patient sample size is mentioned.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical ground truth establishment is described for a test set.
4. Adjudication method for the test set
- Not applicable/Not provided.
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
- No. This device is a radiofrequency therapy hand piece for BPH treatment and is not an imaging or diagnostic device that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (a hand piece for RF ablation), not an algorithm.
7. The type of ground truth used
- Not applicable/Not provided. The "ground truth" for this submission is implicitly the performance and safety characteristics of the predicate device, to which the modified device is compared to establish substantial equivalence.
8. The sample size for the training set
- Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary:
This 510(k) focuses on demonstrating that a modified version of an existing device remains substantially equivalent to its predicate. The "study" referenced is "design verification testing," which typically involves engineering and bench testing to ensure the device modification doesn't compromise its safety or performance, rather than clinical trials with detailed performance metrics against specific acceptance criteria. The document does not provide the kind of performance data, study design, or ground-truth establishment details you would find for a novel device or AI/ML product.
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KO82464 Page
August 2008
Prostiva RF Model 8929 Hand Piece Special 510(k) Change Being Effected
OCT 2 7 2008
2. 510(k) Summary
Date Summary Prepared: August 26, 2008 Applicant: Medtronic Neuromodulation 710 Medtronic Pkwy., N.E. Minneapolis, MN 55432-5604 Contact: Jeanmarie Sales Regulatory Affairs Director, Gastro/Uro 763-505-0256 763-505-0258 (fax)
Trade Name: TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece)
Classification Name: 21 CFR 876.4300 (Endoscopic electrosurgical unit and accessories)
Name of Predicate Device: TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece)
Device Description
The Medtronic TUNA (Transurethral Needle Ablation) Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Medtronic is commercializing the branded product as the PROSTIVA® RF Therapy System which 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 TUNA 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 results of the design verification testing indicate that the modified PROSTIVA RF Therapy Model 8929 Hand Piece with handle modifications is substantially equivalent to the currently marketed device. There are no changes in specifications or indications for use.
Image /page/0/Picture/17 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo and the word "Medtronic" is the word "Confidential" in a smaller, non-bold font. The Medtronic logo is a stylized image of a person inside of a circle.
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Prostiva RF Model 8929 Hand Piece Special 510(k) Change Being Effected August 2008
Summary of Testing
Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device and the device met all design and performance requirements.
Conclusion
The modified device is substantially equivalent to the currently marketed PROSTIVA RF Therapy Model 8929 Hand Piece based upon design verification test results and the indications for use.
Image /page/1/Picture/7 description: The image shows the Medtronic logo with the word "Confidential" underneath. The Medtronic logo consists of a stylized human figure inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanmarie Sales Regulatory Affairs Director, Gastro/Uro Medtronic, Inc. 710 Medtronic Parkway, N.E. MINNEAPOLIS MN 55432-5604
OCT 2 7 2008
Re: K082464
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: Class II Product Codes: KNS and GEI Dated: August 26, 2008 Received: August 27, 2008
Dear Ms. Sales:
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. Ilsting 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 such 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); 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.
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Page 2 - Ms. Sales
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Hala Leen
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K082464
Device Name: PROSTIVA® RF Therapy Model 8929 Hand Piece
Indications for Use:
The TUNA 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
Helene Lemer
(Division Sign-Off) Division of Reproductive, Abdomina 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).